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Recruiting Phase 3

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

About this study

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.

Condition
Obesity, Overweight and/or Obesity, Overweight
Tested
PF-08653944, Placebo
Sponsor
Pfizer

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 4

  • Minimum age: 18 years
  • Study condition: Obesity, Overweight and/or Obesity, Overweight
  • 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 4

  • 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

58 sites, 58 recruiting

Saraiva & Berlinger Ltda EPP Instituto de Pesquisa Clínica de Campinas

Campinas, São Paulo, Brazil

Recruiting

Fundação Faculdade Regional de Medicina de São José do Rio Preto

São José do Rio Preto, São Paulo, Brazil

Recruiting

CEPIC - Centro Paulista de Investigação Clínica

São Paulo, Brazil

Recruiting

Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, Brazil

Recruiting

Winterberry Research Inc.

Hamilton, Ontario, Canada

Recruiting

The Wharton Medical Clinic Clinical Trials Inc

Hamilton, Ontario, Canada

Recruiting

and 52 more sites on ClinicalTrials.gov

Contact

Potential match only. Final eligibility is determined by the study team.