CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 162 enrolled
Drug / intervention
TERN-501 +2 moredrug
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Age 18 to 75 years
  • ✓Overweight or obese with BMI ≥25 kg/m²
  • ✓Presumed NASH diagnosed by prior biopsy and/or imaging criteria
Key exclusion· 10
  • ✕History or clinical evidence of chronic liver diseases other than NAFLD
  • ✕Evidence of cirrhosis, esophageal varices, hepatic decompensation, or other severe liver impairment
  • ✕History of liver transplant or current placement on liver transplant list
  • ✕Current diagnosis or history of pituitary or thyroid disorders, except primary hypothyroidism on stable hormone replacement

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05415722
NCT05415722Phase 2Completed
CompareCT.gov

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Orally Administered TERN-501 as Monotherapy as Well as in Combination With TERN-101 in Noncirrhotic Adults With Presumed Non-Alcoholic Steatohepatitis (NASH)

Terns, Inc.·interventional·Posted Jun 13, 2022·Updated Mar 12, 2025

In Brief

A Phase 2 clinical trial evaluating TERN-501, TERN-101, and 1 other intervention for NASH - Nonalcoholic Steatohepatitis. Completed, enrolled 162 participants across 35 sites.

Detailed Summary

This is a Phase 2a Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Orally Administered TERN-501 as Monotherapy as well as in Combination with TERN-101 in Noncirrhotic Adults with Presumed Non-Alcoholic Steatohepatitis (NASH)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNASH - Nonalcoholic Steatohepatitis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedJun 13, 2022
Enrollment StartJun 28, 2022
Primary CompletionJul 10, 2023
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 4.1 years ago

Interventions

TERN-501drug

Investigational drug

TERN-101drug

Investigational drug

Placeboother

Matching placebo