Status:
RECRUITING
A Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D)
Lead Sponsor:
Pfizer
Conditions:
Obesity
Overweight and/or Obesity
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 m...
Eligibility Criteria
Inclusion Criteria:
-
Provision of signed and dated informed consent form (ICF)
-
Male or female adults, aged ≥18 years
-
Have a BMI at Screening of ≥27.0 kg/m2
-
Have T2DM for at least 6 months before Screening based on participant reported history or documentation of the disease diagnostic criteria
-
Have HbA1c value between ≥6.5% (48 mmol/mol) and ≤10.0% (86.0 mmol/mol) at Screening with stable therapy for at least 90 days prior to Screening/Visit 1. T2DM may be treated with:
--Diet and exercise alone or in combination with: Any oral antidiabetic therapy per local labeling EXCEPT DPP-4 inhibitors. Participant may NOT be on GLP-1 agonists or insulin
-
Participants must be motivated and willing to:
- Self-inject study medication (or be aided by caregiver if needed),
- Perform finger-stick glucose monitoring as required.
-
Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
Exclusion Criteria:
- Female who is breastfeeding, or who is pregnant
- Unwilling or unable to follow contraceptive requirements
- Diagnosis of Type 1 diabetes, or any other types of diabetes except T2DM.
- Severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to Screening
- Poorly controlled hypertension
- Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed >1 year prior to screening)
- Have taken within 3 months prior to randomization, medications (prescribed or over-the counter) intended to promote weight loss
- Are receiving or have received within 3 months prior to screening chronic (>2 weeks or 14 days) systemic glucocorticoid therapy
Key Trial Info
Start Date :
February 24 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 16 2028
Estimated Enrollment :
999 Patients enrolled
Trial Details
Trial ID
NCT07400653
Start Date
February 24 2026
End Date
May 16 2028
Last Update
March 30 2026
Active Locations (184)
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1
CenExel Anaheim Clinical Trials
Anaheim, California, United States, 92801
2
Alliance Research Institute
Canoga Park, California, United States, 91304
3
Core Healthcare Group
Cerritos, California, United States, 90703
4
CenExel CNS - Collaborative Neuroscience Research
Los Alamitos, California, United States, 90720