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
NCT05415722 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 162
Last updated 2025-03-12
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)
Conditions
- NASH - Nonalcoholic Steatohepatitis
Interventions
- DRUG
-
TERN-501
Investigational drug
- DRUG
-
TERN-101
Investigational drug
- OTHER
-
Placebo
Matching placebo
Sponsors & Collaborators
-
Terns, Inc.
lead INDUSTRY
Principal Investigators
-
Study Director · Terns, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-28
- Primary Completion
- 2023-07-10
- Completion
- 2023-07-10
- FDA Drug
- Yes
Countries
- United States
Study Locations
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