- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07845500
A Study to Learn About Switching to a Monthly Study Medicine Called Berobenatide (PF-08653944) to Help Keep Weight Off in People With Overweight or Obesity
A PHASE 3 STUDY TO EVALUATE THE SWITCH TO MONTHLY BEROBENATIDE FOR MAINTAINING WEIGHT IN ADULTS WHO ARE ON WEEKLY SEMAGLUTIDE OR TIRZEPATIDE (VESPER-SWITCH)
The purpose of this study is to learn about the safety and effectiveness of berobenatide in adults with overweight or obesity who have already lost weight while taking semaglutide or tirzepatide. The study does not include people with diabetes.
Participants will be in the study for about 11 months.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Pfizer CT.gov Call Center
- Phone Number: 1-800-718-1021
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- Recruiting
- University of Alabama at Birmingham
-
-
California
-
Los Angeles, California, United States, 90017
- Not yet recruiting
- Velocity Clinical Research - Los Angeles
-
Santa Ana, California, United States, 92701
- Not yet recruiting
- Southern California Clinical Research
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Walnut Creek, California, United States, 94598
- Not yet recruiting
- Diablo Clinical Research, LLC dba Flourish Research
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-
Florida
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Jacksonville, Florida, United States, 32216
- Not yet recruiting
- Jacksonville Center for Clinical Research
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New Port Richey, Florida, United States, 34652
- Not yet recruiting
- Suncoast Clinical Research
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Oviedo, Florida, United States, 32765
- Not yet recruiting
- Oviedo Medical Research
-
-
Kentucky
-
Louisville, Kentucky, United States, 40213
- Recruiting
- Monroe Biomedical Research
-
-
Michigan
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Flint, Michigan, United States, 48504
- Not yet recruiting
- Aa Mrc Llc
-
-
Mississippi
-
Ridgeland, Mississippi, United States, 39157
- Not yet recruiting
- SKY Integrative Medical Center/SKYCRNG
-
-
Missouri
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Chesterfield, Missouri, United States, 63005
- Recruiting
- Clinical Research Professionals
-
-
Montana
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Butte, Montana, United States, 59701
- Recruiting
- Mercury Street Medical Group, PLLC
-
-
North Carolina
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Monroe, North Carolina, United States, 28112
- Not yet recruiting
- Monroe Biomedical Research
-
Wilmington, North Carolina, United States, 28401
- Not yet recruiting
- Accellacare - Wilmington
-
-
Ohio
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Cincinnati, Ohio, United States, 45219
- Recruiting
- Velocity Clinical Research, Mt. Auburn
-
-
South Carolina
-
Greenville, South Carolina, United States, 29607
- Not yet recruiting
- Tribe Clinical Research, LLC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged ≥18 years.
- Currently taking semaglutide or tirzepatide for obesity management.
Exclusion Criteria:
- Diagnosis of any form of diabetes.
- History of acute or chronic pancreatitis.
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Active Comparator
Participants will receive Semaglutide or Tirzepatide by Subcutaneous Injection. |
Participants will receive Semaglutide administered subcutaneously. Participants will receive Tirzepatide administered subcutaneously. |
|
Experimental: Experimental
Participants will receive Berobenatide by Subcutaneous Injection. |
Participants will receive berobenatide solution for injection as subcutaneous injection.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percent change from baseline in body weight
Time Frame: Baseline, Week 32
|
Baseline, Week 32
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from baseline in body weight
Time Frame: Baseline, Week 32
|
Baseline, Week 32
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame: Baseline, Week 32
|
Baseline, Week 32
|
|
Number of Participants with Serious adverse events (SAEs)
Time Frame: Baseline, Week 32
|
Baseline, Week 32
|
|
Number of Participants with adverse events leading to discontinuation
Time Frame: Baseline, Week 32
|
Baseline, Week 32
|
|
Number of Participants with Adverse Events of Special Interest (AESIs)
Time Frame: Baseline, Week 32
|
Baseline, Week 32
|
|
Number of Participants with Clinical Laboratory Abnormalities
Time Frame: Baseline, Week 32
|
Baseline, Week 32
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Overnutrition
- Body Weight
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Overweight
- Obesity
- Nutrition Disorders
- Amino Acids, Peptides, and Proteins
- Proteins
- Glucagon-Like Peptide-1 Receptor
- Glucagon-Like Peptide Receptors
- Receptors, G-Protein-Coupled
- Receptors, Cell Surface
- Membrane Proteins
- Receptors, Gastrointestinal Hormone
- Receptors, Peptide
- Tirzepatide
- semaglutide
Other Study ID Numbers
- C6491015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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