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AbbVie Announces Positive Topline Results from a Phase 1 Multiple Ascending Dose Study of ABBV-295, a Long-Acting Amylin Analog, in Adults
AbbVie (NYSE: ABBV) today announced positive topline results1 from the multiple ascending dose (MAD) part of its Phase 1 study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous ABBV-295, in adults with a mean body mass index (BMI) of less than 30 kg/m2. ABBV-295 is a long-acting amylin analog that represents a mechanistically distinct class from incretin-based therapies such as GLP-1 and GIP receptor agonists.
About this update from Abbvie Inc.
[{"type":"list","items":[{"val":[{"type":"text","content":"ABBV-295 treatment showed clinically meaningful body weight reduction from -7.75% to -9.79% (least-squares mean) at week 12 (weekly dosing), to -7.86% to -9.73% at week 13 (every other week and monthly dosing after week 5)1","length":223,"tagName":"p"}]},{"val":[{"type":"text","content":"ABBV-295 demonstrated a favorable tolerability profile at all evaluated dose levels. No serious adverse events were reported1","length":125,"tagName":"p"}]},{"val":[{"type":"text","content":"Data support continued development of ABBV-295 as a potentially differentiated treatment for chronic weight management, with a non-incretin-based mechanism of action","length":170,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":518,"olType":false},{"type":"text","content":"NORTH CHICAGO, Ill., March 9, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive topline results1 from the multiple ascending dose (MAD) part of its Phase 1 study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous ABBV-295, in adults with a mean body mass index (BMI) of less than 30 kg/m2. ABBV-295 is a long-acting amylin analog that represents a mechanistically distinct class from incretin-based therapies such as GLP-1 and GIP receptor agonists.","length":516,"tagName":"p"},{"type":"text","content":"Study enrollment mostly comprised male participants (88.3%). Different doses (2-14 mg), titrations and dose frequencies were tested in the study. ABBV-295 was generally well tolerated across all dose levels evaluated. The most commonly reported adverse events were gastrointestinal disorders, which were mostly mild, and predominantly occurred during the first 6 weeks of treatment.1","length":383,"tagName":"p"},{"type":"text","content":"ABBV-295 demonstrated clinically meaningful, dose-dependent reductions in body weight from baseline, over a 12-13-week treatment period. In the ABBV-295 treated groups dose-dependent least-squares (LS) mean percentage change in body weight ranged from -7.75% to -9.79% at week 12 (for weekly dosing groups), to -7.86% to -9.73% at week 13 (for every other week dosing group and monthly dosing group after week 5), compared to -0.26% and -0.25% in the placebo group at week 12 and week 13, respectively.1","length":503,"tagName":"p"},{"type":"text","conte...