NCT07427680RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 19 May 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 99 (estimated)
- First submitted
- 30 Jan 2026
- Start date
- 3 Mar 2026
- Primary completion date
- 31 Mar 2028
- Lead sponsor
- Tangram Therapeutics Plc
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07427680
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 99
- From 3 Mar 2026 to the primary completion date, 31 Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of medications that are prohibited by the protocol.
Other illness
- Any other condition that would make the individual unsuitable for study participation as determined by the investigator.
Lab values
- 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.
Other
- Recent participation in another investigational study.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Richmond Pharmacology Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.