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PF-08653944 injections for weight loss in adults with overweight or obesity and type 2 diabetes

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)

Phase 3 Interventional Pfizer · NCT07400653

This test tries a weekly injectable medicine (PF-08653944) to help adults with overweight or obesity and type 2 diabetes lose weight.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment999 (estimated)
Ages18 Years and up
SexAll
SponsorPfizer Industry-sponsored
Locations184 sites (Anaheim, California and 183 other locations)
Trial IDNCT07400653 on ClinicalTrials.gov

What this trial studies

This is a randomized, placebo-controlled Phase 3 study that will enroll about 1,000 adults and assign roughly two-thirds to receive PF-08653944 and one-third to receive placebo. The medicine is given by a weekly subcutaneous injection that participants are trained to self-administer at home, and the study lasts about 21 months with roughly 14 in-person visits and 5 phone visits. Eligible participants have BMI ≥27 kg/m2, type 2 diabetes for at least 6 months, and an HbA1c between 6.5% and 10.0% while on stable non‑insulin therapy; GLP-1 agonists, insulin, and DPP-4 inhibitors are not allowed. Investigators will compare safety, weight change, and metabolic outcomes between the PF-08653944 and placebo groups over the treatment period.

Who should consider this trial

Good fit: Adults ≥18 years with BMI ≥27 kg/m2, type 2 diabetes for ≥6 months, HbA1c 6.5–10.0% on stable non‑insulin therapy (no GLP‑1 agonists or DPP‑4 inhibitors), who can self‑inject and commit to study visits are the intended participants.

Not a fit: People on insulin or GLP‑1 treatments, those with HbA1c outside the 6.5–10.0% range, pregnant or breastfeeding individuals, or anyone unable/unwilling to self‑inject or attend scheduled visits are unlikely to be eligible or to benefit from this study.

Why it matters

Potential benefit: If effective, PF-08653944 could help people with overweight or obesity and type 2 diabetes lose weight and improve blood sugar control.

How similar studies have performed: Other incretin-class therapies (for example GLP‑1 and dual GIP/GLP‑1 agents) have produced substantial weight loss and better glycemic control in people with obesity and type 2 diabetes, so this approach has precedent.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Anaheim, California and 183 other locations

+134 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions ObesityOverweight and/or ObesityOverweightDiabetes, Type 2Type 2 DiabetesOvernutritionNutrition DisordersNutritional and Metabolic Diseases
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.