AbbVie presents Phase 1 data for obesity candidate ABBV-295 at EASD 2026

AbbVie said detailed results from the multiple ascending dose part of its Phase 1 study of ABBV-295 will be presented in a short oral presentation at the European Association for the Study of Diabetes (EASD) 2026 Annual Meeting in Milan, Italy, on September 30, 2026. The study assessed the tolerability, pharmacokinetics and pharmacodynamics of the subcutaneous investigational amylin analog in adults with a mean body mass index below 30 kg/m2.

The detailed results come from 60 participants in Parts 2B and 2C of the study, who were randomized to receive ABBV-295 (45) or placebo (15). Participants had a mean age of 41.5 years, a mean body mass index 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 given for 12 or 13 weeks.

AbbVie said the mean half-life of ABBV-295 ranged from 10.7 to 12.3 days, with dose-proportional increases in plasma exposure across cohorts. It said this profile supports evaluation of dosing intervals beyond weekly administration, including every-other-week and monthly regimens.

Body weight declined in a dose-dependent manner over the 12- to 13-week treatment period. Least-squares mean changes ranged from -7.8% to -9.8% at Week 12 in the once-weekly cohorts, and were -9.7% in the every-other-week cohort and -7.9% in the monthly cohort at Week 13, compared with about -0.3% for placebo.

Most gastrointestinal adverse events were mild and occurred mainly during the first six weeks. Nausea was reported by 33.3% of participants receiving ABBV-295 and 20.0% receiving placebo, and diarrhea by 20.0% and 0.0%, respectively. No serious treatment-emergent adverse events were reported. AbbVie said it looks forward to advancing ABBV-295 into Phase 2 development.