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

Pfizer

Status and phase: Not yet enrolling; Phase 3

Conditions: Overweight; Obesity

Treatments: Other: Placebo; Drug: Berobenatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT07874633

C6491029

Details and patient eligibility

About

Overweight and obesity are long-term health conditions that can increase the possibility of serious health problems. These problems include heart disease, type 2 diabetes (a condition that causes high blood sugar), and other medical conditions. The purpose of this study is to learn whether berobenatide (PF-08653944) is safe and effective for adults in China who are overweight or obese. Researchers will compare berobenatide with a placebo. A placebo looks like study treatment but does not contain active medicine.

About 432 adults will take part in this study. This study is seeking adults who

• are obese
• are overweight 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. Study treatment will be administered as a shot under the skin. All participants will also receive lifestyle counseling throughout the study.

Researchers will monitor participants throughout the study. They will assess participants' body weight, overall health, and any reactions that may occur. During the study, participants will attend study visits and complete study-related assessments.

Participants may take part in the study for up to approximately 59 weeks. This period includes screening, treatment, and follow-up visits. 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.

Enrollment: 432 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults ≥18 years of age.
• BMI ≥28 kg/m²; or BMI ≥24 kg/m² and <28 kg/m² with at least one of the following weight-related co-morbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2D.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

432 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants will receive matching placebo by Subcutaneous Injection.

Treatment:

Other: Placebo

Treatment Arm 1

Experimental group

Description:

Participants will receive Berobenatide by Subcutaneous Injection.

Treatment:

Drug: Berobenatide

Treatment Arm 2

Experimental group

Description:

Participants will receive Berobenatide by Subcutaneous Injection.

Treatment:

Drug: Berobenatide

Treatment Arm 3

Experimental group

Description:

Participants will receive Berobenatide by Subcutaneous Injection.

Treatment:

Drug: Berobenatide

Treatment Arm 4

Experimental group

Description:

Participants will receive Berobenatide by Subcutaneous Injection.

Treatment:

Drug: Berobenatide