PF-08653944 for Obesity and Type 2 Diabetes

Recruiting at 183 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

999 Participants Needed

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 safety and effects of the study medicine to help adults with obesity or overweight and type 2 diabetes lose weight. Being overweight or obese means carrying too much body weight. Type 2 diabetes is a condition where there is too much sugar in the blood.

The study medicine is given by a shot under the skin in the belly area. The participants will be trained to do this at home once every week.

About 660 out of 1000 adults will also receive the study medicine and about 330 out of 1000 adults will receive placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. The investigators will compare the experiences of people receiving the study medicine to those of the people who do not. This will help us assess if the study medicine is safe and effective.

People will take part in this study for about 21 months. During this time, they will have about 14 study visits at the site and 5 over the phone.

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

Inclusion Criteria

My BMI is 27 or higher.

I am 18 years old or older.

Participants must be motivated and willing to self-inject study medication (or be aided by caregiver if needed) and perform finger-stick glucose monitoring as required

Exclusion Criteria

I am currently pregnant or breastfeeding.

I have had or plan to have weight loss surgery.

I have taken steroid medications for more than 2 weeks in the past 3 months.

What Are the Treatments Tested in This Trial?

Interventions

• PF-08653944
• Placebo

How Is the Trial Designed?

Group I: Treatment Arm 3 Experimental Treatment 1 Intervention

Participants will receive PF-08653944 by Subcutaneous Injection.

Group II: Treatment Arm 2 Experimental Treatment 1 Intervention

Participants will receive PF-08653944 by Subcutaneous Injection.

Group III: Treatment Arm 1 Experimental Treatment 1 Intervention

Participants will receive PF-08653944 by Subcutaneous Injection.

Group IV: Placebo Placebo Group 1 Intervention

Participants will receive matching placebo by Subcutaneous Injection.

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

Pfizer

Chief Medical Officer

MD from McGill University