AbbVie Announces Positive Topline Results from a Phase 1 Multiple Ascending Dose Study of ABBV-295, a Long-Acting Amylin Analog, in Adults
MWN-AI** Summary
AbbVie Inc. (NYSE: ABBV) recently announced positive topline results from the Phase 1 Multiple Ascending Dose (MAD) study of its investigational drug, ABBV-295, a long-acting amylin analog aimed at addressing obesity. This study evaluated the drug's safety, tolerability, pharmacokinetics, and pharmacodynamics among adult participants with a body mass index (BMI) under 30 kg/m².
The findings revealed clinically significant weight reductions, with the least-squares mean percentage change in body weight at week 12 ranging from -7.75% to -9.79% for varying weekly doses. In cohorts receiving every other week and monthly dosing, the changes were similarly notable, ranging between -7.76% to -9.73% at week 13. This contrasts sharply with the placebo group, which experienced negligible changes in weight. Importantly, ABBV-295 was well-tolerated, with mild gastrointestinal issues being the most commonly reported adverse events occurring primarily during the first six weeks of treatment.
AbbVie highlighted that the mechanism of action for ABBV-295 is distinct from existing incretin-based therapies, which may offer a new therapeutic avenue for weight management. Dr. Primal Kaur, AbbVie’s Senior Vice President of Global Development, noted the importance of developing effective yet tolerable treatments for obesity, citing the substantial impact of the condition on individuals and healthcare systems.
The Phase 1 study involved 76 adult participants and demonstrated a consistent safety profile across all tested dose levels. Although full data from the study will be presented at a future scientific conference, AbbVie remains optimistic about the role ABBV-295 could play in the obesity treatment landscape, marking a potential innovation in therapeutic options for individuals struggling with weight management.
MWN-AI** Analysis
AbbVie's recent announcement regarding positive topline results from the Phase 1 study of ABBV-295, a long-acting amylin analog, presents a significant opportunity for market participants. With demonstrated weight loss ranging from approximately 7.75% to 9.79% in clinical trials, ABBV-295 positions itself as a promising alternative to current obesity treatments, especially given its non-incretin-based mechanism. This differentiation may grant AbbVie a competitive edge in a crowded market where alternatives like GLP-1 and GIP receptor agonists dominate.
Notably, the favorable tolerability profile, with no serious adverse events reported, is a critical factor that could facilitate its acceptance among patients and healthcare providers. Its ability to achieve clinically meaningful weight loss while being generally well tolerated indicates strong potential for widespread adoption, perhaps aiding in long-term adherence to treatment.
From a financial perspective, investors should consider AbbVie’s current market fundamentals, including its robust product portfolio and established market presence, as the company seeks to enhance its pipeline against the backdrop of patent expirations in other areas. The successful development of ABBV-295 could not only diversify AbbVie’s offerings but also shield the company from revenue losses associated with older products nearing the end of their patent life.
It is essential, however, to remain cognizant of potential risks. The pharmacovigilance landscape can be unpredictable, and the outcome of further studies will be critical in determining ABBV-295’s market viability. Additionally, possible competition from other emerging therapies could influence market positioning.
In summary, AbbVie’s positive data for ABBV-295 may present a bullish case for long-term investment in ABBV stock, contingent on further successful trial results and eventual market approval. Investors should keep an eye on upcoming updates from AbbVie and the broader market dynamics in obesity treatments.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
PR Newswire
- ABBV-295 treatment showed clinically meaningful body weight reduction from -7.75% to -9.79% (least-squares mean) at week 12 (weekly dosing), to -7.86% to -9.73% at week 13 (every other week and monthly dosing after week 5)1
- ABBV-295 demonstrated a favorable tolerability profile at all evaluated dose levels. No serious adverse events were reported1
- Data support continued development of ABBV-295 as a potentially differentiated treatment for chronic weight management, with a non-incretin-based mechanism of action
NORTH CHICAGO, Ill., March 9, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive topline results1 from the multiple ascending dose (MAD) part of its Phase 1 study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous ABBV-295, in adults with a mean body mass index (BMI) of less than 30 kg/m2. ABBV-295 is a long-acting amylin analog that represents a mechanistically distinct class from incretin-based therapies such as GLP-1 and GIP receptor agonists.
Study enrollment mostly comprised male participants (88.3%). Different doses (2-14 mg), titrations and dose frequencies were tested in the study. ABBV-295 was generally well tolerated across all dose levels evaluated. The most commonly reported adverse events were gastrointestinal disorders, which were mostly mild, and predominantly occurred during the first 6 weeks of treatment.1
ABBV-295 demonstrated clinically meaningful, dose-dependent reductions in body weight from baseline, over a 12-13-week treatment period. In the ABBV-295 treated groups dose-dependent least-squares (LS) mean percentage change in body weight ranged from -7.75% to -9.79% at week 12 (for weekly dosing groups), to -7.86% to -9.73% at week 13 (for every other week dosing group and monthly dosing group after week 5), compared to -0.26% and -0.25% in the placebo group at week 12 and week 13, respectively.1
"Obesity is a complex, chronic disease that places a substantial burden on patients, healthcare systems and society, and there remains a critical need for therapies that combine efficacy with tolerability and support long-term adherence," said Primal Kaur, M.D., senior vice president, global development of immunology, neuroscience, eye care and specialty at AbbVie. "We are encouraged by these early results for ABBV-295, which demonstrate meaningful weight loss together with a well-tolerated safety profile. These initial results further reinforce the potential of ABBV-295 as a novel therapeutic option for people living with obesity."
Results from the single ascending doses (SAD) part and other cohorts from the MAD part of the study were announced previously. Full data from the study will be presented at a future scientific conference.
Summary of Phase 1 MAD Study Key Results1 (Percent Change from Baseline in Body Weight at Week 12 and Week 13)
Cohorta | LS Mean (95% CI) at week 12b | LS Mean (95% CI) at week 13b |
All Placebo | -0.26 (-1.89, 1.37) | -0.25 (-1.88, 1.38) |
Cohort 3 (weekly dosing) | -7.75 (-9.89, -5.61) | - |
Cohort 4 (weekly dosing) | -8.70 (-10.75, -6.65) | - |
Cohort 5a (weekly dosing) | -9.79 (-11.99, -7.59) | - |
Cohort 5b (every other week dosing) | -7.76 (-9.82, -5.70) | -9.73 (-11.79, -7.67) |
Cohort 6 (monthly dosing after week 5) | -6.74 (-8.70, -4.79) | -7.86 (-9.80, -5.91) |
a Doses from 2mg to 14mg were tested using different dose escalations and dosing frequencies. |
b LS mean estimates were derived using a Mixed Model for Repeated Measures (MMRM). Participants were required to adhere to the dosing plan and those unable to continue treatment were withdrawn from the study with no further efficacy data collected. |
About ABBV-295
ABBV-295 is an investigational, long-acting amylin analog being developed for the treatment of obesity. It is an agonist that specifically activates amylin and calcitonin receptors. 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 Study
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 (GUB014295). A total of 76 participants were enrolled in the MAD study. More information on this trial can be found at https://www.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 2024 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:
- AbbVie Data on File: ABVRRTI82837
- 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 March 3, 2026.
Contacts:
Media: | Investors: | |
Sourojit (Jit) Bhowmick, Ph.D. | Liz Shea | |
SOURCE AbbVie
FAQ**
How does AbbVie Inc. ABBV plan to differentiate ABBV-295 from existing weight management therapies, particularly in terms of its non-incretin-based mechanism of action?
What safety and tolerability data can we expect from further phases of the ABBV-295 study, considering the gastrointestinal disorders reported in the Phase 1 results?
Given the promising weight loss results observed (up to -9.79%), what are AbbVie Inc. ABBV's next steps regarding regulatory submissions for ABBV-295?
How does AbbVie Inc. ABBV intend to address the potential risks and uncertainties in the development of ABBV-295, particularly in light of its forward-looking statements?
**MWN-AI FAQ is based on asking OpenAI questions about AbbVie Inc. (NYSE: ABBV).
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