Clinical trial

A Study to Learn About the Study Medicine Called PF-08653944 Taken Once-Weekly Compared to Placebo in Chinese Adults With Overweight or Obesity

Opening soon · Phase 3 · 1 countries · Registry ID NCT07792954

Opening soonPhase 3Interventional

What this study is about

Overweight and obesity are long-term health conditions that can increase the risk of serious health problems, including heart disease, type 2 diabetes, and other medical conditions. The purpose of this study is to learn whether berobenatide is safe and effective for adults in China who have overweight or obesity. Researchers will compare berobenatide with a placebo, which looks like the study treatment but does not contain active medicine. People may be able to participate if they are adults with obesity or if they have overweight together with certain weight-related health conditions. Some participants may also have type 2 diabetes. Specific eligibility requirements will be reviewed by the study doctor before enrollment. Participants will be randomly assigned to receive either berobenatide or placebo. The study treatment will be administered according to the study protocol, and participants will be monitored throughout the study to assess changes in body weight and overall health, as well as any side effects that may occur. During participation, participants will attend study visits and complete study-related assessments. Researchers will collect information about participants' health, body weight, and safety throughout the study. Details about the number of visits, study duration, and study procedures will be explained by the study team before participation. The information learned from this study may help researchers better understand whether berobenatide could be a treatment option for adults living with overweight or obesity.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionObesity, Overweight

Full registry criteria

Inclusion Criteria: * Adults ≥18 years of age. * BMI ≥28 kg/m²; or BMI ≥24 kg/m² and \<28 kg/m² with at least one weight-related comorbidity. * Participants with T2D must have HbA1c 6.5% to 10.0%. * At least one prior unsuccessful dietary weight-loss attempt. Exclusion Criteria: * Significant recent weight change (\>5% within 3 months). * Type 1 diabetes mellitus. * History of pancreatitis. * Personal or family history of Medullary Thyroid Carcinoma (MTC) or Multiple endocrine neoplasia type 2 (MEN2). * Recent bariatric surgery or obesity procedures. * Pregnancy or breastfeeding.

Treatments and study arms

Berobenatide

Drug

Solution for injection

Placebo

Other

Solution for injection

Primary outcomes

Percent Change From Baseline in Body Weight at Week 48Baseline to Week 48

Study locations

33 locations were listed when this page was built. The first 40 are shown.

Beijing Friendship Hospital🇨🇳 Beijing, Beijing Municipality, China