PF-08653944 for Obesity or Overweight and Type 2 Diabetes

This study is looking into the safety and effects of a medicine called PF-08653944 for adults who have obesity (carrying too much body weight) or are overweight, and also have type 2 diabetes (too much sugar in the blood). You could join if you are 18 or older, have a BMI of 27.0 kg/m2 or higher, and have had type 2 diabetes for at least 6 months with an HbA1c between 6.5% and 10.0%. The medicine, PF-08653944, is given as a shot under the skin once a week. Some participants will receive PF-08653944, while others will receive a placebo (a shot with no medicine). The main goal is to see how much your body weight changes from the start of the study to Week 64. The current recruitment status is unclear.

Study design
This is an interventional study with an unclear phase, planning to enroll 1044 participants. About two-thirds of participants will receive PF-08653944, and one-third will receive a placebo.
What's involved
You would receive weekly subcutaneous injections of either PF-08653944 or a placebo, which you would be trained to do at home. Your body weight will be measured at the beginning of the study and again at Week 64.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for changes in body weight up to Week 64.

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NCT07400653

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

Active, Not Recruiting
PHASE3Ages 18+InterventionalTreatment
Pfizer
~1,044 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:PF-08653944Placebo

At a glance

Recruiting sites
0 of 183 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent Change from baseline in body weight
Measured over Baseline, Week 64
Obesity
Overweight and/or Obesity
Overweight
Diabetes, Type 2
Type 2 Diabetes
183 sites across 31 states
Poland26
United Kingdom24
Germany17
Bulgaria14
Florida11
Romania11
Argentina9
California8
  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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
  • Percent Change from baseline in body weightBaseline, Week 64