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

StatusRecruiting
PhasePhase 2
SponsorAbbVie
Started

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Record History

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  1. Minor Trial sites expanded: 57 → 61 locations
  2. Minor Trial sites expanded: 54 → 57 locations
  3. Minor Study sites: 56 to 57
  4. Minor Study sites: 55 to 56
  5. Minor Study sites: 54 to 55
Show 8 earlier versionsHide 8 earlier versions
  1. Minor Study sites: 52 to 54
  2. Minor Study sites: 50 to 52
  3. Minor Study sites: 48 to 50
  4. Minor Study sites: 46 to 48
  5. Minor Study sites: 44 to 46
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 2 of 13 entries
  6. Minor Study sites: 42 to 44v8
  7. Minor Study sites: 40 to 42v7
  8. Minor Study sites: 38 to 40v6
  1. Notable Recruitment opened
    • Trial sites expanded: 0 → 33 locations
    v5
  2. Minor Study sites: 34 to 36v4
  3. Minor Study sites: 33 to 34v3
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 33
    • Start date changed from estimate of Aug 7, 2026 to Aug 4, 2026
    v2
  5. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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 Details
NCT Number NCT07752979
Lead Sponsor AbbVie
Conditions
(from sponsor)
Obesity, Overweight
Related terms Obesity, Overweight
Enrollment 360 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov