Phase 2Recruiting

Safety and Efficacy of ABBV-295 in Adults With Obesity or Overweight With Weight-Related Comorbidities

A Phase 2 Dose-Finding Study to Assess the Safety and Efficacy of ABBV-295 in Adults With Obesity or Overweight With Weight-Related Comorbidities

Sponsor
AbbVie (Industry)
Enrolment
360 planned
Conditions
Obesity; Overweight
Interventions
ABBV-295; Placebo
Ages
adults, older adults
Registry
NCT07752979

From the registry

Obesity is a condition where a person has excessive body fat, defined by a body mass index (BMI) of 30 kg/m2 or higher. The goal of this study is to evaluate the effect of various doses of ABBV-295 compared to placebo on reducing body weight at Week 32 in participants with obesity or overweight with weight-related comorbidities. ABBV-295 is an investigational long-acting amylin analog being developed for chronic weight management. Participants are placed into multiple treatment groups with different dosing paradigms of ABBV-295 or placebo. Participants will not know which treatment they are receiving, and there is a chance of being assigned to placebo. Adults with obesity or overweight (as defined by BMI) with weight-related comorbidities will be enrolled. Approximately 360 participants will be enrolled in the study at approximately 70 sites in the United States and Puerto Rico. Participants will receive subcutaneous (SC) injections of ABBV-295 solution for injection or matching placebo administered via pre-filled syringes for 52 weeks during the Double-Blind Period. There may be…

Primary outcomes

  • Percent Change From Baseline in Body Weight
  • Number of Participants with Adverse Events (AEs)
Full record on ClinicalTrials.gov