Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

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)

Official Title

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)

Keywords

NASH - Nonalcoholic Steatohepatitis, Nonalcoholic steatohepatitis (NASH), FXR agonist, Nonalcoholic Fatty Liver Disease (NAFLD), THR-β agonist, Fatty Liver, Non-alcoholic Fatty Liver Disease, TERN-501, TERN-101, TERN-501 1 mg, TERN-501 3 mg, TERN-501 6 mg, TERN-501 3 mg + TERN-101 10 mg, TERN-501 6 mg + TERN-101 10 mg

Eligibility

You can join if…

Open to people ages 18-75

  • Male or female, 18 to 75 years of age
  • Overweight or obese with a body mass index (BMI) ≥ 25 kg/m2
  • Presumed NASH diagnosed by prior biopsy and/or imaging criteria
  • Written informed consent

You CAN'T join if...

  • History or clinical evidence of chronic liver diseases other than NAFLD
  • History or known clinical evidence of cirrhosis, esophageal varices, hepatic decompensation or other severe liver impairment,
  • History of liver transplant, or current placement on a liver transplant list
  • Current diagnosis or history of pituitary or thyroid disorders - except for patients with primary hypothyroidism on a stable dose of thyroid hormone replacement therapy.
  • Abnormal TSH or free T4 levels
  • Weight loss of > 5% total body weight within 3 months prior to Screening
  • Uncontrolled diabetes
  • Uncontrolled hyperlipidemia
  • Unstable cardiovascular disease
  • Excessive alcohol consumption

    Other protocol-defined I/E criteria that apply.

Locations

  • Site 1013 University of California, San Diego - Altman Clinical and Translational Research Institute
    La Jolla California 92037 United States
  • Site 1004 Southern California Research Center
    Coronado California 92118 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Terns, Inc.
ID
NCT05415722
Phase
Phase 2 research study
Study Type
Interventional
Participants
About 162 people participating
Last Updated