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

Terns, Inc.162 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

162

Conditions

NASH - Nonalcoholic Steatohepatitis

Interventions

TERN-501DRUG

Investigational drug

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Key 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 Key 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 Other protocol-defined I/E criteria that apply.

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

Outcomes

Primary Outcomes

Relative Change From Baseline in MRI-PDFF at Week 12 for TERN-501 Monotherapy (Arms 1, 2 and 3) Compared to Placebo.

Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) is a non-invasive imaging technique that measures fat content in tissue, particularly in the liver. Relative change from baseline is calculated for each subject as 100 x \[(Week 12 Value - Baseline Value)/Baseline Value\].

Time frame: 12 weeks

Secondary Outcomes

Change From Baseline in cT1 Relaxation Time at Week 12 for TERN-501 Monotherapy (Arms 1, 2 and 3) Compared to Placebo

Corrected T1 (cT1) is a quantitative MRI relaxation parameter that measures liver inflammation and fibrosis. Change from baseline is calculated for each subject as (Week 12 Value - Baseline Value).

Time frame: 12 weeks

Relative Change From Baseline in MRI-PDFF at Week 12 for TERN-501+TERN-101 Combination (Arms 4 and 5) Compared to Placebo

Time frame: 12 weeks

Change From Baseline in cT1 Relaxation Time at Week 12 for TERN-501+TERN-101 Combination (Arms 4 and 5) Compared to Placebo

Corrected T1 (cT1) is a quantitative MRI relaxation parameter that measures liver inflammation and fibrosis. Change from baseline is calculated for each subject as (Week 12 Value - Baseline Value).

Time frame: 12 weeks

Number and Percentage of Participants With Any Treatment Emergent Adverse Event for All Treatment Groups (Threshold of 0%)

This outcome measures the number and percentage of participants with any Treatment Emergent Adverse Event (TEAE) for All Treatment Groups (0% Threshold). TEAEs by System Organ Class and Preferred Term meeting the 5% Threshold are reported in the Other Adverse Events section.

Time frame: 16 weeks