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BMF-650 Phase 1 results: early weight-loss signal, with a placebo caveat

Published in Diseases!, Drugs development & discovery.

Published October 13, 2026.

Biomea Fusion reported initial Phase 1 results on October 13 for BMF-650, an investigational oral GLP-1 receptor agonist. The randomized, blinded GLP-131 study enrolled otherwise healthy adults with overweight or obesity; safety and tolerability were its primary objectives.

In outpatient cohorts 1–4, average weight reduction at day 29 ranged from 1.5% to 3.2%, versus 0.1% for pooled placebo. These are preliminary company-reported findings.

A separate confined cohort recorded 6.1% average weight loss, but its two placebo participants experienced similar reductions and ate approximately one-third of the food provided. That result cannot establish a drug-specific weight-loss benefit and should be interpreted separately.

Among 40 participants receiving repeated active doses, reported treatment-emergent adverse events were mild or moderate, with no serious events or adverse-event-related discontinuations. Four weeks of observation cannot establish long-term safety or durable efficacy.

Further clinical development requires longer-term toxicology studies. Dosing without titration remains a proposed future investigation.

Source: Biomea Fusion release, October 13, 2026. Trial: NCT07223216.