Clinical trial NCT04897594
Conditions: NASH - Nonalcoholic Steatohepatitis
Keywords: Vascular adhesion protein-1(VAP-1)/ semicarbazide-sensitive amine oxidase (SSAO) Nonalcoholic steatohepatitis (NASH) Nonalcoholic Fatty Liver Disease (NAFLD)
Sponsor: Terns, Inc.
Start date: 2021-05-20; Completion date: 2022-09-02
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This is a Phase 1b multi-center, randomized, double-blind, dose-ranging, placebo-controlled, adaptive study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) of TERN-201 in patients with non-cirrhotic NASH.

Detailed description:

Arms: arm 1: Orally administered arm 2: Orally Administered arm 3: Orally administered
Interventions: intervention 1: TERN-201 intervention 2: Placebo
Intervention descriptions: intervention 1: Investigational drug intervention 2: Matching placebo

Protocol documents:
Prot_000.pdf: 
CLINICAL STUDY PROTOCOL 
Protocol Title: 
A Multi-Center, Randomized, Double-Blind, Dose-Ranging, 
Placebo-Controlled, Proof of Concept, Adaptive, Phase 1b Clinical 
Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, 
and Efficacy of Orally Administered TERN-201 in Patients with 
Presumed Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH) 
Protocol Number: 
TERN201-1007 
Protocol Version:  
Amendment 3 
Version Date:  
17 August 2021 
Supersedes: 
Amendment 2; 21 June 2021 
Compound:  
TERN-201 
Study Phase:  
1b 
Sponsor Name:  
Terns Inc.  
Legal Registered 
Address:  
1065 E. Hillsdale Blvd. Suite 100 
Foster City, California 94404 
Regulatory Agency 
Identifier Number(s) 
US FDA IND:  
 
CONFIDENTIAL 
This document contains confidential information, which should not be copied, referred to, 
released, or published without written approval from Terns, Inc. 


Protocol TERN201-1007 
Terns, Inc.  
Version: Amendment 3 
Version Date: 17 August 2021 
CONFIDENTIAL 
Page 2 of 92 
Sponsor Signatory:
 
President and Chief Medical Officer
Terns, Inc.
 
Date 
 
  



Protocol TERN201-1007 
Terns, Inc.  
Version: Amendment 3 
Version Date: 17 August 2021 
 
CONFIDENTIAL 
Page 3 of 92 
Table of Contents 
1. 
Protocol Summary ..........................................................................................................6 
1.1. 
Synopsis ............................................................................................................................6 
1.2. 
Schema ............................................................................................................................11 
1.3. 
Schedule of Activities .....................................................................................................12 
2. 
Introduction ...................................................................................................................19 
2.1. 
Overview of NASH and Role of VAP-1/SSAO in Disease............................................19 
2.2. 
VAP-1/SSAO Inhibition in NASH and TERN-201 Background ...................................20 
2.2.1. 
Summary of Nonclinical Studies ....................................................................................21 
2.2.2. 
Clinical Studies of TERN-201 ........................................................................................24 
2.3. 
Benefit/Risk Assessment ................................................................................................25 
3. 
Objectives and Endpoints ............................................................................................27 
4. 
Study Design ..................................................................................................................29 
4.1. 
Overall Design ................................................................................................................29 
4.2. 
Scientific Rationale for Study Design ............................................................................30 
4.3. 
Justification for Dose ......................................................................................................31 
5. 
Study Population ...........................................................................................................32 
5.1. 
Inclusion Criteria ............................................................................................................32 
5.2. 
Exclusion Criteria ...........................................................................................................33 
5.3. 
Lifestyle Considerations .................................................................................................37 
5.3.1. 
Lifestyle Counseling .......................................................................................................37 
5.3.2. 
Meals and Dietary Restrictions .......................................................................................37 
5.3.3. 
Alcohol, Cannabis, and Illicit Drug Use .........................................................................37 
5.4. 
Screen Failures ................................................................................................................38 
6. 
Study Drug.....................................................................................................................39 
6.1. 
Study Drug(s) Administered ...........................................................................................39 
6.2. 
Study Drug Administration .............................................................................................39 
6.3. 
Preparation/Handling/Storage/Accountability ................................................................40 
6.4. 
Measures to Minimize Bias: Randomization and Blinding ............................................40 
6.4.1. 
Unblinding ......................................................................................................................41 
6.4.2. 
Patient Enrollment and Study Drug Assignment ............................................................42 
6.5. 
Study Drug Compliance..................................................................................................42 
6.6. 
Concomitant Therapy .....................................................................................................42 
6.7. 
Dose Modifications .........................................................................................................43 
6.8. 
Dose Interruptions...........................................................................................................44 
6.8.1. 
Dose Interruptions due to COVID-19 .............................................................................44 
6.9. 
Intervention after the End of the Study ...........................................................................44 
7. 
Discontinuation of Study Drug and Patient 
Discontinuation/Withdrawal........................................................................................45 
7.1. 
Discontinuation of Study Drug .......................................................................................45 
7.2. 
Patient Discontinuation/Withdrawal from the Study ......................................................46 
7.3. 
Lost to Follow up ............................................................................................................46 


Protocol TERN201-1007 
Terns, Inc.  
Version: Amendment 3 
Version Date: 17 August 2021 
 
CONFIDENTIAL 
Page 4 of 92 
8. 
Study Assessments and Procedures.............................................................................47 
8.1. 
Study Assessments ..........................................................................................................47 
8.1.1. 
Demographics .................................................................................................................47 
8.1.2. 
Height and Weight ..........................................................................................................47 
8.1.3. 
Medical History ..............................................................................................................48 
8.1.4. 
Physical Examinations ....................................................................................................48 
8.1.5. 
Vital Signs .......................................................................................................................48 
8.1.6. 
Electrocardiograms .........................................................................................................48 
8.1.7. 
Clinical Laboratory Assessments ....................................................................................49 
8.1.8. 
Transient Elastography and Controlled Attenuation Parameter .....................................49 
8.1.9. 
Magnetic Resonance Imaging: Correct T1 and Proton Density 
Fat Fraction .....................................................................................................................50 
8.2. 
Pharmacokinetics ............................................................................................................51 
8.3. 
Pharmacodynamics .........................................................................................................52 
8.4. 
Biomarkers ......................................................................................................................52 
8.5. 
Adverse Events and Serious Adverse Events .................................................................53 
8.5.1. 
Time Period and Frequency for Collecting AE and SAE 
Information .....................................................................................................................53 
8.5.2. 
Method of Detecting AEs and SAEs ..............................................................................54 
8.5.3. 
Follow-up of AEs and SAEs ...........................................................................................54 
8.5.4. 
Regulatory Reporting Requirements for SAEs ...............................................................54 
8.5.5. 
Pregnancy ........................................................................................................................55 
8.6. 
Treatment of Overdose ...................................................................................................55 
9. 
Statistical Considerations .............................................................................................56 
9.1. 
Statistical Hypotheses .....................................................................................................56 
9.2. 
Sample Size Determination ............................................................................................56 
9.3. 
Analysis Sets ...................................................................................................................56 
9.4. 
Statistical Analyses .........................................................................................................57 
9.4.1. 
General Considerations ...................................................................................................57 
9.4.2. 
Primary Endpoint(s) ........................................................................................................57 
9.4.3. 
Secondary Endpoints ......................................................................................................57 
9.4.4. 
Exploratory Endpoints ....................................................................................................58 
9.5. 
Interim Analysis ..............................................................................................................59 
10. 
Regulatory, Ethical, and Study Oversight Considerations .......................................61 
10.1. 
Regulatory and Ethical Considerations...........................................................................61 
10.1.1. Financial Disclosure........................................................................................................61 
10.1.2. Informed Consent Process ..............................................................................................62 
10.1.3. Data Protection................................................................................................................62 
10.1.4. Dissemination of Clinical Study Data.............................................................................63 
10.1.5. Data Quality Assurance ..................................................................................................63 
10.1.6. Protocol Deviations .........................................................................................................64 
10.1.7. Source Documents ..........................................................................................................64 
10.1.8. Study and Site Start and Closure ....................................................................................65 
Appendix 1: Clinical Laboratory Tests ..........................................................................................67 


Protocol TERN201-1007 
Terns, Inc.  
Version: Amendment 3 
Version Date: 17 August 2021 
 
CONFIDENTIAL 
Page 5 of 92 
Appendix 2: Sample Collection for Pharmacokinetics and 
Pharmacodynamics .........................................................................................................70 
Appendix 3: Liver Chemistry Increased Monitoring Criteria ........................................................72 
Appendix 4: Fridericia’s Formula ..................................................................................................73 
Appendix 5: Chronic Kidney Disease Epidemiology Collaboration (CKD-
EPI) Formula to Estimate Glomerular Filtration Rate ....................................................74 
Appendix 6: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-up, and Reporting ............................................................................75 
Appendix 7: Contraceptive Guidance and Collection of Pregnancy 
Information .....................................................................................................................80 
Appendix 8: COVID-19 Assessments ...........................................................................................84 
Appendix 9: Abbreviations ............................................................................................................85 
Appendix 10: Investigator Signature Page ....................................................................................89 
Appendix 11: Protocol Amendment History .................................................................................90 
Appendix 12: References ...............................................................................................................91 
 
List of Tables 
Table 1 
Study Drug by Dose Group ............................................................................... 40 
Table 2 
Protocol-Required Clinical Laboratory Assessments ....................................... 67 
Table 3 
PK/PD Sampling Timepoints ............................................................................ 70 
Table 4 
Liver Chemistry Increased Monitoring Criterion and Follow-Up .................... 72 
Table 5 
Contraceptive Methods ..................................................................................... 82 
 
List of Figures 
Figure 1 Efficacy of TERN-201 in a CDHFD+NaNO2 Rat Model of NASH .............................. 22 
 


Protocol TERN201-1007 
Terns, Inc.  
Version: Amendment 3 
Version Date: 17 August 2021 
 
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1. 
Protocol Summary 
1.1. 
Synopsis 
Protocol Title:  
A Multi-Center, Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled, Proof of 
Concept, Adaptive, Phase 1b Clinical Study to Evaluate the Safety, Pharmacokinetics, 
Pharmacodynamics, and Preliminary Efficacy of Orally Administered TERN-201 in Patients 
with Presumed Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Protocol TERN201-1007 
Terns, Inc.  
Version: Amendment 3 
Version Date: 17 August 2021 
 
CONFIDENTIAL 
Page 7 of 92 
Objectives:  
Primary Objective:  
x To characterize the safety and tolerability of TERN-201 versus placebo for 12 weeks in 
non-cirrhotic presumed NASH patients, with clinical or histological NASH diagnosis 
Secondary Objectives: 
x To assess the plasma and urine PK of TERN-201 for 12 weeks in non-cirrhotic presumed 
NASH patients 
x To assess the PD effect of TERN-201 versus placebo for 12 weeks on plasma VAP-
1/SSAO activity in non-cirrhotic presumed NASH patients 
Exploratory Objectives: 
x To assess the plasma and urine PK of TERN-201 metabolites (including TRN-001021 
and TRN-001744) at steady state 
x To assess the effect of TERN-201 versus placebo on imaging assessments and blood 
biomarkers of NASH activity  
x To assess the effect of TERN-201 versus placebo on biomarkers of inflammation 
x To explore the potential for TERN-201 to improve proteinuria due to endothelial effects 
x To explore other PD markers, and overall exposure-response and dose-response 
relationship of TERN-201, as applicable 
x To explore the exposure-response and dose-response relationship, as applicable, of 
TERN-201 and baseline patient characteristics such as soluble VAP-1 (sVAP-1), body 
mass index (BMI), diabetes mellitus, and others 
Endpoints:  
Primary Endpoint:  
x Overall safety assessed by treatment emergent AEs (TEAEs) and treatment emergent 
clinical safety laboratory abnormalities  
Secondary Endpoints:  
x Plasma and urine PK parameters for TERN-201  


Protocol TERN201-1007 
Terns, Inc.  
Version: Amendment 3 
Version Date: 17 August 2021 
 
CONFIDENTIAL 
Page 8 of 92 
x Percent change from baseline in plasma VAP-1/SSAO activity 
Exploratory Endpoints:  
x Plasma and urine PK parameters for TERN-201 metabolites (including TRN-001021 and 
TRN-001744) 
x Change from baseline in corrected T1 (cT1) by magnetic resonance imaging (MRI) 
x Change from baseline in liver fat content by magnetic resonance imaging-proton density 
fat fraction (MRI-PDFF) 
x Change from baseline in stiffness by transient elastography  
x Change from baseline in alanine aminotransferase (ALT)  
x Change from baseline in gamma-glutamyl transpeptidase (GGT) 
x Change from baseline in aspartate aminotransferase (AST) 
x Change from baseline in NASH and fibrosis biomarkers including cytokeratin-18 (CK-
18) (M30 and M65), procollagen III n-terminal propeptide (PIIINP), tissue inhibitor of 
metalloproteinases-1 (TIMP-1), hyaluronic acid (HA), pro-peptide of type III collagen 
(PRO-C3), and type III collagen (C3M). Other non-invasive tests for NASH fibrosis may 
also be assessed including the fibrosis-4 (FIB-4) index, enhanced liver fibrosis (ELF) test, 
NAFLD fibrosis score (NFS), and PRO-C3/C3M ratio. 
x Change from baseline in inflammatory biomarkers including high sensitivity C-reactive 
protein (hs-CRP), interleukin-6 (IL-6), intercellular adhesion molecule-1 (ICAM-1), and 
vascular cell adhesion molecule-1 (VCAM-1) 
x Change from baseline in estimated glomerular filtration rate (eGFR), urine protein 
including urine protein-to-creatinine ratio (UPCR), and urine albumin-to-creatinine ratio 
(UACR) 
x Change from baseline in plasma methylamine levels (PD marker of VAP-1/SSAO 
inhibition) 
x Exposure-response and dose-response relationship of TERN-201 over 12 weeks, as 
applicable  
x Exposure-response and dose-response relationship, as applicable, of TERN-201 and 
baseline patient characteristics such as sVAP-1, BMI, diabetes mellitus, and others 
Overall Design: 


Protocol TERN201-1007 
Terns, Inc.  
Version: Amendment 3 
Version Date: 17 August 2021 
 
CONFIDENTIAL 
Page 9 of 92 
The study is a multi-center, randomized, double-blind, placebo-controlled, adaptive study. 
Approximately 80 clinically or histologically diagnosed adult non-cirrhotic presumed NASH 
patients who meet study eligibility criteria will be enrolled and randomized at an overall ratio of 
2:1 into 3 dose groups and placebo across 2 parts of the study.  
Part 1  
In Part 1, approximately 30 patients will receive 10 mg TERN-201 (n = 20) or matching placebo 
(n = 10) orally once daily, for 12 weeks.  
In Part 1 of the study, approximately 12 randomized patients will take part in an intensive PK 
and PD collection after the first dose (Week 0/Day 1), at Week 6, and after the last dose of study 
drug (Week 12). Randomization will ensure approximately 8 patients in the TERN-201 group 
and approximately 4 patients in the placebo group are assigned to the PK/PD sub-study. Patients 
who are not participating in the PK/PD sub-study will have trough PK/PD sampling only. 
Part 2 may be enrolled based on an interim analysis, as follows: 
An interim analysis will be performed after all patients in Part 1 have completed Week 6 
assessments. Interim PK and PD data will be assessed. Blinded safety data will also be reviewed. 
Enrollment of cohorts to assess 4 mg and up to 20 mg TERN-201 may be initiated per the 
following criteria: 
x TERN-201 4 mg: 
o If robust VAP-1/SSAO activity suppression is observed  and available PK from 
Part 1 suggests that a lower dose may also possibly lead to robust VAP-1/SSAO 
activity suppression, enrollment in Part 2 with 4 mg TERN-201 may be initiated. 
x TERN-201 up to 20 mg: 
o If safety data indicates 10 mg TERN-201 is overall safe and well-tolerated, and 
available PK from Part 1 predicts that targeted exposures for a dose up to 20 mg 
will be below an upper limit of 5400 ng•hr/mL for AUC0-24hr and 768 ng/mL for 
Cmax, enrollment in Part 2 with a dose up to 20 mg TERN-201 may be initiated. 
Part 2  
In Part 2, if initiated, approximately 50 patients will receive 4 mg TERN-201 (n = 20), and/or up 
to 20 mg TERN-201 (n = 20), or matching placebo (n = 10) orally once daily, for 12 weeks. 


Protocol TERN201-1007 
Terns, Inc.  
Version: Amendment 3 
Version Date: 17 August 2021 
 
CONFIDENTIAL 
Page 10 of 92 
In Part 2 of the study, approximately 15 randomized patients will take part in an intensive PK 
and PD collection after the first dose (Week 0/Day 1), at Week 6, and after the last dose of study 
drug (Week 12). Randomization will ensure approximately 6 patients at each TERN-201 dose 
level and approximately 3 patients in the placebo group are assigned to the PK/PD sub-study. 
Patients who are not participating in the PK/PD sub-study will have trough PK/PD sampling 
only. 
The total duration of study participation will be approximately 22 weeks, consisting of a 6-week 
Screening Period, a 12-week Treatment Period and a 4-week Follow-up Period.  
Number of Patients: 
Approximately 80 patients will be randomly assigned to treatment with TERN-201 capsule or 
matching placebo. 
Patients who are randomized but do not receive study drug for any reason may be replaced. In 
addition, patients who discontinue treatment early for reasons other than safety (i.e., withdrawal 
of consent, lost to follow-up, patient relocated, etc.) may also be replaced. Replacement patients 
will receive the same treatment assignment as the patient that discontinued treatment early. 
Study Centers Planned:  
Up to 15 centers in the United States. 


Protocol TERN201-1007 
Terns, Inc. 
 
Version: Amendment 3 
Version Date: 17 August 2021 
 
 
CONFIDENTIAL 
Page 11 of 92 
1.2. 
Schema 
 


Protocol TERN201-1007 
Terns, Inc. 
 
Version: Amendment 3 
Version Date: 17 August 2021 
 
 
 
CONFIDENTIAL 
Page 12 of 92 
 
1.3. 
Schedule of Activities 
 
Screening 
Treatment Perioda  
ETb 
Follow-Upc  
Notes 
Visit 
Screening 
Week 0  Week 2 Week 4 Week 6 Week 8 Week 12 
 
Week 16 
 
Study Day 
-42 to Day 
-1 
Day 1 
15 
29 
43 
57 
85 
 
113 
Visit windows post-randomization 
through Week 12: ± 3 days from the 
specified study day. Visit window 
Week 16: 1 week prior/+2 days from the 
specified study day. 
Procedures 
Written Informed 
Consent 
X 
 
 
 
 
 
 
 
 
Written informed consent may be 
obtained via telephone in accordance with 
Section 10.1.2. Screening may be 
initiated via telephone. 
Patient Fasting 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Patients must be in fasted state for at least 
8 hours prior to blood collection and 
study drug administration, where 
applicable.  
Randomization  
 
X 
 
 
 
 
 
 
 
 
Review Inclusion 
and Exclusion 
Criteria 
X 
X 
 
 
 
 
 
 
 
Recheck clinical status before 
randomization and first dose of study 
drug.  
Demographics 
X 
 
 
 
 
 
 
 
 
Includes age, sex, and race/ethnicity.  
Height and 
Weight 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Height and weight are collected at 
Screening and will be used to calculate 
BMI for eligibility. Waist circumference 
is also measured at Screening. Only 
weight is collected on other days 
indicated.  
Medical History  
X 
X 
 
 
 
 
 
 
 
Includes details of illnesses and allergies, 
date(s) of onset, whether condition(s) is 
currently ongoing, and medication 
history, including alcohol use. 


Protocol TERN201-1007 
Terns, Inc. 
 
Version: Amendment 3 
Version Date: 17 August 2021 
 
 
 
CONFIDENTIAL 
Page 13 of 92 
 
 
Screening 
Treatment Perioda  
ETb 
Follow-Upc  
Notes 
Visit 
Screening 
Week 0  Week 2 Week 4 Week 6 Week 8 Week 12 
 
Week 16 
 
Study Day 
-42 to Day 
-1 
Day 1 
15 
29 
43 
57 
85 
 
113 
Visit windows post-randomization 
through Week 12: ± 3 days from the 
specified study day. Visit window 
Week 16: 1 week prior/+2 days from the 
specified study day. 
Physical 
Examination 
X 
X 
X 
X 
X 
X 
X 
X 
X 
A complete physical examination will be 
performed at Screening and Week 16. A 
targeted physical examination will be 
performed at all other visits, as needed. 
Vital Signs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Includes temperature, pulse rate, 
respiratory rate, and blood pressure. 
Chemistryd 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Specific analytes are listed in Appendix 1. 
ALT and AST stability may be evaluated 
prior to randomization per Section 5. 
Increased monitoring criteria for elevated 
ALT and/or AST above 2 × Baseline or 
above 5 × ULN for < 1 week is outlined 
in Appendix 3. 
 
Refer to Appendix 5 for the eGFR 
formula, to be calculated by central lab.  
Hematologyd 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Specific analytes are listed in Appendix 1. 
Coagulationd 
X 
X 
 
 
 
 
 
 
 
Specific analytes are listed in Appendix 1. 
PT/INR will be tested at Screening, Week 
0, and if significant abnormal liver 
function tests are observed. 
Fasting Lipid 
Profiled 
 
X 
 
 
X 
 
X 
X 
 
Specific analytes are listed in Appendix 1. 
Serology 
X 
 
 
 
 
 
 
 
 
Includes HBsAg, anti-HCV, and anti-
HIV.  


Protocol TERN201-1007 
Terns, Inc. 
 
Version: Amendment 3 
Version Date: 17 August 2021 
 
 
 
CONFIDENTIAL 
Page 14 of 92 
 
 
Screening 
Treatment Perioda  
ETb 
Follow-Upc  
Notes 
Visit 
Screening 
Week 0  Week 2 Week 4 Week 6 Week 8 Week 12 
 
Week 16 
 
Study Day 
-42 to Day 
-1 
Day 1 
15 
29 
43 
57 
85 
 
113 
Visit windows post-randomization 
through Week 12: ± 3 days from the 
specified study day. Visit window 
Week 16: 1 week prior/+2 days from the 
specified study day. 
COVID-19 
Assessmentd,e 
X 
X 
 
 
X 
 
X 
 
 
Screening and on-study COVID-19 
assessments should be conducted in 
accordance with Appendix 8.  
Serum pregnancy 
testd 
X 
X 
 
X 
 
X 
X 
X 
 
WOCBP only.  
Serum FSH 
X 
 
 
 
 
 
 
 
 
To confirm postmenopausal status, as 
outlined in Appendix 7.  
Blood Alcohol 
Test 
X 
 
 
 
 
 
 
 
 
 
Urinalysisd 
X 
X 
 
 
X 
 
X 
X 
X 
Specific analytes are listed in Appendix 1. 
Microscopic examination is required if 
blood or protein is abnormal. 
Urine Drug 
Screend 
X 
X 
 
X 
 
X 
X 
X 
X 
 
Total Urine 
Collection 
(PK/PD Sub-
Study only) 
 
X 
 
 
X 
 
 
 
 
Total urine collection from 0-8 hours post 
dose as specified in Appendix 2. 
Intensive PK and 
PD Sampling 
(PK/PD Sub-
Study only) 
 
X 
 
 
X 
 
X 
 
 
Intensive PK sampling will be performed 
pre-dose and 0.5, 1, 2, 4, 6, 8 and 
24 hours after the first dose of study drug 
on Week 0/Day 1 and Week 6, and at pre-
dose and 0.5, 1, 2, 4, 6, 8, 24, 48 and 
72 hours after the last dose of study drug 
at Week 12. Refer to Appendix 2 for 
additional detail.  


Protocol TERN201-1007 
Terns, Inc. 
 
Version: Amendment 3 
Version Date: 17 August 2021 
 
 
 
CONFIDENTIAL 
Page 15 of 92 
 
 
Screening 
Treatment Perioda  
ETb 
Follow-Upc  
Notes 
Visit 
Screening 
Week 0  Week 2 Week 4 Week 6 Week 8 Week 12 
 
Week 16 
 
Study Day 
-42 to Day 
-1 
Day 1 
15 
29 
43 
57 
85 
 
113 
Visit windows post-randomization 
through Week 12: ± 3 days from the 
specified study day. Visit window 
Week 16: 1 week prior/+2 days from the 
specified study day. 
Trough PK and 
PD Samplingd  
 
X 
X 
X 
X 
X 
X 
X 
 
Only one sample will be collected at each 
visit prior to drug administration on the 
visit day. Patients discontinuing the study 
at any time for any reason will have one 
sample collected at the ET visit. Refer to 
Appendix 2 for additional detail. 
Baseline sVAP-1f 
 
X 
 
 
 
 
 
 
 
 
NASH/Fibrosis 
Biomarkersd 
 
X 
 
 
X 
 
X 
X 
 
Includes CK-18 (M30 and M65), PIIINP, 
TIMP-1, HA, PRO-C3, and C3M.
Inflammation 
Biomarkersd 
 
X 
X 
X 
X 
X 
X 
X 
 
Includes hs-CRP, IL-6, ICAM-1, and 
VCAM-1. 
12-lead ECG 
X 
X 
 
 
X 
 
X 
 
 
In addition to the scheduled timepoints, 
perform ad-hoc ECG in the instance of 
patient-reported symptoms considered 
potentially cardiac in nature such as chest 
pain/pressure, palpitations, dizziness, 
shortness of breath, or report of patient 
recently seeking medical care for such 
symptoms (e.g., emergency room visit); 
obtain cardiology consult based on the 
clinical judgement of the Investigator. 


Protocol TERN201-1007 
Terns, Inc. 
 
Version: Amendment 3 
Version Date: 17 August 2021 
 
 
 
CONFIDENTIAL 
Page 16 of 92 
 
 
Screening 
Treatment Perioda  
ETb 
Follow-Upc  
Notes 
Visit 
Screening 
Week 0  Week 2 Week 4 Week 6 Week 8 Week 12 
 
Week 16 
 
Study Day 
-42 to Day 
-1 
Day 1 
15 
29 
43 
57 
85 
 
113 
Visit windows post-randomization 
through Week 12: ± 3 days from the 
specified study day. Visit window 
Week 16: 1 week prior/+2 days from the 
specified study day. 
Transient 
Elastography 
X 
 
 
 
 
 
X 
X 
 
A historical transient elastography report 
within 3 months of Screening may be 
used to determine eligibility for this 
study. See inclusion/exclusion criteria for 
details.  
MRI cT1g 
X 
 
 
 
X 
 
X 
X 
 
A Screening MRI cT1 may proceed on 
the basis of the initial ALT and AST 
levels at Screening, given all other 
eligibility criteria are met, but 
randomization should not occur prior to 
confirmation of ALT and AST stability, 
as necessary.  
 
An MRI cT1 should be performed at ET 
if the patient has had at least 4 weeks of 
dosing. 
Dispense Study 
Drugh 
 
X 
 
X 
 
X 
 
 
 
Study drug will be assigned via the 
IWRS. Patients will be supplied with 
enough study capsules for 4-week use.  
Drug 
Accountability  
 
 
X 
X 
X 
X 
X 
X 
 
 
Lifestyle 
Counseling 
 
X 
X 
X 
X 
X 
X 
X 
X 
Guidance should be provided on key 
elements of a healthy lifestyle at each 
visit including diet, exercise, weight loss, 
and avoidance of alcohol per standard of 
care management for a NASH patient 
population.  


Protocol TERN201-1007 
Terns, Inc. 
 
Version: Amendment 3 
Version Date: 17 August 2021 
 
 
 
CONFIDENTIAL 
Page 17 of 92 
 
 
Screening 
Treatment Perioda  
ETb 
Follow-Upc  
Notes 
Visit 
Screening 
Week 0  Week 2 Week 4 Week 6 Week 8 Week 12 
 
Week 16 
 
Study Day 
-42 to Day 
-1 
Day 1 
15 
29 
43 
57 
85 
 
113 
Visit windows post-randomization 
through Week 12: ± 3 days from the 
specified study day. Visit window 
Week 16: 1 week prior/+2 days from the 
specified study day. 
Adverse Events 
Review 
X 
 
Å=====================================Æ 
X 
X 
After informed consent but prior to 
initiation of study drug, all AEs and SAEs 
related to protocol-mandated procedures 
should be reported.   
 
All AEs and SAEs, regardless of cause or 
relationship, will be collected from the 
start of study drug through the Follow-Up 
Period.  
Concomitant 
Medications 
Review  
 
 
Å=====================================Æ 
X 
X 
 
Take Study Drug 
Capsules 
 
 
Å=====================================Æ 
 
 
Patients must be in fasted state for at least 
8 hours prior to study drug 
administration. At all study visits, study 
drug administration will be observed at 
the study site. Patients should be 
instructed to hold their dose of study drug 
on visit days until all visit procedures 
have been completed.   
 
On all other days, patients will self-
administer the study drug orally once 
daily in the morning on an empty 
stomach, after an 8 hour fast.  
a. 
If a patient requires home quarantine due to SARS-CoV-2 infection or exposure, or due to COVID-19 symptoms or other associated concern with attending an in-person study 
visit, home health care visits may be conducted to continue study assessments in the patient’s home where feasible, and/or remote visits via telephone, telemedicine, or other 
appropriate virtual communication may be substituted for a visit to the site.  


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b. 
Patients discontinuing the study at any time for any reason prior to Week 12 (Early Termination) should complete the ET visit as soon as feasible and return for a Follow-Up 4 
weeks (-1 week /+2 days) after the last dose of study drug.  
c. 
The Follow-Up may take place at Week 16 (-1 week /+2 days) or 4 weeks (-1 week /+2 days) after the last dose of study drug if patients discontinue the study at any time for any 
reason prior to Week 12 (Early Termination).   
d. 
Samples collected during the treatment period should be collected pre-dose. 
e. 
In the event of symptoms suggestive of COVID-19, ad hoc testing (including molecular test such as PCR or viral antigen serology, and/or antibody testing), may be completed at 
Investigator’s discretion.  
f. 
sVAP-1 will be collected along with trough PD sampling.   
g. 
MRI-PDFF data will be collected along with MRI cT1. 
h. 
If a patient is required to be quarantined due to active infection of COVID-19 or exposure to COVID-19, or is otherwise unable to visit the site due COVID-19, study drug may be 
mailed to the patient or made available via another appropriate mechanism (i.e., curbside pickup, etc.). See Section 6.8.1 for additional guidance in the event of hospitalization for 
COVID-19. 
Abbreviations: AE = adverse event; ALT = alanine transaminase; AST = aspartate transaminase; BMI = body mass index; CK-18 = cytokeratin-18; COVID-19 = coronavirus disease 2019; 
cT1 = corrected T1; ECG = electrocardiogram; ET = early termination; eGFR = estimated glomerular filtration rate;; FSH = follicle stimulating hormone; HA = hyaluronic acid; HbA1c = 
hemoglobin A1c; HBsAg = hepatitis B surface antigen; HCV = hepatitis C virus; HIV = human immunodeficiency virus; hsCRP = high sensitivity C-reactive protein; ICAM-1= intercellular 
adhesion molecule 1; INR = international normalized ratio; IWRS = interactive web response system; MRI = magnetic resonance imaging; MRI-PDFF = MRI-proton density fat fraction; PCR 
= polymerase chain reaction; PD = pharmacodynamics; PIIINP = Procollagen III N-Terminal Propeptide; PK = pharmacokinetics; PRO-C3 = pro-peptide of type III collagen; ULN = upper 
limit of normal; SAE = serious adverse event; sVAP-1= soluble vascular adhesion protein-1; TIMP-1 = tissue inhibitor of metalloproteinases-1; VCAM-1 = vascular cell adhesion molecule 
1; WOCBP = women of childbearing potential.


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2. 
Introduction 
2.1. 
Overview of NASH and Role of VAP-1/SSAO in Disease 
Terns is developing TERN-201, an investigational, potent, and highly selective, irreversible 
covalent inhibitor of human vascular adhesion protein-1(VAP-1)/semicarbazide-sensitive amine 
oxidase for the treatment of patients with non-alcoholic steatohepatitis (NASH).  
NASH is an advanced form of non-alcoholic fatty liver disease (NAFLD), the most common 
cause of chronic liver disease in North America (Chalasani 2018). NASH is characterized by the 
presence of hepatic inflammation and hepatocellular ballooning, with or without fibrosis. NASH 
is a progressive condition that can lead to cirrhosis, decompensated liver disease, and increased 
risk for hepatic carcinoma and liver-related mortality (Ekstedt 2015). Currently, there are no 
approved therapies for the treatment of NASH. With an aging population and the emergence of 
overlapping epidemics of obesity, diabetes, and dyslipidemia/metabolic syndrome, NAFLD and 
NASH have increased greatly in prevalence (Andronescu 2018), posing a significant healthcare 
challenge. 
VAP-1/SSAO is a cellular adhesion protein and ectoenzyme expressed on the vascular 
endothelium that has long been recognized as a mediator of leukocyte adhesion and 
extravasation in the setting of inflammation (Salmi 2019). The enzymatic activity of VAP-1 
further contributes to inflammation and oxidative stress by converting primary amines to 
aldehyde, ammonia, and hydrogen peroxide. VAP-1 levels are increased in the liver tissue and 
blood of patients with NASH and circulating VAP-1, termed soluble VAP-1 (sVAP-1), is 
independently associated with fibrosis stage (Weston 2015). Genetic and pharmacology studies 
indicate VAP-1 deficiency or inhibition attenuate steatosis, inflammation, and fibrosis in NASH 
models. VAP-1 deficiency attenuates carbon tetrachloride (CCl4)-induced hepatic fibrosis and 
VAP-1 knockout mice exhibit reduced hepatic steatosis and fibrosis when fed a western lifestyle 
diet. Moreover, treatment with a VAP-1 antibody reduces inflammation, steatosis, and fibrosis in 
a methionine choline–deficient diet mouse model of NASH (Weston 2015).  
Based on these observations, VAP-1 inhibition is anticipated to reduce inflammation and fibrosis 
in NASH patients. This novel mechanism provides a potential opportunity to treat NASH, a 
disease with significant unmet medical needs.  
Of note, historically, VAP-1 has also been referred to as SSAO due to its sensitivity to inhibition 
by semicarbazide, a property that distinguishes it from flavin adenine dinucleotide (FAD)-
containing monoamine oxidases (e.g., MAO-A and MAO-B) (Smith 1998). In this document, the 


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terms VAP-1 and SSAO (or VAP-1/SSAO) are used interchangeably. Additional information on 
nomenclature is available in the Investigator’s Brochure. 
2.2. 
VAP-1/SSAO Inhibition in NASH and TERN-201 Background 
VAP-1 has been identified as a target for NASH due to the inflammatory component of NASH 
pathogenesis, association of increased VAP-1 levels in NASH patients, and nonclinical studies 
supporting potential benefit in NASH from VAP-1/SSAO deficiency or suppression 
(Section 2.1). One other VAP-1/SSAO inhibitor has been studied in NASH patients 
(ClinicalTrials.gov Identifier: NCT03166735). Pharmaxis (Frenchs Forest, AUS) identified an 
oral VAP-1 inhibitor, BI 1467335 (formerly PXS-4728A), which was advanced into clinical 
development for NASH by Boehringer Ingelheim. Preliminary data suggest dose-dependent 
reductions in alanine aminotransferase (ALT) and CK-18 with 12-weeks of treatment with BI 
1467335, and an overall reassuring safety profile in NASH patients (ClinicalTrials.gov Identifier: 
NCT03166735). In addition to its activity against VAP-1, BI 1467335 also inhibits monoamine 
oxidase B (MAO-B) (Schilter 2015), albeit to a lesser extent, with potential implications for 
drug-drug interactions associated with monoamine oxidase inhibition. In addition to NASH, 
VAP-1 inhibitors have also been explored for other indications including kidney disease. In a 
phase 2 study (ALBUM, ClinicalTrials.gov Identifier: NCT02358096), the VAP-1 inhibitor 
ASP8232 (Astellas Pharma) was effective at reducing albuminuria in patients with diabetic 
kidney disease, suggesting the possibility of benefit outside of liver, perhaps attributable to 
endothelial effects (de Zeeuw 2018). 
TERN-201 is a potent, irreversible, highly specific inhibitor of VAP-1/SSAO, formulated for 
oral administration in a capsule form. Nonclinical studies have demonstrated that TERN-201 is 
efficacious in models of liver fibrosis and NASH, and does not have activity against monoamine 
oxidase A or B. 
TERN-201 has been evaluated in an extensive nonclinical program, including PK, safety 
SKDUPDFRORJ\JHQRWR[LFLW\DQGUHSHDWGRVHWR[LFRORJ\WR[LFRNLQHWLFVWXGLHVRIXSWRௗZHHNV
in duration. TERN-201 has also been evaluated in a first-in-human (FIH) study (N=61), where it 
was found to be overall safe and well-tolerated.  
Below is a brief summary of these studies. Detailed results are available in the TERN-201 
Investigator’s Brochure. 


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2.2.1. 
Summary of Nonclinical Studies 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 


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2.2.2. 
Clinical Studies of TERN-201 
The initial, FIH Phase 1 clinical study, TERN201-US-A101, was a double-blind, randomized, 
placebo-controlled study to investigate the safety, tolerability, pharmacokinetics (PK), and 
pharmacodynamics (PD) of single and multiple ascending oral doses of TERN-201 in healthy 
participants. The study was also designed to investigate the effect of food (high-fat/high-calorie 
meal) on the PK of TERN-201. Study TERN201-US-A101 was comprised of 3 parts. In Part A, 
4 single-ascending dose (SAD) cohorts (8 participants each [6 TERN-201, 2 placebo]) were 
completed, in which participants received oral TERN-201 or matching placebo doses of 1, 3, 6, 
or 10 mg. A fifth SAD cohort (20 mg) was planned but not enrolled due to public health 
restrictions resulting from the Coronavirus Disease 2019 (COVID-19) pandemic. In Part B, 
3 multiple-ascending dose (MAD) cohorts (8 participants each [6 TERN-201, 2 placebo]) were 
completed, in which participants received oral TERN-201 or matching placebo daily doses of 
1 mg for 7 days, 4 mg for 7 days, or 10 mg for 14 days. Part C, the Food Effect cohort, was 
initiated with 5 of the 16 planned participants enrolled; however, enrollment was discontinued 
early due to the -19 pandemic. The 5 participants enrolled in Part C received both doses of 
TERN-201 10 mg (single doses on Days 1 and 8, fed and fasted) as planned in the study 
protocol. 
During the study, no safety or tolerability concerns were identified, and no predefined stopping 
criteria were met. All AEs were Grade 1 or 2 (National Cancer Institute [NCI] Common 
Terminology Criteria for Adverse Events [CTCAE] Version 5.0) in severity. All AEs in 
participants who received TERN-201 were reported to be mild in severity. With exception of 
mild contact dermatitis at the site of electrocardiogram (ECG) leads that was considered 
unrelated to study drug, and headache (2 participants), all AE types were isolated to a single 
participant. There were no serious AEs, deaths, or AEs that led to discontinuation of study drug 


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in any cohort. Laboratory, vital signs, and other safety assessments including EEG monitoring 
showed no notable findings across individual participants or cohorts.  
Plasma exposures to TERN-201 were greater than dose proportional. TERN-201 was rapidly 
cleared from plasma. Steady state was achieved in the highest dose group (10 mg) after Day 7 of 
dosing. The half-life of TERN-201 increased with dose, suggesting saturable, target-mediated 
clearance.  
Single and multiple doses of TERN-201 significantly suppressed plasma total amine oxidase 
activity at all doses studied. Using an exploratory assay to assess the effect of TERN-201 on 
VAP-1/SSAO-specific amine oxidase activity in the plasma, near complete inhibition (>80% 
with 1 mg, > 90% with 10 mg) was observed after only a single dose on Day 1 (achieved within 
4 hours after dosing) with sustained suppression over the dosing period in MAD cohorts. Dose-
dependent increases in methylamine, an endogenous substrate of VAP-1/SSAO predicted to 
increase upon VAP-1/SSAO inhibition, were observed after the first dose of TERN-201 and 
continued to increase in a dose-dependent manner after multiple doses of TERN-201.  
Based on the exploratory assessment on plasma PK of two TERN-201 metabolites, TRN-001021 
and TRN-001744, the percentages of either metabolite AUC relative to the total TERN-201-
related plasma AUC (sum of TERN-201, TRN-001021, and TRN-001744) were calculated. 
Median TRN-001021 AUC was <10% and 13.7% of the total plasma AUC associated with 
TERN-201 in the 4 mg and 10 mg groups, respectively. Median TRN-001744 AUC was 11.5% 
and <10% of the total plasma AUC associated with TERN-201 in the 4 mg and 10 mg groups, 
respectively. 
Additional details on Study TERN201-US-A101 are available in the Investigator’s Brochure. 
2.3. 
Benefit/Risk Assessment 
 
 
 
 
 
  
 
  
 
 


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The protocol has been designed to minimize the risk to patients. Patients will be monitored to 
detect AEs during the study and will be followed appropriately to ensure resolution of AEs. 
Standard hematology, chemistry, urinalysis, lipid levels, and ECGs will be obtained and 
monitored for abnormalities. Prior to administration of a dose up to 20 mg TERN-201, available 
PK from the 10 mg cohort will be assessed to predict that projected exposures are below the 
limits noted above. 
Taking into account the measures taken to minimize risk to patients in this study, the potential 
risks identified in association with TERN-201 are justified by the anticipated benefits that may 
be afforded to patients with NASH. 
Please refer to the Investigator’s Brochure for a summary of data on TERN-201 and guidance for 
Investigators.   


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3. 
Objectives and Endpoints 
Primary Objective:  
x To characterize the safety and tolerability of TERN-201 versus placebo for 12 weeks in 
non-cirrhotic presumed NASH patients, with a clinical or histological NASH diagnosis 
Secondary Objectives: 
x To assess the plasma and urine PK of TERN-201 for 12 weeks in non-cirrhotic presumed 
NASH patients 
x To assess the PD effect of TERN-201 versus placebo for 12 weeks on plasma VAP-
1/SSAO activity in non-cirrhotic presumed NASH patients 
Exploratory Objectives: 
x To assess the plasma and urine PK of TERN-201 metabolites (including TRN-001021 
and TRN-001744) at steady state 
x To assess the effect of TERN-201 versus placebo on imaging assessments and blood 
biomarkers of NASH activity  
x To assess the effect of TERN-201 versus placebo on biomarkers of inflammation 
x To explore the potential for TERN-201 to improve proteinuria due to endothelial effects 
x To explore other PD markers, and overall exposure-response and dose-response 
relationship of TERN-201, as applicable  
x To explore the exposure-response and dose-response relationship, as applicable, of 
TERN-201 and baseline patient characteristics such as soluble VAP-1 (sVAP-1), body 
mass index (BMI), diabetes mellitus, and others  
Endpoints:  
Primary Endpoint:  
x Overall safety assessed by treatment emergent AEs (TEAEs), and treatment emergent 
clinical safety laboratory abnormalities  
Secondary Endpoints:  
x Plasma and urine PK parameters for TERN-201  


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x Percent change from baseline in plasma VAP-1/SSAO activity 
Exploratory Endpoints:  
x Plasma and urine PK parameters for TERN-201 metabolites (including TRN-001021 and 
TRN-001744) 
x Change from baseline in corrected T1 (cT1) by magnetic resonance imaging (MRI) 
x Change from baseline in liver fat content by magnetic resonance imaging-proton density 
fat fraction (MRI-PDFF) 
x Change from baseline in stiffness by transient elastography  
x Change from baseline in alanine aminotransferase (ALT)  
x Change from baseline in gamma-glutamyl transpeptidase (GGT) 
x Change from baseline in aspartate aminotransferase (AST) 
x Change from baseline in NASH and fibrosis biomarkers including cytokeratin-18 (CK-
18) (M30 and M65), procollagen III n-terminal propeptide (PIIINP), tissue inhibitor of 
metalloproteinases-1 (TIMP-1), hyaluronic acid (HA), pro-peptide of type III collagen 
(PRO-C3), and type III collagen (C3M). Other non-invasive tests for NASH fibrosis may 
also be assessed including the fibrosis-4 (FIB-4) index, enhanced liver fibrosis (ELF) test, 
NAFLD fibrosis score (NFS), and PRO-C3/C3M ratio. 
x Change from baseline in inflammatory biomarkers including high sensitivity C-reactive 
protein (hs-CRP), interleukin-6 (IL-6), intercellular adhesion molecule-1 (ICAM-1), and 
vascular cell adhesion molecule-1 (VCAM-1) 
x Change from baseline in estimated glomerular filtration rate (eGFR), urine protein 
including urine protein-to-creatinine ratio (UPCR), and urine albumin-to-creatinine ratio 
(UACR) 
x Change from baseline in plasma methylamine levels (PD marker of VAP-1/SSAO 
inhibition) 
x Exposure-response and dose-response relationship of TERN-201 over 12 weeks, as 
applicable  
x Exposure-response and dose-response relationship, as applicable, of TERN-201 and 
baseline patient characteristics such as sVAP-1, BMI, diabetes mellitus, and others 


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4. 
Study Design 
4.1. 
Overall Design 
The study is a multi-center, randomized, double-blind, placebo-controlled, adaptive study. 
Approximately 80 clinically or histologically diagnosed adult non-cirrhotic presumed NASH 
patients who meet study eligibility criteria will be enrolled and randomized at an overall ratio of 
2:1 in up to 3 dose groups and placebo across 2 parts of the study. 
Part 1  
In Part 1, approximately 30 patients will receive 10 mg TERN-201 (n = 20) or matching placebo 
(n = 10) orally once daily, for 12 weeks. Part 2 may be enrolled based on an interim analysis, as 
follows: 
In Part 1 of the study, approximately 12 randomized patients will take part in an intensive PK 
and PD collection after the first dose (Week 0/Day 1), at Week 6, and after the last dose of study 
drug (Week 12). Randomization will ensure approximately 8 patients in the TERN-201 group 
and approximately 4 patients in the placebo group are assigned to the PK/PD sub-study. Patients 
who are not participating in the PK/PD sub-study will have trough PK/PD sampling only. 
An interim analysis will be performed after all patients in Part 1 have completed Week 6 
assessments. Interim PK and PD data will be assessed. Blinded safety data will also be reviewed. 
Enrollment of cohorts to assess 4 mg and up to 20 mg TERN-201 may be initiated per the 
following criteria: 
x TERN-201 4 mg: 
o If robust VAP-1/SSAO activity suppression is observed and available PK from 
Part 1 suggests that a lower dose may also possibly lead to robust VAP-1/SSAO 
activity suppression, enrollment in Part 2 with 4 mg TERN-201 may be initiated. 
x TERN-201 up to 20 mg: 
o If safety data indicates 10 mg TERN-201 is overall safe and well-tolerated, and 
available PK from Part 1 predicts that targeted exposures for a dose up to 20 mg 
will be below an upper limit of 5400 ng•hr/mL for AUC0-24hr and 768 ng/mL for 
Cmax, enrollment in Part 2 with a dose up to 20 mg TERN-201 may be initiated. 
Part 2  
In Part 2, if initiated, approximately 50 patients will receive 4 mg TERN-201 (n = 20), and/or up 
to 20 mg TERN-201 (n = 20), or matching placebo (n = 10) orally once daily, for 12 weeks. 


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In Part 2 of the study, approximately 15 randomized patients will take part in an intensive PK 
and PD collection after the first dose (Week 0/Day 1), at Week 6, and after the last dose of study 
drug (Week 12). Randomization will ensure approximately 6 patients at each TERN-201 dose 
level and approximately 3 patients in the placebo group are assigned to the PK/PD sub-study.  
The total duration of study participation will be approximately 22 weeks, consisting of a 6-week 
Screening Period, a 12-week Treatment Period and a 4-week Follow-up Period.  
4.2. 
Scientific Rationale for Study Design 
Collectively, results from nonclinical studies and FIH study, TERN201-US-A101, support the 
development of TERN-201 as an orally administered VAP-1/SSAO inhibitor to reduce 
inflammation and fibrosis in the liver of patients with NASH. TERN-201 provides a promising 
potential treatment for NASH, a disease with significant unmet medical need. 
 
 
 
 
  
The initiation of Part 1 of the study will evaluate the highest dose studied in the FIH study (10 
mg TERN-201), which was safe and well-tolerated and will allow for the PD effect of TERN-
201 (e.g., inhibition of plasma VAP-1/SSAO activity) to be assessed in the NASH population. 
 
 
 
 
The placebo-controlled nature of the study will allow for a control group to characterize the 
safety and preliminary efficacy of TERN-201 in a NASH population. Given the efficacy of 
TERN-201 has not yet been confirmed, there is no clear detriment to patients who may be 
randomized to receive placebo rather than active treatment in this study. 
The study will enroll a non-cirrhotic presumed NASH population based on clinical 
characteristics and imaging (without a requirement for liver biopsy), to characterize safety and 
efficacy in this population. While there is not an expected risk of neurological toxicity at the 
clinical doses proposed based nonclinical toxicity studies and the FIH study, patients with a 
history of seizures and select other co-morbidities will be excluded toavoid interference from 
disease processes in the safety assessment of TERN-201 in this study.  


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4.3. 
Justification for Dose 
Doses for this study were based on results from the FIH Phase 1 study, TERN201-US-A101, 
which evaluated 4 SAD cohorts of TERN-201 or matching placebo at 1 mg, 3 mg, 6 mg, or 
10 mg, and 3 MAD cohorts of TERN-201 or matching placebo at 1 mg for 7 days, 4 mg for 
7 days, or 10 mg for 14 days.  
In the FIH study, single or multiple doses of TERN-201 resulted in rapid inhibition of plasma 
amine oxidase activity, with sustained inhibition during 14 days of dosing. TERN-201 
demonstrated a favorable safety profile and was overall well-tolerated at all doses studied 
(Section 2.2.2). 
Part 1 of this study assesses 10 mg of TERN-201, the highest dose studied in the FIH study. In 
the FIH study, this dose led to >90% suppression of plasma VAP-1/SSAO-specific amine 
oxidase activity in healthy participants. NASH patients are expected to have a higher baseline 
level of VAP-1, and thus the PD effect of TERN-201 in NASH patients may differ from healthy 
participants. A higher dose of up to 20 mg may be enrolled based on assessment of safety and 
PK with the 10 mg dose, and a lower dose of 4 mg may be enrolled based on observation of a 
robust PD effect of TERN-201 on plasma VAP-1/SSAO activity in the 10 mg cohort, thus 
minimizing the number of patients exposed until the PK and PD effects of TERN-201 can be 
confirmed in Part 1 of the study.  
Toxicity and safety pharmacology studies support starting with the 10 mg dose and enrolling a 
higher dose up to 20 mg. 
 
 
 
 
 
 
 
 
Additional details on available data from Study TERN201-US-A101 are provided in the 
TERN-201 Investigator’s Brochure. 


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5. 
Study Population 
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as 
protocol waivers or exemptions, is not permitted. 
5.1. 
Inclusion Criteria 
Patients are eligible to be included in the study only if all of the following criteria apply at 
Screening: 
1. Must be 18 to 75 years of age inclusive, at the time of signing the informed consent 
2. Male or female, willing to follow contraception requirements defined by study protocol 
(Appendix 7); female patients of childbearing potential must also have negative serum 
pregnancy test, not be breastfeeding, and not plan to become pregnant during the study or 
within 30 days after last dose of study drug 
3. 2YHUZHLJKWRUREHVHZLWKD%0,NJP2  
4. NASH by clinical diagnosis or biopsy as follows:  
a. For clinical diagnosis:  
i. Step 1: Liver stiffness measured by transient elastography of 6.5 - 21 kPa 
and controlled attenuation parameter (CAP) > 280 dB/m within 3 months 
prior to Screening (if results available within this timeframe, assessment 
does not need to be repeated at Screening). 
ii. Step 2: Patients meeting these and all other eligibility criteria will undergo 
MRI cT1 and must have a cT1 value > 800 ms for randomization.  
b. For biopsy diagnosis:  
i. Step 1: Fibrotic NASH (NASH CRN F1, F2, or F3) without cirrhosis 
diagnosed by biopsy within 2 years prior to randomization, with no 
subsequent treatment for NASH and stable weight (< 5% weight loss) 
since the time of the biopsy. Results from a previous study end of 
treatment biopsy are permissible if drug was deemed non-therapeutic or 
patient received placebo. 
ii. Step 2: Patients meeting these and all other eligibility criteria will undergo 
MRI cT1 and must have a cT1 value > 800 ms for randomization.  
5. All patients must have: 
x $/743 U/L for men DQG8 U/L for women 
x MRI-cT1 liver inflammation > 800 ms 


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6. Capable of giving signed informed consent as described in Section 10.1.2 which 
includes compliance with the requirements and restrictions listed in the informed 
consent form (ICF) and in this protocol 
5.2. 
Exclusion Criteria  
Patients are excluded from the study if any of the following criteria apply at Screening: 
Medical Conditions 
1. History or clinical evidence of chronic liver diseases other than NAFLD or NASH 
including but not limited to: 
x Active hepatitis B virus (HBV) infection defined as positive HBV surface antigen 
at screening  
x Active hepatitis C virus (HCV) infection defined as positive HCV antibody (anti-
HCV) and HCV ribonucleic acid (RNA). Patients with anti-HCV but negative 
HCV RNA will be eligible for participation if HCV RNA has been negative for at 
least 1 year. 
x Autoimmune liver disease 
x Primary biliary cirrhosis 
x Primary sclerosing cholangitis 
x Wilson’s disease (history should include normal serum ceruloplasmin and 24-
hour urinary copper) 
x Gilbert’s syndrome  
x Hemochromatosis or other iron overload  
x Alpha-1-antitrypsin (AAT) deficiency (history should include normal AAT 
genotype and serum AAT level) 
x Alcoholic liver disease 
x Prior known drug-induced hepatotoxicity 
x Known bile duct obstruction 
x Suspected or proven liver cancer  
2. History or clinical evidence of cirrhosis, hepatic decompensation, or other severe liver 
impairment, including ascites, hepatic encephalopathy, and variceal bleeding 
3. History of liver transplant, or current placement on a liver transplant list 
4. ALT or AST > 5 × upper limit of normal (ULN)  
5. Unstable elevated ALT or AST. Patients with ALT or AST > 60 IU/L must have 
evidence of a stable ALT and AST over at least a 2-week time period prior to 
randomization as evidenced by one of the following:  


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x Comparison to prior ALT and AST (historical values) obtained within 2-12 weeks 
prior to the Screening visit: Screening ALT and AST values VKRXOGEH
higher than a documented prior result, OR 
x Repeat ALT and AST values at least 2 weeks after the Screening visit: Repeat 
ALT and $67VKRXOGEHKLJKHUWKDQWKe values from the Screening visit, 
and the repeat values must be  5 × ULN 
x If the Investigator has clinical suspicion for acute liver injury in a patient for other 
reasons, the patient should be excluded after discussion with the Medical Monitor. 
x The MRI cT1 may proceed on the basis of the initial ALT and AST values at 
Screening, given all other eligibility criteria are met, but randomization should not 
occur prior to confirmation of ALT and AST stability, as necessary.  
 
6. Total bilirubin > 1.2 mg/dL  
7. Albumin < 3.3 g/dL  
8. International normalized ratio (INR) > 1.3 
9. Alkaline phosphatase (ALP) > 159 IU/L 
10. Platelet count < 150,000 /mm3 
11. eGFR < 60 mL/min/1.73m2   
12. Weight loss of > 5% total body weight within 3 months prior to Screening 
13. History of a malignancy within 2 years of Screening, with the following exceptions:  
a) Adequately treated carcinoma in situ of the cervix 
b) Adequately treated basal or squamous cell cancer or other localized non-melanoma 
skin cancer  
14. Uncontrolled diabetes with hemoglobin A1c (HbA1c) > 9.5% or actively undergoing 
anti-diabetes medication titration (see Exclusions 35, 36, and 39 for additional details). 
Note: Patients with or without diabetes may be enrolled provided all eligibility criteria 
are met.  
15. Average weekly alcohol consumption of > 21 standard drinks for males and > 14 
standard drinks for females over a period of more than 3 consecutive months in the year 
prior to Screening. Remote history of alcoholism with abstinence > 12 months prior to 
Screening and no history of alcoholic liver disease is permissible.  


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Note: A standard drink is defined as 12 oz (360 ml) beer, 1.5 oz (45 ml) liquor, or 5 
oz (150 ml) wine.  
16. Illicit substance/chemical abuse in the 12 months prior to Screening 
17. Cannabis use (tetrahydrocannabinol [THC] and cannabidiol [CBD]) within 14 days of 
randomization 
18. Unwilling to abstain from excessive alcohol use (defined in #15 above), cannabis use, 
and illicit substance use during study participation 
19. Positive for human immunodeficiency virus (HIV) infection 
20. QTcF > 450 ms for males, > 470 ms for females 
21. Unstable cardiovascular disease defined as myocardial infarction, unstable angina, 
percutaneous intervention, coronary artery bypass graft, or stroke within 6 months prior 
to randomization 
22. New York Heart Association class III or IV heart failure, or know left ventricular 
ejection fraction < 30% 
23. Uncontrolled hypertension defined as systolic blood pressure > 160 mmHg or a 
diastolic blood pressure > 100 mmHg (treated or untreated) on at least two occasions 
more than 10 minutes apart 
24. History of hypotension including orthostatic or postprandial hypotension  
25. History of seizure disorder 
26. History of known or suspected serotonin syndrome 
27. Schizophrenia or bipolar disorder 
28. Parkinson’s disease  
29. Known or suspected pheochromocytoma 
30. Known allergy to study drug  
31. Clinically significant multiple or severe drug allergies, or severe post-treatment 
hypersensitivity reactions  
32. Laboratory or clinical evidence of current infection with Severe Acute Respiratory 
Syndrome Coronavirus 2 (SARS-CoV-2), i.e., COVID-19 


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33. Presence of any condition that could, in the opinion of the Investigator, compromise the 
patient’s ability to participate in the study 
Prior Therapy 
34. Use within 6 months prior to Screening: Treatment with monoamine oxidase inhibitors 
including but not limited to isoniazid, linezolid, methylene blue, tranylcypromine, 
isorboxazid, phenelzine, selegiline, rasagiline, safinamide; these therapies are also 
prohibited from randomization through end of study follow-up per Section 6.6 
 
35. Use within 3 months prior to Screening: obeticholic acid, SLRJOLWD]RQHRURWKHU33$5Ȗ
agonists, or high-dose vitamin E (> 400 IU/day); these therapies are also prohibited 
from randomization through end of study follow-up per Section 6.6  
36. Initiation or dose adjustment within 3 months prior to Screening (i.e., must be on stable 
dose for 3 months prior to Screening):  
x GLP-1 analogues, DPP-4 inhibitors, and SGLT2 inhibitors  
x 9LWDPLQ(,8GD\  
37. Use within 3 months prior to Randomization: 
x Medications potentially impacting steatohepatitis, including but not limited to 
systemic corticosteroids (prednisone equivalent of > 10 mg/day for > 2 weeks), 
amiodarone, tamoxifen, and methotrexate; these therapies are also prohibited 
from randomization through end of study follow-up per Section 6.6 
38. Initiation or dose titration within 3 months prior to Randomization: 
x Hormonal contraceptives 
39. Initiation or dose titration within 2 months prior to Randomization (i.e., must be on 
stable dose for 2 months prior to Randomization): 
x Metformin and other antidiabetic drugs not described above. 
40. Use within 2 weeks prior to Randomization:  
x Oral creatine supplementation; this is also prohibited from randomization 
through end of study follow-up per Section 6.6 
x Vaccination for influenza, COVID-19, or other routine vaccinations 
x Potent CYP3A inducers or inhibitors; these therapies are also prohibited from 
randomization through end of study follow-up per Section 6.6 
Prior Clinical Study Experience 


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41. Participation in another clinical trial within 3 months or 5 half-lives of the other 
investigational agent (whichever is longer) prior to randomization. Patients who can 
demonstrate they did not receive active drug or who received an investigational 
treatment that was deemed non-therapeutic during clinical trial participation are eligible 
for enrollment 
5.3. 
Lifestyle Considerations 
Contraceptives or other means of birth control are required for patients of childbearing potential 
during study participation (see Appendix 7). 
5.3.1. 
Lifestyle Counseling 
Guidance should be provided on key elements of a healthy lifestyle at each visit including diet, 
exercise, weight loss, and avoidance of alcohol per standard of care management for this patient 
population.  
5.3.2. 
Meals and Dietary Restrictions 
Patients should arrive at the clinic fasting for assessments and study drug administration as 
defined in the Schedule of Activities (Section 1.3). This includes at least an 8-hour fast prior to 
the visit, during which food and drink is restricted. Water is allowed ad libitum.  
On all other days, patients will self-administer the study drug orally once daily in the morning on 
an empty stomach, after an 8-hour fast. 
Patients participating in the PK/PD sub-study at Week 0/Day 1, Week 6, and Week 12 should 
arrive at the clinic fasting (an 8-hour fast prior to the visit) and restrict food and drink until 2 
hours post-dose. Food and drink may resume after this timepoint. Patients participating in the 
PK/PD sub-study do not need to be fasting for blood collection at 24, 48, or 72 hours post last 
dose of study drug at Week 12. 
5.3.3. 
Alcohol, Cannabis, and Illicit Drug Use 
Patients must agree to not consume > 21 standard drinks per week for males and > 14 standard 
drinks per week for females. A standard drink is defined as 12 oz (360 ml) beer, 1.5 oz (45 ml) 
liquor, or 5 oz (150 ml) wine.  
Patients must abstain from THC (cannabis) and illicit drug use during study participation.  
Patients must abstain from CBD use during study participation. Short term topical CBD use 
(< 14 days) is acceptable.   


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5.4. 
Screen Failures 
Screen failures are defined as patients who consent to participate in the clinical study but are not 
subsequently randomized. A minimal set of screen failure information is required and will be 
documented to ensure transparent reporting of screen failure patients to meet the Consolidated 
Standards of Reporting Trials (CONSORT) publishing requirements and to respond to queries 
from regulatory authorities. Minimal information includes demography, screen failure details, 
eligibility criteria, and any serious adverse event (SAE). 
An otherwise eligible patient who is completing a vaccination series prior to enrollment may 
have the Screening window extended to allow for vaccination completion; laboratory 
assessments to confirm eligibility should be repeated if the Screening window has been 
exceeded. An otherwise eligible patient who screen fails due to SARS-CoV-2 testing or clinical 
status may re-screen at the discretion of the Investigator once SARS-CoV-2 infection has 
resolved. Any other requests for re-screening must be discussed with the Sponsor.  


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6. 
Study Drug 
Study drug is defined as any investigational intervention(s), marketed product(s), or placebo 
intended to be administered to a study patient according to the study protocol. 
6.1. 
Study Drug(s) Administered 
Investigational 
Medicinal Product 
TERN-201 capsules 
Placebo-to-match (identical in 
shape, size, appearance, and 
color to TERN-201 capsules) 
Type  
Drug 
Drug 
Dose Formulation 
Capsule 
Capsule 
Unit Dose 
Strength(s) 
1, 3, or 10 mg per capsule 
Matching placebo per capsule 
Route of 
Administration 
Oral 
Oral 
Use 
Experimental 
Placebo  
IMP/NIMP 
IMP  
IMP  
Sourcing 
Provided centrally by the 
Sponsor 
Provided centrally by the 
Sponsor 
Packaging and 
Labeling 
Study drug will be provided in a 
labeled carton that contains 
HDPE bottle(s). In Part 1, each 
carton will contain one bottle for 
4-week usage. In Part 2, each 
carton will contain two bottles 
for 4-week usage.  Each bottle 
will be labeled as required per 
country requirements.  
Study drug will be provided in a 
labeled carton that contains 
HDPE bottle(s). In Part 1, each 
carton will contain one bottle for 
4-week usage. In Part 2, each 
carton will contain two bottles 
for 4-week usage. Each bottle 
will be labeled as required per 
country requirements.  
Abbreviations: HDPE = High-density polyethylene; IMP = investigational medicinal product; NIMP = non 
investigational medicinal product 
6.2. 
Study Drug Administration  
Patients will be instructed to take capsules as shown in Table 1.  


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Table 1 
Study Drug by Dose Group 
Dose Group 
TERN-201 Capsules 
Placebo-to-Match 
Part 1 – 10 mg 
One 10-mg capsule QD  
One placebo capsule QD  
Part 2 – 4 mg 
One 1-mg capsule and one 3 mg 
capsule QD  
Two placebo capsules QD 
Part 2 – 20 mg 
Two 10-mg capsules QD  
Two placebo capsules QD 
Abbreviations: QD = once per day 
6.3. 
Preparation/Handling/Storage/Accountability 
The Investigator or designee must provide acknowledgement of receipt of each shipment of 
study drug including appropriate temperature conditions have been maintained during transit for 
all study drug received and any discrepancies are reported and resolved before use of the study 
drug. 
Only patients enrolled in the study may receive study drug and only authorized site staff may 
supply or administer study drug. All study drug must be stored in a secure, environmentally 
controlled, and monitored (manual or automated) area in accordance with the labeled storage 
conditions with access limited to the Investigator and authorized site staff. 
The Investigator, institution, or the head of the medical institution (where applicable) is 
responsible for study drug accountability, reconciliation, and record maintenance (i.e., receipt, 
reconciliation, and final disposition records). 
Further guidance and information for the final disposition of unused study drugs are provided in 
the Pharmacy Manual.  
6.4. 
Measures to Minimize Bias: Randomization and Blinding 
Patients will be randomized to TERN-201 or placebo using an Interactive Web Response System 
(IWRS). Before the study is initiated, the log-in information and directions for the IWRS will be 
provided to each site. 
Approximately 80 patients will be enrolled in this study. In Part 1, approximately 30 patients will 
be randomized at a ratio of 2:1 to receive 10 mg TERN-201 (n = 20) or matching placebo (n = 
10). In Part 2, if initiated, approximately 50 patients will be randomized at a ratio of 2:1 to 
receive 4 mg TERN-201 (n = 20), and/or 20 mg TERN-201 (n = 20), or matching placebo (n = 
10). Randomization will be stratified by Screening MRI cT1 values  900 ms versus > 900 ms. 


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In Part 1 of the study, approximately 12 randomized patients will take part in an intensive PK 
and PD collection after the first dose and after the last dose of study drug. Randomization will 
ensure approximately 6 patients in the TERN-201 group and approximately 6 patients in the 
placebo group are assigned to the PK/PD sub-study. Patients who are not participating in the 
PK/PD sub-study will have trough PK/PD sampling only. 
In Part 2 of the study, approximately 15 randomized patients will take part in an intensive PK 
and PD collection after the first dose and after the last dose of study drug. Randomization will 
ensure approximately 6 patients at each TERN-201 dose level and approximately 3 patients in 
the placebo group are assigned to the PK/PD sub-study. Patients who are not participating in the 
PK/PD sub-study will have trough PK/PD sampling only. 
Investigators, patients, all study personnel, and the Sponsor will remain blinded to each patient’s 
assigned dose group throughout the course of the study, unless otherwise specified in 
Section 6.4.1. Study drug will be dispensed at the study visits as summarized in Schedule of 
Activities. Returned study drug should not be re-dispensed to patients.  
A planned interim analysis will be conducted after all patients in Part 1 have completed Week 6 
assessments, and an administrative interim analysis may be conducted after the completion of 
Part 1 of the study. For these analyses, the study team will be blinded at the individual patient 
level, with designated personnel responsible for producing the summary results. The details will 
be addressed in a separate plan.  
6.4.1. 
Unblinding 
Treatment assignment may be unblinded if knowing the patient’s treatment assignment would 
affect immediate medical management of the patient. The IWRS will be programmed with blind-
breaking instructions. In case of an emergency, the Investigator has the sole responsibility for 
determining if unblinding of a patient’s intervention assignment is warranted. Patient safety must 
always be the first consideration in making such a determination. If the Investigator decides that 
unblinding is warranted, the Investigator should make every effort to contact the Sponsor prior to 
unblinding a patient’s intervention assignment unless this could delay emergency treatment of 
the patient. If a patient’s intervention assignment is unblinded, the Sponsor must be notified 
within 24 hours after breaking the blind. The date and reason that the blind was broken must be 
recorded in the source documentation and case report form, as applicable. 
Any unblinding of Sponsor personnel for expedited reporting of suspected unexpected serious 
adverse reactions (SUSARs) or other reasons including planned interim analyses will be 
addressed in a separate plan.  


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6.4.2. 
Patient Enrollment and Study Drug Assignment 
It is the responsibility of the Investigator to ensure that patient eligibility is confirmed prior to 
randomization. Documentation of the personally signed and dated informed consent of each 
patient, using the study-specific ICF, is required before initiating the Screening Period.  
After written informed consent has been obtained, the patient’s identification number will be 
obtained from the IWRS. Once eligibility to participate has been established, the randomized 
treatment assignment will be obtained from the IWRS. 
6.5. 
Study Drug Compliance 
Patients will be dispensed study during their study visits and will self-administer study drug at 
home. Patients must be in fasted state for at least 8 hours prior to study drug administration. At 
all study visits, study drug administration will be observed at the study site. Patients should be 
instructed to hold their dose of study drug on visit days until all visit procedures have been 
completed. On all other days, patients will self-administer the study drug orally once daily in the 
morning on an empty stomach, after an 8 hour fast. 
Compliance will be assessed by direct questioning and counting returned capsules during the 
study visits and documented in the source documents and electronic case report form (eCRF). 
Deviation(s) from the prescribed dosage regimen should be recorded in the eCRF.   
If a patient is required to be quarantined due to active infection of COVID-19 or exposure to 
COVID-19, or is otherwise unable to visit the site due to COVID-19, study drug may be mailed 
to the patient or made available via another appropriate mechanism (i.e., curbside pickup, etc). 
Patients will be asked to maintain records of self-administered drug on non-study visit days. A 
record of the number of study drug capsules dispensed to and taken by each patient must be 
maintained and reconciled with study drug and compliance records at the site. Study drug start 
and stop dates, including dates for delays will also be recorded in the eCRF. 
6.6. 
Concomitant Therapy 
Any medication or vaccine (including over-the-counter or prescription medicines, vitamins 
and/or herbal supplements) that the patient is receiving at the time of randomization or receives 
during the study must be recorded at each study visit along with: 
x Reason for use 
x Dates of administration including start and end dates 
x Dosage information including dose and frequency 


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Medications prohibited from randomization through end of study follow-up:  
x Monoamine oxidase inhibitors including isoniazid, linezolid, methylene blue, 
tranylcypromine, isorboxazid, phenelzine, selegiline, rasagiline, safinamide  
x Medications with potential impact on NASH outcome, including obeticholic acid, 
pioglitazone or other PPARȖ agonists, or high-dose vitamin E (> 400 IU/day) 
o 3DWLHQWVUHFHLYLQJ,8GD\SULRUWRVWXG\VKRXOGQRWKDYHGRVHDGMXVWPHQW
on-study  
x Medications potentially impacting steatohepatitis, including but not limited to systemic 
corticosteroids (prednisone equivalent of > 10 mg/day for > 2 weeks), amiodarone, 
tamoxifen, and methotrexate. Use of systemic corticosteroids for < 2 weeks within 
3 months prior to randomization and while on study is allowed. 
x Oral creatine supplementation 
x Potent inducers or inhibitors of CYP3A; a noncomprehensive list for known CYP3A 
strong inducers and inhibitors is provided below: 
o Potent CYP3A inhibitors prohibited on study include but are not limited to: 
boceprevir, cobicistat, ritonavir, grapefruit juice, itraconazole, ketoconazole, 
posaconazole, telaprevir, telithromycin, troleandomycin, voriconazole, 
clarithromycin, idelalisib, nefazodone, and nelfinavir 
o Potent CYP3A inducers prohibited on study include but are not limited to: 
apalutamide, carbamazepine, enzalutamide, mitotane, phenytoin, rifampin, and St. 
John’s wort 
o Patients who require initiation of potent CYP3A inducers and inhibitors during 
the study should discontinue study drug. For patients who subsequently 
discontinue prohibited medications, study drug administration may not be 
resumed unless discussed with the Medical Monitor. Patients who do not resume 
study drug should continue in the study for Follow-Up. 
x Other investigational agents 
All other medications not listed above are acceptable for use from randomization through end of 
study follow-up. The Medical Monitor should be contacted if there are any questions regarding 
concomitant therapy.  
6.7. 
Dose Modifications 
Dose modifications of study drug are not permitted.  


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6.8. 
Dose Interruptions  
On all non-study visit days, patients will self-administer the study drug orally once daily in the 
morning, on an empty stomach, after an 8 hour fast. If a patient forgets to self-administer study 
drug in the morning on a given day, the dose can be taken on the same day when the patient 
remembers, with the exception below:  
x For patients participating in the PK/PD sub-study, drug must be self-administered the 
morning of the day prior to the Week 6 and Week 12 visits. If not, the visit should be re-
scheduled for the following day. 
If a patient forgets to self-administer study drug on a given day, it will be designated a missed 
dose. Dosing may continue orally once daily according to the protocol schedule after a missed 
dose.  
If study drug is discontinued or suspended for safety reasons considered related to study drug, 
dosing should not be resumed without consultation with the Medical Monitor. Information on 
stopping study drug for patients due to safety/other reasons is detailed in Section 7.  
6.8.1. 
Dose Interruptions due to COVID-19 
If a patient requires home quarantine due to SARS-CoV-2 infection or exposure, or due to 
COVID-19 symptoms, the patient may continue study drug provided that appropriate safety 
follow-up is possible, and that hospitalization is not required. Home health care visits may be 
conducted to continue study assessments in the patient’s home where feasible, and/or remote 
visits via telephone, telemedicine, or other appropriate virtual communication may be substituted 
for a visit to the site. Sites should discuss the mechanism for safety follow-up with the Medical 
Monitor. 
If a patient has symptoms of COVID-19 requiring hospitalization, study drug must be 
discontinued during hospitalization. A case-by-case assessment of whether to resume study drug 
can be done upon discharge. Dosing should not be resumed without consultation with the 
Medical Monitor. The patient should be encouraged to remain in the study to be evaluated during 
the Follow-Up Period.  
6.9. 
Intervention after the End of the Study 
No further interventions are planned after the end of the study.  


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7. 
Discontinuation of Study Drug and Patient 
Discontinuation/Withdrawal 
7.1. 
Discontinuation of Study Drug 
Study drug must be discontinued for an individual patient in the following instances:  
x If an AE of Grade 3 or above (National Cancer Institute (NCI) CTCAE 5.0) occurs and 
is considered related to study drug as judged by the Investigator per the guidance in 
Appendix 6 
x Symptoms of COVID-19 requiring hospitalization 
x Change in clinical status that, in the judgement of the Investigator compromises the 
patient’s ability to continue treatment or is not considered to be in the patient’s best 
interest  
x Patient request to discontinue study drug for any reason 
x Pregnancy during the study (refer to Appendix 7) 
x Sponsor discretion  
x Discontinuation of the study at the request of the Sponsor, a regulatory agency, or 
Institutional Review Board (IRB)/Independent Ethics Committee (IEC) 
Resumption of study drug may be considered in discussion with the Medical Monitor and 
Sponsor. 
If one of the following situations occurs and is considered related to the study drug without 
alternative etiology, study drug may be discontinued at the discretion of the Investigator and the 
Medical Monitor should be informed (with repeat test performed within 48-72 hours once initial 
abnormality is detected): 
x ALT or AST > 8 × ULN  
x ALT or AST > 5 × ULN for more than 1 week, confirmed with a repeat assessment  
x ALT or AST > 2 × Baseline with the appearance of fatigue, nausea, vomiting, right 
upper quadrant pain or tenderness, fever, rash, and/or eosinophilia > 5% 
x ALT or AST > 2 × Baseline and total bilirubin > 2 × ULN or INR > 1.5 for more than 1 
week, confirmed with a repeat assessment 
In addition, Investigators may permanently discontinue study drug at their discretion due to 
patient non-compliance with study drug or study assessments. 
If study drug is permanently discontinued, the patient will remain in the study to be evaluated 
during the Follow-Up Period. See the Schedule of Activities for data to be collected at the time 
of discontinuation of study drug and follow-up and for any further evaluations that need to be 
completed. 


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7.2. 
Patient Discontinuation/Withdrawal from the Study 
A patient may withdraw from the study at any time at his/her own request or may be withdrawn 
at any time at the discretion of the Investigator for safety, behavioral, compliance, or 
administrative reasons.  
Patients discontinuing the study at any time for any reason prior to Week 12 (Early Termination) 
should complete the early termination (ET) visit as soon as feasible and return for a Follow-Up 
approximately 4 weeks after the last dose of study drug. See the Schedule of Activities for data 
to be collected at the time of study discontinuation and follow-up and for any further evaluations 
that need to be completed. 
If the patient withdraws consent for disclosure of future information, the Sponsor may retain and 
continue to use any data collected before such a withdrawal of consent. 
If a patient withdraws from the study, he/she may request destruction of any samples taken and 
not tested, and the Investigator must document this in the site study records. 
7.3. 
Lost to Follow up 
A patient will be considered lost to follow-up if he or she repeatedly fails to return for a 
scheduled visit and is unable to be contacted by the study site. 
The following actions must be taken if a patient fails to return to the clinic for a required study 
visit: 
x 
The site must attempt to contact the patient and reschedule the missed visit as soon as 
possible, counsel the patient on the importance of maintaining the assigned visit 
schedule, and ascertain whether or not the patient wishes to and/or should continue in 
the study. 
x 
Before a patient is deemed lost to follow up, the Investigator or designee must make 
every effort to regain contact with the patient (where possible, 3 telephone calls and, if 
necessary, a certified letter to the patient’s last known mailing address or local 
equivalent methods). These contact attempts should be documented in the patient’s 
medical record. 
x 
Should the patient continue to be unreachable, he/she will be considered to have 
withdrawn from the study.  
Discontinuation of specific sites or of the study as a whole are addressed in Section 10.1.8. 


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8. 
Study Assessments and Procedures 
Study procedures and their timing are summarized in the Schedule of Activities. Protocol 
waivers or exemptions are not allowed. 
Adherence to the study design requirements, including those specified in the Schedule of 
Activities, is essential and required for study conduct. 
All screening evaluations must be completed and reviewed to confirm that potential patients 
meet all eligibility criteria. The Investigator will maintain a screening log to record details of all 
patients screened and to confirm eligibility or record reasons for screening failure, as applicable. 
The maximum amount of blood collected from each patient over the duration of the study is not 
expected to exceed 650 mL. Repeat or unscheduled samples may be taken for safety reasons or 
for technical issues with the samples. 
If a patient requires home quarantine due to SARS-CoV-2 infection or exposure, or due to 
COVID-19 symptoms or other associated concern with attending an in-person study visit; home 
health care visits may be conducted to continue study assessments in the patient’s home where 
feasible, and/or remote visits via telephone, telemedicine, or other appropriate virtual 
communication may be substituted for a visit to the site. 
8.1. 
Study Assessments 
Planned time points for all safety assessments are provided in the Schedule of Activities.  
8.1.1. 
Demographics 
Demographic data includes age, sex, and race/ethnicity.  
8.1.2. 
Height and Weight 
Height and weight are collected at Screening and will be used to calculate BMI. Waist 
circumference is also measured at Screening. Only weight is collected on other days specified in 
the Schedule of Activities.  
Waist (abdominal) circumference is measured with measuring-tape position as follows (National 
Heart, Lung, and Blood Institute 2000): The upper hip bone and the top of the right iliac crest 
should be located and measuring tape placed in a horizontal plane around the abdomen at the 
level of the iliac crest. The tape should be snug but should not compress the skin, and should be 
parallel to the floor, at the time of measurement. The measurement should be taken at the end of 
a normal expiration. 


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8.1.3. 
Medical History 
Medical and surgical history, including details of illnesses and allergies, date(s) of onset, whether 
condition(s) is currently ongoing, and medication history, including alcohol use, will be collected 
for all patients at Screening.  
8.1.4. 
Physical Examinations 
A complete physical examination will include assessments of general appearance, 
cardiovascular, respiratory, abdomen, head and neck (including ears, eyes, nose, throat, and 
thyroid), lymph nodes, musculoskeletal systems, and neurological exam.  
A targeted physical examination may be conducted to evaluate reported current or prior AEs, 
symptoms reported by the patient, or abnormal laboratory readouts.  
Investigators should pay special attention to clinical signs related to previous serious illnesses. 
8.1.5. 
Vital Signs 
Temperature, pulse rate, respiratory rate, and blood pressure will be assessed and maintained in 
source documentation.  
Blood pressure and pulse measurements will be assessed with a completely automated device. 
Manual techniques will be used only if an automated device is not available. 
Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest for the 
patient in a quiet setting without distractions (e.g., television, cell phones). 
8.1.6. 
Electrocardiograms 
Single 12-lead ECGs will be obtained as outlined in the Schedule of Activities using an ECG 
machine that automatically calculates the heart rate and measures PR, QRS, and QT intervals. 
QTc will be calculated using the formula outlined in Appendix 4. 
An ad hoc ECG should be performed in the instance of patient-reported symptoms considered 
potentially cardiac in nature such as chest pain/pressure, palpitations, dizziness, shortness of 
breath, or report of patient recently seeking medical care for such symptoms (e.g., emergency 
room visit); cardiology consult should be obtained based on the clinical judgement of the 
Investigator.  
The Investigator will review the ECGs for any clinically significant abnormalities.  


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8.1.7. 
Clinical Laboratory Assessments 
See Appendix 1 for the list of clinical laboratory tests to be performed and the Schedule of 
Activities for the timing and frequency. 
The Investigator must review the laboratory report, document this review, and record any AEs 
per the guidance in Appendix 6. The laboratory reports must be filed with the source documents.  
Clinically significant laboratory shifts, or any clinically significant abnormalities considered 
possibly related to study drug in the opinion of the Investigator, should be repeated within 48-72 
hours and followed to resolution or until stable. 
All protocol-required laboratory assessments, as defined in Appendix 1, must be conducted in 
accordance with the laboratory manual and the Schedule of Activities. 
8.1.7.1. 
Liver Function Tests 
In order to be eligible for this study, patients must have an $/743 U/L for men or 28 U/L 
for women. ALT and AST stability may be evaluated prior to randomization per Section 5.  
During the course of the study, liver function tests (LFTs) will be monitored per the Schedule of 
Activities. Refer to Appendix 1 for a list of tests to be performed, and to Appendix 3 for 
additional information on criteria for increased liver chemistry monitoring. 
8.1.8. 
Transient Elastography and Controlled Attenuation Parameter 
Liver stiffness will be assessed by vibration-controlled transient elastography (via FibroScan®) at 
Screening to determine study eligibility. If results from transient elastography measurement 
within 3 months of Screening are available, these values can be used to assess eligibility and do 
not need to be repeated.  
The transient elastography requirement is intended to select for patients likely to have at least F1 
fibrosis. The protocol excludes patients with cirrhosis based on medical history or clinical signs 
or symptoms (Exclusion criteria #2). Prior studies indicate variability in the ranges of liver 
stiffness measured by transient elastography in NASH patients with fibrosis or cirrhosis. In 
STELLAR-3, which enrolled patients with bridging fibrosis, median liver stiffness at baseline 
was approximately 13 kPa, with an interquartile range between 10 and 17 kPa (Harrison 2020). 
In STELLAR-4, which enrolled patients with cirrhosis, median liver stiffness at baseline was 
approximately 20-21 kPa, with an interquartile range between 14 and 30 kPa (Harrison 2020). 
The utility of transient elastography to diagnose cirrhosis in the setting of NASH also appears 
limited based on the low positive predictive value (PPV) of even relatively high kPa thresholds. 
For a threshold of 21 kPa, the upper limit for this study, the PPV for F4 fibrosis (i.e., cirrhosis) in 
the setting of NASH is 0.37 (which may be even lower in a population with low prevalence of 


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cirrhosis, such as one in which cirrhosis is excluded on clinical grounds), with a negative 
predictive value of 0.96 (Eddowes 2019). This threshold has a sensitivity of 0.59 and a 
specificity of 0.90 for a diagnosis of cirrhosis in the setting of NASH (Eddowes 2019). 
CAP is an assessment of liver steatosis and is generally used to complement the assessment of 
liver stiffness by transient elastography for evidence of NASH (Eddowes 2019). CAP estimates 
the total ultrasonic attenuation (go-and-return path), expressed in dB/m, based on the postulate 
that fat affects ultrasound propagation. A CAP threshold of 274 dB/m has sensitivity of 0.9 and 
specificity of 0.6 IRULGHQWLILFDWLRQRIOLYHUVWHDWRVLVRI(Eddowes 2019). The threshold of 
280 dB/m was chosen to identify patients who are likely to have elevated liver steatosis, in 
conjunction with the other imaging assessments at screening, including cT1. 
Patients who meet NASH entry criteria based on a liver biopsy (Inclusion Criteria #4) should 
still undergo transient elastography at Screening to enable assessment of change from baseline in 
stiffness by transient elastography. 
Transient elastography will also be conducted at Week 12, and at ET.  
8.1.9. 
Magnetic Resonance Imaging: Correct T1 and Proton Density Fat Fraction  
MRI cT1 will be conducted as specified in the Schedule of Activities.  
MRI cT1 is a novel MRI-based quantitative metric for assessing a composite of liver 
inflammation and fibrosis. This assessment is based on multiparametric MRI data, measuring 
relaxation time that varies based on extracellular tissue fluid attributed to inflammation and 
fibrosis, with a longer relaxation time occurring with more extracellular fluid; the measurement 
is corrected for elevated iron content, which has an opposing effect on relaxation time (Banerjee 
2014). Values for cT1 have been shown to correlate with the NAFLD Activity Score (NAS) and 
its components, as well as with degree of fibrosis by liver histology (Banerjee 2014; Dennis 
2021). A population at low risk for NAFLD was found to have values ranging from 573 to 
852 ms with a median of 666 ms and interquartile range from 643 to 694 ms, with high cT1 
values (e.g. > 875 ms) having been shown to strongly predict liver-related clinical outcomes 
(e.g., hepatic encephalopathy, variceal bleeding, ascites, death) (Mojtahed 2019). In conjunction 
with other screening assessments, a threshold of 800 ms will enrich for a NASH population with 
fibrosis; this threshold has a sensitivity of 86% and a specificity of 93% for identifying patients 
ZLWK)ILEURVLVBanerjee 2014). Stratification for values > 900 ms will ensure a balance 
between higher vs moderate baseline values between treatment groups. 
An MRI cT1 may proceed on the basis of the initial screening ALT and AST values, given all 
other eligibility criteria are met, but randomization should not occur prior to confirmation of 
ALT and AST stability as necessary, per Section 5.  


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An MRI cT1 should be performed at ET if the patient has had at least 4 weeks of dosing.   
The images will be analyzed by a central reader.  
MRI-PDFF quantifies the relative amount of water vs fat in a tissue bases on signals from proton 
groups that vary depending on tissue cell type (Caussy 2018). PDFF is expressed as a percentage 
(range from 0-100%) representing the ratio of density of mobile protons from triglycerides 
relative to total triglyceride and water mobile proton density (although there are also triglyceride 
elements that are not visible by magnetic resonance and do not contribute to PDFF 
determination). In the liver, PDFF correlates with histological assessment of hepatic steatosis, 
and PDFF has been advanced as a measure of liver fat content to assess treatment response in 
NASH studies (Caussy 2018). PDFF values correlate with NAS score on liver histology, with a 
strong correlation with steatosis (rs = 0.68, p < 0.001) (Dennis 2021). A PDFF threshold of 
generally reflects abnormal steatosis as seen in NAFLD or NASH (Szczepaniak 2005; Tang 
2013). PDFF and cT1 values have been shown to be strongly correlated with each other in 
NASH patients (rs = 0.66, p < 0.001) (Dennis 2021), but it is not yet established how values with 
these modalities may change in response to anti-inflammatory therapies such as TERN-201. 
MRI-PDFF data will be collected along with MRI cT1. 
8.2. 
Pharmacokinetics 
Plasma samples will be collected for measurement of plasma concentrations of study drug and 
metabolites as specified in the Schedule of Activities and Appendix 2. 
Urine samples will be collected for measurement of urine concentrations of study drug and 
metabolites as specified in the Schedule of Activities and Appendix 2.  
Patients in the PK/PD sub-study will undergo intensive and trough PK sample collection as 
specified in the Schedule of Activities and Appendix 2. 
Patients who are not participating in the PK/PD sub-study will undergo trough PK sampling 
only, as specified in the Schedule of Activities and Appendix 2. 
Instructions for the collection and handling of biological samples will be provided by the 
Sponsor. The actual date and time (24-hour clock time) of each sample will be recorded. 
Samples will be used to evaluate the PK of study drug and its metabolites. Samples collected for 
analyses of parent drug and metabolite concentration may also be used to evaluate safety or 
efficacy aspects related to concerns arising during or after the study. 
Parent drug and metabolite concentration information that may unblind the study will not be 
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In addition, any remaining (leftover) samples may be stored and used for optional exploratory 
future research on biomarker variants thought to play a role in NASH or to develop methods or 
assays related to the disease process or mechanism of action of the study drug.  Patients must 
provide informed consent for optional exploratory future research as specified in Section 10.1.2. 
8.3. 
Pharmacodynamics  
Plasma samples will be collected for measurement of VAP-1/SSAO activity and methylamine 
levels as specified in the Schedule of Activities and Appendix 2.  
Patients in the PK/PD sub-study will undergo intensive PD sample collection as specified in the 
Schedule of Activities and Appendix 2.  
Patients who are not participating in the PK/PD sub-study will undergo trough PD sampling only 
as specified in the Schedule of Activities and Appendix 2.   
Instructions for the collection and handling of biological samples will be provided by the 
Sponsor. The actual date and time (24-hour clock time) of each sample will be recorded.  
Samples will be used to evaluate the pharmacodynamics of study drug. Samples collected for 
analyses of study drug pharmacodynamics may also be used to evaluate safety or efficacy 
aspects related to concerns arising during or after the study.  
PD sampling information that may unblind the study will not be reported to investigative sites or 
blinded personnel until the study has been unblinded. 
In addition, any remaining (leftover) samples may be stored and used for optional exploratory 
future research on biomarker variants thought to play a role in NASH or to develop methods or 
assays related to the disease process or mechanism of action of the study drug. Patients must 
provide informed consent for optional exploratory future research as specified in Section 10.1.2. 
8.4. 
Biomarkers 
Collection of samples for biomarkers related to NASH and inflammation are also part of this 
study. The following samples will be collected from all patients in this study as specified in the 
Schedule of Activities:  
x Blood collection for the following NASH/fibrosis biomarkers: CK-18 (M30 and M65), 
PIIINP, TIMP-1, HA, PRO-C3, and C3M 
x Blood collection for the following inflammation biomarkers: hs-CRP, IL-6, ICAM-1, and 
VCAM-1 


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The following exploratory fibrosis scores may also be calculated: FIB-4, enhanced liver fibrosis 
(ELF), and NAFLD. The PRO-C3/C3M ratio may be calculated. 
In addition, any remaining (leftover) samples may be stored and used for optional exploratory 
future research on biomarker variants thought to play a role in NASH or to develop methods or 
assays related to the disease process or mechanism of action of the study drug. Patients must 
provide informed consent for optional exploratory future research as specified in Section 10.1.2. 
8.5. 
Adverse Events and Serious Adverse Events 
An AE is any untoward medical occurrence in a patient or clinical study patient, temporally 
associated with the use of study drug, whether or not considered related to the study drug.  
An SAE is defined as any untoward medical occurrence that, at any dose, results in the 
following: death; is life threatening; requires in-patient hospitalization; results in persistent 
disability or incapacity; is a congenital anomaly or birth defect; or is a medically important event 
or reaction that may not be immediately life-threatening or result in death or hospitalization but 
may jeopardize the patient or may require medical or surgical intervention to prevent one of the 
other outcomes in the definition.  
Events meeting the definition of an AE or SAE are defined in Appendix 6, including details on 
recording, reporting, and follow-up of AEs and SAEs, assessment of severity, and assessment of 
causality. AEs will be reported by the patient (or, when appropriate, by a caregiver, surrogate, or 
the patient's legally authorized representative) at every study visit. 
The Investigator and any qualified designees are responsible for detecting, documenting, and 
recording events that meet the definition of an AE or SAE and remain responsible for following 
up AEs that are serious, considered related to the study drug or study procedures, or that caused 
the patient to discontinue the study drug (see Section 7). 
8.5.1. 
Time Period and Frequency for Collecting AE and SAE Information 
After informed consent but prior to initiation of study drug, the following types of events should 
be reported: all AEs and SAEs related to protocol-mandated procedures.  
Medical occurrences (events considered not related to protocol-mandated procedures) that begin 
before the start of study drug but after obtaining informed consent will be recorded on the 
Medical History/Current Medical Conditions section of the eCRF, not the AE section. 
All AEs and SAEs, regardless of cause or relationship, will be collected from the start of study 
drug through the Follow-Up Period, at every study visit, as specified in the Schedule of 
Activities (Section 1.3). 


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All SAEs will be recorded and reported to the Sponsor or designee immediately and under no 
circumstance should this exceed 24 hours, as indicated in Appendix 6. The Investigator will 
submit any updated SAE data to the Sponsor within 24 hours of it being available. 
Investigators are not obligated to actively seek reports of AEs or SAEs after conclusion of the 
study participation. However, if the Investigator learns of any SAE, including a death, at any 
time after a patient has been discharged from the study, and he/she considers the event to be 
reasonably related to the study drug or study participation, the Investigator must promptly notify 
the Sponsor. 
8.5.2. 
Method of Detecting AEs and SAEs 
The method of recording, evaluating, and assessing causality of AEs and SAEs and the 
procedures for completing and transmitting SAE reports are provided in Appendix 6. 
Care will be taken not to introduce bias when detecting AEs and/or SAEs. Open-ended and 
non-leading verbal questioning of the patient is the preferred method to inquire about 
AE occurrences. 
8.5.3. 
Follow-up of AEs and SAEs 
After the initial AE and/or SAE report, the Investigator is required to proactively follow each 
patient at subsequent visits/contacts. All SAEs will be followed until resolution, stabilization, the 
event is otherwise explained, or the patient is lost to follow-up (as defined in Section 7.3). 
Further information on follow-up procedures is provided in Appendix 6. 
8.5.4. 
Regulatory Reporting Requirements for SAEs 
Prompt notification by the Investigator to the Sponsor of a SAE is essential so that legal 
obligations and ethical responsibilities towards the safety of patients and the safety of a study 
drug under clinical investigation can be met. 
The Sponsor has a legal responsibility to notify both the local regulatory authority and other 
regulatory agencies about the safety of a study drug under clinical investigation. The Sponsor 
will comply with country-specific regulatory requirements relating to safety reporting to the 
regulatory authority, IRB/IEC, and Investigators. 
Investigator safety reports must be prepared for SUSARs according to local regulatory 
requirements and sponsor policy and forwarded to Investigators as necessary. 
An Investigator who receives an investigator safety report describing a SAE or other specific 
safety information (e.g., summary or listing of SAEs) from the sponsor will review and then file 


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it along with the Investigator’s Brochure and will notify the IRB/IEC, if appropriate according to 
local requirements. 
8.5.5. 
Pregnancy 
Details of all pregnancies in female patients and female partners of male patients will be 
collected after the start of study drug until 30 days following the last dose of the study drug. 
If a pregnancy is reported, the Investigator should inform the Sponsor within 24 hours of 
learning of the pregnancy and should follow the procedures outlined in Appendix 6 and 
Appendix 7. 
Abnormal pregnancy outcomes (e.g., spontaneous abortion, fetal death, stillbirth, congenital 
anomalies, ectopic pregnancy) are considered SAEs. 
8.6. 
Treatment of Overdose 
Overdose with this product has not been reported. Neither the effect of overdose nor antidote are 
known. The maximum amount of TERN-201 that can be safely administered in a single dose has 
not been determined. The highest single dose of TERN-201 capsules in clinical studies was 
10 mg. Patients who receive higher than the protocol-defined dose should be carefully monitored 
for adverse events, and the quantity of the excess dose and duration of excess dose should be 
documented in the eCRF; the Medical Monitor should be notified immediately. Refer to 
Appendix 6 for additional information on AE reporting.  
In an instance in which a patient receives higher than the protocol-defined dose, decisions 
regarding any future dosing of study drug will be made by the Investigator in consultation with 
the Sponsor based on the clinical evaluation of the patient. 


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9. 
Statistical Considerations 
9.1. 
Statistical Hypotheses 
The primary objective of the study is to evaluate the safety and tolerability of orally administered 
TERN-201. No statistical hypothesis testing will be applied. 
9.2. 
Sample Size Determination 
The sample size is based on clinical feasibility and adequate size to characterize safety in the 
study population, without consideration for statistical power.   
Patients who are randomized but do not receive study drug for any reason may be replaced. 
Patients who discontinue treatment early for reasons other than safety (e.g., withdrawal of 
consent, lost to follow-up, patient relocated) may also be replaced. Replacement patients will 
receive the same treatment assignment as the patient that discontinued treatment early.   
9.3. 
Analysis Sets 
The following analysis sets are defined: 
Analysis Sets 
Description 
Randomized 
All patients who are randomized into any one of the 
treatment groups 
PK 
All randomized patients who received at least 1 dose of 
TERN-201 and have evaluable PK data 
PD 
All randomized patients who received at least 1 dose of study 
drug (TERN-201 or placebo) and have evaluable PD data 
Safety 
All patients who received at least 1 dose of study drug. 
Patients will be analyzed according to the intervention they 
actually received. 
Efficacy Analysis Set  
All randomized patients who received at least 1 dose of study 
drug. Patients will be analyzed according to the intervention 
they are planned to receive. 
Per Protocol Analysis Set (PP)  All randomized patients who have completed the study 
without any major protocol deviations. The major protocol 
deviations will be defined in the Statistical Analysis Plan 
(SAP) and finalized prior to database lock (DBL). A separate 
completer analysis set may also be defined in the SAP.  
 


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A patient is considered to have completed the study if he/she has completed all phases of the 
study including the last scheduled assessment in the Follow-Up Period. 
9.4. 
Statistical Analyses 
This section presents a summary of the planned statistical analyses. The SAP will provide the 
details and will be finalized prior to clinical database lock. 
9.4.1. General Considerations 
For continuous data, summary statistics will include the arithmetic mean, arithmetic standard 
deviation, median, minimum, maximum, and number of patients with non-missing assessments. 
For log-normal data (e.g., the PK parameters: AUCs and maximum observed concentration 
[Cmax]), the geometric mean and coefficient of variation (CV%) will also be presented. For 
categorical data, frequency counts and percentages will be presented.   
9.4.2. 
Primary Endpoint(s) 
The primary safety parameters will include TEAEs and treatment emergent clinical safety 
laboratory parameters.  
Reported AEs will be coded using the latest version of Medical Dictionary for Regulatory 
Activities (MedDRA) and graded for severity according to NCI CTCAE, Version 5.0.  
All TEAEs will be listed and incidence summarized by MedDRA Preferred Term and System 
Organ Class, as well as by maximum severity and study drug causality. Summaries of treatment 
emergent SAEs, TEAEs related to study drug, TEAEs resulting in study drug discontinuations, 
and deaths will also be produced. 
Changes and percent changes from baseline of quantitative measurements will be summarized by 
treatment group and timepoints. Laboratory abnormalities will be graded according to NCI 
CTCAE Version 5.0, where applicable. Shifts in CTCAE grade from baseline will be 
summarized by treatment group.  
Further details on the analysis of additional safety parameters will be provided in the SAP. 
9.4.3. 
Secondary Endpoints 
9.4.3.1. 
Pharmacokinetic Endpoints 
Noncompartmental PK analysis will be performed on individual plasma and urine concentration 
data. 


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Individual plasma concentrations of TERN-201 and its metabolites, if applicable, will be listed 
by timepoint and summarized by treatment group. Individual and mean concentration-time 
profiles will be presented graphically in linear and semi-log scales.  
PK parameters of TERN-201 and its metabolites (exploratory endpoint) will be listed 
individually and summarized with descriptive statistics, including arithmetic and geometric 
mean, median, standard deviation, arithmetic and geometric CV%, minimum and maximum. The 
Cmax and AUC will be plotted. 
9.4.3.2. 
Change from Baseline in Plasma VAP-1/SSAO Activity 
A secondary efficacy endpoint is change from baseline in plasma VAP-1/SSAO activity with 12 
weeks of treatment in patients treated with either TERN-201 or matching placebo. The change 
and percent change from baseline in plasma VAP-1/SSAO amine oxidase activity in each 
TERN-201 group will be compared with placebo separately at each post baseline visit, without 
controlling for any family-wise error rate (overall type I error), using MMRM (mixed model 
repeated measures) model with treatment group, visit, and treatment group by visit interaction as 
factors and baseline value as covariate. 
Change and percent change from baseline plasma VAP-1/SSAO amine oxidase activity will be 
listed and summarized with descriptive statistics including arithmetic and geometric mean, 
median, standard deviation, arithmetic and geometric CV, minimum, and maximum. Exposure-
response and dose-response relationships of orally administered TERN-201 will also be assessed 
as applicable (exploratory endpoints). 
Exposure-response and dose-response analysis may be produced if Part 2 of the study is enrolled, 
as applicable. The change and percent change from baseline in plasma VAP-1/SSAO activity 
will be compared between the different TERN-201 dose groups and placebo using an analysis of 
covariance (ANCOVA) model with the treatment group as a factor and baseline values as a 
covariate. Corresponding least square mean treatment differences with 2 sided 95% confidence 
limits will be computed for each pairwise comparison.  
Further details on the analysis models will be provided in the SAP. 
9.4.4. 
Exploratory Endpoints 
Descriptive statistics for the values, change from baseline, and percent change from baseline will 
be summarized by treatment group over time.  


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The following exploratory endpoints will be analyzed at each visit using an MMRM model 
similar to the model described in Section 9.4.3.1. Exposure-response and dose-response analysis 
may be produced if Part 2 of the study is enrolled, as applicable.  
x Change from baseline in cT1 by MRI 
x Change from baseline in liver fat content by MRI-PDFF 
x Change from baseline in stiffness by transient elastography  
x Change from baseline in ALT  
x Change from baseline in GGT  
x Change from baseline in AST 
x Change from baseline in NASH and fibrosis biomarkers 
x Change from baseline in inflammatory biomarkers 
x Change from baseline in eGFR, urine protein, UPCR, and UACR  
x Change from baseline in plasma methylamine levels (PD marker of VAP-1/SSAO 
inhibition) 
9.4.4.1. 
PD Endpoints 
In addition to analyses described above, pharmacodynamic parameters (plasma VAP-1/SSAO 
activity and plasma methylamine levels) will be listed, summarized, and described by plotting 
the concentration-time curve or time-effect curve. The correlation of PK and PD parameters will 
also be explored.  
9.5. 
Interim Analysis 
An interim analysis will be performed after all patients in Part 1 have completed Week 6 
assessments. Interim PD data will be assessed as described in Section 9.4.4.1. If robust VAP-
1/SSAO activity suppression is observed and available PK suggests that a lower dose may also 
possibly lead to robust VAP-1/SSAO activity suppression, enrollment in Part 2 with 4 mg 
TERN-201 may be initiated. Additionally, if safety data indicates 10 mg TERN-201 is overall 
safe and well-tolerated and anticipated exposures with a higher dose remain below the exposure 
limit (see Section 4.3), enrollment in Part 2 to assess a dose up to 20 mg TERN-201 in Part 2 
may be initiated. 


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Additionally, an administrative interim analysis may be conducted after the completion of Part 1 
of the study and will be detailed in the SAP. 


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10. 
Regulatory, Ethical, and Study Oversight Considerations  
10.1. 
Regulatory and Ethical Considerations 
This study will be conducted in accordance with the protocol and with the following: 
x Consensus ethical principles derived from international guidelines including the 
Declaration of Helsinki and Council for International Organizations of Medical Sciences 
(CIOMS) International Ethical Guidelines 
x Applicable International Council for Harmonisation (ICH) Good Clinical Practice 
(GCP) Guidelines 
x Applicable laws and regulations 
The protocol, protocol amendments, ICF, Investigator Brochure, and other relevant documents 
(e.g., advertisements) must be submitted to an IRB/IEC by the Investigator and reviewed and 
approved by the IRB/IEC before the study is initiated. 
Any amendments to the protocol will require IRB/IEC approval before implementation of 
changes made to the study design, except for changes necessary to eliminate an immediate 
hazard to study patients. 
The Investigator will be responsible for the following: 
x Providing written summaries of the status of the study to the IRB/IEC annually or more 
frequently in accordance with the requirements, policies, and procedures established by 
the IRB/IEC 
x Notifying the IRB/IEC of SAEs or other significant safety findings as required by 
IRB/IEC procedures 
x Providing oversight of the conduct of the study at the site and adherence to requirements 
of 21 Code of Federal Regulations (CFR), ICH guidelines, the IRB/IEC, European 
regulation 536/2014 for clinical studies (if applicable), and all other applicable local 
regulations 
10.1.1. 
Financial Disclosure 
Investigators and Sub-Investigators will provide the sponsor with sufficient, accurate financial 
information as requested to allow the sponsor to submit complete and accurate financial 
certification or disclosure statements to the appropriate regulatory authorities. Investigators are 
responsible for providing information on financial interests during the course of the study and for 
1 year after completion of the study. 


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10.1.2. 
Informed Consent Process 
The Investigator or his/her representative will explain the nature of the study to the patient or 
his/her legally authorized representative and answer all questions regarding the study. 
Patients must be informed that their participation is voluntary. Patients or their legally authorized 
representative will be required to sign a statement of informed consent that meets the 
requirements of 21 CFR 50, local regulations, ICH guidelines, Health Insurance Portability and 
Accountability Act (HIPAA) requirements, where applicable, and the IRB/IEC or study center. 
The medical record must include a statement that written informed consent was obtained before 
the patient was enrolled in the study and the date the written consent was obtained. The 
authorized person obtaining the informed consent must also sign the ICF. 
Patients must be re-consented to the most current version of the ICF(s) during their participation 
in the study. 
A copy of the ICF(s) must be provided to the patient or the patient’s legally authorized 
representative. 
The ICF will contain a separate section that addresses the use of remaining mandatory samples 
for optional exploratory research for up to 15 years after the end of the study. The Investigator or 
authorized designee will explain to each patient the objectives of the exploratory research. 
Patients will be told that they are free to refuse to participate and may withdraw their consent at 
any time and for any reason during the storage period. A separate signature will be required to 
document a patient's agreement to allow any remaining specimens to be used for exploratory 
research. Patients who decline to participate in this optional research will not provide this 
separate signature. 
Written informed consent may be obtained via telephone with appropriate documentation of how 
the informed consent form was transmitted to the patient, (such as via email, fax, or mail) and 
how signature was obtained. Screening may be initiated via telephone to avoid a visit to the site 
if the patient is disqualified based on medical history. 
10.1.3. 
Data Protection 
Patients will be assigned a unique identifier by the sponsor. Any patient records or datasets that 
are transferred to the sponsor will contain the identifier only; patient names or any information 
which would make the patient identifiable will not be transferred. 
The patient must be informed that his/her personal study-related data will be used by the sponsor 
in accordance with local data protection law. The level of disclosure must also be explained to 


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the patient who will be required to give consent for their data to be used as described in the 
informed consent.  
The patient must be informed that his/her medical records may be examined by Clinical Quality 
Assurance auditors or other authorized personnel appointed by the sponsor, by appropriate 
IRB/IEC members, and by inspectors from regulatory authorities. 
10.1.4. 
Dissemination of Clinical Study Data 
A clinical study report (CSR) will be prepared and provided to the regulatory agency(ies) by 
Terns, as appropriate. Terns will ensure that the report meets the standards set out in the ICH 
Guideline for Structure and Content of Clinical Study Reports (ICH E3). Note that an 
abbreviated report may be prepared in certain cases. Public disclosure of study results will be in 
accordance with all applicable laws and ICH guidelines. The posting of company-sponsored 
study information and tabular study results may be presented on the US National Institutes of 
Health’s website www.ClinicalTrials.gov and other publicly accessible sites. 
10.1.5. 
Data Quality Assurance 
All patient data relating to the study will be recorded on printed or electronic CRF unless 
transmitted to the sponsor or designee electronically (e.g., laboratory data). The Investigator is 
responsible for verifying that data entries are accurate and correct by physically or electronically 
signing the CRF. 
The Investigator must maintain accurate documentation (source data) that supports the 
information entered in the eCRF. 
The Investigator must permit study-related monitoring, audits, IRB/IEC review, and regulatory 
agency inspections and provide direct access to source data documents. 
Monitoring details describing strategy (e.g., risk-based initiatives in operations and quality such 
as Risk Management and Mitigation Strategies and Analytical Risk-Based Monitoring), methods, 
responsibilities and requirements, including handling of noncompliance issues and monitoring 
techniques (central, remote, or on-site monitoring) are available in the Monitoring Plan and site-
specific contracts.  
The sponsor or designee is responsible for the data management of this study including quality 
checking of the data. 
The sponsor assumes accountability for actions delegated to other individuals (e.g., Contract 
Research Organizations). 


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Study monitors will perform ongoing source data verification to confirm that data entered into 
the eCRF by authorized site personnel are accurate, complete, and verifiable from source 
documents; that the safety and rights of patients are being protected; and that the study is being 
conducted in accordance with the currently approved protocol and any other study agreements, 
ICH GCP, and all applicable regulatory requirements. 
Records and documents, including signed ICFs, pertaining to the conduct of this study must be 
retained by the Investigator until at least 2 years after the last approval of a marketing application 
in an ICH region (i.e., United States, Europe, or Japan) and until there are no pending or 
contemplated marketing applications in an ICH region (i.e., United States, Europe, or Japan) or 
at least 2 years have elapsed since the formal discontinuation of clinical development of the 
investigational product. These documents should be retained for a longer period however if 
required by the applicable regulatory requirement(s) or if needed by the sponsor. No records may 
be destroyed during the retention period without the written approval of the sponsor. No records 
may be transferred to another location or party without written notification to the sponsor. 
10.1.6. 
Protocol Deviations 
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as 
protocol waivers or exemptions, is not permitted. In the event of a significant deviation related to 
gross non-compliance from the protocol, or events that impose significant risk to patient safety, 
the Investigator or designee must notify the Sponsor or designee immediately. Deviations must 
be documented in accordance with the Sponsor’s procedures, and in accordance with any site 
procedures or processes.  
10.1.7. 
Source Documents 
Source documents provide evidence for the existence of the patient and substantiate the integrity 
of the data collected. Source documents are stored at the Investigator’s site. 
Data reported on the eCRF or entered in the eCRF that are transcribed from source documents 
must be consistent with the source documents or the discrepancies must be explained. The 
Investigator may need to request previous medical records or transfer records, depending on the 
study.  
The required source data should include notes containing at least the following information for 
each patient:  
x Patient identification (name, date of birth, gender) 
x Documentation that the patient meets eligibility criteria 


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x Documentation of the reason(s) a consented patient is not enrolled 
x Participation in study (including study number) 
x Study discussed and date of informed consent 
x Dates of all visits 
x Documentation that protocol specific procedures were performed 
x Results of efficacy parameters, as required by the protocol 
x Start and end date (including dose regimen) of study drug administration, including dates 
of dispensation and return as applicable 
x Record of all adverse events and other safety parameters (start and end date, and 
including causality and severity) 
x Concomitant medication (including start and end date, dose if relevant; dose changes) 
x Date of study completion and reason for early discontinuation, if applicable  
10.1.8. 
Study and Site Start and Closure 
The first patient screened is considered the first act of recruitment and will be the study start 
date. 
The sponsor or designee reserves the right to close the study site or terminate the study at any 
time for any reason at the sole discretion of the sponsor. Study sites will be closed upon study 
completion. A study site is considered closed when all required documents and study supplies 
have been collected and a study-site closure visit has been performed. 
The Investigator may initiate study-site closure at any time, provided there is reasonable cause 
and sufficient notice is given in advance of the intended termination. 
Reasons for the early closure of a study site by the sponsor or Investigator may include but are 
not limited to: 
x 
Failure of the Investigator to comply with the protocol, the requirements of the IRB/IEC 
or local health authorities, the sponsor's procedures, or GCP guidelines 
x 
Inadequate recruitment of patients by the Investigator 
x 
Discontinuation of further study drug development 
If the study is prematurely terminated or suspended, the sponsor shall promptly inform the 
Investigators, the IECs/IRBs, the regulatory authorities, and any contract research 


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organization(s) used in the study of the reason for termination or suspension, as specified by the 
applicable regulatory requirements. The Investigator shall promptly inform the patient and 
should assure appropriate follow-up care as warranted by the protocol or as medically necessary. 


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Appendix 1: Clinical Laboratory Tests 
The tests detailed in Table 2 will be performed by the central laboratory. Local laboratory testing 
should only be used in the event that central laboratory results would not available in time for 
necessary clinical decision making. If a local sample is required, it is important that a sample for 
central analysis is obtained at the same time. Additionally, if the local laboratory results are used 
to make either a study drug decision or response evaluation, the results must be entered into the 
eCRF. 
Protocol-specific requirements for inclusion or exclusion of patients are detailed in Section 5. 
Additional tests may be performed at any time during the study as determined necessary by the 
Investigator or required by local regulations. 
Table 2 
Protocol-Required Clinical Laboratory Assessments 
Laboratory 
Assessments 
Parameters 
Hematology 
Hematocrit 
Hemoglobin 
Hemoglobin A1c1 
Platelet Count 
RBC Count 
RBC Indices:  
x MCV 
x MCH 
x MCHC 
x % Reticulocytes 
WBC count with Differential: 
x Neutrophils 
x Lymphocytes 
x Monocytes 
x Eosinophils 
x Basophils 
Clinical 
Chemistry2 
Bicarbonate 
BUN 
Calcium 
Chloride 
CPK 
Creatinine 
eGFR3 
Glucose  
Phosphorus  
Potassium 
Sodium 
Liver Function Tests:  
x ALT 
x Albumin 
x AST 
x ALP 
x GGT 
x Total and Direct Bilirubin4 


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Laboratory 
Assessments 
Parameters 
Total Protein 
Coagulation5 
aPTT1 
PT/INR  
Fasting Lipid 
Profile 
HDL 
LDL 
Total Cholesterol 
Triglycerides  
VLDL 
Urinalysis 
x Specific gravity 
x pH, glucose, protein, albumin, creatinine, blood, ketones, bilirubin, 
urobilinogen, nitrite, leukocyte esterase by dipstick, UPCR, and UACR 
x Microscopic examination (if blood or protein is abnormal) 
Pregnancy  
Highly sensitive sHUXPȕ-hCG (WOCBP only) 
Other Tests 
x FSH (to confirm post-menopausal status)1 
x Blood alcohol test1 
x Urine drug screen including amphetamines, barbiturates, cocaine, 
opiates, cannabinoids and benzodiazepines 
x Serology1: HIV antibody, HBsAg, and HCV antibody6 
x COVID-19: SARS-CoV-2 test for active infection (e.g., molecular test 
such as PCR or viral antigen serology), and SARS-CoV-2 Ab test (IgG 
and IgM) 
NOTES: 
1 Only collected at Screening. 
2 Details of liver chemistry increased monitoring criteria are given in Appendix 3.  
3 eGFR to be calculated by central lab; refer to Appendix 5 for the formula. 
4 If total bilirubin is increased above the upper limit of normal there should be a reflex to direct and indirect 
bilirubin, as outlined in Appendix 3. 
5 At Screening, Week 0, and if significant abnormal liver function is observed, as outlined in Appendix 3. 
6 If HCV antibody positive, conduct HCV RNA test.  
Abbreviations: ALP = alkaline phosphatase; ALT = alanine transaminase; AST = aspartate transaminase; aPTT = 
activated partial thromboplastin time; ȕ-K&* ȕ-human chorionic gonadotropin; BUN = blood urea nitrogen; 
CPK = creatine phosphokinase; eGFR = estimated glomerular filtration rate; FSH = Follicle-stimulating hormone 
GGT = gamma-glutamyl transpeptidase; HbA1c = hemoglobin A1c; HBsAg = hepatitis B surface antigen; HCG = 
human chorionic gonadotropin; HCV = hepatitis C virus; HDL = high-density lipoprotein; HIV = human 
immunodeficiency virus; IgG = immunoglobulin G; IgM = immunoglobulin M; INR = international normalized 
ratio; LDL = low-density lipoprotein; MCH = mean corpuscular hemoglobin; MCHC = mean corpuscular 
hemoglobin concentration; MCV = mean corpuscular volume; PCR = polymerase chain reaction; PT = 


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prothrombin time; RBC = red blood cell; RNA = ribonucleic acid; SARS-CoV-2 = Severe Acute Respiratory 
Syndrome Coronavirus 2; UACR = urine albumin:creatinine ratio; UPCR = urine protein:creatinine ratio; VLDL 
= very low-density lipoprotein; WBC = white blood cell; WOCBP = women of childbearing potential 
Investigators must document their review of each laboratory safety report. Clinically significant 
laboratory shifts, or any clinically significant abnormalities considered possibly related to study 
drug in the opinion of the Investigator, should be repeated within 48-72 hours and followed to 
resolution or until stable. 
 


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Appendix 2: Sample Collection for Pharmacokinetics and Pharmacodynamics  
Table 3 presents a description of PK/PD sample requirements at each study visit and timepoint. 
Table 3 
PK/PD Sampling Timepoints  
Week 
Day 
Timepoint  
01 
1 
x Pre-dose (All Patients) 
x Post dose at the following timepoints (PK/PD sub-study only): 
o 30 ± 2 minutes 
o 1 hour ± 5 minutes 
o 2 hours ± 5 minutes 
o 4 hours ± 15 minutes 
o 6 hours ± 15 minutes 
o 8 hours ± 30 minutes 
x Total urine collection from 0-8 hours post dose (PK/PD sub-study 
only) 
0 
2 
x Post Day 1 dose at the following timepoint (PK/PD sub-study 
only): 
o 24 hours ± 1 hour 
2 
15 ± 3 
x Pre-dose (All Patients) 
4 
29 ± 3 
x Pre-dose (All Patients) 
6 
43 ± 3 
x Pre-dose (All Patients) 
x Post dose at the following timepoints (PK/PD sub-study only): 
o 30 ± 2 minutes 
o 1 hour ± 5 minutes 
o 2 hours ± 5 minutes 
o 4 hours ± 15 minutes 
o 6 hours ± 15 minutes 
o 8 hours ± 30 minutes 
x Total urine collection from 0-8 hours post dose (PK/PD sub-study 
only) 
6 
44 
x Post Week 6 dose at the following timepoint (PK/PD sub-study 
only): 
o 24 hours ± 1 hour 
8 
57 ± 3 
x Pre-dose (All Patients) 


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Week 
Day 
Timepoint  
12 
85 ± 3 
x Pre-dose (All Patients) 
x Post dose at the following timepoints (PK/PD sub-study only): 
o 30 ± 2 minutes 
o 1 hour ± 5 minutes 
o 2 hours ± 5 minutes 
o 4 hours ± 15 minutes 
o 6 hours ± 15 minutes 
o 8 hours ± 30 minutes 
12 
86  
x Post Week 12 dose at the following timepoint (PK/PD sub-study 
only): 
o 24 hours ± 1 hour 
12 
87  
x Post Week 12 dose at the following timepoint (PK/PD sub-study 
only): 
o 48 hours ± 2 hours 
12 
88  
x Post Week 12 dose at the following timepoint (PK/PD sub-study 
only): 
o 72 hours ± 4 hours 
ET 
ET 
x At the ET Visit, for all patients discontinuing the study at any time 
for any reason prior to Week 12 
NOTES:  
1 sVAP-1 will be collected along with PD sampling at Week 0/Day 1 pre-dose.   
Abbreviations: ET = early termination; PD = pharmacodynamics; PK = pharmacokinetics; sVAP-1 = soluble 
vascular adhesion protein-1 
 


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Appendix 3: Liver Chemistry Increased Monitoring Criteria 
Table 4 summarizes requirements for follow-up of liver function test abnormalities. 
Table 4 
Liver Chemistry Increased Monitoring Criterion and Follow-Up 
Criterion 
Actions 
Elevated ALT and/or AST above 2 × 
Baseline or above 5 × ULN for < 1 
week 
x Patient can continue study drug at the discretion 
of the Investigator 
x Repeat measurement of LFTs (including ALT, 
AST, ALP, and total bilirubin) will be performed 
within 48-72 hours to confirm the abnormalities 
and to determine if they are increasing or 
decreasing. If total bilirubin is increased there 
should be a reflex to direct and indirect bilirubin.  
x PT/INR and albumin will be tested when 
significantly abnormal liver function is observed, 
and repeated with repeat measurement of LFTs. 
x Upon confirmation of elevated LFTs, close 
observation by repeating LFTs every 24 to 72 
hours will be initiated immediately.  
x Frequency of monitoring can be decreased as 
LFTs decrease at the Investigator’s discretion.  
x The Investigator will collect detailed history 
information on concomitant symptoms, new 
medications, drug or alcohol exposure, etc., to 
identify possible cause of abnormal LFTs.  
x Close observation on abnormal LFTs will last 
until the parameters return to baseline, or to a 
stable level judged by the Investigator.   
Note: If one of the following situations occurs and is considered related to the study drug without 
alternative etiology, study drug may be discontinued at the discretion of the Investigator and the 
Medical Monitor should be informed (with repeat test performed within 48-72 hours once initial 
abnormality is detected):  
x 
ALT or AST > 8 × ULN  
x 
ALT or AST > 5 × ULN for more than 1 week  
x 
ALT or AST > 2× Baseline with the appearance of fatigue, nausea, vomiting, right upper quadrant 
pain or tenderness, fever, rash, and/or eosinophilia (> 5%) 
x 
ALT or AST > 2 × Baseline and total bilirubin > 2 × ULN or INR >1.5 for more than 1 week, 
confirmed with a repeat assessment 
Abbreviations: ALP = alkaline phosphatase; ALT = alanine transaminase; AST = aspartate transaminase; INR = 
international normalized ratio; LFT = liver function test; PT = prothrombin time; ULN = upper limit of normal  
 
 


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Appendix 4: Fridericia’s Formula 
A single 12-lead ECG will be obtained as outlined in the Schedule of Activities (see Section 1.3) 
using an ECG machine that automatically calculates the heart rate and measures PR, QRS, and 
QT intervals. QTc will be calculated using Fridericia’s Formula as outlined below.  
The Investigator will review the ECGs for any clinically significant abnormalities.  
Fridericia’s Formula:  
QTcF = QT/(RR^0.33) 
http://www.thecalculator.co/health/QTc-Calculator-385.html 
 
 


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Appendix 5: Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 
Formula to Estimate Glomerular Filtration Rate  
 
GFR = 141 × min(ScrțĮ × max(Scrț-1.209 × 0.993Age × 1.018 [if female] × 1.159 [if black] 
 
Abbreviations / Units:  
SCr (standardized serum creatinine) = mg/dL 
ț IHPDOHVRUPDOHV 
Į -0.329 (females) or -0.411 (males) 
PLQ LQGLFDWHVWKHPLQLPXPRI6&UțRU 
PD[ LQGLFDWHVWKHPD[LPXPRI6&Uț or 1 
age = years 
 
 


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Appendix 6: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-up, and Reporting 
AE Definition 
x An AE is any untoward medical occurrence in a patient or clinical study patient, 
temporally associated with the use of study drug, whether or not considered related to 
the study drug. 
x NOTE: An AE can therefore be any unfavorable and unintended sign (including an 
abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally 
associated with the use of study drug. 
 
Events Meeting the AE Definition 
x Any safety assessment (e.g., ECG, radiological scans, vital signs measurements), 
including those that worsen from baseline, considered clinically significant in the 
medical and scientific judgment of the Investigator (i.e., not related to progression of 
underlying disease). 
x A clinical condition or symptom associated with an abnormal laboratory test result 
(e.g., hematology, clinical chemistry, or urinalysis). An abnormal laboratory test that is 
not accompanied with other signs or symptoms should not be reported as an AE.  
x Exacerbation of a chronic or intermittent pre-existing condition including either an 
increase in frequency and/or severity of the condition. 
x New conditions detected or diagnosed after study drug administration even though it 
may have been present before the start of the study. 
x Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction. 
x Signs, symptoms, or the clinical sequelae of a suspected overdose of either study drug 
or a concomitant medication. Overdose per se will not be reported as an AE/SAE 
unless it is an intentional overdose taken with possible suicidal/self-harming intent. 
Such overdoses should be reported regardless of sequelae. 
 


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Events NOT Meeting the AE Definition 
x Abnormal laboratory findings or other abnormal safety assessments that are associated 
with an underlying disease present at baseline without worsening, unless judged by the 
Investigator to be more severe than expected for the patient’s condition. 
x An abnormal laboratory test that is not accompanied with other signs or symptoms. 
x The disease/disorder being studied or signs, or symptoms of the disease/disorder being 
studied, unless more severe than expected for the patient’s condition. 
x Medical or surgical procedure (e.g., endoscopy, appendectomy): the condition that 
leads to the procedure is the AE. 
x Situations in which an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital). 
x Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present or 
detected at the start of the study that do not worsen. 
Definition of SAE 
An SAE is an AE that meets the following criteria: 
An SAE is defined as any untoward medical occurrence that, at any dose: 
a. Results in death 
b. Is life-threatening 
The term 'life-threatening' in the definition of 'serious' refers to an event in which the patient 
was at risk of death at the time of the event. It does not refer to an event, which hypothetically 
might have caused death, if it were more severe. 
c. 
Requires inpatient hospitalization or prolongation of existing hospitalization 
x In general, hospitalization signifies that the patient has been detained (usually 
involving at least an overnight stay) at the hospital or emergency ward for observation 
and/or treatment that would not have been appropriate in the physician’s office or 
outpatient setting. Complications that occur during hospitalization are AEs. If a 
complication prolongs hospitalization or fulfills any other serious criteria, the event is 
serious. When in doubt as to whether “hospitalization” occurred or was necessary, the 
AE should be considered serious. 
x Hospitalization for elective treatment of a pre-existing condition that did not worsen 
from baseline is not considered an AE. 
d. Results in persistent disability/incapacity 


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x The term disability means a substantial disruption of a person’s ability to conduct 
normal life functions. 
x This definition is not intended to include experiences of relatively minor medical 
significance such as uncomplicated headache, nausea, vomiting, diarrhea, influenza, 
and accidental trauma (e.g., sprained ankle) which may interfere with or prevent 
everyday life functions but do not constitute a substantial disruption. 
e. 
Is a congenital anomaly/birth defect 
f. 
Other situations: 
x Medical or scientific judgment should be exercised in deciding whether SAE reporting 
is appropriate in other situations such as important medical events that may not be 
immediately life-threatening or result in death or hospitalization but may jeopardize the 
patient or may require medical or surgical intervention to prevent one of the other 
outcomes listed in the above definition. These events should usually be considered 
serious. 
x 
Examples of such events include invasive or malignant cancers, intensive treatment in 
an emergency room or at home for allergic bronchospasm, blood dyscrasias or 
convulsions that do not result in hospitalization, or development of drug dependency or 
drug abuse. 
If an event does not meet the AE definition, then it cannot be an SAE even if serious conditions 
are met (e.g., hospitalization for signs/symptoms of the disease under study, death due to 
progression of disease). 
Recording and Follow-Up of an AE and/or SAE 
AE and SAE Recording 
x When an AE and/or SAE occurs, it is the responsibility of the Investigator to review all 
documentation (e.g., hospital progress notes, laboratory reports, and diagnostics 
reports) related to the event. 
x The Investigator will then record all relevant AE and/or SAE information in the eCRF. 
x It is not acceptable for the Investigator to send photocopies of the patient’s medical 
records to the Sponsor or designee in lieu of completion of the AE or SAE eCRF. 
x There may be instances when copies of medical records for certain cases are requested 
by the Sponsor or designee. In this case, all patient identifiers, with the exception of 
the patient number, will be redacted on the copies of the medical records before 
submission to the Sponsor or designee. 


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x The Investigator will attempt to establish a diagnosis of the event based on signs, 
symptoms, and/or other clinical information. Whenever possible, the diagnosis (not the 
individual signs/symptoms) will be documented as the AE and/or SAE. 
Assessment of Severity  
The Investigator will be asked to provide an assessment of the severity of the AE using NCI 
CTCAE v5.0 categories as follows:  
x Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations 
only; intervention not indicated.  
x Grade 2: Moderate; minimal, local, or noninvasive intervention indicated; limiting age 
appropriate instrumental ADL.  
x Grade 3: Severe or medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; disabling; limiting self-
care ADL.  
x Grade 4: Life-threatening consequences; urgent intervention indicated.  
x Grade 5: Death related to AE. 
For detailed organ system AE severity grading, please refer to NCI CTCAE v5.0:  
https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_8.5x11.pdf 
 
Assessment of Causality 
x The Investigator is obligated to assess the relationship between study drug and each 
occurrence of each AE and/or SAE. 
x The Investigator (or designee) will make a determination of the relationship of the AE 
to the study drug using a 4-category system according to the following guidelines:  
o Not Related: The AE is definitely caused by the subject’s clinical state or the 
study procedure/conditions.  
o Unlikely Related: The temporal association between the AE and the drug is 
such that the drug is not likely to have any reasonable association with the AE.  
o Possibly Related: The AE follows a reasonable temporal sequence from the 
time of drug administration but could have been produced by the subject’s 
clinical state or the study procedures/conditions.  
o Related: The AE follows a reasonable temporal sequence from administration 
of the drug, abates upon discontinuation of the drug, follows a known or 
hypothesized cause effect relationship, and (if appropriate) reappears when the 
drug is reintroduced. 
x For each AE and/or SAE, the Investigator must document in the medical notes that 
he/she has reviewed the AE and/or SAE and has provided an assessment of causality. 
x There may be situations in which an SAE has occurred and the Investigator has 
minimal information to include in the initial report to the Sponsor or designee. 
However, it is very important that the Investigator always make an assessment of 


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causality for every event before the initial transmission of the SAE data to the Sponsor 
or designee. 
x The Investigator may change his/her opinion of causality in light of follow-up 
information and send a SAE follow-up report with the updated causality assessment. 
x The causality assessment is one of the criteria used when determining regulatory 
reporting requirements. 
Follow-up of AEs and SAEs 
x The Investigator is obligated to perform or arrange for the conduct of supplemental 
measurements and/or evaluations as medically indicated or as requested by the 
Sponsor or designee to elucidate the nature and/or causality of the AE or SAE as fully 
as possible. This may include additional laboratory tests or investigations, 
histopathological examinations, or consultation with other health care professionals. 
x If a patient dies during participation in the study or during a recognized follow-up 
period, the Investigator will provide the Sponsor or designee with a copy of any 
post-mortem findings including histopathology.  
x New or updated information will be recorded in the originally completed CRF. 
x The Investigator will submit any updated SAE data to the Sponsor or designee within 
24 hours of receipt of the information. 
Reporting of SAEs 
SAE Reporting to Sponsor or designee via Paper CRF 
x Email transmission of the SAE paper Report Form is the preferred method to transmit 
this information to the CATO Safety Group (Terns-PhV@cato-sms.com). 
x Notification by facsimile transmission to the CATO Safety Group is also acceptable 
(919-361-2536) 
x Initial notification via telephone or email does not replace the need for the Investigator 
to complete, sign, and return the SAE report form within the designated reporting time 
frames. 
x Contacts and additional instructions for SAE reporting can be found in in the Study 
Procedures Manual provided.  
 
 


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Appendix 7: Contraceptive Guidance and Collection of Pregnancy 
Information 
Definitions: 
Woman of Childbearing Potential (WOCBP) 
A woman is considered fertile following menarche and until becoming post-menopausal unless 
permanently sterile (see below).  
Women in the following categories are not considered WOCBP 
1. Premenopausal female with surgical sterility defined as 1 of the following: 
x Documented hysterectomy 
x Documented bilateral salpingectomy 
x Documented bilateral oophorectomy 
 
2. Postmenopausal female 
x A postmenopausal state is defined as no menses for 12 months without an alternative 
medical cause. 
o A high follicle stimulating hormone (FSH) level in the postmenopausal range should 
be used to confirm a postmenopausal state in women not using hormonal 
contraception or hormonal replacement therapy (HRT).  
x Females on HRT and whose menopausal status is in doubt will be required to follow the 
protocol-mandated contraception guidance if they wish to continue their HRT during the 
study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal 
status before study enrollment. 
For individuals with permanent infertility due to an alternate medical cause not listed above, 
(e.g., mullerian agenesis, androgen insensitivity), Investigator discretion should be applied to 
determining study entry.  
Note: Documentation can come from the site personnel’s: review of the patient’s medical 
records, medical examination, or medical history interview. 
Contraception Guidance: 
Male patients who are sexually active with a female partner of childbearing potential must be 
either surgically sterile (confirmed by documented azoospermia > 90 days after the procedure) or 
follow the guidance per Table 5, during the study and until 30 days following the last dose of 
study drug. Male patients must not donate sperm from the first dose of study drug until 30 days 
following the last dose of the study drug. 


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Female patients of childbearing potential must have negative serum pregnancy test at screening 
and randomization, not be breastfeeding, and not plan to become pregnant during study or within 
30 days after dosing of study drug. Female patients of childbearing potential must either be 
surgically sterile (documented hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or 
follow the guidance per Table 5, during the study and until 30 days following the last dose of the 
study drug.  


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Table 5 
Contraceptive Methods  
CONTRACEPTIVE METHODS ALLOWED DURING THE STUDY INCLUDE:  
A. Highly Effective Methods That Have Low User Dependency and May be Used Alone  
Failure rate of <1% per year when used consistently and correctly. 
x Documented bilateral tubal occlusion  
x Vasectomized partner 
Vasectomized partner is a highly effective contraceptive method provided that the partner is the sole sexual 
partner of the woman of childbearing potential and the absence of sperm has been confirmed. If not, an 
additional highly effective method of contraception should be used. Spermatogenesis cycle is approximately 
90 days. 
B. Highly Effective Methods That Must be Used in Combination with a Barrier Method Failure rate of 
<1% per year when used consistently and correctly. 
Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation 
 oral 
 intravaginal 
 transdermal 
 injectable 
Male condoms must be used in addition to hormonal contraception. Hormonal contraception must be at a stable 
GRVHIRUPRQWKVSULRUWRUDQGRPL]DWLRQ 
Progestogen-only hormone contraception associated with inhibition of ovulation 
 oral 
 injectable 
Male condoms must be used in addition to hormonal contraception. Hormonal contraception must be at a stable 
GRVHIRUPRQWKVSULRUWRUDQGRPL]DWLRQ 
Implantable progestogen-only hormone contraception associated with inhibition of ovulation 
Intrauterine device (IUD) 
Intrauterine hormone-releasing system (IUS)  
C. Barrier Methods That Must be Used in Combination with a Highly Effective Method (B, above) 
Male condom with or without spermicide (single barrier).  
D. Double Barrier Methods That May be Used Alone 
A combination of male condom with either cervical cap, diaphragm, or sponge with spermicide (double-barrier).  
E. SEXUAL ABSTINENCE 
Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual 
intercourse during the entire period of risk associated with the study intervention. The reliability of sexual 
abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the 
patient.  
UNACCEPTABLE CONTRACEPTIVE METHODS 
Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), 
spermicides only, and lactational amenorrhoea method (LAM) are not acceptable methods of contraception. 
Collection of Pregnancy Information:  
Male Patients with Partners Who Become Pregnant 
The Investigator will attempt to collect pregnancy information on any male patient’s female 
partner who becomes pregnant while the male patient is in this study, or if they become pregnant 


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within 30 days following the last dose of the study drug. This applies only to male patients who 
receive study drug. 
After obtaining the necessary signed informed consent from the pregnant female partner directly, 
the Investigator will record pregnancy information on the appropriate form and submit it to the 
sponsor within 24 hours of learning of the partner’s pregnancy. The female partner will also be 
followed to determine the outcome of the pregnancy. Information on the status of the mother and 
child will be forwarded to the sponsor. Generally, the follow-up will be no longer than 6 to 8 
weeks following the estimated delivery date. Any termination of the pregnancy will be reported 
regardless of fetal status (presence or absence of anomalies) or indication for the procedure.  
Female Patients Who Become Pregnant 
Any female patient who becomes pregnant while participating in the study will discontinue study 
drug.  
The Investigator will collect pregnancy information on any female patient who becomes 
pregnant while participating in this study, or if they become pregnant 30 days following the last 
dose of study drug. The initial information will be recorded on the appropriate form and 
submitted to the sponsor within 24 hours of learning of a patient's pregnancy.  
The patient will be followed to determine the outcome of the pregnancy. The Investigator will 
collect follow-up information on the patient and the neonate and the information will be 
forwarded to the sponsor. Generally, follow-up will not be required for longer than 6 to 8 weeks 
beyond the estimated delivery date. Any termination of pregnancy will be reported, regardless of 
fetal status (presence or absence of anomalies) or indication for the procedure. 
While pregnancy itself is not considered to be an AE or SAE, any pregnancy complication or 
elective termination of a pregnancy for medical reasons will be reported as an AE or SAE.  
A spontaneous abortion (occurring at < 22 weeks gestational age) or still birth (occurring at > 
22 weeks gestational age) is always considered to be an SAE and will be reported as such.  
Any post-study pregnancy related SAE considered reasonably related to the study drug by the 
Investigator will be reported to the sponsor as described in Section 8.5.5. While the Investigator 
is not obligated to actively seek this information in former study patients, he or she may learn of 
an SAE through spontaneous reporting. 
 


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Version: Amendment 3 
Version Date: 17 August 2021 
 
 
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Appendix 8: COVID-19 Assessments 
At Screening:  
x SARS-CoV-2 testing to assess for active infection (e.g., molecular test such as 
polymerase chain reaction [PCR] or viral antigen serology) and past infection 
(Immunoglobulin G [IgG] and Immunoglobulin M [IgM] antibodies)  
x Testing at Screening may be omitted for patients who have completed a COVID-19 
vaccination series, with adequate documentation, at the Investigator’s discretion  
At Week 0, 6, and 12:  
x Testing for past infection via antibody testing (IgG and IgM) if prior IgG was negative  
x If Week 0 occurs within 2 weeks of Screening, site may omit repeat SARS-CoV-2 testing 
at Investigator’s discretion 
x If IgM antibody test is positive, may reflex to test for SARS-CoV-2 active infection at 
Investigator’s discretion 
x Testing at these timepoints may be omitted for patients who have completed a COVID-19 
vaccination series, with adequate documentation, at the Investigator’s discretion  
Ad-hoc:  
x In the event of symptoms suggestive of COVID-19, ad hoc testing (including molecular 
test such as PCR or viral antigen serology, and/or antibody testing), may be completed at 
Investigator’s discretion 
Sites may use local laboratory testing for COVID-19 assessments instead of central laboratory, 
per site preference. If a local laboratory is used, the results must be entered into the eCRF. 
Results from previous testing may be used if completed within 2 weeks of a scheduled Screening 
or on-study visit. 
Any positive tests reflecting active or recent infection (e.g., molecular test such as PCR or viral 
antigen serology, or IgM antibody) require management per local public health guidelines, at the 
direction of the Investigator.  
If technological changes result in changes to the assays implemented to assess for SARS-CoV-2, 
available central lab assays and testing mechanisms may change. 
The testing approach and schedule may be modified based on the evolving landscape of the 
pandemic or in response to local public health requirements. In that event, regulatory 
requirements, IRB requirements, and local institutional guidelines will be followed, as necessary. 
 
 


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Version: Amendment 3 
Version Date: 17 August 2021 
 
 
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Appendix 9: Abbreviations 
Abbreviation or 
special term 
Explanation 
AAT 
Alpha-1 antitrypsin 
AE 
Adverse event 
ALP 
Alkaline phosphatase 
ALT 
Alanine aminotransferase 
ANCOVA 
Analysis of covariance  
anti-HCV 
HCV antibody 
AST 
Aspartate transaminase 
AUC 
Area under the plasma concentration-time curve 
ȕ-hCG 
Human chorionic gonadotropin 
BMI 
Body mass index 
BUN 
Biliary urea nitrogen 
C3M 
Type III collagen  
CAP 
Controlled attenuation parameter 
CBD 
Cannabidiol 
CCl4 
Carbon tetrachloride 
CDHFD 
Choline deficient high fat diet 
CFR 
Code of Federal Regulations 
CIOMS 
Council for International Organizations of Medical Sciences 
CK-18 
Cytokeratin-18  
Cmax 
Maximum observed plasma concentration 
CNS 
Central nervous system 
CPK 
Creatinine phosphokinase 
CONSORT 
Consolidated Standards of Reporting Trials 
COVID-19 
Coronavirus disease 2019  
CRF 
Case report form 
CSR 
Clinical study report 
CTCAE 
Common Terminology Criteria for Adverse Events 
cT1 
Corrected T1  
CV 
Coefficient of variation 
CYP 
Cytochrome P450 
DBL 
Database lock 
eCRF 
Electronic case report form 
eGFR 
Estimated glomerular filtration rate 
ECG 
Electrocardiogram 
EEG 
Electroencephalogram 


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Abbreviation or 
special term 
Explanation 
ELF 
Enhanced liver fibrosis 
ET 
Early termination 
FAD 
Flavin adenine dinucleotide 
FAS 
Full Analysis Set 
FDA 
Food and Drug Administration 
FIB-4 
Fibrosis-4 index  
FIH 
First-in-human 
FSH 
Follicle stimulating hormone 
GCP 
Good clinical practice  
GFR 
Glomerular filtration rate  
GGT 
Gamma-glutamyl transpeptidase 
GLP 
Good Laboratory Practice 
GPCR 
G-protein coupled receptors 
HA 
Hyaluronic acid  
HbA1c 
Hemoglobin A1c  
HBsAg 
Hepatitis B virus surface antigen 
HCV 
Hepatitis C virus 
HDL 
High-density lipoprotein 
HDPE 
High-density polyethylene 
HIV 
Human immunodeficiency virus 
HIPAA 
Health Insurance Portability and Accountability Act 
HRT 
Hormone replacement therapy 
HSC 
Hepatic stellate cell 
hs-CRP 
High sensitivity C-reactive protein 
IC50 
Half maximal inhibitory concentration 
ICAM-1 
Intercellular adhesion molecule-1 
ICF 
Informed consent form 
ICH 
International Council for Harmonisation 
IEC 
Independent Ethics Committee 
IgG 
immunoglobulin G 
IgM 
Immunoglobulin  
 
IL-6 
Interleukin-6 
IMP 
Investigational medicinal product 
IND 
Investigational new drug 
INR 
International normalized ratio 
IRB 
Institutional Review Board 


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Version: Amendment 3 
Version Date: 17 August 2021 
 
 
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Abbreviation or 
special term 
Explanation 
IUD 
Intrauterine device 
IUS 
Intrauterine hormone-releasing system 
IWRS 
Interactive web response system 
LAM 
Lactational amenorrhoea method 
LFT 
Liver function test 
LDL 
Low-density lipoprotein  
MAD 
Multiple ascending dose 
MCH 
Mean corpuscular hemoglobin 
MCHC 
Mean corpuscular hemoglobin concentration 
MCV 
Mean corpuscular volume 
MedDRA 
Medical Dictionary for Regulatory Activities 
MMRM 
Mixed model for repeated measures 
MRI 
Magnetic Resonance Imaging 
MRI-PDFF 
Magnetic Resonance Imaging Proton Density Fat Fraction  
mRNA 
Messenger RNA 
MTD 
Maximum tolerated dose 
NAFLD 
Nonalcoholic fatty liver disease  
NASH 
Nonalcoholic Steatohepatitis  
NCI 
National Cancer Institute 
NFS 
NAFLD fibrosis score 
NIMP 
Noninvestigational medicinal product 
NOAEL 
No observed adverse effect level 
PCR 
Polymerase chain reaction 
PD 
Pharmacodynamic(s)  
PIIINP 
Procollagen III N-terminal propeptide  
PK 
Pharmacokinetic(s) 
po 
Per os (oral) 
PP 
Per protocol 
PPV 
Positive predictive value 
PRO-C3 
Pro-peptide of type III collagen  
PT 
Prothrombin time 
PTZ 
Pentylenetetrazole  
QD 
Once daily 
RBC 
Red blood cell 
RNA 
Ribonucleic acid 
SAD 
Single ascending dose 
SAE 
Serious adverse event 


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Version: Amendment 3 
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Abbreviation or 
special term 
Explanation 
SAP 
Statistical analysis plan 
SARS-COV-2 
Severe Acute Respiratory Syndrome Coronavirus 2 
SCr 
Standardized serum creatinine 
SSAO 
Semicarbazide-sensitive amine oxidase  
SUSAR 
Suspected unexpected serious adverse reactions 
TEAE 
Treatment emergent adverse event 
TERN-201 
An investigational selective VAP-1/SSAO inhibitor; a.k.a., LSN3415221 
(LSN3379274·TsOH), LSN3394258 (LSN3379274·2HCl) and LSN3379274 
(free base)) 
THC 
Tetrahydrocannibinol 
TIMP-1 
Tissue inhibitor of metalloproteinases-1  
TRN-001021 
O-demethylation metabolite of TERN-201 
TRN-001744 
O-dealkylation metabolite of TERN-201 
UACR 
Urine albumin:creatinine 
ULN 
Upper limit of normal  
UPCR 
Urine protein: creatinine 
US 
United States 
VAP-1 
Vascular Adhesion Protein-1 
VCAM-1 
Vascular cell adhesion molecule-1 
VLDL 
Very low-density lipoprotein 
WBC 
White blood cell 
WOCBP 
Women of childbearing potential 
 
 
 


Protocol TERN201-1007 
Terns, Inc.  
Version: Amendment 3 
Version Date: 17 August 2021 
 
 
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Page 89 of 92 
 
Appendix 10: Investigator Signature Page 
A Multi-Center, Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled, Proof of 
Concept, Adaptive, Phase 1b Clinical Study to Evaluate the Safety, Pharmacokinetics, 
Pharmacodynamics, and Efficacy of Orally Administered TERN-201 in Patients with Presumed 
Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH) 
Protocol Number:  
 
TERN201-1007 
Protocol Version/Date:  
Amendment 3; 17 August 2021  
 
I confirm that I have read the above-mentioned protocol and its attachments. I agree to conduct 
the described study in compliance with all stipulations of the protocol, regulations and ICH E6 
Guideline for Good Clinical Practice (GCP). I will provide all study personnel under my 
supervision copies of the protocol and access to all information provided by Terns, Inc. I will 
discuss this material with them to ensure that they are fully informed about the study drug and 
the study. 
____________________________________ 
Principal Investigator Name (Printed)  
 
____________________________________ 
Signature  
 
____________________________________ 
Date 
 
 
 
 


Protocol TERN201-1007 
Terns, Inc.  
Version: Amendment 3 
Version Date: 17 August 2021 
 
 
CONFIDENTIAL 
Page 90 of 92 
 
Appendix 11: Protocol Amendment History 
This document (dated 17 August 2021) is Amendment 3. The document history is below. The 
Summary of Changes for each amendment listed below will be provided separately.  
DOCUMENT HISTORY 
Document 
Date 
Amendment 3 
17 August 2021 
Amendment 2 
21 June 2021 
Amendment 1 
20 April 2021 
Original 
18 December 2020 
 


Protocol TERN201-1007 
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Version: Amendment 3 
Version Date: 17 August 2021 
 
 
CONFIDENTIAL 
Page 91 of 92 
 
Appendix 12: References 
Andronescu CI, Purcarea MR, Babes PA. Nonalcoholic fatty liver disease: epidemiology, 
pathogenesis and therapeutic implications. J Med Life. 2018;11(1):20–23. 
Banerjee R, Pavlides M, Tunnicliffe EM, et al. Multiparametric magnetic resonance for the non-
invasive diagnosis of liver disease. J Hepatol. 2014;60(1):69-77.  
Caussy C, Reeder SB, Sirlin CB, Loomba R. Noninvasive, quantitative assessment of liver fat by 
MRI-PDFF as an endpoint in NASH trials. Hepatology. 2018;68(2):763-772.  
Chalasani N, Younossi Z,2 Lavine JE, Charlton M, Cusi K, Rinella M, Harrison SA, Brunt EM, 
and Sanyal AJ. The Diagnosis and Management of Nonalcoholic Fatty Liver Disease: Practice 
Guidance from the American Association for the Study of Liver Diseases. Hepatol. 2018;67:328-
57. 
Dennis A, Kelly MD, Fernandes C et al. Correlations between MRI biomarkers PDFF and cT1 
with histopathological features of non-alcoholic steatohepatitis. Front Endocrinol. 
2021:11:575843.  
de Zeeuw D. Efficacy of a novel inhibitor of vascular adhesion protein-1 in reducing albuminuria 
in patients with diabetic kidney disease (ALBUM): a randomised, placebo-controlled, phase 2 trial. 
Lancet Diabetes Endocrinol 2018; 6: 925–33. 
Eddowes PJ et al. Accuracy of FibroScan® controlled attenuation parameter and liver stiffness 
measurement in assessing steatosis and fibrosis in patients with nonalcoholic fatty liver disease. 
Gastroenterol. 2019;156:1717–30. 
Ekstedt M, Hagstrom H, Nasr P, Fredrikson M, Stal P, Kechagias S et al. Fibrosis Stage is the 
Strongest Predictor for Disease-specific Mortality in NAFLD After up to 33 years of Follow-up. 
Hepatology. 2015;61:1547-54. 
Harrison SA et al. Selonsertib for patients with bridging fibrosis or compensated cirrhosis due to 
NASH: Results from randomized phase III STELLAR trials J. Hepatol. 2020; 73:26-39. 
Mojtahed A et al. Reference range of liver corrected T1 values in a population at low risk for fatty 
liver disease—a UK Biobank sub-study, with an appendix of interesting cases. Abdom Radiol. 
2019;44:72–84. 
National Heart, Lung, and Blood Institute. The Practical Guide: Identification, Evaluation, and 
Treatment of Overweight and Obesity in Adults. US Department of Health and Human Services, 
Public Health Service, National Institutes of Health, National Heart Lung and Blood Institute, 
Bethesda, MD, October 2000. Accessed on 29 January 220 at 
https://www.nhlbi.nih.gov/files/docs/guidelines/prctgd_c.pdf. 
Salmi M. Vascular Adhesion Protein-1: A Cell Surface Amine Oxidase in Translation. 
Antioxidants Redox Signaling. 2019a;30:314-32. 


Protocol TERN201-1007 
Terns, Inc.  
Version: Amendment 3 
Version Date: 17 August 2021 
 
 
CONFIDENTIAL 
Page 92 of 92 
 
Schilter HC, Collison A, Russo RC, et al. Effects of an anti-inflammatory VAP-1/SSAO inhibitor, 
PXS-4728A, on pulmonary neutrophil migration. Respir Res. 2015;16:42. 
Smith DJ, Salmi M, Bono P, Hellman J, Leu T, Jalkanen S. Cloning of vascular adhesion protein 
1 reveals a novel multifunctional adhesion molecule. J Exp Med. 1998;188:17-27. Szczepaniak 
LS. Magnetic resonance spectroscopy to measure hepatic triglyceride content: prevalence of 
hepatic steatosis in the general population. Am J Physiol Endocrinol Metab 2005;288:E462–
E468. 
Tang A et al. Nonalcoholic Fatty Liver Disease: MR Imaging of Liver Proton Density Fat 
Fraction to Assess Hepatic Steatosis. Radiology 2013; 267:422–431. 
Weston CJ, Shepherd EL, Claridge LC, Rantakari P, Curbishley SM, Tomlinson JW, Hubscher 
SG, Reynolds GM, Aalto K, Anstee QM, Jalkanen S, Salmi M, Smith DJ, Day CP, Adams DH. 
Vascular adhesion protein-1 promotes liver inflammation and drives hepatic fibrosis. J Clin Invest. 
2015;125(2):501-20. 
 
 
 

SAP_001.pdf: 
Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                                                                                    18 November 2021   
Statistical Analysis Plan                                                                                                                           CONFIDENTIAL
Page 1 of 50
Statistical Analysis Plan
Protocol Title:
A Multi-Center, Randomized, Double-Blind, Dose-Ranging, 
Placebo-Controlled, Proof of Concept, Adaptive, Phase 1b Clinical 
Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, 
and Efficacy of Orally Administered TERN-201 in Patients with
Presumed Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)
Compound: 
TERN-201
US IND Number:  
ClinicalTrials.gov 
Identifier:
NCT04897594
Protocol Version and 
Date:
Original, 18 December 2020
Amendment 1, 20 April 2021
Amendment 2, 21 June 2021
Amendment 3, 17 August 2021
Phase:
1b
Methodology:
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group
Sponsor:
Terns Pharmaceuticals, Inc.
1065 E. Hillsdale Blvd. Suite 100
Foster City, California 94404
Analysis Plan Date:
18 November 2021
Analysis Plan 
Version:
Final
CONFIDENTIAL
This document contains confidential information, which should not be copied, referred to, 
released or published without written approval from Terns, Inc.


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
18 November 2021   
Statistical Analysis Plan                                                                                
CONFIDENTIAL
Page 2 of 50 
TABLE OF CONTENTS 
1.
Introduction........................................................................................................... 7
2.
Information from the Study Protocol.................................................................... 7 
2.1. 
Study Objectives .............................................................................................................. 7
2.2.
Study Design .................................................................................................................... 8
2.2.1.
Study Procedures .................................................................................... 8
2.2.2.
Study Population..................................................................................... 8 
2.2.3.
Study Drug .............................................................................................. 8 
2.2.4.
Treatment Assignment, Blinding, and Randomization Methodology .... 9 
2.3. 
Study Endpoints ............................................................................................................. 10
2.3.1.
Primary Endpoints ................................................................................ 10 
2.3.2.
Secondary Endpoints ............................................................................ 10 
2.3.3.
Exploratory Endpoints .......................................................................... 10 
3.
Sample Size Justification .................................................................................... 11 
4.
General Statistical Methods ................................................................................ 11 
4.1. 
Reporting Conventions................................................................................................... 11
4.2. 
Computing Environments .............................................................................................. 12
4.3. 
Partial Dates ................................................................................................................... 13
4.4. 
Data Conventions........................................................................................................... 13
4.5. 
Standard Calculations..................................................................................................... 13
4.6. 
Treatments...................................................................................................................... 14
4.7. 
Visits............................................................................................................................... 14
4.7.1. 
Windows ..................................................................................................................... 14
4.7.2. 
Definition of Baselines ............................................................................................... 15


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
18 November 2021   
Statistical Analysis Plan                                                                                
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Page 3 of 50 
4.7.3. 
Definition of End of Treatment .................................................................................. 15
5.
Analysis Sets....................................................................................................... 16 
6.
Examination of Subgroups.................................................................................. 16
7.
Study Population................................................................................................. 17
7.1.
Patient Disposition ......................................................................................................... 17
7.2. 
Demographics and Baseline Characteristics .................................................................. 17
7.3. 
Protocol Deviations ........................................................................................................ 19
7.4. 
General Medical History ................................................................................................ 19
7.5. 
Prior and Concomitant Medications............................................................................... 19
8.
Efficacy Analyses ............................................................................................... 20 
8.1. 
Adjustments for Covariates............................................................................................ 20
8.2. 
Handling of Dropouts or Missing Data .......................................................................... 20
8.3. 
Interim Analyses and Data Monitoring.......................................................................... 20
8.4. 
Multicenter Studies ........................................................................................................ 20
8.5. 
Use of an “Efficacy Subset” of Patients ......................................................................... 21
8.6.
Multiple Comparisons/Multiplicity................................................................................ 21
8.7. 
Pharmacokinetic (PK) Analyses..................................................................................... 21
8.7.1.
Below the Quantification Level (BLQ) Values .................................... 21 
8.7.2.
Anomalous Values ................................................................................ 21 
8.7.3.
Concentration-Time Data...................................................................... 22 
8.7.4.
Plasma Pharmacokinetic Parameters .................................................... 22 
8.7.4.1.
Pharmacokinetic Parameter Data Handling..................................................... 25
8.7.4.2.
Calculation of AUC......................................................................................... 25
8.7.4.3.
Criteria for Calculation and Goodness of Fit................................................... 25
8.7.5.
Statistical Methods for Pharmacokinetic Parameters ........................... 25 


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
18 November 2021   
Statistical Analysis Plan                                                                                
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Page 4 of 50 
8.7.6.
Urine Pharmacokinetic Parameters....................................................... 25 
8.8. 
Pharmacodynamic (PD) Analyses.................................................................................. 26
8.8.1.
Below the Quantification Level (BLQ) Values .................................... 26
8.8.2.
VAP-1/SSAO Activity Levels and Methylamine Concentration Time Data 26
8.8.3.
Change from Baseline........................................................................... 27
8.8.4.
Plasma PD Parameters .......................................................................... 27 
8.8.4.1.
PD Parameter Data Handling .......................................................................... 29
8.8.4.2.
Calculation of AUC......................................................................................... 29
8.8.4.3.
Statistical Methods for PD Parameters ............................................................ 29
8.8.4.4.
Dose Response................................................................................................. 30
8.9. 
Exposure Response Analyses ......................................................................................... 30
8.10. 
Exploratory Efficacy Analyses ................................................................................... 31
8.10.1.
Magnetic Resonance Imaging ........................................................... 31 
8.10.1.1.
Corrected T1 (cT1).......................................................................................... 31
8.10.1.2.
Liver Fat Content by MRI Proton Density Fat Fraction (PDFF) .................... 32
8.10.2.
Transient Elastography...................................................................... 33 
8.10.3.
Liver Function Tests.......................................................................... 33 
8.10.3.1.
Change from End of Treatment in ALT.......................................................... 33
8.10.4.
NASH and Fibrosis Biomarkers........................................................ 34 
8.10.4.1.
Enhanced Liver Fibrosis (ELF) Score............................................................. 34
8.10.4.2.
Fibrosis-4 (FIB-4) Score ................................................................................. 34
8.10.4.3.
Nonalcoholic Fatty Liver Disease (NAFLD) Fibrosis Score .......................... 34
8.10.5.
Inflammation Biomarkers ................................................................. 34 
8.10.6.
Proteinuria Biomarkers ..................................................................... 35 
8.10.7.
Anthropometric Measures ................................................................. 35 
8.10.8.
Dose Response .................................................................................. 35 


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
18 November 2021   
Statistical Analysis Plan                                                                                
CONFIDENTIAL
Page 5 of 50 
9.
Safety Analyses................................................................................................... 35 
9.1. 
Extent of Exposure ......................................................................................................... 35
9.2.
Adverse Events............................................................................................................... 36
9.2.1.
Overall Summary of Adverse Events ................................................... 36
9.2.2.
Patient Incidence of Adverse Events .................................................... 37
9.3. 
Clinical Safety Laboratory Evaluations ......................................................................... 38
9.3.1.
Treatment Emergent Abnormalities...................................................... 38 
9.3.2.
Assessments of Potential Drug Induced Liver Injury ........................... 39 
9.3.3.
Shifts in CTCAE Grade ........................................................................ 39 
9.3.4.
COVID-19............................................................................................. 40 
9.4. 
Vital Signs ...................................................................................................................... 40
9.5. 
Electrocardiograms......................................................................................................... 40
10. Other Assessments .............................................................................................. 41 
11. Changes to Protocol Planned Analyses............................................................... 41 
12. References........................................................................................................... 42 
13. Appendices.......................................................................................................... 43
Appendix 1.
Other General Programming Specifications ..................................... 44 
Appendix 2.
Imputation Rules for Missing or Partial Dates for Adverse Events and 
Concomitant Medications ........................................................................................... 46 
Appendix 3.
Abbreviations .................................................................................... 47 
Appendix 4.
Document History ............................................................................. 49 
Appendix 5.
Approval Page ................................................................................... 50 


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
18 November 2021   
Statistical Analysis Plan                                                                                
CONFIDENTIAL
Page 6 of 50 
LIST OF TABLES 
Table 1:
Study Drug.........................................................................................................9
Table 2:
Study Administration by Dose Group................................................................9
Table 3:
Treatment Group Labels and Ordering............................................................14
Table 4: 
Treatment Period Visit Windows.....................................................................15
Table 5: 
Analysis Sets....................................................................................................16
Table 6:
Plasma Pharmacokinetic Parameters ...............................................................23
Table 7:
Urine Pharmacokinetic Parameters..................................................................26
Table 8: 
VAP-1/SSAO Plasma PD Parameters .............................................................27
Table 9: 
Methylamine Plasma PD Parameters...............................................................29
Table 10: 
CTCAE Laboratory Tests with Clinical Criteria .............................................39
LIST OF FIGURES
No table of figures entries found. 


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
18 November 2021   
Statistical Analysis Plan                                                                                
CONFIDENTIAL
Page 7 of 50 
1.
INTRODUCTION 
This statistical analysis plan (SAP) document outlines the statistical methods to be implemented 
during the analyses of Study Protocol TERN201-1007.  The purpose of this plan is to provide 
specific guidelines from which the analyses will proceed.  Any deviations from these guidelines 
will be documented in the clinical study report (CSR).    
This SAP supersedes the statistical considerations identified in the protocol; where 
considerations are substantially different, they are identified in Section 11. Any post-hoc or 
unplanned analyses, or significant changes from the planned analysis in this SAP performed to 
provide results for inclusion in the clinical study report (CSR) but not included in this SAP, will 
be clearly identified in the CSR. Changes to planned analyses do not require an updated SAP but 
should be included in the CSR if significant. 
2. 
INFORMATION FROM THE STUDY PROTOCOL 
2.1.
Study Objectives 
Primary Objective: 
 To characterize the safety and tolerability of TERN-201 versus placebo for 12 weeks 
in non-cirrhotic presumed NASH patients, with clinical or histological NASH 
diagnosis 
Secondary Objectives: 
 To assess the plasma and urine PK of TERN-201 for 12 weeks in non-cirrhotic 
presumed NASH patients
 To assess the PD of TERN-201 versus placebo for 12 weeks on plasma VAP-1/SSAO 
activity in non-cirrhotic presumed NASH patients 
Exploratory Objectives: 
 To assess the plasma and urine PK of TERN-201 metabolites (TRN-001021 and 
TRN-001744) at steady state 
To assess the effect of TERN-201 versus placebo on imaging assessments and blood 
biomarkers of NASH activity 
 To assess the effect of TERN-201 versus placebo on biomarkers of inflammation 
 To explore the potential for TERN-201 to improve proteinuria due to endothelial 
effects 
 To explore other PD markers, and overall exposure-response and dose-response 
relationship of TERN-201, as applicable  
 To explore the exposure-response and dose-response relationship, as applicable, of 
TERN-201 and baseline patient characteristics such as soluble VAP-1 (sVAP-1), 
body mass index (BMI), diabetes mellitus, and others  
• 
• 
• 
• 
• 
• 
• 
• 
• 


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
18 November 2021   
Statistical Analysis Plan                                                                                
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Page 8 of 50 
2.2.
Study Design 
The study is a multi-center, randomized, double-blind, placebo-controlled, adaptive study. 
Up to approximately 80 clinically or histologically diagnosed adult non-cirrhotic presumed 
NASH patients who meet study eligibility criteria will be enrolled and randomized at an overall 
ratio of 2:1 in up to 3 dose groups and placebo across 2 parts of the study. 
Part 1  
In Part 1, approximately 30 patients will receive 10 mg TERN-201 (n = 20) or matching placebo 
(n = 10) orally once daily, for 12 weeks. Part 2 may be enrolled based on an interim analysis, as 
follows: 
In Part 1 of the study, approximately 12 randomized patients will take part in an intensive PK 
and PD collection after the first dose (Week 0/Day 1), at Week 6, and after the last dose of study 
drug (Week 12). Randomization will ensure approximately 8 patients in the TERN-201 group 
and approximately 4 patients in the placebo group are assigned to the PK/PD sub-study. Patients 
who are not participating in the PK/PD sub-study will have trough PK/PD sampling only. 
Part 2  
In Part 2, if initiated, up to approximately 50 patients will receive 4 mg TERN-201 (n = 20), 
and/or up to 20 mg TERN-201 (n = 20), or matching placebo (n = 10) orally once daily, for 12 
weeks. 
In Part 2 of the study, approximately 15 randomized patients will take part in an intensive PK 
and PD collection after the first dose (Week 0/Day 1), at Week 6, and after the last dose of study 
drug (Week 12). Randomization will ensure approximately 6 patients at each TERN-201 dose 
level and approximately 3 patients in the placebo group are assigned to the PK/PD sub-study. 
Patients who are not participating in the PK/PD sub-study will have trough PK/PD sampling 
only. 
The total duration of study participation will be approximately 22 weeks, consisting of a 6-week 
Screening Period, a 12-week Treatment Period and a 4-week Follow-up Period. 
2.2.1. 
Study Procedures 
The overall schedule of activities is outlined in Section 1.3 of the study protocol.  See study 
protocol for complete details. 
2.2.2. 
Study Population 
This study includes clinically or histologically diagnosed adult non-cirrhotic presumed NASH 
patients.  Inclusion and exclusion criteria are provided in Sections 5.1 and 5.2, respectively, of 
the study protocol. 
2.2.3. 
Study Drug 
Study drug is defined as any investigational intervention(s), marketed product(s), or placebo 
intended to be administered to a study patient according to the study protocol. 


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
18 November 2021   
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Table 1: 
Study Drug  
Investigational 
Medicinal Product
TERN-201 capsules
Placebo-to-match (identical in 
shape, size, appearance, and 
color to TERN-201 capsules)
Type  
Drug 
Drug 
Dose Formulation 
Capsule 
Capsule 
Unit Dose 
Strength(s)
1, 3, or 10 mg per capsule 
Matching placebo per capsule
Route of 
Administration
Oral 
Oral
Use
Experimental
Placebo 
IMP/NIMP
IMP  
IMP 
Sourcing
Provided centrally by the 
Sponsor 
Provided centrally by the 
Sponsor
Packaging and 
Labeling
Study drug will be provided in a 
labeled carton that contains 
HDPE bottle(s). In Part 1, each 
carton will contain one bottle for 
4-week usage. In Part 2, each 
carton will contain two bottles 
for 4-week usage.  Each bottle 
will be labeled as required per 
country requirements. 
Study drug will be provided in a 
labeled carton that contains 
HDPE bottle(s). In Part 1, each 
carton will contain one bottle for 
4-week usage. In Part 2, each 
carton will contain two bottles 
for 4-week usage. Each bottle 
will be labeled as required per 
country requirements. 
Abbreviations: HDPE = High-density polyethylene; IMP = investigational medicinal product; NIMP = non 
investigational medicinal product 
Patients will be instructed to take capsules as shown in Table 2.  
Table 2: 
Study Administration by Dose Group  
Dose Group
TERN-201 Capsules
Placebo-to-Match 
Part 1 – 10 mg
One 10 mg capsule QD 
One placebo capsule QD 
Part 2 – 4 mg 
One 1 mg capsule and one 3 mg capsule QD 
Two placebo capsules QD
Part 2 – 20 mg 
Two 10 mg capsules QD  
Two placebo capsules QD
Abbreviations: QD = once per day 
2.2.4. 
Treatment Assignment, Blinding, and Randomization Methodology 
Patients will be randomized to TERN-201 or placebo using an Interactive Web Response System 
(IWRS). Before the study is initiated, the log-in information and directions for the IWRS will be 
provided to each site.
Up to approximately 80 patients will be enrolled in this study. In Part 1, approximately 30 
patients will be randomized at a ratio of 2:1 to receive TERN-201 10 mg (n = 20) or matching 


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
18 November 2021   
Statistical Analysis Plan                                                                                
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Page 10 of 50 
placebo (n = 10). In Part 2, if initiated, up to approximately 50 patients will be randomized at a 
ratio of 2:1 to receive TERN-201 4 mg (n = 20), and/or 20 mg TERN-201 (n = 20), or matching 
placebo (n = 10). 
versus > 900 ms.    
The randomization codes will be provided to bioanalytics to allow for the exclusion of placebo 
patients from the PK assay. Bioanalytics will not disclose the randomization code or the results 
of their measurements until the trial is officially unblinded. 
Emergency unblinding procedures are outlined in Section 6.4.1 of the study protocol and in the 
unblinding plan.     
2.3. 
Study Endpoints 
2.3.1. 
Primary Endpoints
Overall safety assessed by treatment emergent AEs (TEAEs) and treatment emergent clinical 
safety laboratory abnormalities. 
2.3.2. 
Secondary Endpoints 
 Plasma and urine PK parameters for TERN-201  
 Percent change from baseline in plasma VAP-1/SSAO activity 
2.3.3. 
Exploratory Endpoints  
 Plasma and urine PK parameters for TERN-201 metabolites (including TRN-001021 
and TRN-001744) 
 Change from baseline in corrected T1 (cT1) by magnetic resonance imaging (MRI) 
 Change from baseline in liver fat content by magnetic resonance imaging-proton 
density fat fraction (MRI-PDFF) 
 Change from baseline in stiffness by transient elastography  
 Change from baseline in alanine aminotransferase (ALT)  
 Change from baseline in gamma-glutamyl transpeptidase (GGT) 
 Change from baseline in aspartate aminotransferase (AST)
 Change from baseline in NASH and fibrosis biomarkers including cytokeratin-18 
(CK-18) (M30 and M65), procollagen III n-terminal propeptide (PIIINP), tissue 
inhibitor of metalloproteinases-1 (TIMP-1), hyaluronic acid (HA), pro-peptide of type 
III collagen (PRO-C3), and type III collagen (C3M). Other non-invasive tests for 
NASH fibrosis may also be assessed including the fibrosis-4 (FIB-4) index, enhanced 
liver fibrosis (ELF) test, NAFLD fibrosis score (NFS), and PRO-C3/C3M ratio. 
 Change from baseline in inflammatory biomarkers including high sensitivity C-
reactive protein (hs-CRP), interleukin-6 (IL-6), intercellular adhesion molecule-1 
(ICAM-1), and vascular cell adhesion molecule-1 (VCAM-1) 
Randomization will be stratified by Screening MRI cTl values :'.S 900 ms 
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Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
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Change from baseline in estimated glomerular filtration rate (eGFR), urine protein 
including urine protein-to-creatinine ratio (UPCR), and urine albumin-to-creatinine 
ratio (UACR) 
 Change from baseline in plasma methylamine levels (PD marker of VAP-1/SSAO 
inhibition) 
 Exposure-response and dose-response relationship of TERN-201 over 12 weeks, as 
applicable  
 Exposure-response and dose-response relationship, as applicable, of TERN-201 and 
baseline patient characteristics such as sVAP-1, BMI, diabetes mellitus, and others 
3. 
SAMPLE SIZE JUSTIFICATION 
The sample size is based on clinical feasibility and adequate size to characterize safety in the 
study population, without consideration for statistical power.   
Patients who are randomized but do not receive study drug for any reason may be replaced. 
Patients who discontinue treatment early for reasons other than safety (e.g. withdrawal of 
consent, lost to follow-up, patient relocated) may also be replaced.
4. 
GENERAL STATISTICAL METHODS 
4.1.
Reporting Conventions
Individual patient data obtained from electronic case report forms (eCRFs), central laboratories, 
external sources, and any derived data will be presented in data listings by patient. The primary 
data source will be used for all analyses. All data listings that contain an evaluation date will 
contain a relative study day. Pre-treatment and on-treatment study days are numbered relative to 
the day of the first dose of study drug which is designated as Day 1. The preceding day is Day -1, 
the day before that is Day -2, etc. 
All outputs will be incorporated into Microsoft Word rich text format (.rtf) files, sorted and 
labeled according to the International Council for Harmonisation (ICH) E3 guideline, E3 
Structure and Content of Clinical Study Reports, and formatted to the appropriate page size(s), 
font type, and font size according to Food and Drug Administration (FDA) guidance of Portable 
Document Format Specifications.
For categorical variables, summary tabulations of the number and percentage of patients within 
each category of the parameter will be presented. Percentage calculations will be based on non-
missing data, unless otherwise specified. If there are missing values, the number missing will be 
presented, but without a percentage. Percentages are rounded to 1 decimal place, unless 
otherwise specified.  
For frequency counts of categorical variables, categories whose counts are zero will be displayed 
for the sake of completeness. For example, if none of the patients discontinue due to “Lost to 
Follow-up,” this reason will be included in the table with a count of 0.  Percentages will be 
• 
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Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
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presented to 1 decimal place, with the exception of 0, which will be presented without percent, 
and 100, which will be presented without decimal places. Values less than 0.1% will be 
presented as “<0.1%.” Values less than 100% but greater than 99.9% will be presented as 
“>99.9%.”   
For continuous variables, the number of patients, mean, standard deviation (SD), median, 25th
(Q1) and 75th (Q3) percentiles, minimum, and maximum values will be presented. The precision 
of summary statistics, unless otherwise specified will be as follows:  mean, median, Q1, and Q3 
to 1 more decimal place than the raw data, SD to 2 decimal places more than the raw data, and 
minimum and maximum to the same decimal places as the raw data. In general, the number of 
decimal places should not exceed 3 decimal places unless appropriate. 
For log-normal data (e.g., the PK parameters of area under the concentration-time curve [AUC]
and maximum observed concentration [Cmax]), the geometric mean and geometric coefficient of 
variation (CV%) will also be presented. The precision of descriptive statistics will be as follows:  
mean, median, Q1, and Q3 to 1 more decimal place than the raw data, SD to 2 decimal places 
more than the raw data, the minimum and maximum to the same number of decimal places as the 
raw data, geometric mean to 3 significant figures, and geometric CV% to 1 decimal place. The 
PK parameters Tmax, Tmin, Tlast, and t1/2 will be presented to 1 decimal place and all other plasma 
and urine PK parameters will be presented to 3 significant figures. 
Confidence intervals (CIs) will be provided and will be rounded to 1 decimal place, unless 
otherwise specified, in the table and listing shell. A full set of summary statistics will only be 
presented if 3 or more values are available. If there are less than 3 values, only the min, max, and 
N will be presented. The other summary statistics will be denoted as not calculated (NC). 
For tables where rounding is required, rounding will be done to the nearest round-off unit. For 
down to 97).
All statistical tests comparing groups will be conducted at the 2-sided, 0.05 level of significance, 
unless otherwise specified. Summary statistics for each treatment group will be presented, as 
well as two-sided 90% and 95% CIs comparing groups will be provided. 
Other general programming specifications are provided in Appendix 1. 
4.2. 
Computing Environments 
All descriptive statistical analyses will be performed using SAS software Version 9.4 or higher, 
unless otherwise noted.  
Plasma PK and PD parameters for TERN-201 will be estimated using non-compartmental 
methods with Phoenix WinNonlin® Version 8.3 or higher.
Medical history and AEs will be coded using Medical Dictionary for Regulatory Activities 
(MedDRA) version 24.0. Concomitant medications will be coded using World Health 
Organization Drug Dictionary (WHODD), B2 Enhanced March 2021.
Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) datasets will be 
prepared using Clinical Data Interchange Standards Consortium (CDISC) SDTM 
example, when rounding to the nearest integer, values 2:XX.5 will be rounded up to XX+ 1 ( e.g., 
97.5 will round up to 98), while values <XX.5 will be rounded down to XX (e.g., 97.4 will round 


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
18 November 2021   
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Implementation Guide (IG) Version 3.3, ADaM Version 2.1, and CDISC ADaM IG Version 1.2 
including most current occurrence and time to event IGs.
4.3. 
Partial Dates  
Imputation of partial adverse event and concomitant medication dates are specified in 
Appendix 2, respectively. 
All data recorded on the case report form will be included in data listings.
4.4.
Data Conventions 
The precision of original measurements will be maintained in summaries, when possible. 
Quantitative safety laboratory tests containing less than (<) and greater than (>) symbols are test 
results that are below and above quantifiable limits, respectively. In order to retain these values 
for analysis purpose, the following will be imputed and stored within the analysis datasets: 
 For values with <, the imputed value will be the numeric portion × 0.9. 
 For values with >, the imputed value will be the numeric portion × 1.1. 
PK and PD imputation of values below the limitation of quantitation (BLQ) are specified in 
Section 8.7.1 and Section 8.8.1, respectively. 
Variables with a non-normal distribution that impacts the interpretation or validity of the planned 
analysis may have a data transformation applied (e.g., ln, log10).  
4.5. 
Standard Calculations 
Variables requiring calculation will be derived using the following formulas: 
 Days – A duration expressed in days between one date (date1) and another later date 
(date2) will be calculated using the following formulas:   
duration in days = date2 – 
 
duration in days = date2 – date1, where date1 <first administration date 
 Months – A duration expressed in months is calculated as the number of days divided by 
30.4375 
 Years – A duration expressed in years between one date (date1) and another date (date2) 
is calculated using the following formulas: 
duration in years = (date2 – 
n 
date 
duration in years = (date2 – date1)/365.25, where date1<first administration date 
 Body Mass Index (BMI) – BMI is calculated using height (cm) and weight (kg) using the 
following formula: 
BMI (kg/m2) = weight (kg) / ([height (cm)/100]2)
• 
• 
• 
date 1 + 1, where date 1 ~first administration date 
• 
• 
datel + 1)/365.25, where datel ~first administratio 
• 


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
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Change (CHG; equivalent to absolute change for liver fat content [LFC]) – Change will 
be calculated as:
Change = later value – earlier (i.e., baseline) value 
 Percent change (PCHG; equivalent to relative change for LFC) – Percent change will be 
calculated as: 
Percent change = ([Change] / earlier [i.e., baseline] value) × 100 
4.6. 
Treatments  
Table 3 presents how the dose groups will be presented on TFLs as treatment groups, including 
the order. If Part 2 enrolls, placebo patients from Part 1 and Part 2 will be pooled. 
Table 3: 
Treatment Group Labels and Ordering 
Treatment Group Label 
Order 
on TFLs 
Placebo 
1
4 mg
2
10 mg
3
20 mg
4
All TERN-201  
5
Overall (where specified) 
6
All TERN-201 will not be included on efficacy, PK, or PD tables. Screen failures will be 
presented on by-patient listings where data is available.   
4.7.
Visits 
4.7.1. 
Windows  
Each visit will be denoted by its visit “Week”. The first dose day is denoted as Day 1. In data 
listings, the relative study day of all dates from first dose will be presented. 
In the event of unscheduled visits or early treatment termination (ET) assessments, these will be 
reassigned to a scheduled visit for analysis purposes according to Table 4 for on treatment 
assessments. If multiple assessments occur within a single visit window, after reassignment of 
unscheduled visits and ET assessments, the assessment closest to the target day of the visit 
window will be used in the analysis. If there is a tie, the later assessment will be used in the 
analysis.   
• 
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Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
18 November 2021   
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Table 4: 
Treatment Period Visit Windows 
Target Scheduled Visit 
Target 
Study 
Day a 
Analysis Window Study Day a 
Low 
High 
Baselineb
1
See Section 4.7.2
Week 2 
15 
2 
22 
Week 4 
29 
23 
36 
Week 6
43
37
50
Week 8 
57 
51 
71 
Week 12c 
85 
72 
92c
a Study day will be calculated from first dose of study drug.  
b Baseline is defined in Section 4.7.2. 
c LFC and cTI by MRI will have no upper limit on Week 12.
The follow up visit (Week 16) will not be windowed.  As described in Section 8.10.3.1, 
sensitivity analyses will be conducted including only Week 16 assessments which are at least 22 
days from last dose.
4.7.2. 
Definition of Baselines 
The baseline value for statistical analyses of quantitative laboratory parameters is defined as the 
mean of all available evaluations, including any unscheduled or repeat assessments, prior to the 
first administration of study drug, unless otherwise specified.  If there is only one evaluation 
prior to the first administration of study drug, then the available data from this evaluation will be 
used as the baseline value.  
For glucose and lipid parameters, only assessments taken while fasting for at least 8 hours will 
be included in the baseline derivation.
The baseline value for analyses of qualitative parameters (e.g., normal/abnormal) is defined as 
the last evaluation prior to the first administration of study drug. 
The baseline value for analyses of height, weight, body mass index (BMI), waist circumference, 
and electrocardiogram parameters is defined as the last evaluation prior to the first administration 
of study drug. 
The baseline value for pharmacodynamic analytes is defined as the Week 0/Day 1 predose value. 
4.7.3. 
Definition of End of Treatment 
The End of Treatment value will be defined as the Week 12 value, either scheduled or windowed 
per Table 4.  If a Week 12 value is not available, the last non-missing on or before the last dose 
date will be used. 
 


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
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5.
ANALYSIS SETS 
Table 5 defines the analysis sets to be used. 
Table 5: 
Analysis Sets  
Analysis Sets 
Description
Screened  
All patients who sign the informed consent form (ICF). 
Randomized
All patients randomized into any one of treatment groups.
Treatment assignment will be based on the randomized 
treatment.
Pharmacokinetic (PK) 
All randomized patients who received at least 1 dose of 
TERN-201 and have evaluable PK data. Evaluable PK data is 
defined in Section 8.7.
Pharmacodynamic (PD) 
All randomized patients who received at least 1 dose of study 
drug (TERN-201 or placebo) and for whom at least one post 
baseline assessment of VAP-1/SSAO activity and 
methylamine is available. Treatment assignment will be 
based on the treatment actually received. 
PK/PD Substudy
All patients who consented to the PK/PD substudy, were 
randomized into the PK/PD substudy, and received at least 1 
dose of study drug (TERN-201 or placebo). Treatment 
assignment will be based on the treatment actually received.
Safety 
All patients who received at least 1 dose of study drug. 
Treatment assignment will be based on the treatment actually 
received.
Efficacy 
All randomized patients who received at least 1 dose of study 
drug. Treatment assignment will be based on the randomized 
treatment.
Per Protocol (PP)  
All randomized patients who have completed the study 
without any major protocol deviations.  Treatment 
assignment will be based on the treatment actually received.
Treatment Completer 
All patients who complete 12 weeks of treatment with at least 
80% compliance based on study drug accountability. 
Treatment assignment will be based on the randomized 
treatment. 
6. 
EXAMINATION OF SUBGROUPS 
No analyses based on subgroups will be conducted. 


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
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7.
STUDY POPULATION
7.1.
Patient Disposition
Patient disposition will be summarized for the Screened Analysis Set by treatment group and 
overall total.  The summary will include:
 Number of patients screened.  
 Number of screen failures, i.e., screened but not randomized, with reasons for screen 
failure.  The denominator for percentage of screen failures will be the number of patients 
screened.  The denominator for percentages for reasons for screen failures will be the 
number of screen failures. 
 Number randomized. The denominator for percentage of randomized patients will be the 
number of patients screened.  
 Number randomized and not treated. The denominator for percentage of randomized and 
not treated patients will be the number of patients randomized. 
 Number in each analysis set. The denominator for percentage in each analysis set will be 
the number of randomized patients.  
 Number who discontinued treatment early and reason(s) for discontinuation of treatment. 
The denominator for percentages will be the number of randomized and treated patients 
(Efficacy Analysis Set). 
 Number who discontinued from study prior to completing the study and reason(s) for 
discontinuation. The denominator for percentages will be the number of randomized and 
treated patients (Efficacy Analysis Set). 
A by-patient data listing of study disposition information including the reasons for treatment 
and/or study termination will be presented for the Safety Analysis Set.  Withdrawal of consent 
details will also be included, if applicable.
A by-patient data listing including the reasons for exclusion from each analysis set will be 
presented.
7.2.
Demographics and Baseline Characteristics
Demographic variables will include the following: 
 Age at informed consent including the subgroup 
 
 Sex 
 Race 
 Ethnicity 
Other baseline characteristics will include the following: 
 Weight (kg) 
 Height (cm) 
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of <65 years vs ~65 years 


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
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 BMI (kg/m2) including the following subgroup: 
-
-
2
Waist circumference (cm)
Baseline liver stiffness by transient elastography (kPa)
Baseline Controlled Attenuation Parameter by transient elastography (CAP; dB/m)
Baseline LFC (%) by MRI-PDFF
 Baseline cTI (msec) by MRI including the following subgroup: Elevated (>800 – 900
msec) and High (>900 msec)
 Liver biopsy within 2 years of randomization 
o
Baseline fibrosis stage (F1, F2, F3)
o
Baseline NAFLD Activity Score (NAS)
Baseline comorbidities will be based on Medical History case report form, Medical 
Dictionary of Regulatory Activities (MedDRA) preferred term (PT)
o
Diabetes status (yes, no) will be defined as PT preferred term (PT) includes “Diabetes 
mellitus” or “Diabetic neuropathy” will be assigned yes, otherwise no.
o Hypertension (yes, no) will be defined as PT of “Hypertension” will be assigned yes, 
otherwise no. 
o Dyslipidemia (yes, no) will be defined as Standardized MedDRA query (SMQ) of 
“Dyslipidemia (SMQ)” will be assigned yes, otherwise no. 
 Baseline medication use, defined as starting prior to first administration of study drug, 
regardless of end date:  
o Statins defined by the WHODD Standardized Drug Grouping (SDG) of “Statins”
o Antihypertension medications defined by the WHODD SDG of “Antihypertensives”
o Antithrombotic medications defined by WHODD SDG of “Antithrombotic drugs”
o Antidiabetic medications defined by the WHODD SDG of “Drugs used in diabetes” 
The following baseline laboratory tests will be summarized as continuous variables and as 
frequencies for categorizations described: 
 Baseline plasma VAP-1/SSAO activity 
 Baseline soluble VAP-1 (sVAP-1) concentration  
 Baseline ALT level:  
o 
 (overall and by sex) 
 Baseline AST level: The same subgroups as specified for ALT above will be used. 
 Baseline GGT level
 >ULN 
 Baseline ALP level: 
 >ULN 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
:560 U/L versus >60 U/L 
: :SULN, 
:SULN, 
<30, 2:30 <35, 2:35 <40, 2:40 kg/m 


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
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 Baseline to
, >ULN
Screening 
Baseline platelet count: 
Demographics and baseline characteristics will be summarized by treatment group and overall,
for Efficacy, Safety, PP, and Treatment Completer Analysis Sets. The Safety, PP, and Treatment 
Completer Analysis Sets will only be presented if the analysis set differs from the Efficacy 
Analysis Set by more than 10% total. 
All demographic and baseline characteristics data will be presented in by-patient data listings 
using the Efficacy Analysis Set.  
No inferential statistical comparisons will be performed. 
7.3. 
Protocol Deviations 
Protocol deviations will be identified and documented in the clinical trial management system 
(CTMS). Major protocol deviations that could potentially affect the conclusions of the study will 
be identified prior to database lock and unblinding of individual patient treatment information.  
Major protocol deviations include, but are not limited to  
 Patients who entered the study even though they did not satisfy the entry criteria.  
 Patients who developed withdrawal criteria during the study but were not withdrawn.  
 Patients who received the wrong treatment or were dispensed an incorrect dose.  
 Patients who received an excluded concomitant treatment. 
All major protocol deviations will be summarized by treatment group and overall total for each 
deviation category using the Efficacy Analysis Set. 
All protocol deviations and separately only major protocol deviations will be presented in a by-
patient data listing. A separate listing for COVID-19 protocol deviations will be presented. 
7.4. 
General Medical History 
All medical history conditions will be coded using the Medical Dictionary of Regulatory 
Activities (MedDRA). Medical history will be summarized by treatment group and overall total, 
by system organ class and preferred term, using the Safety Analysis Set.  Summaries will be 
ordered by descending order of the overall total incidence of system organ class and preferred 
term within each system organ class.   
7.5. 
Prior and Concomitant Medications  
Prior medications are defined as medications that started before first study drug administration 
and either stopped before or continued after first study drug administration.  Concomitant 
medications are defined as medications that are being taken while on study drug. Medications 
that are ongoing on the date of the first administration of study drug will be classified as both 
prior and concomitant. Any medication that cannot be confirmed as stopping before the start of 
• 
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• 
• 
• 
• 
• 
tal bilirubin level: ::SULN 
HbAlc: < 7%, 2: 7% 
::SULN, > ULN 


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
18 November 2021   
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study drug will be classified as both a prior and a concomitant medication. Imputation of partial 
dates is defined in Appendix 2. 
Prior and concomitant medications will be summarized separately and the number and 
percentage of patients in each treatment group who took at least one prior (concomitant) 
medication as well as the number and percentage of patients who took each type of medication 
will be summarized by Anatomic Therapeutic Class (ATC) Level 2, ATC Level 4, and preferred 
name for the Safety Analysis Set.  If a patient has more than one occurrence of the same 
preferred name, then the preferred name will be counted only once for that patient.  Similarly, if 
a patient has more than one preferred name within ATC Level 4 or ATC Level 4 within ATC 
Level 2, then the patient will be counted only once in that ATC Level 4 or ATC Level 2.   
8.
EFFICACY ANALYSES 
8.1.
Adjustments for Covariates
For comparison of treatment groups with respect to change and percent change from baseline, 
analysis of covariance (ANCOVA) and restricted maximum likelihood (REML) based mixed 
model repeated measures (MMRM) models will be used.  The corresponding baseline value will 
be used as a covariate in the model.   
8.2. 
Handling of Dropouts or Missing Data 
Primary analyses will be based on observed data. Sensitivity analyses will be conducted for 
patients who do not have data at the Week 12 visit, where the last on treatment value will be used 
for Week 12. 
8.3. 
Interim Analyses and Data Monitoring 
No data monitoring committees are planned for this study.
An interim analysis will be performed after all patients in Part 1 have completed Week 6 
assessments. Blinded adverse event and laboratory data will be reviewed.  PK and PD data will 
be provided to the Sponsor with a dummy subject identification and treatment assignment.  If 
robust VAP-1/SSAO activity suppression is observed, and available PK suggest a lower dose 
may also possibly lead to robust VAP-1/SSAO activity suppression, enrollment in Part 2 with 4 
mg TERN-201 may be initiated.  Additionally, if safety data indicates 10 mg TERN-201 is 
overall safe and well-tolerated and anticipated exposures with a higher dose remain below the 
exposure limit (see section 4.3 of the protocol), enrollment in Part 2 to assess a dose up to 20 mg 
TERN-201 in Part 2 may be initiated. 
Additionally, an interim analysis will be conducted after the completion of Part 1.  All data from 
Part 1 will be cleaned and locked prior to unblinding and analyses. 
8.4. 
Multicenter Studies 
The randomization is not stratified by site. Likewise, analyses of data will not be stratified by 
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Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
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8.5.
Use of an “Efficacy Subset” of Patients 
Not Applicable. 
8.6. 
Multiple Comparisons/Multiplicity
There will be no adjustment for multiplicity. Statistical testing will be considered nominal, 
descriptive and exploratory. 
8.7. 
Pharmacokinetic (PK) Analyses 
Analyses of trough PK concentrations will use the PK Analysis Set. Analyses of intensive PK 
concentrations and PK parameters will use the PK/PD Substudy Analysis Set.  All PK endpoints, 
recorded and derived, will be presented in by-patient data listings. 
Plasma and urine TERN-201 and metabolite (TRN-001021 and TRN-001744) concentrations 
will be used as supplied by the analytical laboratory for PK analysis. The units of concentration 
and resulting PK parameters, with amount or concentration in the unit, will be presented as they 
are received from the analytical laboratory, with the exception of metabolite to parent ratios 
which will be corrected for differences in molecular weight. Urine volume will be presented with 
urine concentrations.  Urine collection dates and times from the EDC will be used for analyses, 
otherwise plasma collection dates and times from the central vendor will be used.
Blood and urine samples will be collected at the timepoints specified in Appendix 2 of the study 
protocol.  
8.7.1. 
Below the Quantification Level (BLQ) Values 
Plasma concentration values that are BLQ will be set to zero, with defined exceptions as follows: 
 Any embedded BLQ value (between 2 quantifiable concentrations) and BLQ values 
following the last quantifiable concentration in a profile will be set to missing for the 
purposes of PK analysis. If an embedded BLQ value is considered anomalous within 
the concentration time profile, this value will be excluded as well. 
 If there are late positive concentration values following 2 BLQ concentration values 
in the apparent terminal phase, these values will be evaluated. If these values are 
considered to be anomalous (see Section 8.9.2), they will be set to missing. 
If an entire plasma concentration-time profile is BLQ, the profile will be excluded from the PK 
analysis.  
Urine concentrations below lower limit of quantification (LLOQ) will be treated as numerical 
zero for the calculation of the urine parameters. 
8.7.2. 
Anomalous Values 
If a value is considered to be anomalous due to being inconsistent with the expected PK profile, 
it may be appropriate to exclude this point from the PK analysis. However, the exclusion of data 
must have strong justification and will be documented in the raw data and CSR. 
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Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
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8.7.3. 
Concentration-Time Data 
Individual plasma TERN-201 and metabolite (TRN-001021 and TRN-001744) concentration 
data will be listed separately for trough concentrations (PK Analysis Set) and trough and 
intensive concentrations (PK/PD Substudy Analysis Set).  Concentrations will be summarized by 
nominal sampling time point and treatment with descriptive statistics (number of non-missing 
observations, arithmetic mean, arithmetic SD, arithmetic coefficient of variation [CV%], median, 
Q1, Q3, minimum, maximum, geometric mean and geometric CV%). The number of values 
below quantification limit (BLQ) will be presented for all patients and separately for PK/PD 
substudy patients. Individual urine TERN-201 and metabolite (TRN-001021 and TRN-001744) 
concentrations and sample volume will be listed for each patient. 
The following rules will be applied in the presentation of plasma concentration data if there are 
values that are BLQ or if there are missing values (e.g., no result [NR]) in a plasma concentration 
data series to be summarized. 
 For the calculation of summary statistics, BLQ values will be set to zero. 
 For the calculation of PK parameters, BLQ values will be set to zero prior to the first 
measurable concentration and set to missing after a measurable concentration is observed.
 If an embedded BLQ value is considered anomalous within the concentration time 
profile, this value will be excluded from the summary statistics. 
 Where there is NR, these will be set to missing. 
 If there are less than three values in the data series, only the minimum, maximum and 
number of observations will be presented. The other summary statistics will be denoted 
as not calculated (NC). BLQ is considered a value. 
 If all the values are BLQ, then the arithmetic mean, arithmetic SD, median, minimum and 
maximum will be presented as zero, and the geometric mean and geometric CV% will be 
denoted as NC. 
 If the value of the arithmetic mean or median is below the lower limit of quantification, 
these values will be presented as zero and the geometric mean and geometric CV% will 
be denoted as NC. 
Individual patient and arithmetic mean concentration-time profiles, for TERN-201 and its 
metabolites (TRN-001021 and TRN-001744), for each TERN-201 dose, will be presented
graphically on linear and logarithmic concentration scales separately for trough concentrations 
(PK Analysis Set) and trough and intensive concentrations (PK/PD Substudy Analysis Set) for 
Week 0/Day 1 and Week 12.  A reference line for LLOQ will be included on graphs. 
Concentration data in listings will be presented to the same number of significant figures as 
provided by the analytical laboratory. Descriptive statistics will be displayed according to the 
rules outlined in Section 3.2.  
8.7.4. 
Plasma Pharmacokinetic Parameters 
Sparse PK samples may be used to calculate PK parameters using population pharmacokinetic 
(Pop PK) modeling. Data from the study may be combined with data from other studies for the 
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Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
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purposes of Pop PK modeling. If Pop PK modeling is performed, the process will be described in 
a separate analysis plan. 
For the purposes of this SAP, plasma PK parameters will be computed for the PK/PD sub-study 
patients only. Plasma PK parameters for TERN-201 and its metabolites (TRN-001021 and TRN-
001744) will be calculated from the individual plasma concentrations using a non-compartmental 
approach for Week 0/Day 1, Week 6, and Week 12.  Week 0/Day 1 and Week 6 will include pre 
dose and all post dose assessments prior to the next dose.  Week 12 will include pre dose and all 
post dose assessments.  The actual PK sampling times will be used for the PK analysis. If actual 
PK sampling times are missing, nominal times will be used. If the 24 hr sample is missing at 
Week 6 or Week 12, the predose sample concentration may be re-used for the 24 hr sample for 
the purposes of calculating PK parameters, if appropriate.
Table 6 presents the plasma PK parameters for TERN-201 and its metabolites (TRN-001021 and 
TRN-001744) to be calculated. 
Table 6: 
Plasma Pharmacokinetic Parameters  
Abbreviation 
Parameter Definition 
AUC0-  
For Week 0/Day 1 only, area under the drug concentration-time curve from time 
zero to infinity, calculated using the linear trapezoidal rule for increasing 
concentrations and the logarithmic rule for decreasing concentrations as AUC0-tlast
t / z. 
%AUCextrap
For Week 0/Day 1 only, percentage of AUC that is due to extrapolation from the 
last measurable concentration to infinity 
AUC0-t
For Week 0/Day 1 only, area under the plasma concentration curve over from time 
0 to time t, i.e. from 0 to 24 hours, calculated using the linear trapezoidal rule for 
increasing concentrations and the logarithmic rule for decreasing concentrations. 
AUC0-8hr
For Week 0/Day 1 and Week 6, area under the plasma concentration curve over 
from time 0 to 8 hours, calculated using the linear trapezoidal rule for increasing 
concentrations and the logarithmic rule for decreasing concentrations. 
AUCtau
For Week 6 and Week 12, area under the plasma concentration curve over a 
dosing interval, i.e. from 0 to 24 hours, calculated using the linear trapezoidal rule 
for increasing concentrations and the logarithmic rule for decreasing 
concentrations. 
Cmax 
Maximum observed plasma concentration, obtained directly from the plasma 
concentration-time profiles within the sampling interval, i.e. calculated for each 
intensive sampling visit separately (Week 0/Day 1, Week 6, Week 12). In the case 
where multiple peaks are of equal magnitude, the earliest peak concentration will 
be reported as Cmax.
Cmin 
Minimum observed plasma concentration, obtained directly from the plasma 
concentration-time profiles at steady state, within the sampling interval, i.e. 
calculated for each intensive sampling visit separately (Week 6 Week 12). In the 
case where multiple minimums are of equal magnitude, the latest minimum 
concentration will be reported as Cmin.  
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Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
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Abbreviation 
Parameter Definition 
Tmax
Time of the maximum observed plasma concentration, obtained directly from the 
plasma concentration-time profiles within the sampling interval, i.e. calculated for 
each intensive sampling visit separately (Week 0/Day 1, Week 6, Week 12). In the 
case where multiple peaks are of equal magnitude, the time of the earliest peak 
will be reported as the tmax.
Tmin
Time of the minimum observed plasma concentration, obtained directly from the 
plasma concentration-time profiles at steady state, within the sampling interval, 
i.e. calculated for each intensive sampling visit separately (Week 6 Week 12). In 
the case where multiple minimums are of equal magnitude, the time of the latest 
minimum will be reported as Tmin.
Tlast 
Time of the last quantifiable plasma concentration, obtained directly from the 
plasma concentration-time profiles within the sampling interval, i.e. calculated for 
each intensive sampling visit separately (Week 0/Day 1, Week 6, Week 12). 
t1/2  
Apparent plasma terminal elimination half-life, calculated as ln(2) / z. 
CL/F 
 
Apparent total plasma clearance calculated as Dose / AUC0- for Week 0/Day 1  
CLss/F 
 
Apparent total plasma clearance at steady state, calculated as Dose / AUCtau for 
Week 6 and Week 12. 
Vz/F  
 
Apparent volume of distribution, calculated as Dose / (
z * AUC0- ) for Week 
0/Day 1  
Vss/F  
 
Apparent volume of distribution, calculated as Dose / (
z * AUCtau) for Week 6 
and Week 12. 
RAAUCtau
Observed accumulation ratio based on AUCtau calculated as  
AUCtau (Week 6 and Week 12) /AUC0-24hr (Day 1).  
RACmax
Observed accumulation ratio based on Cmax, calculated as  
Cmax (Week 6 and Week 12) /Cmax (Day 1).
LR 
Linearity ratio calculated as AUCtau (Week 6 and Week 12) / AUC0-
 
Cavg
Average observed drug concentration at steady state (Week 6 and Week 12 only) 
C24
For Week 0/Day 1, observed drug concentration at the end of the dosing interval, 
e.g. from 0 to 24 hours 
Ctau 
Observed drug concentration at the end of the dosing interval, e.g. from 0 to 24 
hours (Week 6 and Week 12 only) 
z
Apparent terminal rate constant (listed only) 
In addition, the metabolite-to-parent ratios will be calculated for AUCtau, Ctau, and Cmax.
Metabolite-to-parent ratios will be corrected for molecular weight differences by multiplying the 
ratio by a correction factor. The correction factor for TRN-001021 ratios is 1.05 and the 
correction factor for TRN-001744 ratios is 1.42.  
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Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
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Additional PK parameters may be determined where appropriate.
8.7.4.1. 
Pharmacokinetic Parameter Data Handling 
8.7.4.2. 
Calculation of AUC 
AUCs will be calculated using linear up / log down trapezoidal rule. For any partial AUC 
determination (i.e., AUC over a dosing interval), nominal time will generally be used for the end 
of the interval. Actual times for partial AUC intervals may be used at the discretion of the 
pharmacokineticist.  
The minimum requirement for the calculation of AUC will be the inclusion of at least three 
consecutive plasma concentrations above the LLOQ, with at least one of these concentrations 
following Cmax.
8.7.4.3. 
Criteria for Calculation and Goodness of Fit 
z, t1/2, AUC0- , CL/F and CLss/F, Vz/F and Vss/F, and LR will only be reported if the 
following criteria for the terminal elimination phases (log-linear phase) for the concentration-
time data are met:
 
A minimum of 3 measurable concentration-time-points during the log-linear portion of the 
terminal elimination phase (after Tmax), excluding Cmax. 
 
r²adj 
80 for the regression of the log-concentration time data during the terminal 
elimination phase.
Negative slope for log regression fit. 
AUC0- values where the percentage extrapolation is greater than 30% will be reported and 
flagged but excluded from descriptive statistics.  Parameters affected by AUC0- such as t1/2, 
CL/F, Vz/F, and LR will be handled the same way as AUC0-
 
Additional analyses will be performed as deemed necessary upon review of the data.
8.7.5. 
Statistical Methods for Pharmacokinetic Parameters
Plasma PK parameters will be summarized by treatment group using descriptive statistics 
(number of non-missing observations, arithmetic mean, SD, median, Q1, Q3, minimum, 
maximum, geometric mean, and geometric CV%).   
For the calculation of summary statistics, all NR and not calculated (NC) values in a data series 
will be set to missing.  
8.7.6. 
Urine Pharmacokinetic Parameters 
Table 7 presents the urine TERN-201 and its metabolites (TRN-001021 and TRN-001744) PK 
parameters to be calculated.  
Values for A 
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Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
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Table 7: 
Urine Pharmacokinetic Parameters 
Abbreviation 
Parameter Definition 
CLR
Renal clearance, calculated over 0-8 h interval by dividing Ae0-8h by AUC0-8h, 
where the 0-8 h interval used is the same for Ae and AUC. 
Ae
Amount of drug recovered from urine, amount will be calculated by multiplying 
urine concentration by urine volume. If the amount of urine is collected as weight 
rather than volume, Ae will be calculated by assuming a urine density of 1.0 g/mL. 
fe
Percentage of dose recovered from urine, percentages will be calculated as 
Ae/dose ×100.   
8.8.
Pharmacodynamic (PD) Analyses
Plasma samples will be collected for measurement of VAP-1/SSAO activity and methylamine 
levels according to the schedule of activities in Section 1.3 of the protocol. 
8.8.1. 
Below the Quantification Level (BLQ) Values 
Plasma concentrations that are BLQ will be set to ½ × BLQ.
8.8.2. 
VAP-1/SSAO Activity Levels and Methylamine Concentration Time Data 
Individual plasma VAP-1/SSAO activity levels and methylamine concentration data will be 
listed separately for trough timepoints (PD Analysis Set) and trough and intensive timepoints 
(PK/PD Substudy Analysis Set).  VAP-1/SSAO activity levels and methylamine concentrations
will be summarized by nominal sampling time point and treatment group with descriptive 
statistics (number of non-missing observations, arithmetic mean, SD, median, Q1, Q3, minimum, 
maximum, geometric mean and geometric coefficient of variation [CV%]). The number of 
values BLQ will be presented for all patients and separately for PK/PD substudy patients.  
The following rules will be applied in the presentation of plasma VAP-1/SSAO activity levels 
and methylamine concentration data if there are values that are BLQ or if there are missing 
values (e.g., no result [NR]) in a data series to be summarized. 
 For the calculation of summary statistics, BLQ values will be set to ½ × BLQ. 
 Where there is NR, these will be set to missing. 
 If there are less than three values in the data series, only the minimum, maximum and 
number of observations will be presented. The other summary statistics will be denoted 
as not calculated (NC). BLQ is considered a value. 
 If all the values are BLQ, then the arithmetic mean, arithmetic SD, median, minimum and 
maximum will be presented as ½ × BLQ, and the geometric mean and geometric CV% 
will be denoted as NC. 
Individual patient, arithmetic mean VAP-1/SSAO activity levels and methylamine concentration 
-time profiles, for each TERN-201 dose, will be presented graphically on linear and logarithmic 
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Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
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scales separately for trough timepoints (PD Analysis Set) and trough and intensive timepoints 
(PK/PD Substudy Analysis Set) patients for Week 0/Day 1, Week 6, and Week 12.  A reference 
line for LLOQ will be included on graphs. 
VAP-1/SSAO activity levels and methylamine concentration data in listings will be presented to 
the same number of significant figures as provided by the analytical laboratory. Descriptive
statistics will be displayed according to the rules outlined in Section 4.1.  
8.8.3. 
Change from Baseline 
Descriptive statistics of VAP-1/SSAO activity and methylamine values, change from baseline, 
and percent change from baseline values will be presented by treatment group for each visit 
separately using the PD Analysis Set for trough timepoints and using the PK/PD Analysis Set for 
trough and intensive timepoints. Baseline is defined as the Week 0/Day 1 pre-dose value.
Analyses of change (and separately percent change) from baseline will be carried out using an 
ANCOVA model at time point with change (and separately percent change) from baseline as the 
dependent variable including treatment group and randomization strata as fixed effects and 
baseline as a covariate.   
The estimates of least-square (LS) means, standard errors (SE), and 90% and 95% CIs will be 
presented by treatment group.  Estimates of the LS mean difference for each pairwise 
comparison will be presented with associated the standard error of the difference, and 90% and 
95% CIs of the difference.
Figures of LS mean (±SE) change from baseline, and percent change from the ANCOVA model
will be presented over time by treatment group.
Analyses to explore the correlation of plasma VAP-1/SSAO activity and methylamine changes 
with liver function tests, LFC, cT1, and other biomarker changes may be evaluated.  
8.8.4. 
Plasma PD Parameters
Plasma PD parameters will be computed for PK/PD sub-study patients only.  Plasma PD 
parameters for plasma VAP-1/SSAO activity and methylamine will be calculated from the
individual plasma VAP-1/SSAO activities and methylamine concentrations using a non-
compartmental approach for Week 0/Day 1, Week 6, and Week 12.  Week 0/Day 1 and Week 6 
will include pre-dose and all post dose assessments prior to the next dose.  Week 12 will include 
pre dose and all post dose assessments.  The actual PD sampling times will be used for the PD 
analysis. If actual PD sampling times are missing, nominal times will be used.  
Table 8 and Table 9 present the plasma PD parameters to be calculated. 
Table 8: 
VAP-1/SSAO Plasma PD Parameters  
Abbreviation 
Parameter Definition 
AAUCtau 
Area under curve for VAP-1/SSAO activity, calculated separately for the value, 
change from baseline, and percent change from baseline over a dosing interval, i.e. 
from 0 to 24 hours, calculated using the linear trapezoidal rule. 


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
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Abbreviation 
Parameter Definition 
Amin 
Minimum observed VAP-1/SSAO activity, calculated separately for the value, 
change from baseline, and percent change from baseline, obtained directly from 
the plasma VAP-1/SSAO activity time profiles. In the case where multiple 
minimums are of equal magnitude, the earliest minimum values will be reported as 
Amin.
Amax
Maximum observed VAP-1/SSAO activity, calculated separately for the value, 
change from baseline, and percent change from baseline, obtained directly from 
the plasma VAP-1/SSAO activity time profiles. In the case where multiple 
maximums are of equal magnitude, the earliest maximum values will be reported 
as Amax.
ATmin 
Time of the minimum observed VAP-1/SSAO activity, calculated separately for 
the value, change from baseline, and percent change from baseline, obtained 
directly from the plasma VAP-1/SSAO activity time profiles. In the case where 
multiple minimums are of equal magnitude, the time of the earliest minimum will 
be reported as the ATmin.
ATmax
Time of the maximum observed VAP-1/SSAO activity (and separately, change 
and percent change from baseline), obtained directly from the plasma VAP-
1/SSAO activity and methylamine concentration-time profiles. In the case where 
multiple maximums are of equal magnitude, the time of the earliest maximums 
will be reported as the ATmax.
ATlast 
Time of the last quantifiable VAP-1/SSAO activity value 
Aavg
Average observed VAP-1/SSAO activity, calculated separately for the value, 
change from baseline, and percent change from baseline at steady state (Week 6 
and Week 12 only) 


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
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Table 9: 
Methylamine Plasma PD Parameters  
Abbreviation 
Parameter Definition 
AUCtau 
Area under curve for methylamine concentration (and separately, change and 
percent change from baseline) over a dosing interval, i.e. from 0 to 24 hours, 
calculated using the linear trapezoidal rule. 
Cmin 
Minimum observed methylamine concentration (and separately, change and 
percent change from baseline) obtained directly from the plasma methylamine 
concentration-time profiles. In the case where multiple minimums are of equal 
magnitude, the earliest minimum values will be reported as Cmin.
Cmax 
Maximum observed methylamine concentration (and separately, change and 
percent change from baseline) obtained directly from the plasma methylamine 
concentration-time profiles. In the case where multiple maximums are of equal 
magnitude, the earliest maximum values will be reported as Cmax.
Tmin
Time of the minimum observed methylamine concentration (and separately, 
change and percent change from baseline), obtained directly from the plasma and 
methylamine concentration-time profiles. In the case where multiple minimums 
are of equal magnitude, the time of the earliest minimum will be reported as the 
Tmin.
Tmax
Time of the maximum observed methylamine concentration (and separately, 
change and percent change from baseline), obtained directly from the plasma 
methylamine concentration-time profiles. In the case where multiple maximums 
are of equal magnitude, the time of the earliest maximums will be reported as the 
Tmax.
Tlast 
Time of the last quantifiable methylamine concentration 
Cavg
Average observed methylamine concentration (and separately, change and percent 
change from baseline) at steady state (Week 6 and Week 12 only) 
8.8.4.1. 
PD Parameter Data Handling
8.8.4.2. 
Calculation of AUC 
AUCs will be calculated using linear trapezoidal rule. For any partial AUC determination (i.e., 
AUC over a dosing interval), nominal time will generally be used for the end of the interval.  
The minimum requirement for the calculation of AUC will be the inclusion of at least three 
consecutive plasma VAP-1/SSAO activity or methylamine concentrations above the LLOQ.
8.8.4.3. 
Statistical Methods for PD Parameters
Plasma PD parameters will be summarized by treatment group using descriptive statistics 
(number of non-missing observations, arithmetic mean, SD, median, Q1, Q3, minimum, 
maximum, geometric mean, and geometric CV%).   
For the calculation of summary statistics, all NR and not calculated (NC) values in a data series 
will be set to missing.  


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
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Analyses of pre-dose/trough values for plasma VAP-1/SSAO activity (Aavg and Amin) and 
methylamine (Cavg and Cmax) at Week 0/Day 1, Week 6, and Week 12 will be carried out using 
an ANCOVA model with the PD parameter as the dependent variable including treatment group 
as a fixed effect and baseline VAP-1/SSAO activity or methylamine concentration as a covariate.
The model will be carried out separately for the PD parameter based on the VAP-1/SSAO 
activity and methylamine value, change from baseline, and percent change from baseline.  The 
estimates of LS means, SE, and 90% and 95% CIs will be presented by treatment group.  
Estimates of the LS mean difference for each pairwise comparison will be presented with 
associated the standard error of the difference, and 90% and 95% CIs of the difference.
The distribution of parameter values will be evaluated visually for normality assumptions.  If 
normality assumptions are violated, first the data will be natural log transformed and the log 
transformed data evaluated for normality.  If the log transformed data are normally distributed, 
the same ANOVA model described above will be used. 
8.8.4.4. 
Dose Response 
If Part 2 enrolls, dose-response may be evaluated, if the data warrants, based on the pairwise 
comparisons of pre-dose/trough values for plasma VAP-1/SSAO activity (Aavg and Amin) and 
methylamine concentration (Cavg and Cmax) from the ANCOVA models specified above (Section 
8.8.4.3).  In addition, pre-dose/trough VAP-1/SSAO activity (Aavg and Amin) and methylamine 
concentration (Cavg and Cmax) will also be plotted by treatment group based on values, change 
from baseline, and percent change from baseline. 
Dose response will also be evaluated using a REML based MMRM.  The dependent variable will 
be the percent change (separately for change) from baseline for plasma VAP-1/SSAO activity 
and methylamine.  The model will include the following fixed effects:
Treatment group (4 levels: placebo [0 mg], 4 mg, 10 mg, 20 mg)
 Categorical time  
Treatment group by time interaction
Baseline value
An unstructured covariance model will be used.  If the computational algorithm fails to 
converge, the following structures will be executed:  heterogeneous Toeplitz, heterogeneous 
First-Order Autoregressive [AR (1)], heterogeneous compound symmetry (HCS), Toeplitz, 
AR(1), and compound symmetry (CS).  The covariance structure converging to the best fit, as 
determined by Akaike’s information criterion (AIC, the smaller the AIC value the better the 
model fit), will be used.  If the model converges with an unstructured covariance matrix, the 
Kenward and Roger method will be used to calculate the denominator degrees of freedom for the 
test of fixed effects. If a structured covariance is used, then a robust sandwich estimator will be 
utilized for estimating the variance of the treatment effect estimate.
8.9.
Exposure Response Analyses
The plasma PK parameters AUCtau, Cmax, and Ctau will be used to evaluate exposure-response.  
PK parameters will be set to 0 for the placebo group for the purpose of PK/PD. 
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Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
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Pharmacodynamic exposure-response analyses of plasma VAP-1/SSAO activity and 
methylamine concentration PD parameters will be performed using several exposure-response 
models for the PK/PD Analysis Set, including but not limited to linear, quadratic, exponential, 
and Emax.  The best fit significant model will be chosen based on AIC, the smaller the AIC value 
the better the model fit. 
Additional exposure-response and dose-response (as applicable) analyses may be explored for 
baseline patient characteristics such as sVAP-1, BMI, diabetes mellitus, or other characteristics 
or additional efficacy, safety, and PD endpoints, as needed.  These analyses will be described in 
a separate document. 
8.10. 
Exploratory Efficacy Analyses  
8.10.1. 
Magnetic Resonance Imaging 
MRIs will be evaluated by a central reader. The following analyses of MRI will use the Efficacy 
Analysis Set. Sensitivity analyses using the PP and Treatment Completer Analysis Sets will be 
presented if the analysis set differs from the Efficacy Analysis Set by more than 10% total. 
8.10.1.1. Corrected T1 (cT1) 
cT1 related to the amount of extracellular fluid present in the liver parenchyma. cT1 is derived 
from T1 and T2* maps. T1 is a measure of the longitudinal (spin-lattice) relaxation time, 
measured in milliseconds (msec), of a given substance. The T1 of a tissue depends on its free 
water content, which relates to the proportion of the extracellular fluid in the tissue. 
Proton-dense tissues with a low water content, such as fat, have very short T1 values, while 
tissues with a high water content, such as muscle and the spleen have much longer T1 values. 
When tissue is inflamed or scarred (fibrotic), changes in the structural organization of the tissue, 
due to tissue remodeling, mean that the water content increases, leading to longer T1 values. 
cT1 is measured in milliseconds (msec).  The cT1 metric is calculated from all pixels with whole 
slice ROIs placed on the cT1 parametric map. The cT1 metric is displayed as a median and IQR, 
the median will be used in all analyses. 
Analyses of cT1 will be based on the Efficacy Analysis Set. Descriptive statistics of the cT1 
values, change from baseline, and percent change will be summarized by treatment group and 
visit.   
Analyses of change (and separately percent change) from baseline will be carried out using an 
ANCOVA model at each scheduled visit with change (and separately percent change) from 
baseline as the dependent variable including treatment group and randomization strata as fixed 
effects and baseline as a covariate.   
The estimates of least-square (LS) means, standard errors (SE), and 90% and 95% CIs will be 
presented by treatment group.  Estimates of the LS mean difference for each pairwise 
comparison will be presented with associated the standard error of the difference, and 90% and 
95% CIs of the difference. 
The primary analysis of change (and separately percent change) at Week 12 will be carried out 
using available observed data only, without imputation for missing data. The same ANCOVA 


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
18 November 2021   
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Page 32 of 50 
model will be used to present the last on treatment value for Week 12, to be labelled as “Week 
12/End of Treatment”.  For patients who complete Week 12, the Week 12 value will be used.  
For patients who do not complete treatment, the last value on treatment will be used. 
The distribution of change (percent change) values will be evaluated visually for normality 
assumptions.  If normality assumptions are violated, first the data will be natural log transformed 
and the log transformed data evaluated for normality.  If the data are not normally distributed, a
Wilcoxon Rank Sum Test will be used to compare treatment groups.  The median differences 
and 90% and 95% CIs of the median differences between treatment groups will be constructed 
using Hodges-Lehmann estimate.   
Sensitivity analyses using the PP and Treatment Completer Analysis Sets will be presented if the 
analysis set differs from the Efficacy Analysis Set by more than 10% total. 
cT1 will be categorized as low (<800 msec), elevated (800 – 900 msec), and high (>900 msec).  
A shift table from baseline to Week 6 and baseline to Week 12 will be presented by treatment 
group. 
In addition, cT1 responders will be defined as any patient with a decrease of at least 80 msec. 
Non-responders will be defined as any patient who did not have at least an 80 msec decrease.  
For both endpoints, the number and percentage, with associated two-sided exact (Clopper-
Pearson) 90 and 95% CIs, of patients in each category will be presented by treatment group at 
each post-baseline visit.  A Chi-square test at each post-baseline visit will be used to compare 
each pairwise comparison between placebo and each active dose of TERN-201. 
The number and percentage of patients who are responders on cT1 and ALT will be summarized 
and analyzed in the same manner as responders. 
8.10.1.2. Liver Fat Content by MRI Proton Density Fat Fraction (PDFF) 
Liver fat content (LFC) or proton density fat fraction (PDFF) is an estimate of the percentage of 
fat within a tissue. It is defined as the proportion of the mobile proton density in the liver 
is expressed as a percentage (%). The PDFF metric on the quantitative analysis output is a 
summarized metric from the individual pixels within all of the region of interests (ROIs) placed 
on the PDFF parametric map or an average of all the pixels within the contour generated by 
automatic liver segmentation. The PDFF metric is displayed as a median and interquartile range 
(IQR), the median will be used in all analyses. 
Analyses of liver fat content (LFC) by MRI by MRI-PDFF will be based on the Efficacy 
Analysis Set. For the purposes of LFC analyses, absolute change is equivalent to change and 
relative change is equivalent to percent change (see Section 4.5). Descriptive statistics of the 
LFC by MRI-PDFF results, absolute change from baseline, and relative change will be 
summarized by treatment group and visit.  
LFC by MRI-PDFF will be analyzed in the same manner as LFC (Section 8.10.1.1).  LFC by 
MRI-PDFF responders will be defined as any patient with a relative decrease of at least 30% 
-30%). Non-responders will be defined as any patient who did not have at least a 30% 
relative decrease (i.e., >-30%). The number and percentage, with associated two-sided exact 
(Clopper-Pearson) 90% and 95% CIs, of patients in each category (response, nonresponse) will 
attributable to fat. PDFF is quantified from the ratio offat/(fat+water) components in images and 
(• 
< 
i.e., -


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
18 November 2021   
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Page 33 of 50 
be presented by treatment group at Week 6 and Week 12. A Chi-square test at Week 6 and Week 
12 will be used to compare each pairwise comparison between placebo and each active dose of 
TERN-201. 
8.10.2. 
Transient Elastography 
Liver stiffness and CAP are measured by transient elastography. Descriptive statistics of 
biomarker values, change from baseline, and percent change from baseline will be presented by 
treatment group for each visit, at which data are collected, using the Efficacy Analysis Set.   
Change (and separately for percent change) from baseline in liver stiffness will be analyzed 
using the same ANCOVA model presented in Section 8.10.1.1 for each post-baseline and follow 
up visit using observed data only.  Sensitivity analyses using the PP and Treatment Completer 
Analysis Sets will be presented if the analysis set differs from the Efficacy Analysis Set by more 
than 10% total. 
Assessments of normality will be performed as described in Section 8.10.1.1. 
8.10.3. 
Liver Function Tests 
LFTs for efficacy analyses include AST, ALT, and GGT.  Descriptive statistics of LFT values, 
change from baseline, and percent change from baseline values will be presented by treatment 
group for each visit using the Efficacy Analysis Set.   
Change (and separately for percent change) from baseline will be analyzed using the same 
ANCOVA model presented in Section 8.10.1.1 for each post-baseline and follow up visit using 
observed data only.  Sensitivity analyses using the PP and Treatment Completer Analysis Sets 
will be presented if the analysis set differs from the Efficacy Analysis Set by more than 10% 
total. 
Assessments of normality will be performed as described in Section 8.10.1.1. 
Figures of LS mean (±SE) change from baseline, and percent change from the ANCOVA model 
will be presented over time by treatment group. 
8.10.3.1. Change from End of Treatment in ALT 
The change (and separately percent change) from end of treatment to follow up visit (Week 16) 
will be summarized by treatment group.  For patients who complete Week 12, the Week 12 value 
will be used for End of Treatment.  For patients who do not complete treatment, the last value on 
treatment will be used for End of Treatment. Descriptive statistics of ALT values, change from 
end of treatment, and percent change from end of treatment will be presented by treatment group 
for each visit using the Efficacy Analysis Set.   
Change (and separately for percent change) from end of treatment in ALT will be analyzed using 
the same ANCOVA model presented in Section 8.10.1.1 for each follow up visit using observed 
data only. Assessments of normality will be performed as described in Section 8.10.1.1. 
Sensitivity analyses using the PP and Treatment Completer Analysis Sets will be presented if the 
analysis set differs from the Efficacy Analysis Set by more than 10% total. 


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
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Sensitivity analyses will be conducted including only Week 16 assessments which are at least 22 
days from last dose.
8.10.4. 
NASH and Fibrosis Biomarkers
Markers of hepatic fibrosis and apoptosis include CK-18 (M30 and M65), PIIINP, TIMP-1, HA, 
PRO-C3, and C3M.  The PRO-C3/C3M ratio will be calculated.  Descriptive statistics of 
biomarker values, change from baseline, and percent change from baseline will be presented by 
treatment group for each visit using the Efficacy Analysis Set.   
Change (and separately for percent change) from baseline will be analyzed using the same 
ANCOVA model presented in Section 8.10.1.1 for each post-baseline and follow up visit using 
observed data only.  Sensitivity analyses using the PP and Treatment Completer Analysis Sets 
will be presented if the analysis set differs from the Efficacy Analysis Set by more than 10% 
total. 
Assessments of normality will be performed as described in Section 8.10.1.1. 
8.10.4.1. Enhanced Liver Fibrosis (ELF) Score 
0.394 ln (TIMP-1). Lab values from the same visit will be used to calculate the ELF 
score.  The ELF score will be calculated at baseline and each post-baseline visit. 
The ELF score will be analyzed in the same manner as specified in Section 8.10.4. 
8.10.4.2. Fibrosis-4 (FIB-4) Score 
The Fibrosis-4 (FIB-4) score helps to estimate the amount of scarring in the liver.  The FIB-4 
score is calculated as: [Age (years) × AST (U/L)] ÷ [Platelet Count (109/L) × ALT (U/L)0.5].  
Age at screening will be used.  Lab values at each visit, from the same visit, will be used.  The 
FIB-4 score will be calculated at baseline and each post-baseline visit.
The FIB-4 score will be analyzed in the same manner as specified in Section 8.10.4. 
8.10.4.3. Nonalcoholic Fatty Liver Disease (NAFLD) Fibrosis Score 
The Nonalcoholic Fatty Liver Disease (NAFLD) fibrosis score will be calculated as: -
0.037 × Age (years
2
status (yes = 1, no =
AST/ALT ratio - 0.013 × Platelet Count (109/L) - 0.66 × Albumin (g/dL). Age and diabetes 
status at informed consent will be used.  BMI at each visit will be calculated using the weight 
from that visit and height from screening.  Lab values at each visit, from the same visit, will be 
used.  The NAFLD fibrosis score will be calculated at baseline and each post-baseline visit. 
The NAFLD fibrosis score will be analyzed in the same manner as specified in Section 8.10.4. 
8.10.5. 
Inflammation Biomarkers 
Markers of inflammation include hs-CRP, IL-6, ICAM-1, and VCAM-1, which will be analyzed 
in the same manner as specified in Section 8.10.4. 
The enhanced liver fibrosis (ELF) score will be calculated as: 2.278+0.851 ln (HA) +0.751 ln 
(PIIINP) + 
1.675 + 
) + 0.094 x BMI (kg/m) + 1.13 x diabetes 
0) + 0.99 X 


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
18 November 2021   
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8.10.6. 
Proteinuria Biomarkers
Proteinuria biomarkers include estimated glomerular filtration rate (eGFR), urine protein 
including urine protein-to-creatinine ratio (UPCR), and urine albumin-to-creatinine ratio 
(UACR), which will be analyzed in the same manner as specified in Section 8.10.4. 
8.10.7. 
Anthropometric Measures
Anthropometric measures include body weight (kg) and BMI (kg/m2).  BMI will be 
programmatically calculated for every visit where there is a weight collected, using the screening 
height.  Weight will be analyzed in the same manner as specified in Section 8.10.4. 
Percent change in weight will be categorized as follows: 
 At Least 5% Decrease 
 All Other Patients (minor decrease [up to 5%], stable, or increase) 
The number and percentage, with associated two-sided exact (Clopper-Pearson) 90 and 95% CIs, 
of patients in each category will be presented by treatment group. P-values from a Chi-square 
test will be presented for each pairwise comparison. 
8.10.8. 
Dose Response 
Dose-response analyses for ALT, AST, GGT, cT1, MRI-PDFF, CK-18 (M30 and M65), PRO-
C3, C3M, and PROro-C3/C3M ratio will be performed using the same methodology specified in 
Section 8.8.4.4. 
9. 
SAFETY ANALYSES 
Safety analyses will be conducted using the Safety Analysis Set.  
No inferential comparison of safety endpoints will be performed, unless otherwise specified.  
9.1.
Extent of Exposure 
Total duration of exposure will be calculated in days as the last date study drug administration –
In addition, duration of exposure accounting for 
days where a dose was missed (referred to as interruptions on CRFs) will be calculated as (last 
date study drug administration – 
) – sum of (Week  
date of resumption – Week  start date of interruption) 
8, and 12.  The dates of interruption are from the Study Drug Interruptions CRF.  If dates of 
missed doses are not available, the number of missed doses will be used. Duration of exposure, 
total and accounting for missed dosing days, will be summarized with descriptive statistics by 
treatment group.   
The number and percentage of patients with any missed dose and the total duration of days 
where doses were missed will be summarized with descriptive statistics by treatment group.
Treatment compliance will be calculated based on the Study Drug Administration and Study 
Drug Interruptions CRFs and separately based on the Study Drug Accountability CRF. 
• 
• 
the first date study drug administration + 1. 
the first date study drug administration + 1 
X 
X 
where X is the week number, i.e., 2, 4, 6, 


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
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Compliance based on the Study Drug Administration and Study Drug Interruptions CRFs will be 
calculated as:  
 100 × [((last date study drug administration – 
) 
– sum of missed dose durations) / (last date study drug administration – the first date 
)]. 
Compliance based on study drug accountability will be calculated as:  
 100 × [(Sum of capsules taken during study) / (Expected Taken)] 
For Part 2, capsules will be summed across the 2 bottles at each week. 
For subjects in Part 1, expected taken is calculated as the study day of the last dose date. For 
subjects in Part 2, expected taken is calculated as the study day of the last dose date × 2. Each 
treatment compliance will be summarized with descriptive statistics by treatment group. Number 
and percent of patients in each of the following compliance categories will be summarized by 
treatment group and overall total:  
 <80% 
 80% to 100% 
 >100%. 
Study drug administration including missed doses, delays, and overdoses, and study drug 
dispensing and accountability, calculated durations of exposure, and calculated compliances will 
be presented in by-patient data listings. Compliance with fasting conditions will be presented in a 
separate by-patient data listings. 
9.2. 
Adverse Events 
Adverse event (AE) verbatim terms on eCRFs will be mapped to preferred terms (PT) and 
system organ classes (SOC) using MedDRA.  AE severity will be categorized using the National 
Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE, Version 5). 
All AEs will be listed, but summaries will be restricted to TEAEs, defined as any AE with a start 
date on or after the date of first administration of study drug through 30 days after the last 
administration of study drug or through the Follow-Up Period (Week 16).  Related SAEs after 
Week 16 will be considered TEAEs. If it cannot be determined whether an AE is treatment 
emergent due to a partial onset date, then it will be counted as such. Methodology for imputation 
of partial AE start and stop dates is described in Appendix 2. Each summary will be displayed by 
treatment group.   
9.2.1. 
Overall Summary of Adverse Events 
An overall summary of TEAEs will be presented by treatment group.  The number and 
percentage of patients who experience at least one of the following: 
 Any TEAE, All CTCAE grades 
 TEAE by Maximum Severity  
 Serious TEAE 
• 
the first date study drug administration + 1 
study drug administration + 1 
• 
• 
• 
< 
• 
• 
• 
• 


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
18 November 2021   
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 TEAE leading to death 
Treatment-related TEAE, All CTCAE grades
Treatment-related Grade 3 or higher TEAE
Treatment-related serious TEAE
TEAE leading to study drug interruption
 TEAE leading to study drug discontinued 
 TEAE leading to discontinuation from the study 
9.2.2. 
Patient Incidence of Adverse Events 
Summaries will be displayed by SOC and PT, and will be ordered by descending order of all 
TERN-201 incidence of system organ class and preferred term within each system organ class.  
Summaries of the following types will be presented:
Patient incidence of TEAEs by MedDRA SOC and PT.
Patient incidence of non-COVID TEAEs for patients who have a TEAE of COVID-
19.
 Patient incidence of TEAEs by MedDRA SOC, PT, and highest severity (CTCAE 
grade). At each level of patient summarization, a patient is classified according to the 
highest severity if the patient reported 1 or more events. AEs with missing severity 
(CTCAE grade) will be considered Grade 3 (severe) for this summary.  
 Patient incidence of CTCAE Grade 3 or higher TEAEs by MedDRA SOC and PT. At 
each level of patient summarization, a patient is classified according to the highest 
severity if the patient reported 1 or more events. AEs with missing severity (CTCAE 
grade) will be considered Grade 3 (severe) for this summary. 
 Patient incidence of treatment-related TEAEs by MedDRA SOC and PT. Related AEs 
are those with relationships reported as “Related” or “Possibly Related”. At each 
level of patient summarization, a patient is classified according to the closest 
relationship to study drug if the patient reported 1 or more events. AEs with a missing 
relationship will be considered related for this summary. 
 Patient incidence of treatment-related CTCAE Grade 3 or higher TEAEs by 
MedDRA SOC and PT. At each level of patient summarization, a patient is classified 
according to the highest severity if the patient reported 1 or more events. AEs with 
missing severity (CTCAE grade) will be considered Grade 3 (severe) for this 
summary. AEs with a missing relationship will be considered related for this 
summary.
Patient incidence of serious TEAEs by MedDRA SOC and PT.
Patient incidence of TEAEs leading to study drug discontinued by MedDRA SOC 
and PT. This is a subset of the AEs where Action Taken with Study Drug is checked 
as “Drug Withdrawn.” 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
18 November 2021   
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The following listings will be presented by treatment group and patient, include study day event 
started and the duration of event: 
 All adverse events. 
 Serious adverse events (subset of the AEs where serious is marked as “Yes”).
CTCAE Grade 3 or higher adverse events (subset of AEs where severity is marked as 
CTCAE Grade 3, 4, or 5). 
 Related adverse events (subset of the AEs where relationship marked as “Related” or 
“Possibly Related”).
 Adverse events leading to study drug interruption (subset of the AEs where Action 
Taken with Study Drug is checked as “Study drug interrupted”).
 Adverse events leading to study drug discontinued (subset of the AEs where Action 
Taken with Study Drug is checked as “Drug Withdrawn”). 
 Adverse events leading to death (subset of the AEs where outcome is indicated as 
“Fatal” or the CTCAE grade is 5 or seriousness criteria is Death). 
9.3. 
Clinical Safety Laboratory Evaluations 
All laboratory assessments are specified in Appendix 1 of the study protocol. Laboratory 
parameters will be summarized in conventional units. Coagulation parameters, hemoglobin A1c, 
direct bilirubin, and indirect bilirubin will not be summarized. 
Quantitative serum chemistry, fasting lipids, and hematology results will be summarized by 
treatment group using descriptive statistics at baseline and at each post-baseline visit.  The 
change and percent change from baseline will also be summarized.  
Values determined to be erroneous will be documented in the trial master file and analysis data 
reviewer’s guide.  Erroneous values will not be included in summary tables or analyses but will 
be included in patient listings. 
All clinical safety laboratory data will be presented in by-patient data listings. A separate listing 
for central laboratory normal ranges, by lab category, lab test, lab parameter, sex, and age, will 
be presented. Any local laboratory normal ranges for COVID-19 will be presented separately.
9.3.1. 
Treatment Emergent Abnormalities 
Quantitative laboratory tests will be assigned grades based on National Cancer Institute Common 
Terminology Criteria for Adverse Events (NCI CTCAE) Version 5. For each applicable 
laboratory test, a treatment emergent abnormality will be defined as a post-baseline through 
Week 16 CTCAE grade worsening 
The number and percentage of patients overall and by laboratory test, with any treatment 
emergent laboratory abnormality, CTCAE worsening 
  
Listings will be presented for any patient with any treatment emergent laboratory abnormality 
(any increase in CTCAE grade). Normal ranges provided by the central laboratory will be 
presented in a listing. 
• 
• 
• 
• 
• 
• 
• 
of~2 grades. 
of~2 grades, will be presented. 


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
18 November 2021   
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9.3.2. 
Assessments of Potential Drug Induced Liver Injury  
Modified Hy’s rule by Bjornsson (Bjornsson 2005) is defined as patients with ALT or AST 
values >3x ULN and total bilirubin >2x ULN (based on the same blood draw of ALT, AST, and 
total bilirubin while on study drug, or within 30 days of last received dose) will be used to assess 
the potential for study drug-induced liver toxicity. Any patient meeting the criteria will be 
presented in a by-patient listing.    
The criteria for increased laboratory monitoring or consideration for study drug discontinuation 
on study are specified in protocol appendix 3 and will be included in the analysis dataset and 
listed.    
9.3.3. 
Shifts in CTCAE Grade
Quantitative laboratory tests will be assigned grades based on National Cancer Institute Common 
Terminology Criteria for Adverse Events (NCI CTCAE) Version 5. Shifts in CTCAE grade of 
laboratory tests will be presented from baseline to worst post-baseline value. Summaries will 
present the number and percentage of patients with shifts in laboratory grade by treatment group. 
Denominators for percentages will be the number of patients with non-missing data at the 
specific assessment and baseline. 
Some lab tests include additional clinical criteria which cannot be determined programmatically. 
Table 10 below specifies the grade with clinical criteria in italics. The text in italics will not be 
considered when assigning grades programmatically. 
Table 10: 
CTCAE Laboratory Tests with Clinical Criteria  
Bicarbonate (Blood bicarbonate decreased):  
 Grade 1:  <LLN and no intervention initiated.  
Prothrombin Time (PT)/International Normalized Ratio (INR) (INR increased):  
 Grade 1: >1.2 - 1.5; >1 - 1.5 x baseline if on anticoagulation; monitoring only 
indicated
 Grade 2: >1.5 - 2.5; >1.5 - 2.5 x baseline if on anticoagulation; dose adjustment 
indicated 
 Grade 3: >2.5; >2.5 x baseline if on anticoagulation; bleeding 
eGFR (Chronic Kidney Disease): 
 Grade 4: <15 ml/min/1.73m2; dialysis or renal transplant indicated 
Glucose (Hypoglycemia):  
 Grade 4: <30 mg/dL; <1.7 mmol/L; life-threatening consequences; seizures.  
• 
• 
• 
• 
• 
• 


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
18 November 2021   
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Potassium (Hypokalemia) 
Grade 2: Symptomatic with <LLN - 3.0 mmol/L; intervention indicated
Grade 3: <3.0 - 2.5 mmol/L; hospitalization indicated
Grade 4: <2.5 mmol/L; life-threatening consequences
Potassium (Hyperkalemia) 
 Grade 2: >5.5 - 6.0 mmol/L; intervention initiated
Grade 3: >6.0 - 7.0 mmol/L; hospitalization indicated
Grade 4: >7.0 mmol/L; life-threatening consequences
Sodium (Hyponatremia)
 Grade 2: 125-129 mmol/L and asymptomatic
 Grade 3: 125-129 mmol/L symptomatic; 120-124 mmol/L regardless of symptoms
 Grade 4: <120 mmol/L; life-threatening consequences 
Sodium (Hypernatremia) 
 Grade 2: >150 - 155 mmol/L; intervention initiated 
 Grade 3: >155 - 160 mmol/L; hospitalization indicated 
 Grade 4: >160 mmol/L; life-threatening consequences 
Albumin (Hypoalbuminemia) 
 Grade 4: Life-threatening consequences; urgent intervention indicated.   
9.3.4. 
COVID-19 
SARS-CoV-2 test for active infection and SARS-CoV-2 antibody test results, using central and 
local labs, will be presented in by-patient listings. A separate listing for central and local
laboratory normal ranges by lab test, lab parameter, sex, and age will be presented. 
9.4.
Vital Signs 
Temperature, pulse rate, respiratory rate, and blood pressure will be assessed and maintained in 
source documentation, not reported in the EDC, and therefore will not be included in analyses.  
Any clinically significant abnormalities will be reported as adverse events. 
9.5.
Electrocardiograms 
The investigator interpretation is collected as normal, abnormal not clinically significant (NCS), 
or abnormal clinically significant (CS).  Patients whose interpretation shifts from normal to 
abnormal (CS or NCS) will be listed separately including description of the abnormality and any 
associated comments. 
All ECG results will be presented in by-patient data listings.  If applicable, cardiologist consult 
information will be presented in a separate by-patient data listing. 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
18 November 2021   
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10.
OTHER ASSESSMENTS
Other assessments will be provided in by-patient data listings only; no summary tables will be 
provided, including but not limited to the following: 
 Eligibility details including unmet eligibility criteria 
 Informed consent and re-consents 
 Randomization schema 
Alcohol use 
Physical examination collection information
Serology
Pregnancy testing
 FSH test 
 Urine drug screen
 Alcohol test
 Urinalysis and Urine Microscopic Examination
 Cardiology consult 
 Overdose 
 Comments 
11. 
CHANGES TO PROTOCOL PLANNED ANALYSES 
Additional exploratory efficacy endpoints were added. 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
18 November 2021   
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12.
REFERENCES
Guidance for Industry E3: Statistical Principles for Clinical Trials. U.S. Department of Health 
and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 
(CDER), Center for Biologics Evaluation and Research (CBER), September 1998. 
Guidance for Industry E9: Statistical Principles for Clinical Trials. U.S. Department of Health 
and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 
(CDER), Center for Biologics Evaluation and Research (CBER), September 1998. 
Guidance for Industry: Drug Induced Liver Injury: Premarketing Clinical Evaluation, CDER, 
FDA (2009).
Guidance for Industry: Providing Regulatory Submissions in Electronic Format — Certain 
Human Pharmaceutical Product Applications and Related Submissions Using the eCTD 
Specifications, Center for Drug Evaluation and Research (CDER), Center for Biologics 
Evaluation and Research (CBER), September 2016. 


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
18 November 2021   
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13.
APPENDICES


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
18 November 2021   
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APPENDIX 1.
OTHER GENERAL PROGRAMMING SPECIFICATIONS
1. All output will have the following two-line header at the upper left margin:
Terns, Inc. 
 
TERN201-1007 
and the following header at the upper right margin:
DRAFT/FINAL (as appropriate)
Page x of y 
2. Each table should be identified by in a sequential numeric order, and the table designation 
should be centered above the title. A decimal system within the numeric numbering (i.e., x.y 
and x.y.z) should be used to identify tables, listings and figures with related contents. The 
title is centered in initial capital characters and should include the analysis set analyzed (e.g. 
SS). The title and table designation are single-spaced, but are separated from the table by at 
least a double space. 
Table No. 
First Line of Title 
Second Line of Title (if needed) 
(Analysis Set Analyzed) 
3. Row labels and column headings will be in title/proper case, unless otherwise specified. 
4. For variables with numeric values, include “unit” in the row label or column heading when 
appropriate.
5. Footnotes should be ordered as follows:  abbreviations, single space, general notes, single 
space, specific numeric footnotes, single space, reference, and with final footnote as program 
name and date of the program run. The notes are aligned vertically by the left vertical border 
of the table. All output should have at least the footnote about the program name and date of 
the program run.   
Abbreviations:  
 
Notes:  
 
[1] Footnote 1 
[2] Footnote 2 
[3] Footnote 3 
 
Reference Listing:  
PROGRAM: program file name                             DDMMMYYYY HH:MM 
6. All tables will include a Reference Footnote.  All figures will include a Reference Table.
7. Unless specified otherwise, all data listings should be sorted by treatment group, followed by 
patient number with the study center, and by visit date within patient, where appropriate.
8. All fractional numeric values should be printed with a zero to the left of the decimal point 
(e.g., 0.12, 0.3), unless otherwise specified.
9. Missing descriptive statistics due to non-estimability in tables, as well as missing data in 
patient listings should be represented as either a hyphen (“-“) with a corresponding footnote 


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
18 November 2021   
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(“ - = unknown or not evaluated”), or as “N/A” with the footnote “N/A = not applicable” 
whichever is appropriate.
10. Dates printed as a result in the table, listing, or graph should be printed in SAS DATE9. 
format (“DDMONYYYY”, e.g. 01JUL2002). Missing portions of dates should be 
represented on patient listings as dashes (--JUL1999). Dates that are missing because they are 
not applicable for the patient should be listed as “N/A”, unless otherwise specified. 
 


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
18 November 2021   
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Page 46 of 50 
APPENDIX 2.
IMPUTATION RULES FOR MISSING OR PARTIAL 
DATES FOR ADVERSE EVENTS AND CONCOMITANT 
MEDICATIONS  
Date 
Situation
Imputation Rule
Start Date
Only month and year are known and month 
and year are prior to first dose date 
Use the last day of the month 
Only month and year are known and month 
and year are the same as first dose date 
Use the first study drug 
administration date 
Only month and year are known and month 
and year are after first dose date
Use the first day of the 
month
Only year is known and year is before first 
dose date 
Use Dec 31 of that year
Only year is known and year is same as first 
dose date 
Use the first study drug 
administration date 
Only year is known and year is after first 
dose date 
Use Jan 1 of that year
Entire date is missing
Use the first study drug 
administration date 
The estimated start date is after a complete 
or imputed AE stop date 
Use the first day of the 
month of the AE/CM stop 
date
Stop/End Date 
Only month and year are known and month 
and year are prior to last dose date 
Use the last day of the month 
Only month and year are known and month 
and year are the same as last dose date
Use the last dose date 
Only month and year are known and month 
and year are after last dose date 
Use the last day of the month 
Only year is known and year is before last 
dose date 
Use Dec 31 of that year
Only year is known and year is same as last
dose date 
Use the last study drug 
administration date 
Only year is known and year is after last 
dose date 
Use Dec 31 of that year
Entire date is missing
Use the last study drug 
administration date 
The estimated stop date is before a complete 
or imputed AE start date
Use the last day of the month 
of the AE/CM start date
AE = adverse event, Dec = December, Jan = January
 


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
18 November 2021   
Statistical Analysis Plan                                                                                
CONFIDENTIAL
Page 47 of 50 
APPENDIX 3.
ABBREVIATIONS
Abbreviation or 
Special Term
Explanation 
ADaM
Analysis Data Model
ADL
activities of daily living 
AE
adverse event
ALP
alkaline phosphatase
ALT
alanine transaminase 
ANCOVA
analysis of covariance
AST
aspartate transaminase
ATC
Anatomical Therapeutic Class
AUC
area under the concentration-time curve
BMI
body mass index
BLQ
below quantification limit
CAP
Controlled Attenuation Parameter 
CDISC
Clinical Data Interchange Standards Consortium
CHG
change from baseline ADaM basic dataset structure defined variable 
CI 
confidence interval
CK-18 
cytokeratin-18 
COVID-19 
Coronavirus disease 2019 
Cmax 
maximal concentration
CRF 
case report form 
CSR 
clinical study report
CTCAE
Common Terminology Criteria for Adverse Events 
CTMS 
clinical trial management system 
CYP
Cytochrome P450
CV 
coefficient of variation
DBL
database lock
eGFR 
estimated glomerular filtration rate
eCRF
electronic case report form
ECG
electrocardiogram 
ET 
early termination
FDA
Food and Drug Administration 
FSH
follicle stimulating hormone 
GCP
Good Clinical Practice
GGT 
gamma-glutamyl transpeptidase
HA
hyaluronic acid
HDL 
high-density lipoprotein
hs-CRP
high sensitivity C-reactive protein 
ICF 
informed consent form
ICH 
International Council for Harmonisation 
IG 
implementation guide
IMP
investigational medicinal product


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
18 November 2021   
Statistical Analysis Plan                                                                                
CONFIDENTIAL
Page 48 of 50 
Abbreviation or 
Special Term 
Explanation 
INR
international normalized ratio
IWRS 
interactive web response system
LDL
low-density lipoprotein 
LFC
liver fat content
LFT
liver function test 
LLN
lower limit of normal
ln
natural log
LS 
least squares 
MedDRA
Medical Dictionary for Regulatory Activities
MMRM
mixed model for repeated measures
MRI-PDFF
Magnetic Resonance Imaging Proton Density Fat Fraction 
NAFLD
non-alcoholic fatty liver disease
NAS
non-alcoholic fatty liver disease activity score
NASH 
non-alcoholic steatohepatitis 
NC 
not calculated
NCA
noncompartmental analysis 
NCI 
National Cancer Institute 
PCHG 
percent change from baseline ADaM basic dataset structure defined variable 
PIIINP 
procollagen III n-terminal peptide 
PD 
pharmacodynamics
PK 
pharmacokinetics 
PRO-C3
pro-peptide of type III collagen
Q1 
25th percentile, first quartile
Q3 
75th percentile, third quartile 
REML 
restricted maximum likelihood
SAE 
serious adverse event 
SAP
statistical analysis plan 
SARS-CoV-2
severe acute respiratory syndrome coronavirus 2 
SD
standard deviation
SDTM 
Study Data Tabulation Model 
SE 
least squares mean standard error 
TEAE 
treatment emergent adverse event
TIMP-1 
tissue inhibitor of metalloproteinases-1
ULN 
upper limit of normal
WHODD 
World Health Organization Drug Dictionary 
 


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                               
18 November 2021   
Statistical Analysis Plan                                                                                
CONFIDENTIAL
Page 49 of 50 
APPENDIX 4.
DOCUMENT HISTORY
Version
Date
Author
Description
1.0
 
 
DrPH
Statistical 
Consultant
Terns, Inc.
Final Version 1 


Terns, Inc.                                                                                                                                                               
Study No: TERN201-1007                                                                                                                    18 November 2021   
Statistical Analysis Plan                                                                                                                           CONFIDENTIAL
Page 50 of 50
APPENDIX 5.
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