Tests TGM-312-SC01 safety in healthy adults and adults with MASH liver disease
Tests the safety and body response to TGM-312-SC01 in healthy adults and adults with MASH.
Plain-language title generated from the registry record
Registry title: Study of TGM-312-SC01 in Healthy Participants and Adults With MASH
Key facts
- Where
- London, United KingdomSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07427680, who can take part
Where in United Kingdom
- Richmond PharmacologyLondon, United KingdomTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tangram Therapeutics Plc
- Trial code
- NCT07427680
- Record updated
- 19 May 2026
- Original description
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).Read full original descriptionShow less
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).
Inclusion: 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: 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; 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.