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)

Terns, Inc.31 sites in 1 country101 target enrollmentJune 18, 2020

ConditionsNASH - Nonalcoholic Steatohepatitis

InterventionsTERN-101 Placebo

DrugsTERN-101

Overview

Phase: Phase 2
Intervention: TERN-101
Conditions: NASH - Nonalcoholic Steatohepatitis
Sponsor: Terns, Inc.
Enrollment: 101
Locations: 31
Primary Endpoint: Number of Participants With Adverse Events for TERN-101 Versus Placebo
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 18, 2020

End Date

May 19, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Terns, Inc.

Responsible Party

Sponsor

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