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

The drug's 10.7- to 12.3-day mean half-life supports further evaluation of dosing intervals beyond weekly administration.

Rhea-AI Summary

AbbVie (ABBV) announced detailed Phase 1 results for investigational ABBV-295, showing weight reduction across weekly and less frequent dosing regimens. The EASD 2026 presentation covers 60 participants randomized to ABBV-295 or placebo for 12 or 13 weeks. Mean body mass index was 29.3 kg/m2, and 88% were male.

Adjusted mean weight changes were -7.8% to -9.8% at Week 12 with weekly dosing, and -9.7% and -7.9% at Week 13 with every-other-week and monthly dosing, respectively, versus approximately -0.3% for placebo. Mean half-life, the time for drug levels to fall by half, ranged from 10.7 to 12.3 days. No serious treatment-emergent adverse events occurred. Nausea affected 33.3% versus 20.0% with placebo; diarrhea affected 20.0% versus 0.0%. Gastrointestinal events led to discontinuation in 4.4% versus 0.0%. AbbVie plans to advance the therapy into Phase 2 for chronic weight management.

Positive

• Minor pointWeekly dosing produced adjusted mean weight changes of -7.8% to -9.8% at Week 12, versus approximately -0.3% for placebo.
• Minor pointEvery-other-week dosing produced an adjusted mean weight change of -9.7% at Week 13, versus approximately -0.3% for placebo.
• Minor pointMonthly dosing produced an adjusted mean weight change of -7.9% at Week 13, versus approximately -0.3% for placebo.
• Minor point. Forward-looking: it has not happened yet and may not happen.Mean half-life of 10.7 to 12.3 days supports evaluation of dosing less frequently than weekly.
• Minor pointDrug exposure in plasma increased in proportion to dose across cohorts.

3 minor points

• Minor pointSafety findings included no serious treatment-emergent adverse events; most events were mild.
• Minor pointGastrointestinal safety findings included no severe events; 92% of affected participants reported mild events as their highest severity.
• Minor point. Forward-looking: it has not happened yet and may not happen.AbbVie plans to advance ABBV-295 into Phase 2 development for chronic weight management.

Negative

• Minor pointNausea occurred in 33.3% receiving ABBV-295, compared with 20.0% receiving placebo.
• Minor pointDiarrhea occurred in 20.0% receiving ABBV-295, compared with 0.0% receiving placebo.
• Minor pointGastrointestinal adverse events caused discontinuation in 4.4% receiving ABBV-295, versus 0.0% receiving placebo.
• Minor pointOther commonly reported adverse events above 20% included decreased appetite, fatigue and headache.

Key Figures

Mean half-life: 10.7–12.3 days Median Tmax: 24.0–48.1 hours Body weight reduction: −7.8% to −9.8% weekly; −9.7% every other week; −7.9% monthly; approximately −0.3% placebo +5 more

Mean half-life

10.7–12.3 days

Phase 1 study; evaluated dosing regimens included weekly, every-other-week and monthly

Median Tmax

24.0–48.1 hours

Phase 1 study

Body weight reduction

−7.8% to −9.8% weekly; −9.7% every other week; −7.9% monthly; approximately −0.3% placebo

Weekly cohorts at Week 12; every-other-week and monthly cohorts at Week 13

Participants

60 total; 45 ABBV-295 and 15 placebo

Parts 2B/2C of the multiple ascending dose study

Mild gastrointestinal adverse events

92%

Among participants reporting a gastrointestinal adverse event, mild events were the highest severity reported

Nausea

33.3% ABBV-295 vs. 20.0% placebo

Phase 1 study

Diarrhea

20.0% ABBV-295 vs. 0.0% placebo

Phase 1 study

Discontinuations due to gastrointestinal adverse events

4.4% active vs. 0.0% placebo

Phase 1 study

Key Terms

pharmacokinetics, pharmacodynamics, multiple ascending dose, body mass index, +1 more

5 terms

pharmacokinetics medical

"tolerability, pharmacokinetics (PK), and pharmacodynamics (PD)"

Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.

pharmacodynamics medical

"pharmacokinetics (PK), and pharmacodynamics (PD)"

Pharmacodynamics is how a drug actually affects the body — the strength, type and duration of its effects and the relationship between dose and response. Think of it like how turning a thermostat changes room temperature: it shows what the drug does and how much is needed to get the desired effect. Investors care because these properties drive clinical success, dosing convenience, safety profile and competitive advantage, all of which influence commercial potential and regulatory approval.

multiple ascending dose medical

"multiple ascending dose (MAD) part of its Phase 1 study"

A multiple ascending dose is a method used in testing new medicines where small groups of people receive gradually larger amounts of the drug over time. This approach helps researchers find the safest and most effective dose without causing too many side effects. For investors, it signals ongoing steps in drug development that can impact a company's potential success or approval prospects.

body mass index medical

"adults with a mean body mass index (BMI) of less than 30 kg/m2"

Body mass index (BMI) is a simple number calculated from a person’s weight and height that gives a rough measure of whether their body size is underweight, normal, overweight, or obese, similar to using a single score to gauge whether a container is underfilled or overfilled. Investors care because average BMI trends affect demand and costs in healthcare, insurance, and consumer markets, and can signal population health risks that influence long-term revenues and liabilities.

amylin analog medical

"an investigational long-acting amylin analog"

An amylin analog is a man-made version of the natural hormone amylin that helps control blood sugar and suppress appetite; it acts like a substitute key that fits the same locks in the body to slow stomach emptying and reduce spikes after meals. Investors watch these drugs because clinical trial results, regulatory approval, safety and manufacturing scale determine their market potential in diabetes and weight-management treatments, affecting revenue and competitive positioning.

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• 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:

Abstract Title	Date/Time	Session
Phase 1 multiple ascending dose study of ABBV-295, a long-acting amylin analog for the treatment of obesity	Wednesday, September 30, 2026; 11:45 AM–12:45 PM CEST	LBA SO 07 Trials of tomorrow: new therapeutic horizons Session C

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.

Media:	Investors:
Sourojit (Jit) Bhowmick, Ph.D.	Liz Shea
jit.bhowmick@abbvie.com	liz.shea@abbvie.com
Andrea Yeakel
andrea.yeakel@abbvie.com

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SOURCE AbbVie

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What dosing regimens were tested in AbbVie's ABBV-295 Phase 1 study?

ABBV-295 was dose-escalated to 4, 6, or 14 mg once weekly, 14 mg every other week, or 8 mg monthly. Treatment lasted 12 or 13 weeks.

How was AbbVie's ABBV-295 Phase 1 trial designed?

The trial was a single-center, randomized, placebo-controlled study, double-blind within cohorts, with single- and multiple-ascending-dose parts. The multiple-ascending-dose study enrolled 76 healthy adults; the detailed Part 2B/2C results cover 45 ABBV-295 recipients and 15 placebo recipients.

What were the objectives of AbbVie's ABBV-295 Phase 1 study?

The primary objective was to assess safety and tolerability. Secondary objectives included characterizing how the drug moves through the body and investigating its effects on the body. Median time to peak drug concentration ranged from 24.0 to 48.1 hours.

When did gastrointestinal side effects occur in AbbVie's ABBV-295 study?

Gastrointestinal adverse events occurred primarily during the first six weeks of treatment. They were predominantly mild.