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)
Phase: PHASE1
Conditions: NASH - Nonalcoholic Steatohepatitis
Sponsor: Terns, Inc.

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 
 
CONFIDENTIAL 
Page 6 of 92 
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.  

Protocol TERN201-1007 
Terns, Inc. 
 
Version: Amendment 3 
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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 
reported to investigative sites or blinded personnel until the study has been unblinded. 

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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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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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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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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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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 
 
 
 

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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 
 
 
 
 

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Version: Amendment 3 
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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 
 

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Appendix 12: References 
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pathogenesis and therapeutic implications. J Med Life. 2018;11(1):20–23. 
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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. 

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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.