AbbVie presents Phase 1 data for obesity drug candidate ABBV-295

AbbVie presented detailed Phase 1 clinical trial results for its investigational obesity candidate, ABBV-295, on September 30, 2026, at the European Association for the Study of Diabetes meeting in Milan, Italy. The drug is a long-acting amylin analog, representing a non-incretin mechanism distinct from GLP-1 and GIP receptor agonists.

The multiple ascending dose study evaluated 60 participants in Part 2B/2C, with 45 receiving ABBV-295 and 15 receiving placebo. Patients had an average age of 41.5 years, a mean body mass index of 29.3 kg/m2, and 88% were male. Over 12 to 13 weeks, least-squares mean weight reductions ranged from -7.8% to -9.8% for once-weekly dosing cohorts, reached -9.7% for every-other-week administration, and hit -7.9% for monthly dosing, compared with roughly -0.3% for placebo.

Pharmacokinetic data revealed a mean half-life of 10.7 to 12.3 days and a median Tmax of 24.0 to 48.1 hours, supporting dosing intervals extended to monthly regimens. Gastrointestinal adverse events were mostly mild, with nausea occurring in 33.3% of treated participants versus 20.0% for placebo, and diarrhea occurring in 20.0% versus 0.0%. Discontinuations due to gastrointestinal issues stood at 4.4% for the active drug. AbbVie plans to advance ABBV-295 into Phase 2 development.