A Study to Learn About the Study Medicine Called Berobenatide (PF-08653944) in People With Overweight or Obesity
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPfizer
About this trial
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
Qualifiers
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.
Disqualifiers
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 design
Treatments tested in this trial
- PF-08653944
- Placebo
Treatment groups
954 Participants
are divided into 5 treatment groupsLocations
9California
ClearVue Eye Care95661, Roseville United States
Clinical Trials Research95821, Sacramento United States
Florida
Nature Coast Clinical Research34429, Crystal River United States
West Coast Eye Institute34461, Lecanto United States
Sponsors and collaborators
Pfizer
Lead sponsor
Source ClinicalTrials.gov