NCT07752979From ClinicalTrials.govRecruiting

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

Obesity
Overweight

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: AbbVie
Enrolment target: 360
Started: 4 August 2026
Main results due: March 2028
Study sites: 50
Registry updated: 29 September 2026

Can you take part?

Ages 18 years to 75 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, 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 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.

Study sites(50)

Cahaba Research - Pelham /ID# 282381
Pelham, Alabama, United States
Recruiting
Headlands Research - Scottsdale /ID# 282571
Scottsdale, Arizona, United States
Recruiting
John Muir Health - Concord /ID# 282469
Concord, California, United States
Recruiting
NorCal Medical Research /ID# 283117
Greenbrae, California, United States
Recruiting
Los Angeles Institute for Metabolic Research /ID# 282059
Los Angeles, California, United States
Recruiting
Southern California Dermatology /ID# 282011
Santa Ana, California, United States
Recruiting
Encompass Clinical Research /ID# 282483
Spring Valley, California, United States
Recruiting
University Clinical Investigators /ID# 282132
Tustin, California, United States
Recruiting
Diablo Clinical Research /ID# 282530
Walnut Creek, California, United States
Recruiting
Innovative Research of West Florida /ID# 281963
Clearwater, Florida, United States
Recruiting
Encore Research Group-Jacksonville Center for Clinical Research /ID# 282740
Jacksonville, Florida, United States
Recruiting
Altus Clinical Research - Lake Worth - South Congress Avenue /ID# 281979
Lake Worth, Florida, United States
Recruiting
South Florida Wellness & Clinic /ID# 282022
Margate, Florida, United States
Recruiting
South Broward Research /ID# 282125
Miramar, Florida, United States
Recruiting
Charter Research - Winter Park /ID# 281968
Orlando, Florida, United States
Recruiting
Florida Institute For Clinical Research /ID# 282739
Orlando, Florida, United States
Recruiting
Progressive Medical Research /ID# 282838
Port Orange, Florida, United States
Recruiting
Charter Research - The Villages /ID# 282376
The Villages, Florida, United States
Recruiting
Metabolic Research Institute /ID# 282350
West Palm Beach, Florida, United States
Recruiting
Encore Medical Research - Weston /ID# 282044
Weston, Florida, United States
Recruiting
Elite Clinical Trials - Blackfoot /ID# 282042
Blackfoot, Idaho, United States
Recruiting
Great Lakes Clinical Trials - West Wilson Avenue /ID# 282378
Chicago, Illinois, United States
Recruiting
L-MARC Research Center /ID# 282008
Louisville, Kentucky, United States
Recruiting
Studymetrix Research /ID# 282163
City of Saint Peters, Missouri, United States
Recruiting
Mercury Street Medical /ID# 282016
Butte, Montana, United States
Recruiting
Vector Clinical Trials /ID# 282265
Las Vegas, Nevada, United States
Recruiting
Rochester Clinical Research /ID# 282484
Rochester, New York, United States
Recruiting
Medication Management /ID# 281965
Greensboro, North Carolina, United States
Recruiting
Monroe Biomedical Research /ID# 282009
Monroe, North Carolina, United States
Recruiting
Centricity Research - Morehead city /ID# 283264
Morehead City, North Carolina, United States
Recruiting
Lucas Research - New Bern /ID# 282747
New Bern, North Carolina, United States
Recruiting
Accellacare - Tradd Court - Wilmington /ID# 282200
Wilmington, North Carolina, United States
Recruiting
Lillestol Research LLC /ID# 281978
Fargo, North Dakota, United States
Recruiting
CTI Clinical Research Center /ID# 282043
Cincinnati, Ohio, United States
Recruiting
Holston Medical Group - Bristol /ID# 282045
Bristol, Tennessee, United States
Recruiting
New Phase Research & Development /ID# 282131
Knoxville, Tennessee, United States
Recruiting
Summit Medical Group- Halls Family Physicians /ID# 282435
Knoxville, Tennessee, United States
Recruiting
Clinical Research Associates - Nashville /ID# 282161
Nashville, Tennessee, United States
Recruiting
Amarillo Medical Specialists /ID# 282380
Amarillo, Texas, United States
Recruiting
Elligo Clinical Research Center /ID# 282166
Austin, Texas, United States
Recruiting
Velocity Clinical Research - Dallas /ID# 282734
Dallas, Texas, United States
Recruiting
PlanIt Research /ID# 282204
Houston, Texas, United States
Recruiting
Dcol Center For Clinical Research /ID# 281961
Longview, Texas, United States
Recruiting
Washington Center For Weight Management And Research /ID# 282047
Arlington, Virginia, United States
Recruiting
Sovah Health - Danville /ID# 282876
Danville, Virginia, United States
Recruiting
Health Research Of Hampton Roads /ID# 282014
Newport News, Virginia, United States
Recruiting
National Clinical Research /ID# 282007
Richmond, Virginia, United States
Recruiting
Advanced Clinical Research - Bayamon /ID# 282250
Bayamón, Puerto Rico
Recruiting
Isis Clinical Res. Ctr P.S.C. /ID# 282252
Guaynabo, Puerto Rico
Recruiting
Latin Clinical Trial Center - San Juan - Avenida Ponce De Leon /ID# 282248
San Juan, Puerto Rico
Recruiting

Showing 50 of 50 sites. 50 of the 50 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07752979. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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