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
1 other identifier
interventional
360
2 countries
54
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 obesity
Started Aug 2026
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2026
CompletedStudy Start
First participant enrolled
August 4, 2026
CompletedFirst Posted
Study publicly available on registry
August 7, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
October 2, 2026
September 1, 2026
1.6 years
August 4, 2026
September 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
Up to approximately week 52
Secondary Outcomes (13)
Percent Change From Baseline in Body Weight
Baseline (Week 0) through Week 52
Change in Body Weight From Baseline
Baseline (Week 0) through Week 32
Change in Body Weight From Baseline
Baseline (Week 0) through Week 52
Change in Body Mass Index From Baseline
Baseline (Week 0) through Week 32
Change in Body Mass Index From Baseline
Baseline (Week 0) through Week 52
- +8 more secondary outcomes
Study Arms (7)
ABBV-295 Arm 1
EXPERIMENTALParticpants will have their doses escalated up to a maintenance dose during the Double-Blind Period.
ABBV-295 Arm 2
EXPERIMENTALParticipants will have their doses escalated up to a maintenance dose during the Double-Blind Period.
ABBV-295 Arm 3
EXPERIMENTALParticipants will have their doses escalated up to a maintenance dose during the Double-Blind Period.
ABBV-295 Arm 4
EXPERIMENTALParticpants will have their doses escalated up to a maintenance dose during the Double-Blind Period.
ABBV-295 Arm 5
EXPERIMENTALParticipants will have their doses escalated up to a maintenance dose during the Double-Blind Period.
ABBV-295 Arm 6
EXPERIMENTALParticpants will have their doses escalated up to a maintenance dose during the Double-Blind Period.
Placebo
PLACEBO COMPARATORParticipants will follow the same dosing schedule as active treatment arms during the Double-Blind Period.
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (54)
Cahaba Research - Pelham /ID# 282381
Pelham, Alabama, 35124, United States
Headlands Research - Scottsdale /ID# 282571
Scottsdale, Arizona, 85260, United States
John Muir Health - Concord /ID# 282469
Concord, California, 94520, United States
NorCal Medical Research /ID# 283117
Greenbrae, California, 94904, United States
Velocity Clinical Research - Huntington Park /ID# 282987
Huntington Park, California, 90255, United States
Los Angeles Institute for Metabolic Research /ID# 282059
Los Angeles, California, 90015, United States
Peninsula Research Associates /ID# 282158
Rolling Hills Estates, California, 90274, United States
Southern California Dermatology /ID# 282011
Santa Ana, California, 92701, United States
Encompass Clinical Research /ID# 282483
Spring Valley, California, 91978, United States
University Clinical Investigators /ID# 282132
Tustin, California, 92780, United States
Diablo Clinical Research /ID# 282530
Walnut Creek, California, 94598, United States
Innovative Research of West Florida /ID# 281963
Clearwater, Florida, 33756, United States
Encore Research Group-Jacksonville Center for Clinical Research /ID# 282740
Jacksonville, Florida, 32216, United States
Altus Clinical Research - Lake Worth - South Congress Avenue /ID# 281979
Lake Worth, Florida, 33461, United States
South Florida Wellness & Clinic /ID# 282022
Margate, Florida, 33063, United States
South Broward Research /ID# 282125
Miramar, Florida, 33027, United States
Charter Research - Winter Park /ID# 281968
Orlando, Florida, 32803-1839, United States
Florida Institute For Clinical Research /ID# 282739
Orlando, Florida, 32825, United States
Progressive Medical Research /ID# 282838
Port Orange, Florida, 32127, United States
Charter Research - The Villages /ID# 282376
The Villages, Florida, 32162, United States
Metabolic Research Institute /ID# 282350
West Palm Beach, Florida, 33401, United States
Encore Medical Research - Weston /ID# 282044
Weston, Florida, 33331, United States
Elite Clinical Trials - Blackfoot /ID# 282042
Blackfoot, Idaho, 83221, United States
Great Lakes Clinical Trials - West Wilson Avenue /ID# 282378
Chicago, Illinois, 60640, United States
L-MARC Research Center /ID# 282008
Louisville, Kentucky, 40213, United States
Studymetrix Research /ID# 282163
City of Saint Peters, Missouri, 63303, United States
Mercury Street Medical /ID# 282016
Butte, Montana, 59701-1652, United States
Vector Clinical Trials /ID# 282265
Las Vegas, Nevada, 89128, United States
Rochester Clinical Research /ID# 282484
Rochester, New York, 14609, United States
Medication Management /ID# 281965
Greensboro, North Carolina, 27401, United States
Monroe Biomedical Research /ID# 282009
Monroe, North Carolina, 28112, United States
Centricity Research - Morehead city /ID# 283264
Morehead City, North Carolina, 28557, United States
Lucas Research - New Bern /ID# 282747
New Bern, North Carolina, 28562, United States
Accellacare - Tradd Court - Wilmington /ID# 282200
Wilmington, North Carolina, 28401, United States
Lillestol Research LLC /ID# 281978
Fargo, North Dakota, 58104, United States
CTI Clinical Research Center /ID# 282043
Cincinnati, Ohio, 45212-3784, United States
Holston Medical Group - Bristol /ID# 282045
Bristol, Tennessee, 37620, United States
New Phase Research & Development /ID# 282131
Knoxville, Tennessee, 37909, United States
Summit Medical Group- Halls Family Physicians /ID# 282435
Knoxville, Tennessee, 37938, United States
Clinical Research Associates - Nashville /ID# 282161
Nashville, Tennessee, 37203, United States
Amarillo Medical Specialists /ID# 282380
Amarillo, Texas, 79124, United States
Elligo Clinical Research Center /ID# 282166
Austin, Texas, 78704, United States
JCCT - Juno Bellaire /ID# 282263
Bellaire, Texas, 77401, United States
Velocity Clinical Research - Dallas /ID# 282734
Dallas, Texas, 75230, United States
Juno Research /ID# 282413
Houston, Texas, 77040, United States
PlanIt Research /ID# 282204
Houston, Texas, 77079-2204, United States
Dcol Center For Clinical Research /ID# 281961
Longview, Texas, 75605, United States
Washington Center For Weight Management And Research /ID# 282047
Arlington, Virginia, 22206, United States
Sovah Health - Danville /ID# 282876
Danville, Virginia, 24541, United States
Health Research Of Hampton Roads /ID# 282014
Newport News, Virginia, 23606, United States
National Clinical Research /ID# 282007
Richmond, Virginia, 23294, United States
Advanced Clinical Research - Bayamon /ID# 282250
Bayamón, 00959, Puerto Rico
Isis Clinical Res. Ctr P.S.C. /ID# 282252
Guaynabo, 00968, Puerto Rico
Latin Clinical Trial Center - San Juan - Avenida Ponce De Leon /ID# 282248
San Juan, 00909, Puerto Rico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2026
First Posted
August 7, 2026
Study Start
August 4, 2026
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
March 1, 2028
Last Updated
October 2, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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.