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Recruiting NCT07595549

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

Phase III Interventional Obesity Overweight and/or Obesity Overweight

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PF-08653944, Placebo.
Who it may be relevant to
Registry conditions: Obesity, Overweight and/or Obesity, Overweight. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONCE-MONTHLY PF-08653944 IN ADULTS WITH OVERWEIGHT OR OBESITY (VESPER-6)

Overview

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.

Interventions

  • Drug PF-08653944
    By Subcutaneous Injection
  • Other Placebo
    By Subcutaneous Injection

Primary outcome measures

  • Percent change from baseline in body weight [Time frame: Baseline, Week 72]
Secondary outcome measures (12)
  • Change from baseline in body weight [Time frame: Baseline, Week 72]
  • Change from baseline in waist circumference [Time frame: Baseline, Week 72]
  • Percentage of Participants achieving ≥5% of body weight reduction from baseline [Time frame: Baseline, Week 72]
  • Percentage of Participants achieving ≥10% of body weight reduction from baseline [Time frame: Baseline, Week 72]
  • Percentage of Participants achieving ≥15% of body weight reduction from baseline [Time frame: Baseline, Week 72]
  • Percentage of Participants achieving ≥20% of body weight reduction from baseline [Time frame: Baseline, Week 72]
  • Percentage of Participants with a waist-to-height ratio of <0.53 [Time frame: Baseline, Week 72]
  • Percent change from baseline in body weight in participants with type 2 diabetes [Time frame: Baseline, Week 72]
  • Change from baseline in Systolic Blood Pressure (SBP) [Time frame: Baseline, Week 72]
  • Change from baseline in Impact of Weight on Quality of Life-Lite-Clinical Trial (IWQoL-Lite-CT) Physical Function composite score [Time frame: Baseline, Week 72]
  • Percentage of Participants achieving ≥25% of body weight reduction from baseline [Time frame: Baseline, Week 72]
  • Change from baseline in Diastolic Blood Pressure (DBP) [Time frame: Baseline, Week 72]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 20 centers
  • ImmuniMet, LLC — Modesto
  • ClearVue Eye Care — Roseville
  • Clinical Trials Research — Sacramento
  • University Clinical Investigators, Inc. — Tustin
  • Diablo Clinical Research, Inc. — Walnut Creek
  • Nature Coast Clinical Research — Crystal River
  • West Coast Eye Institute — Lecanto
  • South Broward Research — Miramar
  • … and 12 more centers
Japan · 5 centers
  • Medical Corporation Heishinkai OCROM Clinic — Suita
  • Tokyo Center Clinic — Chuo-ku
  • Tokyo-Eki Center-Building Clinic — Chuo-ku
  • Fukuwa Clinic — Chuo-ku
  • Medical Corporation Heishinkai ToCROM Clinic — Shinjuku-ku

Identifiers

NCT: NCT07595549 · C6491013 · VESPER-6 · 2026-525318-75-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗