Sagimet Biosciences reported that its first‑in‑human, open‑label, two‑cohort Phase 1 pharmacokinetic study of a once‑daily oral combination of denifanstat and resmetirom was completed in 40 healthy adults and produced a clean safety profile, with no serious adverse events, clinically significant laboratory abnormalities, or treatment discontinuations.
The 12‑day study confirmed that the two drugs do not generate clinically relevant drug‑drug interactions, a key prerequisite for moving the combination into a Phase 2 efficacy trial. The data also support the feasibility of a fixed‑dose combination tablet, which could simplify treatment for patients with metabolic dysfunction‑associated steatohepatitis (MASH) and cirrhosis (F4). Denifanstat, a selective fatty‑acid‑synthase inhibitor, has already earned FDA Breakthrough Therapy designation for MASH with moderate to advanced fibrosis, while resmetirom is the first FDA‑approved therapy for non‑cirrhotic MASH.
Sagimet plans to use the Phase 1 data to design a Phase 2 proof‑of‑concept study slated for the second half of 2026. The trial will enroll patients with advanced MASH and cirrhosis, a population that currently has no approved options. The combination’s complementary mechanisms—denifanstat’s inhibition of lipid synthesis and resmetirom’s selective activation of thyroid hormone receptor‑β in the liver—are expected to produce synergistic reductions in hepatic steatosis and fibrosis, as suggested by pre‑clinical studies presented at EASL 2024.
Financially, Sagimet posted a net loss of $12.9 million in Q3 2025, an improvement from the $16.2 million loss reported in Q4 2024. The company’s cash position remains robust, providing the runway to fund the upcoming Phase 2 program and other development milestones. The positive safety data reinforce investor confidence in the company’s ability to advance its pipeline without significant safety‑related setbacks.
CEO David Happel emphasized that the Phase 1 results “are an important step in our journey to develop a potentially synergistic combination treatment for MASH patients with cirrhosis, a population that currently has no approved options.” He added that the fixed‑dose combination could improve adherence and clinical outcomes, positioning Sagimet to capture a sizable share of the growing MASH market, which is projected to reach $10 billion by 2035.
The study’s success also strengthens Sagimet’s partnership with TAPI, which supplies the resmetirom active pharmaceutical ingredient, and underscores the company’s strategy of leveraging existing approvals to accelerate development of novel combination therapies.
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