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

NCT07595549 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: C6491013VESPER-62026-525318-75-00
• Study Type: interventional
• Target: 954
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Obesity; Overweight and/or Obesity; Overweight

Keywords

Overnutrition; Nutrition Disorders; Diabetes Mellitus, Type 2; Type 2 Diabetes; Body Weight; Diabetes Mellitus; Glucose Metabolism Disorders; Endocrine System Diseases; Overweight; Obesity; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Metabolic Diseases

Outcome Measures

Primary Outcomes (1)

• Percent change from baseline in body weight

  Baseline, Week 72

Secondary Outcomes (36)

• Change from baseline in body weight

  Baseline, Week 72

• Change from baseline in waist circumference

  Baseline, Week 72

• Percentage of Participants achieving ≥5% of body weight reduction from baseline

  Baseline, Week 72

• Percentage of Participants achieving ≥10% of body weight reduction from baseline

  Baseline, Week 72

• Percentage of Participants achieving ≥15% of body weight reduction from baseline

  Baseline, Week 72

Study Arms (5)

Treatment Arm 1

EXPERIMENTAL

Participants will receive PF-08653944 by Subcutaneous Injection.

Drug: PF-08653944

Treatment Arm 2

EXPERIMENTAL

Participants will receive PF-08653944 by Subcutaneous Injection.

Drug: PF-08653944

Treatment Arm 3

EXPERIMENTAL

Participants will receive PF-08653944 by Subcutaneous Injection.

Drug: PF-08653944

Treatment Arm 4

EXPERIMENTAL

Participants will receive PF-08653944 by Subcutaneous Injection.

Drug: PF-08653944

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo by Subcutaneous Injection.

Other: Placebo

Interventions

PF-08653944 DRUG

By Subcutaneous Injection

Treatment Arm 1; Treatment Arm 2; Treatment Arm 3; Treatment Arm 4

Placebo OTHER

By Subcutaneous Injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pfizer: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Obesity; Overweight; Overnutrition; Nutrition Disorders; Diabetes Mellitus, Type 2; Body Weight; Diabetes Mellitus; Glucose Metabolism Disorders; Endocrine System Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Metabolic Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): June 2, 2026
• Primary Completion (Estimated): May 4, 2028
• Study Completion (Estimated): June 21, 2028
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share