AbbVie announced positive topline results from a Phase 1 multiple ascending dose (MAD) study of ABBV-295, a long-acting amylin analog licensed from Gubra in March 2025.
Weekly dosing cohorts showed average weight loss of 7.7%, 8.7%, and 9.8% at week 12, with dose-dependent reductions from -7.75% to -9.79% (least-squares mean).
Other regimens (every other week and monthly after week 5) showed -7.86% to -9.73% weight loss at week 13, compared to -0.25% to -0.26% in placebo.
ABBV-295 demonstrated a favorable tolerability profile with no serious adverse events; most common issues were mild gastrointestinal disorders in the first 6 weeks.
Data supports continued development for chronic weight management; full results expected at a future conference like EASD.
Analysts view the ~10% weight loss as competitive in the amylin class, potentially informing Phase 2 design later in 2026.