Phase 1b Study of ABBV-295 Injections to Evaluate Safety and Body Weight Changes in Adults With Obesity

What this Trial Is About

Researchers are evaluating ABBV-295, a drug administered by subcutaneous injections, in adults with obesity to assess its safety, effects on body weight, and how the body processes the drug. This Phase 1b study focuses on monitoring adverse events and pharmacokinetics in participants with a body mass index between 30.0 and 45.0 kgm2, including those with stable weight-related health conditions. The study is sponsored by AbbVie and aims to better understand ABBV-295s impact in this population. Participants will be randomly assigned to receive either ABBV-295 or a matching placebo through subcutaneous injections for a treatment period lasting 13 to 20 weeks, depending on their assigned group. Several groups are involved, with some receiving 13 weeks of treatment and others up to 20 weeks. The study is triple-blinded, meaning neither participants nor researchers know who receives the drug or placebo during the trial. Throughout the study, participants will be regularly monitored for adverse events, vital signs, electrocardiogram changes, and clinical laboratory test results for up to approximately 194 days. Researchers will also measure various pharmacokinetic parameters of ABBV-295, including plasma concentration levels and antibody development. Body weight changes from baseline will be tracked as a key outcome. The trial includes ongoing safety assessments and a follow-up period to observe lasting effects.

A Study of ABBV-295 Subcutaneous Injections to Assess Adverse Events and Pharmacokinetics in Adult Participants With Obesity