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Recruiting NCT07427680

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

Phase I / Phase II Interventional Healthy Participants MASH - Metabolic Dysfunction-Associated Steatohepatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TGM-312-SC01, Placebo.
Who it may be relevant to
Registry conditions: Healthy Participants, MASH - Metabolic Dysfunction-Associated Steatohepatitis. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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).

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.

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

Primary outcome measures

  • 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 outcome measures (4)
  • 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.]
  • 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.]
  • 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 target protein levels in tissue homogenate [Time frame: From start of study drug administration through 16 weeks after the last study drug administration.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United Kingdom · 1 center
  • Richmond Pharmacology — London

Identifiers

NCT: NCT07427680 · TGM-312-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗