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NCT Number: NCT07427680

Study 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).

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Key information

Conditions

Healthy Participants MASH - Metabolic Dysfunction-Associated Steatohepatitis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Incidence and severity of treatment-emergent adverse events [Safety and tolerability]

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

Secondary outcomes

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

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

    Maximum observed plasma concentration derived from plasma concentration-time data.

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

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

    Area under the plasma concentration-time curve derived from plasma concentration-time data.

  3. Change from baseline in target gene mRNA expression levels in tissue homogenate

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

    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.

  4. Change from baseline in target protein levels in tissue homogenate

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsor Clinical Trials Office

CONTACT

[email protected]

+44 20 4558 3826

Sponsors and collaborators

Lead sponsor

Tangram Therapeutics Plc

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 23, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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