AbbVie Presents Detailed Phase 1 Data for ABBV-295, a Long-Acting Amylin Analog

 

• Detailed findings, to be presented in a short oral presentation, demonstrated an approximately 11- to 12-day half-life and dose-proportional increases in plasma exposure, supporting evaluation of ABBV-295 at dosing intervals beyond weekly administration, including every-other-week and monthly regimens
• ABBV-295 showed meaningful body weight reduction and a favorable tolerability profile at all evaluated dose levels, with topline results announced earlier this year
• Findings support advancement of ABBV-295 — a non-incretin, amylin-based mechanism — into Phase 2 development for chronic weight management

AbbVie (NYSE: ABBV) today announced that detailed results from the multiple ascending dose (MAD) part of its Phase 1 study evaluating ABBV-295 will be presented in a short oral presentation at the European Association for the Study of Diabetes (EASD) 2026 Annual Meeting (Milan, Italy; September 28 – October 2). The study evaluated the tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous ABBV-295, an investigational long-acting amylin analog, in adults with a mean body mass index (BMI) of less than 30 kg/m2.

These detailed results being presented are from the 60 participants in Part 2B/2C of the MAD study, who were randomized to receive ABBV-295 (n = 45) or placebo (n = 15). Participants had a mean age of 41.5 years and a mean BMI of 29.3 kg/m2, and 88% were male. ABBV-295 was dose-escalated to 4, 6, or 14 mg once weekly, 14 mg every other week, or 8 mg monthly, and administered for 12 or 13 weeks.1 ABBV-295 is an investigational therapy that represents a mechanistically distinct class from incretin-based therapies such as GLP-1 and GIP receptor agonists

https://news.abbvie.com/2026-09-30-AbbVie-Presents-Detailed-Phase-1-Data-for-ABBV-295,-a-Long-Acting-Amylin-Analog,-Demonstrating-Favorable-Tolerability-and-Pharmacokinetic-Profile-at-EASD-2026