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

ConditionsHealthy ParticipantsMASH - Metabolic Dysfunction-Associated Steatohepatitis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTangram Therapeutics Plc

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

99 Participants
are divided into 2 treatment groups
Group A: TGM-312-SC01Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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)

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

Time frame
From start of study drug administration through 48 hours after the last study drug administration.
2

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.

Time frame
From start of study drug administration through 48 hours after the last study drug administration.
3

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.

Time frame
From start of study drug administration through 16 weeks after the last study drug administration.
4

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tangram Therapeutics Plc

Lead sponsor

Source ClinicalTrials.gov
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