AbbVie releases new positive topline results from phase 1 multiple ascending dose study of ABBV-295
Posted on March 16, 2026
AbbVie has recently announced positive topline results from the multiple ascending dose part of its Phase 1 study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneous ABBV-295, in adults with a mean body mass index of less than 30 kg/m. 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.
Note that this study enrollment mostly comprised male participants. Different doses, 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.
In addition, 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 mean percentage change in body weight ranged from -7.75% to -9.79% at week 12, to -7.86% to -9.73% at week 13, compared to -0.26% and -0.25% in the placebo group at week 12 and week 13, respectively.
“Obesity is a complex, chronic disease that places a substantial burden on patients, healthcare systems and society, and there remains a critical need for therapies that combine efficacy with tolerability and support long-term adherence,” said Primal Kaur, M.D., senior vice president, global development of immunology, neuroscience, eye care and specialty at AbbVie. “We are encouraged by these early results for ABBV-295, which demonstrate meaningful weight loss together with a well-tolerated safety profile. These initial results further reinforce the potential of ABBV-295 as a novel therapeutic option for people living with obesity.”
Summary of Phase 1 MAD Study Key Results
|
Cohorta |
LS Mean (95% CI) at week 12b |
LS Mean (95% CI) at week 13b |
|
All Placebo |
-0.26 (-1.89, 1.37) |
-0.25 (-1.88, 1.38) |
|
Cohort 3 (weekly dosing) |
-7.75 (-9.89, -5.61) |
– |
|
Cohort 4 (weekly dosing) |
-8.70 (-10.75, -6.65) |
– |
|
Cohort 5a (weekly dosing) |
-9.79 (-11.99, -7.59) |
– |
|
Cohort 5b (every other week dosing) |
-7.76 (-9.82, -5.70) |
-9.73 (-11.79, -7.67) |
|
Cohort 6 (monthly dosing after week 5) |
-6.74 (-8.70, -4.79) |
-7.86 (-9.80, -5.91) |
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