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NCT07427680RECRUITINGanonymous

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

Sponsor

Source record

Tangram Therapeutics Plc

Phase

Source record

Phase 1/2

Modality

AI-normalized

small molecule

Target

AI-normalized

Investigational target related to metabolic dysfunction-associated steatohepatitis (MASH), potentially involving pathways associated with lipid metabolism and inflammation.

Indication / condition

AI-normalized

Healthy Participants

Intervention

Source record

TGM-312-SC01, Placebo

Source & freshness

Source record

NCT ID

NCT07427680

Original source

ClinicalTrials.gov

Source last updated

May 19, 2026

Ingested at

Jun 13, 2026

Internal sync

Jun 13, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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NCT ID

NCT07427680

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

Sponsor

Tangram Therapeutics Plc

Status

RECRUITING

Phase

Phase 1/2

Condition raw

Healthy Participants, MASH - Metabolic Dysfunction-Associated Steatohepatitis

Condition normalized

Healthy Participants, MASH - Metabolic Dysfunction-Associated Steatohepatitis

Modality raw

small molecule

Modality normalized

small molecule

Target raw

Investigational target related to metabolic dysfunction-associated steatohepatitis (MASH), potentially involving pathways associated with lipid metabolism and inflammation.

Target normalized

Investigational target related to metabolic dysfunction-associated steatohepatitis (MASH), potentially involving pathways associated with lipid metabolism and inflammation.

Interventions

TGM-312-SC01, Placebo

Public preview

Source record

Tangram Therapeutics Plc is advancing TGM-312-SC01, an investigational drug aimed at treating metabolic dysfunction-associated steatohepatitis (MASH), a condition with increasing prevalence linked to obesity and metabolic syndrome. The Phase 1/2 trial is designed to assess safety, tolerability, pharmacokinetics, and pharmacodynamics, which are critical for establishing the drug's therapeutic profile. The market for MASH treatments is expanding, driven by rising obesity rates and the need for effective therapies. Competitive analysis indicates a growing interest in this space, with several companies exploring similar targets. Successful trial outcomes could position Tangram favorably in a competitive landscape, potentially leading to partnerships or acquisition interest. Diligence implications include a thorough review of safety data and regulatory pathways, given the drug's investigational status.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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