Sagimet Biosciences (SGMT) announced that the Company has dosed the first participants in a Phase 1 pharmacokinetic trial of a combination of its oral once-daily fatty acid synthase inhibitor, denifanstat, and a thyroid hormone receptor beta agonist, resmetirom. Topline data from this trial are anticipated in the first half of 2026 and, if positive, are planned to be used to advance the development of the combination for patients living with metabolic dysfunction-associated steatohepatitis into Phase 2, subject to consultation with regulatory authorities. The Phase 1 PK trial of denifanstat and resmetirom is an open-label, 2-cohort study and will enroll approximately 40 healthy adult participants. The objectives are to evaluate multiple-dose and single-dose pharmacokinetics, identify any potential drug-drug interactions, and assess the safety and tolerability of the combination. Results from this Phase 1 PK trial will be used to inform the optimal dose levels of denifanstat and resmetirom to evaluate in a Phase 2 combination proof-of-concept efficacy trial in F4 MASH patients.
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