AbbVie reports positive Phase 1 MAD trial results for its long-acting amylin analog ABBV-295, showing up to ~9.8% weight loss over 12–13 weeks with a generally well-tolerated safety profile in adults.
Written By: Sana Khan, BPharm
Reviewed By: Pharmacally Editorial Team
AbbVie has reported positive topline results from the multiple ascending dose (MAD) portion of its Phase 1 GUC17-01 clinical trial (NCT06144684) evaluating the investigational obesity therapy ABBV-295, a long-acting amylin analog administered subcutaneously.
The early-stage study assessed the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ABBV-295 in adults with a mean body mass index (BMI) below 30 kg/m². The trial tested several dose levels ranging from 2 mg to 14 mg, including different titration schedules and dosing frequencies.
Dose-Dependent Weight Loss Observed
Across the 12–13-week treatment period, ABBV-295 produced clinically meaningful, dose-dependent reductions in body weight.
Participants receiving weekly dosing experienced least-squares mean body-weight reductions ranging from −7.75% to −9.79% at week 12, while those receiving every-other-week or monthly dosing achieved −7.86% to −9.73% reductions by week 13.
In contrast, participants receiving placebo showed minimal weight change, with −0.26% at week 12 and −0.25% at week 13.
Safety and Tolerability
The MAD portion enrolled 76 participants, the majority of whom were male (88.3%). ABBV-295 was generally well tolerated across all dose levels evaluated.
The most frequently reported adverse events were gastrointestinal disorders, which were mostly mild and occurred predominantly during the first six weeks of treatment.
Primal Kaur, M.D., senior vice president of global development at AbbVie, said the results highlight the potential of a new therapeutic approach for obesity. “Obesity is a complex, chronic disease that places a substantial burden on patients and healthcare systems. We are encouraged by these early results for ABBV-295, which demonstrate meaningful weight loss together with a well-tolerated safety profile.”
ABBV-295 represents a mechanistically distinct approach compared with incretin-based therapies such as GLP-1 or dual GLP-1/GIP receptor agonists.
The investigational therapy acts as an agonist of amylin and calcitonin receptors. Amylin is a satiety hormone that signals the brain to reduce appetite and food intake while also slowing gastric emptying, making it a potential target for obesity treatment.
AbbVie previously disclosed results from the single ascending dose (SAD) portion and other cohorts of the study. The company plans to present full Phase 1 data at a future scientific conference.
ABBV-295 remains investigational, and its safety and efficacy have not yet been established by any regulatory authority.
References
AbbVie Announces Positive Topline Results from a Phase 1 Multiple Ascending Dose Study of ABBV-295, a Long-Acting Amylin Analog, in Adults. https://news.abbvie.com/2026-03-09-AbbVie-Announces-Positive-Topline-Results-from-a-Phase-1-Multiple-Ascending-Dose-Study-of-ABBV-295,-a-Long-Acting-Amylin-Analog,-in-Adults
A Two-Part First-In-Human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GUB014295, ClinicalTrials.gov ID NCT06144684. https://clinicaltrials.gov/study/NCT06144684
About the Writer
Sana Jamil Khan is a B.Pharm graduate with a strong interest in medical writing and scientific communication. Her work focuses on interpreting clinical research, exploring developments in pharmaceutical science, and presenting complex medical information in a clear and accessible manner. She is particularly interested in topics related to human clinical studies, drug safety observations, and emerging therapeutic research.