NCT07427680

Study of TGM-312-SC01 in Healthy Participants and Adults With MASH

RESTORE-MASH: A Phase 1/2 Randomized, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of TGM-312-SC01 in Healthy Participants and Adults With MASH

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 99 (estimated)
• Sponsor: Tangram Therapeutics Plc · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) effects of single ascending doses of TGM-312-SC01 in healthy adults and multiple ascending doses in patients with metabolic dysfunction-associated steatohepatitis (MASH).

Detailed description

This is a Phase 1/2, randomised, masked, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of TGM-312-SC01 administered by subcutaneous injection. The study includes a single ascending dose component in healthy participants and a multiple ascending dose component in adults with metabolic dysfunction-associated steatohepatitis, with an optional expansion phase.

Conditions

• Healthy Participants
• MASH - Metabolic Dysfunction-Associated Steatohepatitis

Interventions

Type	Name	Description
DRUG	TGM-312-SC01	TGM-312-SC01 is an investigational medicinal product administered by subcutaneous injection according to a protocol-defined regimen.
DRUG	Placebo	Placebo administered by subcutaneous injection according to a protocol-defined regimen.

Timeline

• Start date: 2026-02-01
• Primary completion: 2028-03-01
• Completion: 2028-06-01
• First posted: 2026-02-23
• Last updated: 2026-03-27

Locations

1 site across 1 country: United Kingdom