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TERN-501

Phase 2

NASH - Nonalcoholic Steatohepatitis | Small molecule | Metabolic |Terns Pharmaceuticals, Inc.|Last Updated: Mar 11, 2025

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment162

FDA Designations

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Clinical trial landscape

TERN-501 · 1 trial · 1 indication

Phase 2 1
NCT05415722DUET 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 SteatohepatitisNASH - Nonalcoholic Steatohepatitis
COMPLETED162 Analytics
PHASE2COMPLETED
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
NASH - Nonalcoholic SteatohepatitisUnlock trial analytics

Study Design & Arms

Interventions

NameTypeDescription
TERN-501DRUGInvestigational drug
TERN-101DRUGInvestigational drug
PlaceboOTHERMatching placebo
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Frequently asked questions about TERN-501

What is TERN-501 used for in NASH?

TERN-501 is an investigational small molecule being developed for the treatment of nonalcoholic steatohepatitis (NASH), a form of fatty liver disease. It is currently in Phase 2 clinical development and has been studied in noncirrhotic adults with presumed NASH.

Who makes TERN-501?

TERN-501 is being developed by Terns Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol TERN. The company is focused on developing therapies for metabolic diseases, including NASH.

What phase is TERN-501 in?

TERN-501 is in Phase 2 clinical development. It has completed one Phase 2 trial, the DUET study, which evaluated the drug as a monotherapy and in combination with TERN-101 in patients with noncirrhotic NASH. It is not yet approved by regulatory authorities.

What clinical trials is TERN-501 in?

TERN-501 has been studied in the DUET study (NCT05415722), a Phase 2 clinical trial that evaluated the safety, efficacy, pharmacokinetics, and pharmacodynamics of orally administered TERN-501 as monotherapy and in combination with TERN-101 in noncirrhotic adults with presumed NASH. The trial enrolled 162 participants and has been completed.

Is TERN-501 the same as TERN-101?

No, TERN-501 and TERN-101 are different investigational drugs. TERN-501 was studied as a monotherapy and in combination with TERN-101 in the DUET trial, indicating they are distinct agents being developed by Terns Pharmaceuticals for NASH.