At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- TGM-312-SC01 (drug), Placebo (drug)
- How long the study runs
- Study runs about 27 months (dates as stated)
- About the drug or intervention
- TGM-312-SC01 — drug: TGM-312-SC01 is an investigational medicinal product administered by subcutaneous injection according to a protocol-defined regimen. · Placebo — drug: Placebo administered by subcutaneous injection according to a protocol-defined regimen.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 70 Years
- Who
- All
- Number of participants
- 99
- Started
- 2026-03-03
- Last checked
- 2026-05
Plain English Summary
What is this study?
- • Testing a new treatment for healthy participants
- • Phase1/Phase2 - 99 participants
- • 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)
Who can take part?
- • Ages 18 Years to 70 Years
- • Diagnosed with healthy participants
Where?
- • London - Richmond Pharmacology
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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).
More detail
This is a Phase 1/2, randomised, masked, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of TGM-312-SC01 administered by subcutaneous injection. The study includes a single ascending dose component in healthy participants and a multiple ascending dose component in adults with metabolic dysfunction-associated steatohepatitis, with an optional expansion phase.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 70 Years
- Who can join: All genders
What the study is looking for
- ✓Adults aged 18 to 70 years who are able to provide written agreement to take part.
- ✓Medically suitable for study participation based on protocol-defined assessments.
- ✓For the disease cohort, participants with clinical features consistent with metabolic dysfunction-associated...
Who cannot take part
- ✗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.
See the full criteria
Where Is This Study? (1 UK site)
Richmond Pharmacology
London, United Kingdom
How to Get in Touch
Sponsor Clinical Trials Office
Sponsor contactCONTACT