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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

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

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)

A Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D) (NCT07400653) is a Phase 3 interventional studying Obesity and Overweight and/or Obesity, sponsored by Pfizer. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Obesity, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 999 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: - Provision of signed and dated willing to sign a consent form 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. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

PF-08653944

By Subcutaneous Injection

OTHER

Placebo

By Subcutaneous Injection

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

CenExel Anaheim Clinical Trials
Anaheim, California, United States
Alliance Research Institute
Canoga Park, California, United States
Core Healthcare Group
Cerritos, California, United States
CenExel CNS - Collaborative Neuroscience Research
Los Alamitos, California, United States
Cure Clinical Research
Orange, California, United States
CenExel CIT
Riverside, California, United States
CenExel Denver CO (Rocky Mountain Clinical Research)
Englewood, Colorado, United States
Miami Eye Institute
Hollywood, Florida, United States
Research Centers of America
Hollywood, Florida, United States
Future Medical Research (Civia Health)
Longwood, Florida, United States
Advanced Clinical Research
Miami, Florida, United States
Oviedo Medical Research
Oviedo, Florida, United States
CenExel FCR - ForCare Clinical Research
Tampa, Florida, United States
DelRicht Research
Atlanta, Georgia, United States
CenExel iResearch, LLC
Decatur, Georgia, United States
CenExel iResearch, LLC
Savannah, Georgia, United States
Patient First Clinical Trials (PFCTRIALS)
Lutherville, Maryland, United States
Civia Health St. Louis
Creve Coeur, Missouri, United States
Civia Health Independence
Independence, Missouri, United States
DelRicht Research @ Command Family Medicine
Springfield, Missouri, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07400653), the sponsor (Pfizer), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07400653 clinical trial studying?

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 a… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07400653?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07400653?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07400653. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07400653. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.