Berobenatide once a month for obesity in adults in Japan

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3, randomized, double-blind, placebo-controlled trial enrolling about 197 adults with obesity disease in Japan. Participants will be assigned to receive berobenatide or placebo via subcutaneous injections once a month and will be followed to assess safety and effects on weight and related health measures. Key eligibility includes adults with BMI in a defined range and at least one obesity-related condition, such as hypertension or dyslipidemia, with some participants also having type 2 diabetes. The study is sponsored by Pfizer and is conducted at multiple clinics in Japan. Primary outcomes focus on safety and weight-related efficacy during the treatment period.

Why it matters

Who can join: the full rules

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).

Where it's running

• Tokuyama Clinic
  Mihama-ku, Chiba, Japan Recruiting
• Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
  Matsuyama, Ehime, Japan Recruiting
• Matsuyama Shimin Hospital
  Matsuyama, Ehime, Japan Recruiting
• Tenjin Sogo Clinic
  Fukuoka, Fukuoka, Japan Recruiting
• Medical Corporation BOOCS BOOCS CLINIC FUKUOKA
  Fukuoka, Fukuoka, Japan Recruiting
• Fukuoka Diagnostic Imaging Clinic Me-Well
  Fukuoka, Fukuoka, Japan Recruiting

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.