Abbvie Shared Detailed Results From The Multiple Ascending Dose Part Of Its Phase 1 Study Evaluating ABBV-295 At EASD Annual Meeting, Showing Favorable Tolerability And Pharmacokinetic Profile

AbbVie (NYSE:ABBV) today announced that detailed results from the multiple ascending dose (MAD) part of its Phase 1 study evaluating ABBV-295 will be presented in a short oral presentation at the European Association for the Study of Diabetes (EASD) 2026 Annual Meeting (Milan, Italy; September 28 – October 2). The study evaluated the tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous ABBV-295, an investigational long-acting amylin analog, in adults with a mean body mass index (BMI) of less than 30 kg/m2.

These detailed results being presented are from the 60 participants in Part 2B/2C of the MAD study, who were randomized to receive ABBV-295 (n = 45) or placebo (n = 15). Participants had a mean age of 41.5 years and a mean BMI of 29.3 kg/m2, and 88% were male. ABBV-295 was dose-escalated to 4, 6, or 14 mg once weekly, 14 mg every other week, or 8 mg monthly, and administered for 12 or 13 weeks.1 ABBV-295 is an investigational therapy that represents a mechanistically distinct class from incretin-based therapies such as GLP-1 and GIP receptor agonists.1,2

"As the obesity treatment landscape evolves, we remain focused on bringing forth differentiated approaches that help expand available therapeutic options for people living with this complex disease," said Primal Kaur, M.D., senior vice president, global development of immunology, neuroscience, eye care and specialty at AbbVie. "These detailed results showed meaningful weight loss alongside a half-life that could support dosing less frequently than once weekly, and they reinforce the scientific rationale for targeting the amylin pathway. We look forward to advancing ABBV-295 into Phase 2 development."

Key highlights from the short oral presentation include:

• Pharmacokinetic profile supports evaluation of dosing intervals beyond weekly administration: ABBV-295 demonstrated dose-proportional increases in plasma exposure across cohorts. Median Tmax ranged from 24.0 to 48.1 hours, and the mean half-life ranged from 10.7 to 12.3 days, a profile that supported the once-weekly, every-other-week, and monthly regimens evaluated in the study.1
• Gastrointestinal (GI) safety findings: GI adverse events (AEs) were predominantly mild and occurred primarily during the first six weeks of treatment. Among participants who reported a GI AE, 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. Diarrhea was reported in 20.0% of participants receiving ABBV-295 compared with 0.0% receiving placebo. No severe GI AEs were reported, and discontinuations due to GI AEs were infrequent overall (4.4% vs. 0.0%, all active vs. placebo).1
• Tolerability: No serious treatment-emergent adverse events (TEAEs) were reported, and most events were mild. The most commonly reported adverse events (AEs) >20% were decreased appetite, fatigue, headache, nausea, and diarrhea.1
• Meaningful weight loss observed across weekly, every-other-week, and monthly regimens: ABBV-295 demonstrated dose-dependent reductions in body weight over a 12- to 13-week treatment period. Least-squares (LS) mean body weight reductions ranged from -7.8% to -9.8% at Week 12 for the once-weekly dosing cohorts and were -9.7% for the every-other-week cohort and -7.9% for the monthly cohort at Week 13, compared with approximately -0.3% for placebo.1 

"Obesity is a chronic disease that requires long-term treatment, and the practical realities of therapy, such as how often someone has to take medication and how they feel while doing it, matter a great deal for patients to stay on treatment," said Juan Pablo Frías, M.D., Medical Director and Primary Investigator at Los Angeles Institute for Metabolic Research and study author. "In this Phase 1 study, ABBV-295 demonstrated meaningful weight loss across multiple dosing regimens and a pharmacokinetic profile supportive of further evaluation of extended dosing intervals. Together, these findings support continued development of this investigational therapy for patients."

EASD Presentation Details:

ABBV-295 is an investigational asset and has not been approved for use by global regulatory authorities.