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

RecruitingPhase 2Ages 18 Years - 75 YearsAllAbbVie
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In plain words

What the trial is, and whether it could suit you

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. Partic

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * BMI โ‰ฅ 30.0 kg/m2 at Screening (BMI is calculated as weight in kg divided by the square of height measured in meters) OR * BMI โ‰ฅ 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 โ‰ฅ 5% within 3 months prior to Screening * Hemoglobin A1c (HbA1c) โ‰ฅ 6.5% (48 mmol/mol) at Screening * Fasting glucose โ‰ฅ126 mg/dL (7.0 mmol/L) or random glucose test โ‰ฅ 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.
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What it tests

  • ABBV-295
  • Placebo
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Where

63 sites
Cahaba Research - Pelham /ID# 282381
Pelham, United States
Headlands Research - Scottsdale /ID# 282571
Scottsdale, United States
Arizona Clinical Trials /ID# 282372
Tucson, United States
John Muir Health - Concord /ID# 282469
Concord, United States
NorCal Medical Research /ID# 283117
Greenbrae, United States
Velocity Clinical Research - Huntington Park /ID# 282987
Huntington Park, United States
Los Angeles Institute for Metabolic Research /ID# 282059
Los Angeles, United States
Peninsula Research Associates /ID# 282158
Rolling Hills Estates, United States

โ€ฆand 55 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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