Study of TGM-312-SC01 in Healthy Participants and Adults With MASH
NCT07427680 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 99
Last updated 2026-05-19
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).
Conditions
- Healthy Participants
- MASH - Metabolic Dysfunction-Associated Steatohepatitis
Interventions
- DRUG
-
TGM-312-SC01
TGM-312-SC01 is an investigational medicinal product administered by subcutaneous injection according to a protocol-defined regimen.
- DRUG
-
Placebo administered by subcutaneous injection according to a protocol-defined regimen.
Sponsors & Collaborators
-
Tangram Therapeutics Plc
lead INDUSTRY
Principal Investigators
-
Sponsor Medical Representative · Tangram Therapeutics
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-03-03
- Primary Completion
- 2028-03-31
- Completion
- 2028-06-30
Countries
- United Kingdom
Study Locations
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