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A Study to Learn About Safety and Effects of Once-weekly Treatment With Berobenatide in Adults With Obesity Disease in Japan (VESPER-JW)

RecruitingPhase 3Ages 18 Years - anyAllPfizer
NCT07794761 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of this clinical study is to learn about safety and effects of berobenatide (PF-08653944) in adults with obesity disease, a condition where a person has too much body fat, which can harm their health and increase the risk of other medical problems. Some people in this study may also have type 2 diabetes, a condition in which the body does not use insulin properly, causing blood sugar levels to become too high. This study is seeking participants in Japan who: * Have obesity disease. * May have type 2 diabetes. * Meet the study-specific age, weight and health requirements. About 180 adults will take part in this study. Participants will be randomly assigned to receive either berobenatide or a placebo. A placebo looks like the study medicine but does not contain any active medicine. Berobenatide or placebo will be given as an injection under the skin of the abdomen (belly ar

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📋 Eligibility rules (as published)
Inclusion Criteria: * Aged ≥18 years. * BMI of: ≥27.0 kg/m2 to \<35.0 kg/m2 with ≥2 obesity-related health disorders or BMI of ≥35.0 kg/m2 with ≥1 obesity-related health disorder. The participant must have at least one of either hypertension, dyslipidemia or glucose intolerance (T2D and impaired glucose tolerance etc.) as an obesity-related health disorder. Exclusion Criteria: * Have a self-reported body weight change greater than 5% within 90 days prior to Screening. * Diagnosis of type 1 diabetes or any other form of diabetes other than T2D. * History of acute or chronic pancreatitis. * Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2).
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What it tests

  • Berobenatide
  • Placebo
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Where

34 sites
Tokuyama Clinic
Chiba, Japan
Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
Matsuyama, Japan
Matsuyama Shimin Hospital
Matsuyama, Japan
Tenjin Sogo Clinic
Fukuoka, Japan
Medical Corporation BOOCS BOOCS CLINIC FUKUOKA
Fukuoka, Japan
Oishi Clinic
Kasuya-gun, Japan
Manda Memorial Hospital
Sapporo, Japan
Yamasaki Family Clinic
Amagasaki, Japan

…and 26 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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