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

Pfizer

Status and phase: Enrolling; Phase 3

Conditions: Obesity

Treatments: Other: Placebo; Drug: Berobenatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT07794761

C6491027

VESPER-JW (Other Identifier)

Details and patient eligibility

About

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 area). The study will compare the experiences of people receiving berobenatide with those receiving placebo to determine whether berobenatide can help people lose weight. The study will also assess the safety of berobenatide and its effects on body weight and other health measures.

People will take part in this study for about 22 months. During this time, they will have about 15 study visits at the site. They will also have 2 study visits over the phone.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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180 participants in 4 patient groups, including a placebo group

Treatment Arm 2

Experimental group

Description:

Participants will receive berobenatide solution for injection as subcutaneous injection.

Treatment:

Drug: Berobenatide

Placebo

Placebo Comparator group

Description:

Participants will receive placebo solution for injection as subcutaneous injection.

Treatment:

Other: Placebo

Treatment Arm 3

Experimental group

Description:

Participants will receive berobenatide solution for injection as subcutaneous injection.

Treatment:

Drug: Berobenatide

Treatment Arm 1

Experimental group

Description:

Participants will receive berobenatide solution for injection as subcutaneous injection.

Treatment:

Drug: Berobenatide