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
Tangram Therapeutics Plc
99 participants
Feb 1, 2026
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria3
- 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 Criteria4
- 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.
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Interventions
TGM-312-SC01 is an investigational medicinal product administered by subcutaneous injection according to a protocol-defined regimen.
Placebo administered by subcutaneous injection according to a protocol-defined regimen.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07427680