Phase 1 Study of ABBV-295 Safety, Tolerability, and Pharmacokinetics in Healthy Japanese Adults with Overweight or Obesity

What this Trial Is About

Researchers are evaluating the safety, tolerability, and pharmacokinetics of ABBV-295 given by subcutaneous injection in healthy adult Japanese participants who are overweight or obese. This Phase 1 trial focuses on understanding the side effects and how the body processes ABBV-295 in this specific population. The study is sponsored by AbbVie and includes healthy volunteers with a body mass index BMI between 23.0 and 35.0 kgm2. Participants will be randomly assigned to receive either subcutaneous injections of ABBV-295 or a placebo for 12 weeks. The study includes two parts, each with groups receiving ABBV-295 or placebo, and uses a triple-blind design to compare outcomes without bias. During the study, participants will be monitored for adverse events up to approximately 138 days. Researchers will track tolerability and the pharmacokinetics of ABBV-295 through regular assessments. Participation involves scheduled visits and monitoring to evaluate safety and drug processing over the study period, which spans from screening through the 12-week treatment and follow-up.

A Study to Assess Adverse Events, Tolerability, and Pharmacokinetics of Subcutaneous Injections of ABBV-295 in Healthy Adult Japanese Participants With Overweight or Obesity.