A Study to Learn About the Study Medicine Called Berobenatide (PF-08653944) in People With Overweight or Obesity

Pfizer

Status and phase: Enrolling; Phase 3

Conditions: Overweight and/or Obesity; Overweight; Obesity

Treatments: Drug: PF-08653944; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07595549

2026-525318-75-00 (Registry Identifier)

VESPER-6 (Other Identifier)

C6491013

Details and patient eligibility

About

The purpose of this clinical study is to learn about the effects and safety of berobenatide (PF-08653944). This may help people with overweight or obesity lose weight. People in this study may also have type 2 diabetes.

About 950 adults will be in this study. Berobenatide will be compared to a placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. Berobenatide or placebo is given by a shot under the skin in the belly area. The objective of the study is to compare the experiences of people receiving berobenatide to those of the people who do not to assess if the study medicine is effective and safe.

People will take part in this study for about 20 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: 954 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged ≥18 years.
• BMI of: ≥30 kg/m2 or ≥27.0 kg/m2 to <30.0 kg/m2 and must have at least 1 of the following weight-related co-morbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2D.

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: Double Blind

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954 participants in 5 patient groups, including a placebo group

Treatment Arm 1

Experimental group

Description:

Participants will receive PF-08653944 by Subcutaneous Injection.

Treatment:

Drug: PF-08653944

Treatment Arm 2

Experimental group

Description:

Participants will receive PF-08653944 by Subcutaneous Injection.

Treatment:

Drug: PF-08653944

Treatment Arm 3

Experimental group

Description:

Participants will receive PF-08653944 by Subcutaneous Injection.

Treatment:

Drug: PF-08653944

Treatment Arm 4

Experimental group

Description:

Participants will receive PF-08653944 by Subcutaneous Injection.

Treatment:

Drug: PF-08653944

Placebo

Placebo Comparator group

Description:

Participants will receive matching placebo by Subcutaneous Injection.

Treatment:

Other: Placebo