AbbVie reports Phase 1 data for ABBV-295 at EASD 2026, showing body-weight reduction, favorable tolerability and a half-life supporting less frequent dosing.
Written By: Malavatu Satvika, PharmD
Reviewed By: Pharmacally Editorial Team
AbbVie presented detailed results from the multiple ascending dose (MAD) portion of its Phase 1 study of ABBV-295 at the European Association for the Study of Diabetes (EASD) 2026 Annual Meeting in Milan, Italy. ABBV-295 is an investigational long-acting amylin analog being studied for the treatment of obesity.
The study evaluated the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic effects of ABBV-295 in adults. The findings showed body-weight reductions across different dosing schedules, while the drug’s pharmacokinetic profile supported further evaluation of dosing intervals beyond once-weekly administration.
A Long-Acting Amylin-Based Approach
Amylin is a hormone involved in regulating appetite and food intake. It contributes to satiety and reduced food intake and provides an inhibitory signal that delays gastric emptying. ABBV-295 is an investigational long-acting amylin analog designed to act through an amylin-based pathway distinct from incretin-based therapies such as GLP-1 and GIP receptor agonists.
Phase 1 Study Design
The Phase 1 study (NCT06144684) was a randomized, placebo-controlled, single-center study evaluating subcutaneous ABBV-295. The study included single-ascending-dose and multiple-ascending-dose components.
The multiple ascending dose portion enrolled 76 healthy adults, while the detailed results presented at EASD 2026 were from 60 participants in Parts 2B and 2C. Among these 60 participants, 45 received ABBV-295 and 15 received placebo.
Participants had a mean age of 41.5 years and a mean baseline body mass index (BMI) of 29.3 kg/m², with 88% being male.
ABBV-295 was evaluated at 4, 6, or 14 mg once weekly, 14 mg every other week, or 8 mg monthly. Treatment continued for 12 or 13 weeks, depending on the dosing cohort.
Body-Weight Reduction Across Dosing Schedules
ABBV-295 showed reductions in body weight across the evaluated dosing schedules during the 12- to 13-week treatment period.
For the once-weekly dosing groups, least-squares mean reductions in body weight ranged from 7.8% to 9.8% at Week 12.
Weight reduction was also observed with less frequent dosing. The every-other-week group showed a 9.7% reduction at Week 13, while the monthly group showed a 7.9% reduction at Week 13. In comparison, the placebo group showed an approximately 0.3% reduction.
Because these findings came from a small, short-duration Phase 1 study, further clinical development will be needed to determine the durability and clinical significance of the observed weight reduction in broader populations.
Pharmacokinetic Findings Support Extended Dosing
The pharmacokinetic analysis showed a dose-proportional increase in plasma exposure across the evaluated cohorts. The median time to maximum plasma concentration (Tmax) ranged from 24.0 to 48.1 hours, while the mean half-life ranged from 10.7 to 12.3 days.
This pharmacokinetic profile supported the evaluation of once-weekly, every-other-week, and monthly dosing schedules. The findings provide a basis for further investigation of dosing intervals beyond weekly administration in future clinical development.
Safety and Tolerability
ABBV-295 was generally well tolerated in the Phase 1 study. No serious treatment-emergent adverse events were reported, and most adverse events were mild.
Gastrointestinal adverse events were mainly mild and occurred primarily during the first six weeks of treatment. Among participants who experienced a gastrointestinal adverse event, 92% reported mild events as the highest severity.
Nausea was reported in 33.3% of participants receiving ABBV-295 compared with 20.0% receiving placebo, while diarrhea occurred in 20.0% and 0.0%, respectively. No severe gastrointestinal adverse events were reported.
Gastrointestinal adverse events led to treatment discontinuation in 4.4% of participants receiving ABBV-295 across all active-dose groups compared with none of the placebo-treated participants. Commonly reported adverse events occurring in more than 20% of participants included decreased appetite, fatigue, headache, nausea, and diarrhea.
ABBV-295 Remains Investigational
ABBV-295 remains an investigational therapy and has not been approved by any health regulatory authority worldwide. The safety and efficacy of the treatment have not yet been established.
The Phase 1 findings provide early clinical data on the safety, tolerability, pharmacokinetics, and body-weight effects of the long-acting amylin analog. However, the study’s relatively small population and short treatment duration limit conclusions about longer-term efficacy and safety.
Path Forward
Based on the Phase 1 findings, AbbVie plans to advance ABBV-295 into Phase 2 development for chronic weight management.
Further studies will be needed to evaluate the treatment over longer periods and in broader patient populations, including its longer-term safety, efficacy, magnitude and durability of weight reduction, and the potential role of less frequent dosing schedules.
Reference
AbbVie. AbbVie Presents Detailed Phase 1 Data for ABBV-295, a Long-Acting Amylin Analog, Demonstrating Favorable Tolerability and Pharmacokinetic Profile at EASD 2026. September 30, 2026
A Two-Part First-In-Human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GUB014295, ClinicalTrials.gov ID NCT06144684
About the Writer
Malavatu Satvika (Linkedin) is a Pharm.D professional and aspiring healthcare medical writer with clinical exposure and research experience. Her interests include medical writing, drug safety, pharmaceutical research, and evidence-based healthcare communication. She has contributed to two research publications in pharmaceutical journals and has gained practical experience in prescription review, patient counselling, medication review, adverse drug reaction monitoring, drug information services, literature review, and clinical documentation through regular hospital training.
She has completed certifications in clinical research, ICH-GCP E6(R3), data management for clinical research, and congenital hypothyroidism. With a strong foundation in pharmacy, clinical practice, and scientific research, she aims to translate complex medical and pharmaceutical information into accurate, clear, and evidence-based healthcare content. She is also preparing to pursue a PhD and further develop her expertise in medical writing and pharmaceutical research.