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

NCT07400653 · Pfizer
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Official 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)
About this study
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.
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
Study design
Enrollment target: 999 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2026-02-24
Estimated completion: 2028-05-16
Last updated: 2026-03-30
Interventions
Drug: PF-08653944Other: Placebo
Primary outcomes
  • Percent Change from baseline in body weight (Baseline, Week 64)
Sponsor
Pfizer · industry
Contacts & investigators
ContactPfizer CT.gov Call Center · contact · ClinicalTrials.gov_Inquiries@pfizer.com · 1-800-718-1021
InvestigatorPfizer CT.gov Call Center · study_director, Pfizer
All locations (184)
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Instituto de Investigaciones Clinicas CordobaNot Yet Recruiting
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CIPADI - Centro Integral de Prevencion Y Atencion en DiabetesNot Yet Recruiting
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IIC Mar del PlataNot Yet Recruiting
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CIAD MoronNot Yet Recruiting
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MC Nova ClinicNot Yet Recruiting
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LMC EtobicokeNot Yet Recruiting
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The Wharton Medical Clinic Clinical Trials IncNot Yet Recruiting
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LMC Diabetes & Endocrinology - Bayview (Centricity Research Toronto LMC Multispecialty)Not Yet Recruiting
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Manna Research MirabelNot Yet Recruiting
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Diacentrum Brandys n.L.Not Yet Recruiting
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Nemocnice JihlavaNot Yet Recruiting
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PratiaNot Yet Recruiting
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Medizentrum Essen BorbeckNot Yet Recruiting
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Praxis am Markt - Dr. Bernd BeckerNot Yet Recruiting
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Klinische Forschung Hamburg GmbH / PratiaNot Yet Recruiting
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Diabetes Studienzentrum WilhelmsburgNot Yet Recruiting
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DZHWNot Yet Recruiting
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Praxis Reinfeld MitteNot Yet Recruiting
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Zentrum fuer klinische Forschung Koeln DuennwaldNot Yet Recruiting
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FutureMeds Frankfurt/OffenbachNot Yet Recruiting
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Zdrowie Osteo Medic sc L i A Racewicz, A i J SupronikNot Yet Recruiting
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Centrum Medyczne Pratia GdyniaNot Yet Recruiting
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Etg WarszawaNot Yet Recruiting
Warsaw, Poland
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Futuremeds S.R.L., BrasovNot Yet Recruiting
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Fundatia Dr Victor BabesNot Yet Recruiting
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Institutul Clinic FundeniNot Yet Recruiting
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Institutul National de Endocrinologie "C.I. Parhon"Not Yet Recruiting
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Futuremeds S.R.L., CraiovaNot Yet Recruiting
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Futuremeds S.R.L., GalatiNot Yet Recruiting
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Centru Medical "GRANDMED"Not Yet Recruiting
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Sc Gensan Srl/Policlinica AstraNot Yet Recruiting
Sibiu, Romania
Centrul Medical Mediab - Mediab SrlNot Yet Recruiting
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MedispektrumNot Yet Recruiting
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DIABEDA s.r.o.Not Yet Recruiting
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Poliklinika Váš LekárNot Yet Recruiting
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Medical group Kosice s.r.o.Not Yet Recruiting
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Tatratrial s.r.o.Not Yet Recruiting
Rožňava, Slovakia
JAL s.r.o.Not Yet Recruiting
Trnava, Slovakia
Medivasa sroNot Yet Recruiting
Žilina, Slovakia
Hospital Universitario Torrecárdenas (CPE Bola Azul)Not Yet Recruiting
Almería, Spain
Hospital Universitari Vall d'HebronNot Yet Recruiting
Barcelona, Spain
Hospital Vithas SevillaNot Yet Recruiting
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Futuremeds Spain CadizNot Yet Recruiting
Chiclana de la Frontera, Spain
Futuremeds Spain MadridNot Yet Recruiting
Madrid, Spain
Hospital Universitario Virgen de la VictoriaNot Yet Recruiting
Málaga, Spain
Hospital Universitari Son EspasesNot Yet Recruiting
Palma, Spain
Hospital Virgen del CaminoNot Yet Recruiting
Sanlúcar de Barrameda, Spain
Nuevas Tecnologías en Diabetes y Endocrinología S.L.Not Yet Recruiting
Seville, Spain
Futuremeds Spain SevillaNot Yet Recruiting
Seville, Spain
Ecg Médica S.L.Not Yet Recruiting
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Bodyline Medical Clinic WarringtonNot Yet Recruiting
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Civia Health SunderlandNot Yet Recruiting
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Bodyline Medical Clinic St HelensNot Yet Recruiting
St Helens, Liverpool, United Kingdom
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Openshaw, Manchester, United Kingdom
Boots NottinghamNot Yet Recruiting
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FutureMeds Glasgow McCafferty HouseNot Yet Recruiting
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Bodyline Medical Clinic Stoke on TrentNot Yet Recruiting
Stoke-on-Trent, Staffordshire, United Kingdom
Synexus/Trialmed GlasgowNot Yet Recruiting
Bellshill, United Kingdom
Synexus/Trialmed MidlandsNot Yet Recruiting
Birmingham, United Kingdom
FutureMeds BirminghamNot Yet Recruiting
Birmingham, United Kingdom
Boots BirminghamNot Yet Recruiting
Birmingham, United Kingdom
Civia Health_Boots BrightonNot Yet Recruiting
Brighton, United Kingdom
Southmead HospitalNot Yet Recruiting
Bristol, United Kingdom
FutureMeds LiverpoolNot Yet Recruiting
Bromborough, United Kingdom
Synexus/Trialmed CardiffNot Yet Recruiting
Cardiff, United Kingdom
Panthera Biopartners Limited - EnfieldNot Yet Recruiting
Enfield, United Kingdom
Panthera Biopartners Limited - GlasgowNot Yet Recruiting
Glasgow, United Kingdom
Bodyline Medical Clinic CrosbyNot Yet Recruiting
Liverpool, United Kingdom
FutureMeds LondonNot Yet Recruiting
London, United Kingdom
Synexus/Trialmed ManchesterNot Yet Recruiting
Manchester, United Kingdom
Kiltearn Medical CentreNot Yet Recruiting
Nantwich, United Kingdom
FutureMeds NewcastleNot Yet Recruiting
Newcastle upon Tyne, United Kingdom
DANES Medical CentreNot Yet Recruiting
Northampton, United Kingdom
Civia Health_Boots PeterboroughNot Yet Recruiting
Peterborough, United Kingdom
Panthera Biopartners Limited - PrestonNot Yet Recruiting
Preston, United Kingdom
Panthera Biopartners Limited - RochdaleNot Yet Recruiting
Rochdale, United Kingdom
Clifton Medical CentreNot Yet Recruiting
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Sandbach GPsNot Yet Recruiting
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Panthera Biopartners Limited - SheffieldNot Yet Recruiting
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Staploe Medical CentreNot Yet Recruiting
Soham, United Kingdom
FutureMeds TeessideNot Yet Recruiting
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Panthera Biopartners Limited - YorkNot Yet Recruiting
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