Clinical trial NCT04328077: LIFT Study: A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of TERN-101 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2a Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Orally Administered TERN-101 Tablets in Adult Patients With Presumed Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: NASH - Nonalcoholic Steatohepatitis
Keywords: Farnesoid X receptor
NASH
Nonalcoholic Steatohepatitis
NAFLD
Nonalcoholic Fatty Liver Disease
FXR
Lead sponsor: Terns, Inc.
Sponsor class: INDUSTRY
First posted: 2020-03-31
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 2, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetics (PK) of TERN-101 in non-cirrhotic NASH patients.


Eligibility criteria: Inclusion Criteria:

* Male or female, 18 to 75 years of age
* Overweight or obese with a body mass index (BMI) ≥ 25 kg/m2
* Presumed NASH based on clinical characteristics or prior liver biopsy
* ALT ≥ 43 IU/L for men and ≥ 28 IU/L for women
* MRI PDFF liver fat content ≥ 10 %
* Written informed consent

Exclusion Criteria:

* History or clinical evidence of chronic liver diseases other than NAFLD
* History or clinical evidence of cirrhosis, hepatic decompensation or other severe liver impairment
* History of liver transplant, or current placement on a liver transplant list
* Total bilirubin \> 1.2 mg/dL
* Albumin \< 3.5 g/dL
* INR \> 1.1
* AST or ALT \> 5 x ULN
* ALP \> 156 IU/L
* Platelet count \< 150,000 /mm3
* eGFR \< 60 mL/min/1.73m2
* Weight loss \> 5% within past 3 months prior to Screening
* Uncontrolled diabetes
* Uncontrolled hyperlipidemia
* Active COVID-19 infection
* Other protocol-defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Number of Participants With Adverse Events for TERN-101 Versus Placebo
timeFrame: 16 weeks
Secondary outcomes:
measure: Percent Change From Baseline in ALT Outcome Measure
timeFrame: 12 weeks
measure: Plasma Concentration of TERN-101 - AUC 0-24
timeFrame: 12 weeks (0-24 hours post dose)
measure: Plasma Concentration of TERN-101 - Cmax
timeFrame: 12 Weeks (0-72 hours post dose)
measure: Plasma Concentration of TERN-101 - Tmax
timeFrame: 12 Weeks (0-72 hours post dose)
measure: Plasma Concentration of TERN-101 - t1/2
timeFrame: 12 Weeks (0-72 hours post dose)
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Terns Clinical Study Site 1017
state: Arizona
city: Tucson
country: United States
facility: Terns Clinical Study Site 1018
state: Arizona
city: Tucson
country: United States
facility: Terns Clinical Study Site 1024
state: Arizona
city: Coronado
country: United States
facility: Terns Clinical Study Site 1004
state: California
city: Fresno
country: United States
facility: Terns Clinical Study Site 1035
state: California
city: La Jolla
country: United States
facility: Terns Clinical Study Site 1013
state: California
city: Los Angeles
country: United States
facility: Terns Clinical Study Site 1016
state: California
city: Montclair
country: United States
facility: Terns Clinical Study Site 1008
state: California
city: Panorama City
country: United States
facility: Terns Clinical Study Site 1001
state: California
city: Gainesville
country: United States
facility: Terns Clinical Study Site 1012
state: Florida
city: Hialeah
country: United States
facility: Terns Clinical Study Site 1007
state: Florida
city: Hialeah
country: United States
facility: Terns Clinical Study Site 1028
state: Florida
city: Miami
country: United States
facility: Terns Clinical Study Site 1009
state: Florida
city: Orlando
country: United States
facility: Terns Clinical Study Site 1033
state: Florida
city: Indianapolis
country: United States
facility: Terns Clinical Study Site 1032
state: Indiana
city: Bastrop
country: United States
facility: Terns Clinical Study Site 1010
state: Louisiana
city: New Orleans
country: United States
facility: Terns Clinical Study Site 1037
state: Louisiana
city: Shreveport
country: United States
facility: Terns Clinical Study Site 1023
state: Louisiana
city: Baltimore
country: United States
facility: Terns Clinical Study Site 1002
state: Maryland
city: Boston
country: United States
facility: Terns Clinical Study Site 1011
state: Massachusetts
city: Florham Park
country: United States
facility: Terns Clinical Study Site 1038
state: New Jersey
city: Durham
country: United States
facility: Terns Clinical Study Site 1027
state: North Carolina
city: Hermitage
country: United States
facility: Terns Clinical Study Site 1014
state: Tennessee
city: Arlington
country: United States
facility: Terns Clinical Study Site 1005
state: Texas
city: Georgetown
country: United States
facility: Terns Clinical Study Site 1025
state: Texas
city: Houston
country: United States
facility: Terns Clinical Study Site 1021
state: Texas
city: Houston
country: United States
facility: Terns Clinical Study Site 1029
state: Texas
city: San Antonio
country: United States
facility: Terns Clinical Study Site 1006
state: Texas
city: San Antonio
country: United States
facility: Terns Clinical Study Site 1003
state: Texas
city: San Antonio
country: United States
facility: Terns Clinical Study Site 1019
state: Texas
city: Seattle
country: United States
facility: Terns Clinical Study Site 1022
state: Washington
Study officials:
affiliation: Terns, Inc.
name: clinicaltrials@ternspharma.com
role: STUDY_DIRECTOR
References: