AbbVie Presents Detailed Phase 1 Data for ABBV-295, a Long-Acting Amylin Analog, Demonstrating Favorable Tolerability and Pharmacokinetic Profile at EASD 2026

• Detailed findings, to be presented in a short oral presentation, demonstrated an approximately 11- to 12-day half-life and dose-proportional increases in plasma exposure, supporting evaluation of ABBV-295 at dosing intervals beyond weekly administration, including every-other-week and monthly regimens
• ABBV-295 showed meaningful body weight reduction and a favorable tolerability profile at all evaluated dose levels, with topline results announced earlier this year
• Findings support advancement of ABBV-295 — a non-incretin, amylin-based mechanism — into Phase 2 development for chronic weight management

NORTH CHICAGO, Ill., Sept. 30, 2026 /PRNewswire/ -- 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.

About ABBV-295

ABBV-295 is an investigational, long-acting amylin analog being developed for the treatment of obesity. Amylin, a satiety hormone, has been identified as a potential therapeutic target for the treatment of obesity given its role in activating signals to the brain that result in appetite suppression and the reduction of food intake, while also acting as an inhibitory signal to delay gastric emptying. ABBV-295 has not been approved by any health regulatory authority worldwide. The safety and efficacy of ABBV-295 have not been established.

About the Phase 1 GUC17-01 Study³

The Phase 1 clinical trial is a two-part, single-center, double-blind (within cohorts), randomized, placebo-controlled, single (Part 1) and multiple (Part 2) ascending dose study of subcutaneous ABBV-295. A total of 76 healthy adult participants were enrolled in the MAD study. In Parts 2B and 2C, participants had a BMI of 27.0 to 35.0 kg/m². The primary objective is to assess the safety and tolerability of ABBV-295. Key secondary objectives are to characterize pharmacokinetics (PK) and to investigate pharmacodynamic effects. More information on this trial can be found at https://clinicaltrials.gov/ (NCT06144684). 

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Forward-Looking Statements 

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

References:

1. Leaback R, Chowdhury E, Ferguson WG, et al. Phase 1 multiple ascending dose study of ABBV-295, a long-acting amylin analog for the treatment of obesity. Presentation ID LBA 87. Presented at: European Association for the Study of Diabetes Annual Meeting, 2026. Milan, Italy.
2. Roth JD, Erickson MR, Chen S, Parkes DG. GLP‐1R and amylin agonism in metabolic disease: complementary mechanisms and future opportunities. British Journal of Pharmacology. 2012;166(1):121-136. doi:10.1111/j.1476-5381.2011.01537.x.
3. A Two-Part First-In-Human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GUB014295. ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT06144684?intr=GUB014295&rank=1#participation-criteria. Accessed September 24, 2026.

SOURCE AbbVie