Sagimet Reports Q4 2025 Results, Plans F4 MASH Combination Trial in Second Half 2026

Sagimet Biosciences Inc. (Nasdaq: SGMT) reported financial results for the fourth quarter and full year ended December 31, 2025, and announced plans to initiate a Phase 2 clinical trial of denifanstat and resmetirom combination in F4 MASH patients in the second half of 2026. The company anticipates a 26-week biomarker readout in the first half of 2028 and a 52-week interim readout in the second half of 2028.

In December 2025, Sagimet announced the completion of its open-label Phase 1 pharmacokinetic (PK) clinical trial of its oral once-daily fatty acid synthase (FASN) inhibitor, denifanstat, and a thyroid hormone receptor beta (THR-β) agonist, resmetirom, to evaluate pharmacokinetics and potential drug-drug interactions (DDI), and to assess the safety and tolerability of the combination. The combination of denifanstat and resmetirom was generally well-tolerated over the duration of the study, with no safety signals. No serious adverse events occurred, and there were no clinically significant laboratory results, and no treatment discontinuations. Sagimet plans to use these data to advance the development of the combination into a Phase 2 proof-of-concept trial for patients living with MASH with F4 fibrosis, for which there are currently no approved treatments.

The company expects enrollment for the F4 study would take roughly 12 to 18 months, consistent with other F4 studies. Sagimet plans to propose that FDA accept a non-invasive measurement for treatment response at 52 weeks, while remaining prepared to extend to 96 weeks with biopsy if required.

In January 2026, Sagimet's license partner Ascletis Bioscience Co. Ltd. reported positive topline results in the open-label Phase 3 trial evaluating the long-term safety of ASC40 (denifanstat) tablets in patients with moderate to severe acne in China. This open-label Phase 3 trial enrolled 240 subjects who received oral denifanstat 50 mg once daily for up to 40 weeks. Subjects who were originally randomized to denifanstat in the 12-week ASC40-303 trial had a total of 52 weeks of denifanstat exposure at the end of the long-term safety study. Primary endpoints evaluated safety, and secondary endpoints evaluated certain efficacy measures for up to 52 weeks of denifanstat treatment. Denifanstat was generally well tolerated. Furthermore, subjects treated with denifanstat showed improvements in all of the efficacy endpoints (secondary endpoints of the trial), beyond those observed at 12 weeks.

China's National Medical Products Administration (NMPA) accepted Ascletis' New Drug Application (NDA) for denifanstat for the treatment of moderate to severe acne.

Ascletis' 12-week Phase III program enrolled 480 patients and met all primary and secondary endpoints, including IGA success and lesion count endpoints (total, inflammatory, and non-inflammatory). The only treatment-emergent adverse events above 5% in the extension study were dry skin and dry eyes.

In June 2025, the Company initiated a first-in-human Phase 1 clinical trial of TVB-3567, a FASN inhibitor that is being developed for an acne indication. The Phase 1 clinical trial is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of TVB-3567 in healthy participants with or without acne.

In December 2025, Sagimet announced its entry into a license agreement with Assia Chemical Industries Ltd. (Assia), doing business as TAPI Technology & API Services (TAPI), a subsidiary of Teva Pharmaceutical Industries Ltd. Under the agreement, TAPI granted Sagimet a global, exclusive license to certain intellectual property rights covering innovative forms of resmetirom active pharmaceutical ingredients (API).

In November 2025, Sagimet presented two posters at the American Association for the Study of Liver Disease (AASLD) - The Liver Meeting® 2025. In a secondary analysis of the denifanstat Phase 2b FASCINATE-2 clinical trial, denifanstat elicited a significant ≥2-stage improvement in fibrosis in F3 MASH patients, and improved liver fibrosis and several noninvasive biomarkers in a subpopulation of qFibrosis stage 4 MASH patients identified by AI-based digital pathology. An analysis utilizing spatial computational histology relying on baseline fibrosis features was used to predict response to denifanstat.