ObesityPhase 2NCT07752979
Safety and Efficacy of ABBV-295 in Adults With Obesity or Overweight With Weight-Related Comorbidities
A Phase 2 study testing ABBV-295 in people with Obesity and Overweight, run by AbbVie at 63 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- ABBV-295
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 63 sitesin 2 countries
- Study dates
- 4 Aug 2026to Mar 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
63 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
63 sites in 2 countries
United States59 sites, 59 recruiting
- Recruiting
Amarillo Medical Specialists /ID# 282380
Amarillo, Texas, 79124
- Recruiting
Washington Center For Weight Management And Research /ID# 282047
Arlington, Virginia, 22206
- Recruiting
Elligo Clinical Research Center /ID# 282166
Austin, Texas, 78704
- Recruiting
JCCT - Juno Bellaire /ID# 282263
Bellaire, Texas, 77401
- Recruiting
Elite Clinical Trials - Blackfoot /ID# 282042
Blackfoot, Idaho, 83221
- Recruiting
Holston Medical Group - Bristol /ID# 282045
Bristol, Tennessee, 37620
- Recruiting
Mercury Street Medical /ID# 282016
Butte, Montana, 59701-1652
- Recruiting
Great Lakes Clinical Trials - West Wilson Avenue /ID# 282378
Chicago, Illinois, 60640
- Recruiting
CTI Clinical Research Center /ID# 282043
Cincinnati, Ohio, 45212-3784
- Recruiting
Studymetrix Research /ID# 282163
City of Saint Peters, Missouri, 63303
- Recruiting
Innovative Research of West Florida /ID# 281963
Clearwater, Florida, 33756
- Recruiting
John Muir Health - Concord /ID# 282469
Concord, California, 94520
- Recruiting
Velocity Clinical Research - Dallas /ID# 282734
Dallas, Texas, 75230
- Recruiting
Sovah Health - Danville /ID# 282876
Danville, Virginia, 24541
- Recruiting
Lillestol Research LLC /ID# 281978
Fargo, North Dakota, 58104
- Recruiting
Prime Health and Wellness /ID# 282254
Fayette, Mississippi, 39069
- Recruiting
Northeast Research Institute (NERI) /ID# 282015
Fleming Island, Florida, 32003
- Recruiting
NorCal Medical Research /ID# 283117
Greenbrae, California, 94904
- Recruiting
Medication Management /ID# 281965
Greensboro, North Carolina, 27401
- Recruiting
Juno Research /ID# 282413
Houston, Texas, 77040
- Recruiting
PlanIt Research /ID# 282204
Houston, Texas, 77079-2204
- Recruiting
Velocity Clinical Research - Huntington Park /ID# 282987
Huntington Park, California, 90255
- Recruiting
Encore Research Group-Jacksonville Center for Clinical Research /ID# 282740
Jacksonville, Florida, 32216
- Recruiting
New Phase Research & Development /ID# 282131
Knoxville, Tennessee, 37909
- Recruiting
Summit Medical Group- Halls Family Physicians /ID# 282435
Knoxville, Tennessee, 37938
- Recruiting
Altus Clinical Research - Lake Worth - South Congress Avenue /ID# 281979
Lake Worth, Florida, 33461
- Recruiting
Vector Clinical Trials /ID# 282265
Las Vegas, Nevada, 89128
- Recruiting
Dcol Center For Clinical Research /ID# 281961
Longview, Texas, 75605
- Recruiting
Los Angeles Institute for Metabolic Research /ID# 282059
Los Angeles, California, 90015
- Recruiting
L-MARC Research Center /ID# 282008
Louisville, Kentucky, 40213
- Recruiting
South Florida Wellness & Clinic /ID# 282022
Margate, Florida, 33063
- Recruiting
Southern Endocrinology Associates /ID# 282558
Mesquite, Texas, 75149
- Recruiting
South Broward Research /ID# 282125
Miramar, Florida, 33027
- Recruiting
Monroe Biomedical Research /ID# 282009
Monroe, North Carolina, 28112
- Recruiting
Centricity Research - Morehead city /ID# 283264
Morehead City, North Carolina, 28557
- Recruiting
Clinical Research Associates - Nashville /ID# 282161
Nashville, Tennessee, 37203
- Recruiting
Lucas Research - New Bern /ID# 282747
New Bern, North Carolina, 28562
- Recruiting
Suncoast Clinical Research Pasco County /ID# 282412
New Port Richey, Florida, 34652
- Recruiting
Health Research Of Hampton Roads /ID# 282014
Newport News, Virginia, 23606
- Recruiting
Charter Research - Winter Park /ID# 281968
Orlando, Florida, 32803-1839
- Recruiting
Florida Institute For Clinical Research /ID# 282739
Orlando, Florida, 32825
- Recruiting
Cahaba Research - Pelham /ID# 282381
Pelham, Alabama, 35124
- Recruiting
Progressive Medical Research /ID# 282838
Port Orange, Florida, 32127
- Recruiting
Rainier Clinical Research /ID# 282157
Renton, Washington, 98055
- Recruiting
National Clinical Research /ID# 282007
Richmond, Virginia, 23294
- Recruiting
Rochester Clinical Research /ID# 282484
Rochester, New York, 14609
- Recruiting
Peninsula Research Associates /ID# 282158
Rolling Hills Estates, California, 90274
- Recruiting
Endocrine Research Solutions /ID# 282020
Roswell, Georgia, 30076
- Recruiting
Texas Diabetes and Endocrinology /ID# 282291
Round Rock, Texas, 78681
- Recruiting
Southern California Dermatology /ID# 282011
Santa Ana, California, 92701
- Recruiting
Headlands Research - Scottsdale /ID# 282571
Scottsdale, Arizona, 85260
- Recruiting
Encompass Clinical Research /ID# 282483
Spring Valley, California, 91978
- Recruiting
Charter Research - The Villages /ID# 282376
The Villages, Florida, 32162
- Recruiting
Arizona Clinical Trials /ID# 282372
Tucson, Arizona, 85711
- Recruiting
University Clinical Investigators /ID# 282132
Tustin, California, 92780
- Recruiting
Diablo Clinical Research /ID# 282530
Walnut Creek, California, 94598
- Recruiting
Metabolic Research Institute /ID# 282350
West Palm Beach, Florida, 33401
- Recruiting
Encore Medical Research - Weston /ID# 282044
Weston, Florida, 33331
- Recruiting
Accellacare - Tradd Court - Wilmington /ID# 282200
Wilmington, North Carolina, 28401
Puerto Rico4 sites, 4 recruiting
- Recruiting
Advanced Clinical Research - Bayamon /ID# 282250
Bayamón, 00959
- Recruiting
Clinical Research Investigator Group /ID# 282203
Bayamón, 00960
- Recruiting
Isis Clinical Res. Ctr P.S.C. /ID# 282252
Guaynabo, 00968
- Recruiting
Latin Clinical Trial Center - San Juan - Avenida Ponce De Leon /ID# 282248
San Juan, 00909
About this study
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
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.
Read more
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
- Being tested
- ABBV-295, Placebo
- Keywords
- Obesity, Overweight, ABBV-295
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-295Drug
Subcutaneous
PlaceboDrug
Subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| ABBV-295 Arm 1 | Experimental | Particpants will have their doses escalated up to a maintenance dose during the Double-Blind Period. Receives: Drug: ABBV-295; Drug: Placebo |
| ABBV-295 Arm 2 | Experimental | Participants will have their doses escalated up to a maintenance dose during the Double-Blind Period. Receives: Drug: ABBV-295; Drug: Placebo |
| ABBV-295 Arm 3 | Experimental | Participants will have their doses escalated up to a maintenance dose during the Double-Blind Period. Receives: Drug: ABBV-295; Drug: Placebo |
| ABBV-295 Arm 4 | Experimental | Particpants will have their doses escalated up to a maintenance dose during the Double-Blind Period. Receives: Drug: ABBV-295; Drug: Placebo |
| ABBV-295 Arm 5 | Experimental | Participants will have their doses escalated up to a maintenance dose during the Double-Blind Period. Receives: Drug: ABBV-295; Drug: Placebo |
| ABBV-295 Arm 6 | Experimental | Particpants will have their doses escalated up to a maintenance dose during the Double-Blind Period. Receives: Drug: ABBV-295; Drug: Placebo |
| Placebo | Placebo comparator | Participants will follow the same dosing schedule as active treatment arms during the Double-Blind Period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Body Weight
The primary efficacy endpoint is the percent change from baseline in body weight. This measure assesses the effect of various doses of ABBV-295 compared to placebo on reducing body weight in subjects with obesity or overweight with weight-related comorbidities.
Measured: Baseline (Week 0) to Week 32
Number of Participants with Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Measured: Up to approximately week 52
Secondary outcomes (13)
Percent Change From Baseline in Body Weight
Percent change from baseline in body weight
Measured: Baseline (Week 0) through Week 52
Change in Body Weight From Baseline
Change in body weight (kg) from baseline
Measured: Baseline (Week 0) through Week 32
Change in Body Weight From Baseline
Change in body weight (kg) from baseline
Measured: Baseline (Week 0) through Week 52
Change in Body Mass Index From Baseline
Change in BMI (kg/m2) from baseline
Measured: Baseline (Week 0) through Week 32
Change in Body Mass Index From Baseline
Change in BMI (kg/m2) from baseline
Measured: Baseline (Week 0) through Week 52
Change in Waist Circumference From Baseline
Change in waist circumference (cm) from baseline
Measured: Baseline (Week 0) through Week 32
Change in Waist Circumference From Baseline
Change in waist circumference (cm) from baseline
Measured: Baseline (Week 0) through Week 52
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Percentage of participants who achieve ≥5% body weight reduction
Measured: Week 32
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Percentage of participants who achieve ≥5% body weight reduction
Measured: Week 52
Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Percentage of participants who achieve ≥10% body weight reduction
Measured: Week 32
Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Percentage of participants who achieve ≥10% body weight reduction
Measured: Week 52
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
Percentage of participants who achieve ≥15% body weight reduction
Measured: Week 32
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
Percentage of participants who achieve ≥15% body weight reduction
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start4 Aug 2026
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752979
- Sponsor's protocol ID
- M25-998
- Status last verified
- Oct 2026
- First submitted
- 4 Aug 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.