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A Study to Learn About the Study Medicine Called Berobenatide (PF-08653944) in People With Overweight or Obesity

StatusRecruiting
PhasePhase 3
SponsorPfizer
Started
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Record History

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  1. Minor Trial sites expanded: 58 → 72 locations
  2. Minor Trial sites expanded: 50 → 58 locations
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 1 of 36 entries
  3. Minor Trial sites expanded: 38 → 50 locationsv7
  4. Minor Trial sites expanded: 25 → 38 locationsv6
  5. Minor Trial sites expanded: 19 → 25 locationsv5
  6. Minor Trial sites expanded: 9 → 19 locationsv4
  7. Notable Recruitment opened
    • Trial sites expanded: 0 → 9 locations
    • Start date changed from estimate of Jun 30, 2026 to Jun 10, 2026
    • Secondary endpoints revised (36)
    v3
  8. Minor Start date: Jun 2, 2026 to Jun 30, 2026v2
  9. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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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The purpose of this clinical study is to learn about the effects and safety of berobenatide (PF-08653944). This may help people with overweight or obesity lose weight. People in this study may also have type 2 diabetes. About 950 adults will be in this study. Berobenatide will be compared to a placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. Berobenatide or placebo is given by a shot under the skin in the belly area. The objective of the study is to compare the experiences of people receiving berobenatide to those of the people who do not to assess if the study medicine is effective and safe. People will take part in this study for about 20 months. During this time, they will have about 15 study visits at the site. They will also have 2 study visits over the phone.
Trial Details
NCT Number NCT07595549
Lead Sponsor Pfizer
Conditions
(from sponsor)
Obesity, Overweight and/or Obesity, Overweight
Related terms Body Weight, Diabetes Mellitus, Diabetes Mellitus, Type 2, Endocrine System Diseases, Glucose Metabolism Disorders, Metabolic Diseases, Nutrition Disorders, Nutritional and Metabolic Diseases, Obesity, Overnutrition, Overweight, Pathological Conditions, Signs and Symptoms, Signs and Symptoms
Enrollment 954 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov