Berobenatide Compared With Placebo in Adults With Overweight or Obesity
Tests berobenatide against placebo in adults living with overweight or obesity.
Key facts
- Who runs it
- Pfizer
- Where
- Brasília, Campinas, São José do Rio Preto, and São Paulo, BrazilSee the 5 sitesAlso in 10 other countries, 76 sites
- Trial code
- Registry title
- A Study to Learn About the Study Medicine Called Berobenatide (PF-08653944) in People With Overweight or Obesity
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 954 people, planned
- Started
- 10 Jun 2026
- Expected to end
- 21 Jun 2028
- Type of study
- Interventional, 5 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- PF-08653944
- Placebo
- Record updated
- 5 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with overweight or obesity. Some may also have type 2 diabetes. It tests a once-monthly shot of berobenatide (PF-08653944) against a placebo.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- BMI of ≥30 kg/m2, or BMI of ≥27.0 kg/m2 to <30.0 kg/m2 plus at least 1 weight-related health problem: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2D.
Main reasons for not taking part
- Self-reported body weight change of more than 5% within 90 days before screening
- Type 1 diabetes or any 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)
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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)
Where in Brazil
Also in 10 other countries, 76 sites
- Associação de Amparo à Saúde, Ensino e PesquisaBrasília, BrazilTaking people
- Saraiva & Berlinger Ltda EPP Instituto de Pesquisa Clínica de CampinasCampinas, BrazilTaking people
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio PretoSão José do Rio Preto, BrazilTaking people
- CEPIC - Centro Paulista de Investigação ClínicaSão Paulo, BrazilTaking people
- Hospital das Clinicas da Faculdade de Medicina da USPSão Paulo, BrazilTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 5 groups in the trial
- Treatment Arm 1Treatment being tested
Participants will receive PF-08653944 by Subcutaneous Injection.
Treatment: PF-08653944
- Treatment Arm 2Treatment being tested
Participants will receive PF-08653944 by Subcutaneous Injection.
Treatment: PF-08653944
- Treatment Arm 3Treatment being tested
Participants will receive PF-08653944 by Subcutaneous Injection.
Treatment: PF-08653944
- Treatment Arm 4Treatment being tested
Participants will receive PF-08653944 by Subcutaneous Injection.
Treatment: PF-08653944
- PlaceboPlacebo, for comparison
Participants will receive matching placebo by Subcutaneous Injection.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- 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)
- Plain-language title
- Berobenatide Compared With Placebo in Adults With Overweight or ObesityGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 11 November 2026.
- Record updated
- 5 November 2026