AbbVie has reported positive topline results from a Phase 1 clinical study of its investigational obesity treatment ABBV-295, showing meaningful weight reduction and a favorable safety profile.
The therapy represents a new treatment approach for chronic weight management, operating through a non-incretin mechanism distinct from popular obesity drugs targeting GLP-1 and GIP receptors.
Significant Weight Loss Observed in Early Trial
The results come from the multiple ascending dose (MAD) portion of a Phase 1 study evaluating the drug’s safety, tolerability, pharmacokinetics, and pharmacodynamics.
Participants receiving ABBV-295 experienced dose-dependent reductions in body weight over a 12–13 week treatment period.
Key findings include:
- 7.75% to 9.79% weight reduction at week 12 in weekly dosing groups
- 7.86% to 9.73% weight reduction at week 13 in every-other-week and monthly dosing groups
- Placebo groups showed only ~0.25% weight change
The study enrolled adults with an average body mass index below 30 kg/m², with 88.3% of participants being male.
Favorable Safety and Tolerability Profile
ABBV-295 was generally well tolerated across all tested doses (2–14 mg).
Notable safety findings:
- No serious adverse events reported
- Most side effects were mild gastrointestinal symptoms
- GI symptoms mainly occurred during the first six weeks of treatment
These results suggest the drug could support long-term adherence, an important factor in obesity therapy.
A Different Mechanism from GLP-1 Drugs
Unlike widely used obesity therapies that target incretin pathways, ABBV-295 is a long-acting amylin analog.
Amylin works by:
- Sending satiety signals to the brain
- Reducing food intake
- Slowing gastric emptying
By activating amylin and calcitonin receptors, the drug aims to suppress appetite through a different biological pathway. This could potentially position ABBV-295 as a differentiated alternative to incretin-based treatments.
Company Perspective
Primal Kaur, Senior Vice President of Global Development at AbbVie, emphasized the need for more effective obesity therapies.
“Obesity is a complex chronic disease, and there remains a critical need for treatments that combine efficacy with tolerability and support long-term adherence.”
She added that the early findings reinforce the potential of ABBV-295 as a novel therapeutic option for people living with obesity.
Next Steps for Development
The Phase 1 trial—registered as NCT06144684—included 76 participants and evaluated both single ascending dose and multiple ascending dose cohorts.
Full data from the study will be presented at a future scientific conference, while the company continues clinical development of the therapy.
ABBV-295 remains investigational and has not yet been approved by any regulatory authority worldwide.
