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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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).

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment Arm 1 		Participants will receive PF-08653944 by Subcutaneous Injection.
  • Drug: PF-08653944
    By Subcutaneous Injection
Experimental
Treatment Arm 2 		Participants will receive PF-08653944 by Subcutaneous Injection.
  • Drug: PF-08653944
    By Subcutaneous Injection
Experimental
Treatment Arm 3 		Participants will receive PF-08653944 by Subcutaneous Injection.
  • Drug: PF-08653944
    By Subcutaneous Injection
Experimental
Treatment Arm 4 		Participants will receive PF-08653944 by Subcutaneous Injection.
  • Drug: PF-08653944
    By Subcutaneous Injection
Placebo Comparator
Placebo 		Participants will receive matching placebo by Subcutaneous Injection.
  • Other: Placebo
    By Subcutaneous Injection

Recruiting Locations

ClearVue Eye Care
Roseville, California 95661

Clinical Trials Research
Sacramento, California 95821

Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico 87102

Rochester Clinical Research, LLC
Rochester, New York 14609

Midwest Eye Center
Cincinnati, Ohio 45202

Velocity Clinical Research, Mt. Auburn
Cincinnati, Ohio 45219

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.