Recruiting

Phase 2

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

Sponsor:

AbbVie

Code:

NCT07752979

Conditions

Obesity

Overweight

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ABBV-295

Placebo

Study Details

Brief 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

Obesity

Overweight

Study ID

NCT07752979

Start date

Aug 4, 2026

Status verified date

Oct, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ABBV-295 Arm 1

Particpants will have their doses escalated up to a maintenance dose during the Double-Blind Period.

experimental: ABBV-295 Arm 2

Participants will have their doses escalated up to a maintenance dose during the Double-Blind Period.

experimental: ABBV-295 Arm 3

Participants will have their doses escalated up to a maintenance dose during the Double-Blind Period.

experimental: ABBV-295 Arm 4

Particpants will have their doses escalated up to a maintenance dose during the Double-Blind Period.

experimental: ABBV-295 Arm 5

Participants will have their doses escalated up to a maintenance dose during the Double-Blind Period.

experimental: ABBV-295 Arm 6

Particpants will have their doses escalated up to a maintenance dose during the Double-Blind Period.

placebo comparator: Placebo

Participants will follow the same dosing schedule as active treatment arms during the Double-Blind Period.

Interventions

ABBV-295

Subcutaneous

Placebo

Subcutaneous

Primary outcome measure

Percent Change From Baseline in Body Weight [ Time Frame: Baseline (Week 0) to Week 32 ]
Number of Participants with Adverse Events (AEs) [ Time Frame: Up to approximately week 52 ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742 abbvieclinicaltrials@abbvie.com

Locations

Cahaba Research - Pelham /ID# 282381

Recruiting

Pelham, Alabama, United States, 35124

Headlands Research - Scottsdale /ID# 282571

Recruiting

Scottsdale, Arizona, United States, 85260

John Muir Health - Concord /ID# 282469

Recruiting

Concord, California, United States, 94520

NorCal Medical Research /ID# 283117

Recruiting

Greenbrae, California, United States, 94904

Velocity Clinical Research - Huntington Park /ID# 282987

Recruiting

Huntington Park, California, United States, 90255

Los Angeles Institute for Metabolic Research /ID# 282059

Recruiting

Los Angeles, California, United States, 90015

Peninsula Research Associates /ID# 282158

Recruiting

Rolling Hills Estates, California, United States, 90274

Southern California Dermatology /ID# 282011

Recruiting

Santa Ana, California, United States, 92701

Encompass Clinical Research /ID# 282483

Recruiting

Spring Valley, California, United States, 91978

University Clinical Investigators /ID# 282132

Recruiting

Tustin, California, United States, 92780

Diablo Clinical Research /ID# 282530

Recruiting

Walnut Creek, California, United States, 94598

Innovative Research of West Florida /ID# 281963

Recruiting

Clearwater, Florida, United States, 33756

Northeast Research Institute (NERI) /ID# 282015

Recruiting

Fleming Island, Florida, United States, 32003

Encore Research Group-Jacksonville Center for Clinical Research /ID# 282740

Recruiting

Jacksonville, Florida, United States, 32216

Altus Clinical Research - Lake Worth - South Congress Avenue /ID# 281979

Recruiting

Lake Worth, Florida, United States, 33461

South Florida Wellness & Clinic /ID# 282022

Recruiting

Margate, Florida, United States, 33063

South Broward Research /ID# 282125

Recruiting

Miramar, Florida, United States, 33027

Suncoast Clinical Research Pasco County /ID# 282412

Recruiting

New Port Richey, Florida, United States, 34652

Charter Research - Winter Park /ID# 281968

Recruiting

Orlando, Florida, United States, 32803-1839

Florida Institute For Clinical Research /ID# 282739

Recruiting

Orlando, Florida, United States, 32825

Progressive Medical Research /ID# 282838

Recruiting

Port Orange, Florida, United States, 32127

Charter Research - The Villages /ID# 282376

Recruiting

The Villages, Florida, United States, 32162

Metabolic Research Institute /ID# 282350

Recruiting

West Palm Beach, Florida, United States, 33401

Encore Medical Research - Weston /ID# 282044

Recruiting

Weston, Florida, United States, 33331

Elite Clinical Trials - Blackfoot /ID# 282042

Recruiting

Blackfoot, Idaho, United States, 83221

Great Lakes Clinical Trials - West Wilson Avenue /ID# 282378

Recruiting

Chicago, Illinois, United States, 60640

L-MARC Research Center /ID# 282008

Recruiting

Louisville, Kentucky, United States, 40213

Prime Health and Wellness /ID# 282254

Recruiting

Fayette, Mississippi, United States, 39069

Studymetrix Research /ID# 282163

Recruiting

City of Saint Peters, Missouri, United States, 63303

Mercury Street Medical /ID# 282016

Recruiting

Butte, Montana, United States, 59701-1652

Vector Clinical Trials /ID# 282265

Recruiting

Las Vegas, Nevada, United States, 89128

Rochester Clinical Research /ID# 282484

Recruiting

Rochester, New York, United States, 14609

Medication Management /ID# 281965

Recruiting

Greensboro, North Carolina, United States, 27401

Monroe Biomedical Research /ID# 282009

Recruiting

Monroe, North Carolina, United States, 28112

Centricity Research - Morehead city /ID# 283264

Recruiting

Morehead City, North Carolina, United States, 28557

Lucas Research - New Bern /ID# 282747

Recruiting

New Bern, North Carolina, United States, 28562

Accellacare - Tradd Court - Wilmington /ID# 282200

Recruiting

Wilmington, North Carolina, United States, 28401

Lillestol Research LLC /ID# 281978

Recruiting

Fargo, North Dakota, United States, 58104

CTI Clinical Research Center /ID# 282043

Recruiting

Cincinnati, Ohio, United States, 45212-3784

Holston Medical Group - Bristol /ID# 282045

Recruiting

Bristol, Tennessee, United States, 37620

New Phase Research & Development /ID# 282131

Recruiting

Knoxville, Tennessee, United States, 37909

Summit Medical Group- Halls Family Physicians /ID# 282435

Recruiting

Knoxville, Tennessee, United States, 37938

Clinical Research Associates - Nashville /ID# 282161

Recruiting

Nashville, Tennessee, United States, 37203

Amarillo Medical Specialists /ID# 282380

Recruiting

Amarillo, Texas, United States, 79124

Elligo Clinical Research Center /ID# 282166

Recruiting

Austin, Texas, United States, 78704

JCCT - Juno Bellaire /ID# 282263

Recruiting

Bellaire, Texas, United States, 77401

Velocity Clinical Research - Dallas /ID# 282734

Recruiting

Dallas, Texas, United States, 75230

Juno Research /ID# 282413

Recruiting

Houston, Texas, United States, 77040

PlanIt Research /ID# 282204

Recruiting

Houston, Texas, United States, 77079-2204

Dcol Center For Clinical Research /ID# 281961

Recruiting

Longview, Texas, United States, 75605

Texas Diabetes and Endocrinology /ID# 282291

Recruiting

Round Rock, Texas, United States, 78681

Washington Center For Weight Management And Research /ID# 282047

Recruiting

Arlington, Virginia, United States, 22206

Sovah Health - Danville /ID# 282876

Recruiting

Danville, Virginia, United States, 24541

Health Research Of Hampton Roads /ID# 282014

Recruiting

Newport News, Virginia, United States, 23606

National Clinical Research /ID# 282007

Recruiting

Richmond, Virginia, United States, 23294

More Information

Sponsor

AbbVie

Last update posted

Oct 14, 2026

Last verified

Oct, 2026

Keywords

Obesity
Overweight
ABBV-295

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by AbbVie on 2026-10-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.