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Safety and Efficacy of ABBV-295 in Adults With Obesity or Overweight With Weight-Related Comorbidities
Sponsor: AbbVie
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2026-08-04
Completion Date
2028-03
Last Updated
2026-08-31
Healthy Volunteers
No
Conditions
Interventions
ABBV-295
Subcutaneous
Placebo
Subcutaneous
Locations (33)
Headlands Research - Scottsdale /ID# 282571
Scottsdale, Arizona, United States
Southern California Dermatology /ID# 282011
Santa Ana, California, United States
Encompass Clinical Research /ID# 282483
Spring Valley, California, United States
Diablo Clinical Research /ID# 282530
Walnut Creek, California, United States
Innovative Research of West Florida /ID# 281963
Clearwater, Florida, United States
Altus Clinical Research - Lake Worth - South Congress Avenue /ID# 281979
Lake Worth, Florida, United States
South Broward Research /ID# 282125
Miramar, Florida, United States
Charter Research - Winter Park /ID# 281968
Orlando, Florida, United States
Florida Institute For Clinical Research /ID# 282739
Orlando, Florida, United States
Progressive Medical Research /ID# 282838
Port Orange, Florida, United States
Charter Research - The Villages /ID# 282376
The Villages, Florida, United States
Metabolic Research Institute /ID# 282350
West Palm Beach, Florida, United States
Encore Medical Research - Weston /ID# 282044
Weston, Florida, United States
Elite Clinical Trials - Blackfoot /ID# 282042
Blackfoot, Idaho, United States
L-MARC Research Center /ID# 282008
Louisville, Kentucky, United States
Studymetrix Research /ID# 282163
City of Saint Peters, Missouri, United States
Medication Management /ID# 281965
Greensboro, North Carolina, United States
Monroe Biomedical Research /ID# 282009
Monroe, North Carolina, United States
Centricity Research - Morehead city /ID# 283264
Morehead City, North Carolina, United States
Lucas Research - New Bern /ID# 282747
New Bern, North Carolina, United States
Accellacare - Tradd Court - Wilmington /ID# 282200
Wilmington, North Carolina, United States
Lillestol Research LLC /ID# 281978
Fargo, North Dakota, United States
CTI Clinical Research Center /ID# 282043
Cincinnati, Ohio, United States
Holston Medical Group - Bristol /ID# 282045
Bristol, Tennessee, United States
New Phase Research & Development /ID# 282131
Knoxville, Tennessee, United States
Summit Medical Group- Halls Family Physicians /ID# 282435
Knoxville, Tennessee, United States
Clinical Research Associates - Nashville /ID# 282161
Nashville, Tennessee, United States
Velocity Clinical Research - Dallas /ID# 282734
Dallas, Texas, United States
Dcol Center For Clinical Research /ID# 281961
Longview, Texas, United States
Washington Center For Weight Management And Research /ID# 282047
Arlington, Virginia, United States
Sovah Health - Danville /ID# 282876
Danville, Virginia, United States
Health Research Of Hampton Roads /ID# 282014
Newport News, Virginia, United States
National Clinical Research /ID# 282007
Richmond, Virginia, United States