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

Condition(s) studied

Investigational drug(s) / intervention(s)

ABBV-295: Subcutaneous

Placebo: Subcutaneous

Study summary

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 higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Eligibility

Primary outcome measure(s)

• Percent Change From Baseline in Body Weight — Baseline (Week 0) to Week 32
  The primary efficacy endpoint is the percent change from baseline in body weight. This measure assesses the effect of various doses of ABBV-295 compared to placebo on reducing body weight in subjects with obesity or overweight with weight-related comorbidities.
• Number of Participants with Adverse Events (AEs) — Up to approximately week 52
  An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.

Trial sites (64)

+ 24 more sites — see the full list on the official registry below.

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