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

NCT07427680 | Recruiting Phase 1 DMC

• 1 other identifier: TGM-312-001
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (4)

• Maximum observed plasma concentration (Cmax) of TGM-312-SC01 (ng/mL)

  From start of study drug administration through 48 hours after the last study drug administration.

• Area under the plasma concentration-time curve (AUC) of TGM-312-SC01 (ng·h/mL)

  From start of study drug administration through 48 hours after the last study drug administration.

• Change from baseline in target gene mRNA expression levels in tissue homogenate

  From start of study drug administration through 16 weeks after the last study drug administration.

• Change from baseline in target protein levels in tissue homogenate

  From start of study drug administration through 16 weeks after the last study drug administration.

Study Arms (2)

TGM-312-SC01

EXPERIMENTAL

Participants will receive study treatment according to the assigned intervention.

Drug: TGM-312-SC01

Placebo

PLACEBO COMPARATOR

Participants will receive study treatment according to the assigned intervention.

Drug: Placebo

Interventions

TGM-312-SC01 DRUG

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

TGM-312-SC01

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tangram Therapeutics Plc: lead

Study Sites (1)

Richmond Pharmacology

London, United Kingdom

RECRUITING

Study Officials

• Sponsor Medical Representative

  Tangram Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Sponsor Clinical Trials Office

CONTACT

+44 20 4558 3826; clinicaltrials@tangramtx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 23, 2026
• Study Start: March 3, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)