AbbVie has reported positive top line data from the multiple ascending dose (MAD) section of its Phase I trial of ABBV-295 for weight loss.
This study focused on assessing the tolerability, safety, pharmacokinetics, and pharmacodynamics of subcutaneous ABBV-295, a long-acting amylin analogue, in adults whose average body mass index (BMI) was below 30kg/m².
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The single-centre, two-part, placebo-controlled, double-blind (within cohorts), randomised trial included both single and multiple ascending dose sections.
In the MAD portion, 76 participants, primarily male (88.3%), received doses ranging from 2mg to 14mg and different titration schedules. The study assessed various dosing frequencies.
ABBV-295 was found to be generally well-tolerated across all tested dose levels. The most common adverse events were mild gastrointestinal disorders, which occurred mainly in the initial six weeks of treatment.
Study results showed clinically meaningful, dose-dependent reductions in body weight during the 12-13-week treatment period, from baseline.
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By GlobalDataFor those treated with ABBV-295, the least-squares mean percentage change in body weight ranged from -7.75% to -9.79% at week 12 for weekly dosing groups, and from -7.86% to -9.73% at week 13 for every-other-week and monthly dosing groups after week five.
In contrast, participants on placebo showed changes of -0.26% and -0.25% at weeks 12 and 13, respectively.
AbbVie’s global development of immunology, neuroscience, eye care and speciality senior vice-president Primal Kaur said: “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.
“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.”
Study data from single-ascending dose cohorts have been reported previously.
ABBV-295 targets amylin and calcitonin receptors to suppress appetite and delay gastric emptying for potential obesity treatment. It has not received regulatory approval globally.
In December 2025, AbbVie reported primary data from the ECLIPSE Phase III study, assessing the tolerability, safety and efficacy of Aquipta (atogepant) 60mg compared to placebo for acute migraine treatment in adults, both with or without aura.
