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Clinical Trials in the UK / NCT07427680
Recruiting Phase 1/2

Study of TGM-312-SC01 in Healthy Participants and Adults With MASH

NCT07427680 · tracked via the Priya Life Science UK tracker
Sponsor
Tangram Therapeutics Plc
Phase
Phase 1/2
Started
2026-03-03
Last updated
2026-05-19

Condition(s) studied

Healthy ParticipantsMASH - Metabolic Dysfunction-Associated Steatohepatitis

Investigational drug(s) / intervention(s)

TGM-312-SC01Placebo

TGM-312-SC01: TGM-312-SC01 is an investigational medicinal product administered by subcutaneous injection according to a protocol-defined regimen.

Placebo: Placebo administered by subcutaneous injection according to a protocol-defined regimen.

Study 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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Incidence and severity of treatment-emergent adverse events [Safety and tolerability] — From start of study drug administration through 16 weeks after the last study drug administration.

Trial sites (1)

FacilityCityRegionStatus
Richmond Pharmacology London United Kingdom Recruiting

More Tangram Therapeutics Plc trials in the UK

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07427680 on ClinicalTrials.gov ↗ ← All trials in the UK