954 Participants NeededMy employer runs this trial

Berobenatide for Obesity

Recruiting at 50 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Pfizer
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for adults aged 18 or older who are overweight or have obesity. People can join if their BMI is at least 30, or between 27 and 30 with a weight-related health issue like high blood pressure, high cholesterol, sleep apnea, heart disease, or type 2 diabetes.

Inclusion Criteria

I am 18 years old or older.
* 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive berobenatide or placebo by subcutaneous injection to assess efficacy and safety

20 months
15 visits (in-person), 2 visits (phone)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares berobenatide (PF-08653944), given as an injection under the skin in the belly area, to a placebo that looks the same but has no medicine. About 950 participants will be randomly assigned to either group and followed for about 20 months.

How Is the Trial Designed?

5

Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment Arm 4Experimental Treatment1 Intervention
Group II: Treatment Arm 3Experimental Treatment1 Intervention
Group III: Treatment Arm 2Experimental Treatment1 Intervention
Group IV: Treatment Arm 1Experimental Treatment1 Intervention
Group V: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University