TGM-312-SC01 injections for healthy adults and people with MASH
Official title: 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
Run by Tangram Therapeutics Plc · NCT07427680 · Data updated 2026-11-12
This trial tests single increasing doses in healthy volunteers and repeated increasing doses in adults with MASH to see if TGM-312-SC01 is safe and how the body processes it.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 99 (estimated) |
| Sponsor | Tangram Therapeutics Plc Industry-sponsored |
| Locations | 1 site (London) |
| Status | Recruiting |
| Started | March 3, 2026 |
| Main results expected | March 2028 |
| Study ends | June 2028 |
| Registry record updated | May 19, 2026 |
| Trial ID | NCT07427680 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–70 who can give informed consent and are either healthy volunteers or have clinical features consistent with MASH and meet protocol-defined health criteria.
✕Probably not a fit
People with major uncontrolled medical conditions, abnormal laboratory findings, recent participation in other investigational studies, use of prohibited medications, or those outside the 18–70 age range are unlikely to qualify or benefit from this early-phase trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, masked, placebo-controlled Phase 1/2 study gives TGM-312-SC01 by subcutaneous injection and measures safety, tolerability, pharmacokinetics, and pharmacodynamic effects. It includes a single ascending dose arm in healthy participants and a multiple ascending dose arm in adults with metabolic dysfunction-associated steatohepatitis, with an optional expansion phase. Participants are assigned to active drug or placebo and followed with clinical and laboratory assessments to characterize dose-related effects. The primary focus is on short-term safety and how the drug is handled by the body, with exploratory PD measures in the MASH cohort.
Why it matters
Potential benefit: If successful, TGM-312-SC01 could provide a new treatment option that reduces liver inflammation and metabolic damage in people with MASH.
How similar studies have gone: Early-phase trials of other experimental agents for MASH have produced mixed but sometimes promising signals, though no single therapy has yet emerged as a definitive, widely effective cure.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Richmond Pharmacology
London, United Kingdom Recruiting
Study contacts
- Study coordinator: Sponsor Clinical Trials Office
- Email: clinicaltrials@tangramtx.com
- Phone: +44 20 4558 3826
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.