A Phase I/II study of TGM-312-SC01 in healthy participants and adults with metabolic dysfunction-associated steatohepatitis

A first-in-human, Phase I/II, randomized, masked, placebo-controlled, parallel-group, dose-escalation, adaptive study to evaluate the safety and pharmacokinetics of a single dose of TGM-312-SC01 in healthy participants and the safety, pharmacokinetics, pharmacodynamics and early signs of efficacy of multiple doses of TGM-312-SC01 in people with metabolic dysfunction-associated steatohepatitis (MASH)

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN65253349

Enrollment

Registered

2026-02-13

Start date

2026-02-16

Completion date

Unknown

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic dysfunction-associated steatohepatitis (MASH) Digestive System

Interventions

Participants will receive either the trial medication (TGM-312-SC01) or placebo via subcutaneous injection. Participants will be randomised to receive TGM-312-SC01 or placebo in a 1:1 ratio in Part A

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 to 70 years 2. Able to provide written informed consent 3. Medically suitable for study participation based on protocol-defined assessments For the disease cohort, participants must have clinical features consistent with metabolic dysfunction-associated steatohepatitis, as defined in the protocol

Exclusion criteria

Exclusion criteria: 1. 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 2. Recent participation in another investigational study 3. Use of medications that are prohibited by the protocol 4. Any other condition that would make the individual unsuitable for study participation as determined by the investigator

Design outcomes

Primary

Measure	Time frame
Safety and tolerability measured using the number and severity of treatment-emergent adverse events at baseline to the end of study visit (week 16 for Part A and week 20 for Parts B and C)	—

Secondary

Measure	Time frame
1. Pharmacokinetics of TGM-312-SC01 measured using blood sampling at predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 36 and 48 hours (Part A) 2. Pharmacokinetics of TGM-312-SC01 measured using blood sampling at predose, 0.5, 1, 2, 4, 6, 8, 24 hours after dosing (Part B) 3. Pharmacodynamics effects of TGM-312-01 measured using tissue and blood sampling at predose, 2, 4, 8, 12 and 16 weeks after dosing (Part B)	—

Measure

Time frame

1. Pharmacokinetics of TGM-312-SC01 measured using blood sampling at predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 36 and 48 hours (Part A) 2. Pharmacokinetics of TGM-312-SC01 measured using blood sampling at predose, 0.5, 1, 2, 4, 6, 8, 24 hours after dosing (Part B) 3. Pharmacodynamics effects of TGM-312-01 measured using tissue and blood sampling at predose, 2, 4, 8, 12 and 16 weeks after dosing (Part B)

—

Countries

England, United Kingdom

Contacts

Public ContactClinical Trials Office

clinicaltrials@tangramtx.com+44 (0)20 4558 3826

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026