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NCT07595549PHASE3Recruiting

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

Pfizer

Start Date

6/10/2026

Completion Date

6/21/2028

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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).

Interventions

DRUG

PF-08653944

OTHER

Placebo

Interested in This Trial?

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Conditions

ObesityOverweight and/or ObesityOverweight

Locations

San Fernando Valley Health Institute

Canoga Park, California 91304

United States

Headlands Research California, LLC

Escondido, California 92025

United States

ImmuniMet, LLC

Modesto, California 95350

United States

Clinical Trials Research

Sacramento, California 95821

United States

University Clinical Investigators, Inc.

Tustin, California 92780

United States

Diablo Clinical Research, Inc.

Walnut Creek, California 94598

United States

Southern California Retina Specialists

West Hills, California 91307

United States

Nature Coast Clinical Research

Crystal River, Florida 34429

United States

West Coast Eye Institute

Lecanto, Florida 34461

United States

South Broward Research

Miramar, Florida 33027

United States

Suncoast Clinical Research, Inc.

New Port Richey, Florida 34652

United States

West Coast Medical Associates

New Port Richey, Florida 34652

United States

Center for Diabetes, Obesity and Metabolism Inc

Pembroke Pines, Florida 33024

United States

Cedar Crosse Research Center

Chicago, Illinois 60607

United States

Northwestern University

Chicago, Illinois 60611

United States

Endeavor Health - Family Medicine Administration

Evanston, Illinois 60201

United States

Endeavor Health- Endocrinology Research

Skokie, Illinois 60077

United States

MediSphere Medical Research Center, LLC

Evansville, Indiana 47714

United States

Monroe Biomedical Research

Louisville, Kentucky 40213

United States

Louisville Retina, PLLC

Louisville, Kentucky 40217

United States

Ascension Saint Agnes Heart Care

Baltimore, Maryland 21229

United States

Aa Mrc Llc

Flint, Michigan 48504

United States

University Of Nebraska Medical Center

Omaha, Nebraska 68198

United States

Albuquerque Clinical Trials, Inc.

Albuquerque, New Mexico 87102

United States

Weill Cornell Medicine - Comprehensive Weight Control Center

New York, New York 10021

United States

Rochester Clinical Research, LLC

Rochester, New York 14609

United States

Medication Management, LLC

Greensboro, North Carolina 27401

United States

Accellacare - Wilmington

Wilmington, North Carolina 28401

United States

Jeffrey Coleman, OD

Wilmington, North Carolina 28401

United States

Midwest Eye Center

Cincinnati, Ohio 45202

United States

Velocity Clinical Research, Mt. Auburn

Cincinnati, Ohio 45219

United States

PlanIt Research, LLC (Monitoring Room)

Houston, Texas 77079

United States

PlanIt Research, LLC

Houston, Texas 77079

United States

VIP Trials

San Antonio, Texas 78230

United States

York Clinical Research, LLC

Norfolk, Virginia 23504

United States

Associação de Amparo à Saúde, Ensino e Pesquisa

Brasília, Federal District 71625-175

Brazil

Saraiva & Berlinger Ltda EPP Instituto de Pesquisa Clínica de Campinas

Campinas, São Paulo 13060-080

Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto

São José do Rio Preto, São Paulo 15090-000

Brazil

CEPIC - Centro Paulista de Investigação Clínica

São Paulo, 04266-010

Brazil

Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, 05400-003

Brazil

Ocean West Research Clinic

Surrey, British Columbia V3Z2N6

Canada

GA Research Associates Ltd.

Moncton, New Brunswick E1G 1A7

Canada

Winterberry Research Inc.

Hamilton, Ontario L8J 0B6

Canada

The Wharton Medical Clinic Clinical Trials Inc

Hamilton, Ontario L8L 5G8

Canada

Canadian Phase Onward Inc.

Toronto, Ontario M3J 0K2

Canada

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

Saint-Herblain, Loire Atlantique 44800

France

CHU Montpellier - Hôpital Lapeyronie

Montpellier, 34090

France

Klinische Forschung Schwerin GmbH

Schwerin, Mecklenburg-Vorpommern 19055

Germany

Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Lübeck, Schleswig-Holstein 23562

Germany

RED - lnstitut für medizinische Forschung GmbH

Oldenburg in Holstein, Schleswig-Holstein 23758

Germany

IRCCS MultiMedica

Sesto San Giovanni, Milano 20099

Italy

Medical Corporation Heishinkai OCROM Clinic

Suita, Osaka 565-0853

Japan

Tokyo Center Clinic

Chuo-ku, Tokyo 103-0027

Japan

Tokyo-Eki Center-Building Clinic

Chuo-ku, Tokyo 103-0027

Japan

Fukuwa Clinic

Chuo-ku, Tokyo 104-0031

Japan

Medical Corporation Heishinkai ToCROM Clinic

Shinjuku-ku, Tokyo 160-0008

Japan

Instituto de Diabetes Obesidad y Nutrición S.C.

Cuernavaca, Morelos 62250

Mexico

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

Bialystok, 15-351

Poland

Penta Hospitals Badania Kliniczne sp. z o.o.

Gdansk, 80-546

Poland

Gabinety Medyczne MATUSZEK Beata Matyjaszek-Matuszek Prywatna Praktyka Specjalistyczna

Lublin, 20-064

Poland

Centrum Zdrowia Metabolicznego Pawel Bogdanski

Poznan, 60-589

Poland

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

Wroclaw, 50-107

Poland

Konyang University Hospital

Daejeon, Daejeon 35365

South Korea

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do 14066

South Korea

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do 50612

South Korea

Gachon University Gil Medical Center

Incheon, Incheon-gwangyeoksi 21565

South Korea

Kangbuk Samsung Hospital

Seoul, Seoul- Teukbyeolsi 03181

South Korea

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Comunidad de 28034

Spain

Hospital San Rafael

A Coruña, 15006

Spain

Hospital General Universitario Gregorio Marañon

Madrid, 28007

Spain

Hospital Universitario QuironSalud Madrid

Pozuelo de Alarcón, 28223

Spain

Hospital Universitario Virgen Del Rocio

Seville, 41013

Spain