Safety and Efficacy of ABBV-295 in Adults With Obesity or Overweight With Weight-Related Comorbidities
Purpose
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
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental ABBV-295 Arm 1 |
Particpants will have their doses escalated up to a maintenance dose during the Double-Blind Period. |
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Experimental ABBV-295 Arm 2 |
Participants will have their doses escalated up to a maintenance dose during the Double-Blind Period. |
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Experimental ABBV-295 Arm 3 |
Participants will have their doses escalated up to a maintenance dose during the Double-Blind Period. |
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Experimental ABBV-295 Arm 4 |
Particpants will have their doses escalated up to a maintenance dose during the Double-Blind Period. |
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Experimental ABBV-295 Arm 5 |
Participants will have their doses escalated up to a maintenance dose during the Double-Blind Period. |
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|
Experimental ABBV-295 Arm 6 |
Particpants will have their doses escalated up to a maintenance dose during the Double-Blind Period. |
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Placebo Comparator Placebo |
Participants will follow the same dosing schedule as active treatment arms during the Double-Blind Period. |
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Recruiting Locations
Scottsdale, Arizona 85260
Santa Ana, California 92701
Spring Valley, California 91978
Walnut Creek, California 94598
Clearwater, Florida 33756
Lake Worth, Florida 33461
Miramar, Florida 33027
Orlando, Florida 32803-1839
Orlando, Florida 32825
Port Orange, Florida 32127
The Villages, Florida 32162
West Palm Beach, Florida 33401
Weston, Florida 33331
Blackfoot, Idaho 83221
Louisville, Kentucky 40213
City of Saint Peters, Missouri 63303
Greensboro, North Carolina 27405
Monroe, North Carolina 28112
Morehead City, North Carolina 28557
New Bern, North Carolina 28562
Wilmington, North Carolina 28401
Fargo, North Dakota 58104
Cincinnati, Ohio 45212-3784
Bristol, Tennessee 37620
Knoxville, Tennessee 37909
Knoxville, Tennessee 37938
Nashville, Tennessee 37203
Dallas, Texas 75230
Longview, Texas 75605
Arlington, Virginia 22206
Danville, Virginia 24541
Newport News, Virginia 23606
Richmond, Virginia 23294
Guaynabo, Puerto Rico 00968
More Details
- Status
- Recruiting
- Sponsor
- AbbVie