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

RESTORE-MASH: A Phase 1/2 Randomized, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of TGM-312-SC01 in Healthy Participants and Adults With MASH

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).

Study Overview

• Status: Recruiting
• Conditions: Healthy Participants; MASH - Metabolic Dysfunction-Associated Steatohepatitis
• Intervention / Treatment: Drug: TGM-312-SC01; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 99
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Sponsor Clinical Trials Office; Phone Number: +44 20 4558 3826; Email: clinicaltrials@tangramtx.com

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • Richmond Pharmacology
    • Contact: Study Director; Phone Number: +44 (0) 20 7042 5800; Email: info@richmondpharmacology.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TGM-312-SC01; Participants will receive study treatment according to the assigned intervention.	Drug: TGM-312-SC01; TGM-312-SC01 is an investigational medicinal product administered by subcutaneous injection according to a protocol-defined regimen.
Placebo Comparator: Placebo; Participants will receive study treatment according to the assigned intervention.	Drug: Placebo; Placebo administered by subcutaneous injection according to a protocol-defined regimen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum observed plasma concentration (Cmax) of TGM-312-SC01 (ng/mL)	Maximum observed plasma concentration derived from plasma concentration-time data.	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)	Area under the plasma concentration-time curve derived from plasma concentration-time data.	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	Change from baseline in mRNA expression levels of the target gene in homogenised tissue samples following administration of TGM-312-SC01, expressed as relative change from baseline.	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	Change from baseline in protein levels of the target gene product in homogenised tissue samples following administration of TGM-312-SC01, expressed as concentration or relative change from baseline.	From start of study drug administration through 16 weeks after the last study drug administration.

Collaborators and Investigators

• Sponsor: Tangram Therapeutics Plc
• Investigators: Study Director: Sponsor Medical Representative, Tangram Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: January 30, 2026
• First Submitted That Met QC Criteria: February 16, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: TGM-312-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study results will be disseminated through publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No