SAN CARLOS, Calif. — October 13, 2026

Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company, announced positive preliminary findings from its Phase 1 GLP-131 clinical trial evaluating BMF-650, an investigational oral small-molecule glucagon-like peptide-1 receptor agonist (GLP-1 RA) for obesity and metabolic disorders. The randomized, double-blind, placebo-controlled study demonstrated weight reduction across multiple dose cohorts over four weeks, alongside an encouraging initial safety and tolerability profile. In Cohorts 1–4, mean weight reduction at Day 29 ranged from 1.5% to 3.2%, compared with 0.1% for pooled placebo. An additional cohort evaluating rapid dose escalation to 400 mg once daily also reported favorable short-term tolerability. The findings provide early clinical evidence supporting the candidate’s development strategy, although longer-term studies are needed to establish its safety, effectiveness and appropriate dosing regimen.

BMF-650 Demonstrates Weight Reduction Across Dose Cohorts

The Phase 1 GLP-131 study evaluated safety and tolerability as co-primary endpoints, with pharmacokinetics, pharmacodynamics and changes in body weight assessed as key secondary endpoints. The trial enrolled otherwise healthy adults who were overweight or had obesity and included a single-ascending-dose portion followed by five multiple-ascending-dose (MAD) cohorts. Across Cohorts 1–4, mean weight reduction at Day 29 ranged from 1.5% to 3.2%, while pooled placebo participants experienced a mean reduction of 0.1%. At daily doses of 200 mg or higher in these outpatient cohorts, the mean weekly weight reduction was approximately 0.97 kg. Cohort 5 was conducted under confinement to improve dosing compliance and further characterize tolerability. Participants received 200 mg once daily for one week, followed by 400 mg once daily for three weeks. At Day 29, mean weight reduction in the active-treatment group was 6.1%, equivalent to 6.2 kg, averaging approximately 1.55 kg per week. However, the company cautioned that the confined setting appeared to influence eating behavior. The two placebo participants consumed only around 33% of the 2,100 kcal of food provided daily and showed similar weight reduction. Biomea therefore recommends interpreting Cohort 5 separately from the outpatient cohorts, and the results should not be directly compared without considering these differences.

Short-Term Safety Supports Further Dose Evaluation

Across the five active-treatment MAD cohorts, comprising 40 participants, all reported treatment-emergent adverse events (TEAEs) were mild or moderate. The company reported no severe or serious TEAEs, no adverse-event-related dose modifications, and no treatment discontinuations attributable to TEAEs. Across all active MAD cohorts, nausea occurred in 17.5% of participants, vomiting in 7.5%, constipation in 10% and diarrhea in 5%. No adverse events involving elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) were reported. In Cohort 5, nausea and vomiting each occurred in one of eight BMF-650-treated participants, or 12.5%; constipation occurred in two participants, or 25%, while no diarrhea was reported. All gastrointestinal events in this cohort were Grade 1. These preliminary results are based on only four weeks of treatment and do not establish the candidate’s longer-term safety profile. Biomea said the findings support additional investigation of a simplified dosing approach, potentially reducing the number of dose-escalation steps needed to reach the target dose. Further studies will be required to determine whether rapid escalation remains tolerable during longer treatment periods and across a broader patient population.

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Oral Dosing Strategy and Next Development Steps

Biomea designed BMF-650 with a medicinal chemistry strategy intended to reduce acute gastrointestinal effects associated with GLP-1 receptor activation while maintaining weight reduction. In Cohort 5, pharmacokinetic findings indicated sustained systemic exposure compatible with once-daily oral administration and a low peak-to-trough ratio. Participants tolerated escalation from 200 mg to 400 mg once daily after one week, with gastrointestinal tolerability reported as similar to that observed in the slower-titration cohorts. The company believes these findings justify further evaluation of a potential no-titration or simplified-titration regimen, but the optimal approach remains unconfirmed. Additional clinical development will also require longer-term toxicology studies. Biomea intends to continue this work while positioning BMF-650 for a potential strategic partnership, including a licensing arrangement for later-stage development and commercialization. The company’s broader metabolic disease strategy also includes icovamenib, a menin inhibitor being developed for type 1 and type 2 diabetes. Biomea has emphasized that icovamenib remains its primary development focus. The BMF-650 Phase 1 study is registered as NCT07223216. Overall, the findings establish an initial clinical data package for the investigational oral GLP-1 receptor agonist, while additional studies will determine its longer-term weight-loss effects, safety, dosing requirements and commercial development prospects.

Source::Biomea Fusion, press release