NCT07752979 · AbbVie
Safety and Efficacy of ABBV-295 in Adults With Obesity or Overweight With Weight-Related Comorbidities
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
ABBV-295
Subcutaneous
DRUG
Placebo
Subcutaneous
Primary outcome measures
Percent Change From Baseline in Body Weight
Time frame: Baseline (Week 0) to Week 32
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.
Number of Participants with Adverse Events (AEs)
Time frame: Up to approximately week 52
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Scottsdale, Arizona
- Santa Ana, California
- Spring Valley, California
- Walnut Creek, California
- Clearwater, Florida
- Lake Worth, Florida
- Miramar, Florida
- Orlando, Florida
- Port Orange, Florida
- The Villages, Florida
- West Palm Beach, Florida
- Weston, Florida
And 19 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 31, 2026 · Source of record for eligibility and locations