Development

AbbVie’s ABBV-295 supports monthly dosing after Phase I obesity study

AbbVie’s ABBV-295 supports monthly dosing after Phase I obesity study

AbbVie presented detailed Phase I data for long-acting amylin analog ABBV-295, showing an approximately 11- to 12-day half-life that could support every-other-week or monthly dosing alongside dose-dependent weight loss.

The EASD 2026 dataset included 60 participants in the multiple-ascending-dose portion of the study, with 45 receiving ABBV-295 and 15 placebo for 12 or 13 weeks. AbbVie said the findings support advancement into Phase II development for chronic weight management.

ABBV-295 is a long-acting amylin analog that activates amylin and calcitonin receptors involved in appetite regulation and gastric emptying. Its non-incretin mechanism distinguishes it from GLP-1 and GIP receptor agonists such as Eli Lilly's Zepbound (tirzepatide) and Novo Nordisk's Wegovy (semaglutide), while its long half-life could allow less frequent dosing than the once-weekly schedules used by those drugs.

Mean weight loss ranged from 7.8% to 9.8% at Week 12 with once-weekly ABBV-295 and reached 9.7% with every-other-week dosing and 7.9% with monthly dosing at Week 13, versus about 0.3% with placebo. The results were consistent with topline findings reported in March.

Interpretation is limited by the small and highly selected Phase I population, which had a mean age of 41.5 years and BMI of 29.3 kg/m² and was 88% male.

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ABBV-295 showed dose-proportional exposure, with a mean half-life of 10.7 to 12.3 days. No serious treatment-emergent adverse events or severe gastrointestinal events were reported. Nausea occurred in 33.3% of ABBV-295-treated participants versus 20.0% on placebo, while diarrhea occurred in 20.0% versus none on placebo.

The most advanced amylin competitor is Zealand Pharma and Roche's petrelintide, which entered registrational Phase III development in September 2026. AbbVie has also moved ABBV-295 into a Phase II dose-finding study in adults with obesity or overweight with comorbidities.


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