Actively Recruiting
Evaluating the Safety and Efficacy of PF-08653944 in Adults With Overweight or Obesity and Type 2 Diabetes A Phase 3 Randomized Placebo-Controlled Trial
Led by Pfizer · Updated on 2026-05-18
999
Participants Needed
183
Research Sites
31 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand the safety and effects of a study medicine called PF-08653944 in adults who are overweight or obese and have type 2 diabetes. Type 2 diabetes is a condition where there is too much sugar in the blood, and being overweight means carrying excess body weight. The study is a phase 3, randomized, placebo-controlled trial sponsored by Pfizer to evaluate this medicines impact on weight loss and diabetes management. Participants will receive the study medicine or a placebo via a shot under the skin in the belly area once every week. About 660 out of 1000 participants will get the study medicine while about 330 out of 1000 will receive a placebo, which looks like the medicine but contains no active drug. The study will last about 21 months and involve approximately 14 in-person visits and 5 phone visits. During the study, participants will be trained to self-inject the medicine at home. Researchers will monitor changes in body weight, blood sugar control HbA1c, waist size, blood pressure, cholesterol levels, and quality of life through various tests and questionnaires at baseline and weeks 64 and 84. Safety will be tracked by recording any side effects or lab abnormalities. The main outcome is the percentage change in body weight from the start of the study to week 64.
CONDITIONS
Brief Title
A Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Male or female adults aged 18 years or older
- Body mass index (BMI) of 27.0 kg/m2 or higher at screening
- Diagnosed with type 2 diabetes for at least 6 months before screening
- HbA1c between 6.5% and 10.0% at screening with stable therapy for at least 90 days
- Type 2 diabetes may be treated with diet and exercise alone or with oral antidiabetic drugs except DPP-4 inhibitors
- Not currently on GLP-1 agonists or insulin
- Motivated and willing to self-inject study medication or be assisted by a caregiver
- Willing to perform finger-stick glucose monitoring as required
- History of at least one unsuccessful attempt to lose weight through diet
You will not qualify if you...
- Female who is pregnant or breastfeeding
- Unwilling or unable to follow contraceptive requirements
- Diagnosis of type 1 diabetes or other diabetes types except type 2 diabetes
- Severe hypoglycemia or hypoglycemia unawareness within 6 months before screening
- Poorly controlled hypertension
- Prior or planned surgical treatment for obesity (except liposuction or abdominoplasty if done more than 1 year before screening)
- Use of medications intended for weight loss within 3 months prior to randomization
- Use of chronic systemic glucocorticoid therapy for more than 2 weeks within 3 months before screening
Research Team
P
Pfizer CT.gov Call Center
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