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

NCT07752979 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2026-08-07

No results posted yet for this 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.

Conditions

Interventions

DRUG

ABBV-295

Subcutaneous

DRUG

Placebo

Subcutaneous

Sponsors & Collaborators

Principal Investigators

  • ABBVIE INC. · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-07
Primary Completion
2028-03-31
Completion
2028-03-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07752979 on ClinicalTrials.gov