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

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).

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.

Inclusion Criteria:

• Adults aged 18 to 70 years who are able to provide written informed consent.
• Medically suitable for study participation based on protocol-defined assessments.
• For the disease cohort, participants with clinical features consistent with metabolic dysfunction-associated steatohepatitis, as defined in the protocol.

Exclusion Criteria:

• Clinically significant medical conditions, laboratory abnormalities, or other findings that, in the opinion of the investigator, could increase risk, interfere with study participation, or confound interpretation of study results.
• Recent participation in another investigational study.
• Use of medications that are prohibited by the protocol.
• Any other condition that would make the individual unsuitable for study participation as determined by the investigator.