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

Phase 2 Completed 162 enrolled Terns, Inc.

RandomizedParallel-groupTriple-blindTreatment

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)

Timeline

Start: 2022-06-28
Primary completion: 2023-07-10
Completion: 2023-07-10

Outcome

Met primary endpoint

registry Arm 2: TERN-501 3 mg vs Arm 7: Matching Placebo; p = 0.0036 NCT05415722 ↗

registry Mean Difference (Final Values) -23.47 (95% CI -39.140 to -7.799) NCT05415722 ↗

registry Arm 3: TERN-501 6 mg vs Arm 7: Matching Placebo; p <0.0001 NCT05415722 ↗

Publications

Noureddin M, Alkhouri N, Lawitz EJ, Kowdley KV, Loomba R, Lee L, Jones C, Schlegel A, Marmon T, Anderson K, Li Y, Quirk E, Harrison SA. TERN-501 monotherapy and combination therapy with TERN-101 in metabolic dysfunction-associated steatohepatitis: the randomized phase 2a DUET trial. Nat Med. 2025 Jul;31(7):2297-2305. doi: 10.1038/s41591-025-03722-7. Epub 2025 Jun 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TERN-101	Small molecule	10 mg	Oral
Subject	TERN-501	Unknown	1 mg	Oral
Subject	TERN-501	Unknown	3 mg	Oral
Subject	TERN-501	Unknown	6 mg	Oral