Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07400653

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CEDIC, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PF-08653944

Drug

By Subcutaneous Injection

Other names: MET097

Placebo

Other

By Subcutaneous Injection

Primary outcomes

  1. Percent Change from baseline in body weight

    Time frame: Baseline, Week 64

Secondary outcomes

  1. Change from baseline in body weight

    Time frame: Baseline, Week 64 and 84

  2. Change in HbA1c (%) from baseline

    Time frame: Baseline, Week 64 and 84

  3. Percentage of Participants achieving ≥5% of body weight reduction from baseline

    Time frame: Baseline, Week 64 and 84

  4. Percentage of Participants achieving ≥10% of body weight reduction from baseline

    Time frame: Baseline, Week 64 and 84

  5. Percentage of Participants achieving ≥15% of body weight reduction from baseline

    Time frame: Baseline, Week 64 and 84

  6. Percentage of Participants achieving ≥20% of body weight reduction from baseline

    Time frame: Baseline, Week 64 and 84

  7. Change from baseline in Fasting triglycerides

    Time frame: Baseline, Week 64 and 84

  8. Change from baseline in Non-high-density lipoprotein cholesterol (non-HDL-C)

    Time frame: Baseline, Week 64 and 84

  9. Change from baseline in Systolic Blood Pressure (SBP)

    Time frame: Baseline, Week 64 and 84

  10. Change from baseline in Short Form 36 health survey (SF-36) physical function domain score

    Time frame: Baseline, Week 64 and 84

  11. Percent change from baseline in body weight

    Time frame: Baseline, Week 84

  12. Change from baseline in waist circumference

    Time frame: Baseline, Week 64 and 84

  13. Percentage of Participants Achieving HbA1c <7%

    Time frame: Week 64 and Week 84

  14. Percentage of Participants Achieving HbA1c ≤6.5%

    Time frame: Week 64 and Week 84

  15. Percentage of Participants Achieving HbA1c <5.7%

    Time frame: Week 64 and Week 84

  16. Change from Baseline in Fasting Glucose

    Time frame: Baseline, Week 64 and 84

  17. Change from Baseline in Fasting insulin

    Time frame: Baseline, Week 64 and 84

  18. Change from baseline in Total Cholesterol

    Time frame: Baseline, Week 64 and 84

  19. Change from baseline in Low-density lipoprotein cholesterol

    Time frame: Baseline, Week 64 and 84

  20. Change from baseline in Very low-density lipoprotein cholesterol

    Time frame: Baseline, Week 64 and 84

  21. Change from baseline in High-density lipoprotein cholesterol

    Time frame: Baseline, Week 64 and 84

  22. Change from Baseline in Diastolic Blood Pressure (DBP)

    Time frame: Baseline, Week 64 and 84

  23. Percent change from baseline in high-sensitivity C-reactive protein

    Time frame: Baseline, Week 64 and 84

  24. Change from Baseline in EuroQoL 5-Dimension 5-Level (EQ5D-5L)

    Time frame: Baseline, Week 64 and 84

  25. Change from Baseline in Control of Eating Questionnaire (CoEQ)

    Time frame: Baseline, Week 64 and 84

  26. Change from Baseline in Food Noise Questionnaire (FNQ)

    Time frame: Baseline, Week 64 and 84

  27. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: Week 84

  28. Number of Participants with Serious adverse events (SAEs)

    Time frame: Week 84

  29. Number of Participants with Adverse Events of Clinical Interest (AECIs)

    Time frame: Week 84

  30. Number of Participants With Clinical Laboratory Abnormalities

    Time frame: Week 84

  31. Number of participants with anti-drug antibodies (ADAs)

    Time frame: Week 84

  32. Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of PF-08653944

    Time frame: Week 84

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

EVALUATING THE EFFICACY AND SAFETY OF MET097, A FULLY-BIASED ULTRA LONG-ACTING GLP-1RA, IN PEOPLE WITH OVERWEIGHT OR OBESITY AND TYPE 2 DIABETES: A PHASE 3, MULTI-CENTER RANDOMIZED PLACEBO-CONTROLLED TRIAL (VESPER-5)

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 10, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.