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DUET Study: A Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Orally Administered TERN-501 as Monotherapy and in Combination With TERN-101 in Noncirrhotic Adults With Presumed Non-Alcoholic Steatohepatitis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

DUET Study: A Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Orally Administered TERN-501 as Monotherapy and in Combination With TERN-101 in Noncirrhotic Adults With Presumed Non-Alcoholic Steatohepatitis

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)

NCT05415722•Terns, Inc.

View on ClinicalTrials.gov

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)

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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 diagnosed by prior biopsy and/or imaging criteria
•Written informed consent

Exclusion Criteria

•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
+1 more criteria

Locations (35)

Site 1017: The Institute for Liver Health dba Arizona Liver Health

Chandler, Arizona, United States

Site 1018: Arizona Liver Health

Tucson, Arizona, United States

Site 1004 Southern California Research Center

Coronado, California, United States

Site 1061 Velocity Clinical Research, Gardena

Gardena, California, United States

Site 1013 University of California, San Diego - Altman Clinical and Translational Research Institute

La Jolla, California, United States

Site 1016 Ruane Clinical Research Group Inc.

Los Angeles, California, United States

Site 1060 Catalina Research Institute, LLC

Montclair, California, United States

Site 1001 National Research Institute

Panorama City, California, United States

Site 1040 Inland Empire Clinical Trials, LLC

Rialto, California, United States

Site 1062 Excel Medical Clinical Trials, LLC

Boca Raton, Florida, United States

Key Dates

Start Date

June 28, 2022

Primary Completion Date

July 10, 2023

Completion Date

July 10, 2023

Last Updated

March 12, 2025

Enrollment

162

ACTUAL participants

Conditions

NASH - Nonalcoholic Steatohepatitis

Interventions

TERN-501

DRUG

TERN-101

DRUG

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

DUET Study: A Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Orally Administered TERN-501 as Monotherapy and in Combination With TERN-101 in Noncirrhotic Adults With Presumed Non-Alcoholic Steatohepatitis

Inclusion Criteria

Exclusion Criteria

Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis

Hepatic Energy Fluxes in NASH and NAS Patients

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