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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: AbbVie • ClinicalTrials.gov ID: NCT07752979

Registry updated: 2026-10-20
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Description

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.

Interventions

  • ABBV-295 (Drug)
    Subcutaneous
  • Placebo (Drug)
    Subcutaneous

Eligibility criteria

Inclusion Criteria: * BMI ≥ 30.0 kg/m2 at Screening (BMI is calculated as weight in kg divided by the square of height measured in meters) OR * BMI ≥ 27.0 to \< 30.0 kg/m2 at Screening (BMI is calculated as weight in kg divided by the square of height measured in meters) with at least one of the following weight-related comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, metabolic dysfunction-associated steatotic liver disease (MASLD). Exclusion Criteria: * Self-reported change in body weight ≥ 5% within 3 months prior to Screening * Hemoglobin A1c (HbA1c) ≥ 6.5% (48 mmol/mol) at Screening * Fasting glucose ≥126 mg/dL (7.0 mmol/L) or random glucose test ≥ 200 mg/dL (11.1 mmol/L) * History of type 1 or type 2 diabetes mellitus * Treatment with any medication or product used for obesity or weight management within 180 days prior to Screening Unstable or severe cardiovascular disease (e.g., myocardial infarction, stroke, hospitalization for: unstable angina pectoris, transient ischemic attack, or heart failure) within 180 days prior to Screening. * The participant has a concurrent disease, condition, or is in a situation which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study.

Conditions

Obesity Overweight

Locations

  • Cahaba Research - Pelham /ID# 282381 — Pelham, Alabama, United States
  • Headlands Research - Scottsdale /ID# 282571 — Scottsdale, Arizona, United States
  • Arizona Clinical Trials /ID# 282372 — Tucson, Arizona, United States
  • John Muir Health - Concord /ID# 282469 — Concord, California, United States
  • NorCal Medical Research /ID# 283117 — Greenbrae, California, United States
  • Velocity Clinical Research - Huntington Park /ID# 282987 — Huntington Park, California, United States
  • Los Angeles Institute for Metabolic Research /ID# 282059 — Los Angeles, California, United States
  • Peninsula Research Associates /ID# 282158 — Rolling Hills Estates, California, United States
  • Southern California Dermatology /ID# 282011 — Santa Ana, California, United States
  • Encompass Clinical Research /ID# 282483 — Spring Valley, California, United States
  • University Clinical Investigators /ID# 282132 — Tustin, California, United States
  • Diablo Clinical Research /ID# 282530 — Walnut Creek, California, United States
  • Innovative Research of West Florida /ID# 281963 — Clearwater, Florida, United States
  • Northeast Research Institute (NERI) /ID# 282015 — Fleming Island, Florida, United States
  • Encore Research Group-Jacksonville Center for Clinical Research /ID# 282740 — Jacksonville, Florida, United States
  • Altus Clinical Research - Lake Worth - South Congress Avenue /ID# 281979 — Lake Worth, Florida, United States
  • South Florida Wellness & Clinic /ID# 282022 — Margate, Florida, United States
  • South Broward Research /ID# 282125 — Miramar, Florida, United States
  • Suncoast Clinical Research Pasco County /ID# 282412 — New Port Richey, 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
  • Endocrine Research Solutions /ID# 282020 — Roswell, Georgia, United States
  • Elite Clinical Trials - Blackfoot /ID# 282042 — Blackfoot, Idaho, United States
  • Great Lakes Clinical Trials - West Wilson Avenue /ID# 282378 — Chicago, Illinois, United States
  • L-MARC Research Center /ID# 282008 — Louisville, Kentucky, United States
  • Prime Health and Wellness /ID# 282254 — Fayette, Mississippi, United States
  • Studymetrix Research /ID# 282163 — City of Saint Peters, Missouri, United States
  • Mercury Street Medical /ID# 282016 — Butte, Montana, United States
  • Vector Clinical Trials /ID# 282265 — Las Vegas, Nevada, United States
  • Rochester Clinical Research /ID# 282484 — Rochester, New York, 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
  • Amarillo Medical Specialists /ID# 282380 — Amarillo, Texas, United States
  • Elligo Clinical Research Center /ID# 282166 — Austin, Texas, United States
  • JCCT - Juno Bellaire /ID# 282263 — Bellaire, Texas, United States
  • Velocity Clinical Research - Dallas /ID# 282734 — Dallas, Texas, United States
  • Juno Research /ID# 282413 — Houston, Texas, United States
  • PlanIt Research /ID# 282204 — Houston, Texas, United States
  • Dcol Center For Clinical Research /ID# 281961 — Longview, Texas, United States
  • Southern Endocrinology Associates /ID# 282558 — Mesquite, Texas, United States
  • Texas Diabetes and Endocrinology /ID# 282291 — Round Rock, 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
  • Rainier Clinical Research /ID# 282157 — Renton, Washington, United States
  • Advanced Clinical Research - Bayamon /ID# 282250 — Bayamón, Puerto Rico
  • Clinical Research Investigator Group /ID# 282203 — Bayamón, Puerto Rico
  • Isis Clinical Res. Ctr P.S.C. /ID# 282252 — Guaynabo, Puerto Rico
  • Latin Clinical Trial Center - San Juan - Avenida Ponce De Leon /ID# 282248 — San Juan, Puerto Rico
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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