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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Page 1 of 46 (184 locations)

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

A Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D) | DecenTrialz