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ObesityPhase 3NCT07595549

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

A Phase 3 study testing PF-08653944 in people with Obesity and Overweight and/or Obesity, run by Pfizer at 72 sites in 11 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Overweight and/or Obesity, Overweight
What is being tested?
PF-08653944
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
954 participants
Where
72 sitesin 11 countries
Study dates
10 Jun 2026to 21 Jun 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 join

  • 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 locations and contacts

72 sites in 11 countries. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

72 sites in 11 countries

United States35 sites, 30 recruiting

  • Albuquerque Clinical Trials, Inc.

    Albuquerque, New Mexico, 87102

    Recruiting

  • Ascension Saint Agnes Heart Care

    Baltimore, Maryland, 21229

    Recruiting

  • San Fernando Valley Health Institute

    Canoga Park, California, 91304

    Recruiting

  • Cedar Crosse Research Center

    Chicago, Illinois, 60607

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Recruiting

  • Midwest Eye Center

    Cincinnati, Ohio, 45202

    Recruiting

  • Velocity Clinical Research, Mt. Auburn

    Cincinnati, Ohio, 45219

    Recruiting

  • Nature Coast Clinical Research

    Crystal River, Florida, 34429

    Recruiting

  • Headlands Research California, LLC

    Escondido, California, 92025

    Recruiting

  • Endeavor Health - Family Medicine Administration

    Evanston, Illinois, 60201

    Recruiting

  • MediSphere Medical Research Center, LLC

    Evansville, Indiana, 47714

    Recruiting

  • Aa Mrc Llc

    Flint, Michigan, 48504

    Recruiting

  • Medication Management, LLC

    Greensboro, North Carolina, 27401

    Recruiting

  • PlanIt Research, LLC (Monitoring Room)

    Houston, Texas, 77079

    Recruiting

  • PlanIt Research, LLC

    Houston, Texas, 77079

    Recruiting

  • West Coast Eye Institute

    Lecanto, Florida, 34461

    Recruiting

  • Monroe Biomedical Research

    Louisville, Kentucky, 40213

    Active, not recruiting

  • Louisville Retina, PLLC

    Louisville, Kentucky, 40217

    Active, not recruiting

  • South Broward Research

    Miramar, Florida, 33027

    Recruiting

  • ImmuniMet, LLC

    Modesto, California, 95350

    Recruiting

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida, 34652

    Active, not recruiting

  • West Coast Medical Associates

    New Port Richey, Florida, 34652

    Active, not recruiting

  • Weill Cornell Medicine - Comprehensive Weight Control Center

    New York, New York, 10021

    Recruiting

  • York Clinical Research, LLC

    Norfolk, Virginia, 23504

    Recruiting

  • University Of Nebraska Medical Center

    Omaha, Nebraska, 68198

    Recruiting

  • Center for Diabetes, Obesity and Metabolism Inc

    Pembroke Pines, Florida, 33024

    Recruiting

  • Rochester Clinical Research, LLC

    Rochester, New York, 14609

    Active, not recruiting

  • Clinical Trials Research

    Sacramento, California, 95821

    Recruiting

  • VIP Trials

    San Antonio, Texas, 78230

    Recruiting

  • Endeavor Health- Endocrinology Research

    Skokie, Illinois, 60077

    Recruiting

  • University Clinical Investigators, Inc.

    Tustin, California, 92780

    Recruiting

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

    Recruiting

  • Southern California Retina Specialists

    West Hills, California, 91307

    Recruiting

  • Accellacare - Wilmington

    Wilmington, North Carolina, 28401

    Recruiting

  • Jeffrey Coleman, OD

    Wilmington, North Carolina, 28401

    Recruiting

Other trials in United States

Brazil5 sites, 5 recruiting

  • Associação de Amparo à Saúde, Ensino e Pesquisa

    Brasília, Federal District, 71625-175

    Recruiting

  • Saraiva & Berlinger Ltda EPP Instituto de Pesquisa Clínica de Campinas

    Campinas, São Paulo, 13060-080

    Recruiting

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto

    São José do Rio Preto, São Paulo, 15090-000

    Recruiting

  • CEPIC - Centro Paulista de Investigação Clínica

    São Paulo, 04266-010

    Recruiting

  • Hospital das Clínicas da Faculdade de Medicina da USP

    São Paulo, 05400-003

    Recruiting

Other trials in Brazil

Canada5 sites, 5 recruiting

  • Winterberry Research Inc.

    Hamilton, Ontario, L8J 0B6

    Recruiting

  • The Wharton Medical Clinic Clinical Trials Inc

    Hamilton, Ontario, L8L 5G8

    Recruiting

  • GA Research Associates Ltd.

    Moncton, New Brunswick, E1G 1A7

    Recruiting

  • Ocean West Research Clinic

    Surrey, British Columbia, V3Z2N6

    Recruiting

  • Canadian Phase Onward Inc.

    Toronto, Ontario, M3J 0K2

    Recruiting

Other trials in Canada

Japan5 sites, 5 recruiting

  • Tokyo Center Clinic

    Chuo-ku, Tokyo, 103-0027

    Recruiting

  • Tokyo-Eki Center-Building Clinic

    Chuo-ku, Tokyo, 103-0027

    Recruiting

  • Fukuwa Clinic

    Chuo-ku, Tokyo, 104-0031

    Recruiting

  • Medical Corporation Heishinkai ToCROM Clinic

    Shinjuku-ku, Tokyo, 160-0008

    Recruiting

  • Medical Corporation Heishinkai OCROM Clinic

    Suita, Osaka, 565-0853

    Recruiting

Other trials in Japan

Poland5 sites, 5 recruiting

  • ZDROWIE OSTEO-MEDIC s.c. L i A Racewicz, A i J Supronik

    Bialystok, 15-351

    Recruiting

  • Penta Hospitals Badania Kliniczne sp. z o.o.

    Gdansk, 80-546

    Recruiting

  • Gabinety Medyczne MATUSZEK Beata Matyjaszek-Matuszek Prywatna Praktyka Specjalistyczna

    Lublin, 20-064

    Recruiting

  • Centrum Zdrowia Metabolicznego Pawel Bogdanski

    Poznan, 60-589

    Recruiting

  • Centrum Medyczne AD-MED Sp. z o.o.

    Wroclaw, 50-107

    Recruiting

Other trials in Poland

South Korea5 sites, 5 recruiting

  • Hallym University Sacred Heart Hospital

    Anyang-si, Gyeonggi-do, 14066

    Recruiting

  • Konyang University Hospital

    Daejeon, Daejeon, 35365

    Recruiting

  • Gachon University Gil Medical Center

    Incheon, Incheon-gwangyeoksi, 21565

    Recruiting

  • Kangbuk Samsung Hospital

    Seoul, Seoul- Teukbyeolsi, 03181

    Recruiting

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsangnam-do, 50612

    Recruiting

Other trials in South Korea

Spain5 sites, 5 recruiting

  • Hospital San Rafael

    A Coruña, 15006

    Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, Comunidad de, 28034

    Recruiting

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

    Recruiting

  • Hospital Universitario QuironSalud Madrid

    Pozuelo de Alarcón, 28223

    Recruiting

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

    Recruiting

Other trials in Spain

Germany3 sites, 3 recruiting

  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck

    Lübeck, Schleswig-Holstein, 23562

    Not yet recruiting

  • RED - lnstitut für medizinische Forschung GmbH

    Oldenburg in Holstein, Schleswig-Holstein, 23758

    Recruiting

  • Klinische Forschung Schwerin GmbH

    Schwerin, Mecklenburg-Vorpommern, 19055

    Recruiting

Other trials in Germany

France2 sites, 2 recruiting

  • CHU Montpellier - Hôpital Lapeyronie

    Montpellier, 34090

    Not yet recruiting

  • Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes

    Saint-Herblain, Loire Atlantique, 44800

    Not yet recruiting

Other trials in France

Italy1 site, 1 recruiting

  • IRCCS MultiMedica

    Sesto San Giovanni, Milano, 20099

    Recruiting

Other trials in Italy

Mexico1 site, 1 recruiting

  • Instituto de Diabetes Obesidad y Nutrición S.C.

    Cuernavaca, Morelos, 62250

    Not yet recruiting

Other trials in Mexico

About this study

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)

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.

Being tested
PF-08653944, Placebo
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
Medical subject headings
Obesity, Overweight, Overnutrition, Nutrition Disorders, Diabetes Mellitus, Type 2, Body Weight, Diabetes Mellitus, Glucose Metabolism Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-08653944Drug

    By Subcutaneous Injection

  • PlaceboOther

    By Subcutaneous Injection

Study groups in NCT07595549
Study groupRoleWhat they receive
Treatment Arm 1ExperimentalParticipants will receive PF-08653944 by Subcutaneous Injection.
Receives: Drug: PF-08653944
Treatment Arm 2ExperimentalParticipants will receive PF-08653944 by Subcutaneous Injection.
Receives: Drug: PF-08653944
Treatment Arm 3ExperimentalParticipants will receive PF-08653944 by Subcutaneous Injection.
Receives: Drug: PF-08653944
Treatment Arm 4ExperimentalParticipants will receive PF-08653944 by Subcutaneous Injection.
Receives: Drug: PF-08653944
PlaceboPlacebo comparatorParticipants will receive matching placebo by Subcutaneous Injection.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent change from baseline in body weight

    Measured: Baseline, Week 72

Secondary outcomes (36)

  1. Change from baseline in body weight

    Measured: Baseline, Week 72

  2. Change from baseline in waist circumference

    Measured: Baseline, Week 72

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

    Measured: Baseline, Week 72

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

    Measured: Baseline, Week 72

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

    Measured: Baseline, Week 72

  6. Percentage of Participants achieving ≥20% of body weight reduction from baseline

    Measured: Baseline, Week 72

  7. Percentage of Participants with a waist-to-height ratio of <0.53

    Measured: Baseline, Week 72

  8. Percent change from baseline in body weight in participants with type 2 diabetes

    Measured: Baseline, Week 72

  9. Change from baseline in Systolic Blood Pressure (SBP)

    Measured: Baseline, Week 72

  10. Change from baseline in Impact of Weight on Quality of Life-Lite-Clinical Trial (IWQoL-Lite-CT) Physical Function composite score

    Measured: Baseline, Week 72

  11. Percentage of Participants achieving ≥25% of body weight reduction from baseline

    Measured: Baseline, Week 72

  12. Change from baseline in Diastolic Blood Pressure (DBP)

    Measured: Baseline, Week 72

  13. Change from Baseline in Fasting Glucose

    Measured: Basline, Week 72

  14. Change from Baseline in Fasting insulin

    Measured: Baseline, Week 72

  15. Change from Baseline in revised Homeostatic Model Assessment insulin sensitivity as a percentage of normal (HOMA2-%S)

    Measured: Baseline, Week 72

  16. Change from Baseline in revised Homeostatic Model Assessment beta-cell function as a percentage of a normal reference population (HOMA2-%B)

    Measured: Baseline, Week 72

  17. Change from Baseline in HbA1c

    Measured: Baseline, Week 72

  18. Change from baseline in Fasting Total Cholesterol

    Measured: Baseline, Week 72

  19. Change from baseline in Fasting Low-density lipoprotein cholesterol

    Measured: Baseline, Week 72

  20. Change from baseline in Fasting Very low-density lipoprotein cholesterol

    Measured: Baseline, Week 72

  21. Change from baseline in Fasting Non-High-density lipoprotein cholesterol

    Measured: Baseline, Week 72

  22. Change from baseline in Fasting High-density lipoprotein cholesterol

    Measured: Baseline, Week 72

  23. Change from baseline in Fasting triglycerides

    Measured: Baseline, Week 72

  24. Change from baseline in high-sensitivity C-reactive protein

    Measured: Baseline, Week 72

  25. Change from baseline in interleukin-6

    Measured: Baseline, Week 72

  26. Change from baseline in interleukin-1 beta

    Measured: Baseline, Week 72

  27. Change from baseline in IWQoL-Lite-CT total score

    Measured: Baseline, Week 72

  28. Change from baseline in IWQoL-Lite-CT Physical composite score

    Measured: Baseline, Week 72

  29. Change from baseline in IWQoL-Lite-CT Psychosocial composite score

    Measured: Baseline, Week 72

  30. Change from baseline in Short Form 36 health survey (SF-36) domain scales and component summary scales

    Measured: Baseline, Week 72

  31. Change from Baseline in Control of Eating Questionnaire (CoEQ) subscales

    Measured: Baseline, Week 72

  32. Change from Baseline in Food Noise Questionnaire (FNQ) total score

    Measured: Baseline, Week 72

  33. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Measured: Baseline, Week 72

  34. Number of Participants with Serious adverse events (SAEs)

    Measured: Baseline, Week 72

  35. Number of Participants with adverse avents leading to discontinuation

    Measured: Baseline, Week 72

  36. Number of Participants with Adverse Events of Special Interest (AESIs)

    Measured: Baseline, Week 72

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2026
  2. Study start10 Jun 2026
  3. Primary completion4 May 2028 (estimated)
  4. Study completion21 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
954 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07595549
Sponsor's protocol ID
C6491013
Other IDs
VESPER-6, 2026-525318-75-00
Status last verified
Oct 2026
First submitted
12 May 2026
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PF-08653944 in people with Obesity and Overweight and/or Obesity, run by Pfizer at 72 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United States, Brazil, Canada, Japan, Poland and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent change from baseline in body weight (time frame: Baseline, Week 72). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07595549.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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Clinical Trial NCT07595549 | AzTrials