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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: double
Age groups: adult, older_adult
Timeline
Starts: 2026-02-24
Estimated completion: 2028-05-16
Last updated: 2026-05-18
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 (183)
CenExel Anaheim Clinical TrialsRecruiting
Anaheim, California, United States
Alliance Research InstituteRecruiting
Canoga Park, California, United States
Core Healthcare GroupRecruiting
Cerritos, California, United States
CenExel CNS - Collaborative Neuroscience ResearchRecruiting
Los Alamitos, California, United States
Cure Clinical ResearchRecruiting
Orange, California, United States
CenExel CITRecruiting
Riverside, California, United States
CenExel Denver CO (Rocky Mountain Clinical Research)Recruiting
Englewood, Colorado, United States
Miami Eye InstituteRecruiting
Hollywood, Florida, United States
Research Centers of AmericaRecruiting
Hollywood, Florida, United States
Future Medical Research (Civia Health)Recruiting
Longwood, Florida, United States
Advanced Clinical ResearchRecruiting
Miami, Florida, United States
Oviedo Medical ResearchRecruiting
Oviedo, Florida, United States
CenExel FCR - ForCare Clinical ResearchRecruiting
Tampa, Florida, United States
DelRicht ResearchRecruiting
Atlanta, Georgia, United States
CenExel iResearch, LLCRecruiting
Decatur, Georgia, United States
CenExel iResearch, LLCRecruiting
Savannah, Georgia, United States
Patient First Clinical Trials (PFCTRIALS)Recruiting
Lutherville, Maryland, United States
Civia Health St. LouisNot Yet Recruiting
Creve Coeur, Missouri, United States
Civia Health IndependenceNot Yet Recruiting
Independence, Missouri, United States
DelRicht Research @ Command Family MedicineRecruiting
Springfield, Missouri, United States
Quality Clinical Research IncRecruiting
Omaha, Nebraska, United States
Primary Care Research (Civia Health)Recruiting
Papillion, Nebraska, United States
CenExel HRI - Hassman Research InstituteRecruiting
Marlton, New Jersey, United States
Forum Health_Cary (Civia)Recruiting
Cary, North Carolina, United States
Eximia EquiHealth ResearchRecruiting
Durham, North Carolina, United States
Eximia Research - NC, LLCRecruiting
Raleigh, North Carolina, United States
Civia Health GoodlettsvilleNot Yet Recruiting
Goodlettsville, Tennessee, United States
Civia Health NashvilleNot Yet Recruiting
La Vergne, Tennessee, United States
Civia Health MemphisNot Yet Recruiting
Memphis, Tennessee, United States
Forum Austin (Civia Health)Recruiting
Austin, Texas, United States
GLRI El Paso ResearchRecruiting
El Paso, Texas, United States
Dallas Clinical Research Center (Pillar Clinical Research)Recruiting
Richardson, Texas, United States
Pantheon Clinical ResearchRecruiting
Bountiful, Utah, United States
CenExel Salt Lake City UT (JBR Clinical Research)Recruiting
Salt Lake City, Utah, United States
Murray Vision Center PCRecruiting
Salt Lake City, Utah, United States
CINMENot Yet Recruiting
Buenos Aires, Argentina
CEDICNot Yet Recruiting
Buenos Aires, Argentina
Centro Medico ViamonteNot Yet Recruiting
Buenos Aires, Argentina
Centro Diabetologico Dr WaitmanNot Yet Recruiting
Córdoba, Argentina
Clinica Privada Velez SarsfieldNot Yet Recruiting
Córdoba, Argentina
Instituto de Investigaciones Clinicas CordobaNot Yet Recruiting
Córdoba, Argentina
CIDIMNot Yet Recruiting
Córdoba, Argentina
CIPADI - Centro Integral de Prevencion Y Atencion en DiabetesNot Yet Recruiting
Godoy Cruz, Argentina
IIC Mar del PlataNot Yet Recruiting
Mar del Plata, Argentina
CIAD MoronNot Yet Recruiting
Morón, Argentina
Centro Medico Privado de ReumatologiaNot Yet Recruiting
San Miguel de Tucumán, Argentina
Instituto Medico Catamarca (IMEC)Not Yet Recruiting
Santa Fe, Argentina
MHAT BotevgradNot Yet Recruiting
Botevgrad, Bulgaria
4 Life EOODNot Yet Recruiting
Burgas, Bulgaria
Multiprofile Hospital for Active Treatment Dobrich AD (MHAT Dobrich AD)Not Yet Recruiting
Dobrich, Bulgaria
Medical Center New Polyclinic Gabrovo Ltd.Not Yet Recruiting
Gabrovo, Bulgaria
Medical Center Zdrave 1Not Yet Recruiting
Kozloduy, Bulgaria
FutureMeds PlovdivNot Yet Recruiting
Plovdiv, Bulgaria
MHAT Sveta Karidad EADNot Yet Recruiting
Plovdiv, Bulgaria
Diagnostic Consultative Center AleksandrovskaNot Yet Recruiting
Sofia, Bulgaria
Medical Center Hera EOODNot Yet Recruiting
Sofia, Bulgaria
Prevencia - 2000 - Medical Center for Prehospital Medical Care OODNot Yet Recruiting
Stara Zagora, Bulgaria
UMHAT "Prof. Dr. Stoyan Kirkovich"ADNot Yet Recruiting
Stara Zagora, Bulgaria
Medical Center - Clinic Nova EOODNot Yet Recruiting
Varna, Bulgaria
Medical Centre Pratia Clinic EOODNot Yet Recruiting
Varna, Bulgaria
MC Nevromedics Ltd.Not Yet Recruiting
Veliko Tarnovo, Bulgaria
Medical Center BerbatovNot Yet Recruiting
Yambol, Bulgaria
Centricity Research Etobicoke EndocrinologyRecruiting
Etobicoke, Ontario, Canada
The Wharton Medical Clinic Clinical Trials IncRecruiting
Hamilton, Ontario, Canada
LMC Diabetes & Endocrinology - Bayview (Centricity Research Toronto LMC Multispecialty)Recruiting
Toronto, Ontario, Canada
Centricity Research Mirabel Multispecialty (Centricity Research)Recruiting
Mirabel, Quebec, Canada
Diacentrum Brandys n.L.Not Yet Recruiting
Brandys Nad Lebem, Czechia
Nemocnice JihlavaNot Yet Recruiting
Jihlava, Czechia
Edumed s.r.o.Not Yet Recruiting
Náchod, Czechia
PreventaMed s.r.o.Not Yet Recruiting
Olomouc, Czechia
CCR OstravaNot Yet Recruiting
Ostrava, Czechia
Pratia PardubiceNot Yet Recruiting
Pardubice, Czechia
Fakultní nemocnice Královské VinohradyNot Yet Recruiting
Prague, Czechia
Synexus/Trialmed PragueNot Yet Recruiting
Prague, Czechia
ResTrial s.r.o.Not Yet Recruiting
Prague, Czechia
CDG Studienambulanz HartardNot Yet Recruiting
Munich, Bavaria, Germany
Studienzentrum FMZ RadowskyNot Yet Recruiting
Leipzig, Saxony, Germany
Klinische Forschung Berlin-Mitte GmbHNot Yet Recruiting
Berlin, Germany
FutureMeds BerlinNot Yet Recruiting
Berlin, Germany
Velocity Clinical Research GermanyNot Yet Recruiting
Berlin, Germany
Diabetespraxis Dr. BraunNot Yet Recruiting
Berlin, Germany
Practice Dr. Kirsch and Colleague, Zentrum fur klinische ForschungNot Yet Recruiting
Cologne, Germany
PratiaNot Yet Recruiting
Dresden, Germany
Medizentrum Essen BorbeckNot Yet Recruiting
Essen, Germany
Praxis am Markt - Dr. Bernd BeckerNot Yet Recruiting
Essen, Germany
Klinische Forschung Hamburg GmbH / PratiaNot Yet Recruiting
Hamburg, Germany
Diabetes Studienzentrum WilhelmsburgNot Yet Recruiting
Hamburg, Germany
Diabeteszentrum Hamburg-WestNot Yet Recruiting
Hamburg, Germany
Praxis Reinfeld MitteNot Yet Recruiting
Holstein, Germany
Klinische Forschung Karlsruhe GmbHNot Yet Recruiting
Karlsruhe, Germany
IDFM GmbHNot Yet Recruiting
Münster, Germany
Gemeinschaftspraxis Dres. H.Kittner und K.HartigNot Yet Recruiting
Naunhof, Germany
FutureMeds Frankfurt/OffenbachNot Yet Recruiting
Offenbach, Germany
Zentrum für klinische Forschung Allgäu-OberschwabenNot Yet Recruiting
Wangen, Germany
Medislim GmbHNot Yet Recruiting
Weinheim, Germany
Santa Familia PTG LodzNot Yet Recruiting
Lodz, WOJ Lodzkie, Poland
Zdrowie Osteo Medic sc L i A Racewicz, A i J SupronikNot Yet Recruiting
Bialystok, Poland
NZOZ Centrum Medyczne KERmedNot Yet Recruiting
Bydgoszcz, Poland
Centrum medyczne Pratia BydgoszczNot Yet Recruiting
Bydgoszcz, Poland
Pratia ChojniceNot Yet Recruiting
Chojnice, Poland
Synexus Polska Sp. z o.o., Oddzial w CzestochowieNot Yet Recruiting
Częstochowa, Poland
Synexus Polska Sp z o.o.Not Yet Recruiting
Gdansk, Poland
Centrum Badan Klinicznych PI-House Sp. z o.o.Not Yet Recruiting
Gdansk, Poland
Centrum Medyczne Pratia GdyniaNot Yet Recruiting
Gdynia, Poland
Synexus Polska Sp. z o.o. Oddzial w GdyniNot Yet Recruiting
Gdynia, Poland
Synexus Polska Sp. Z O.O. Oddzial W KatowicachNot Yet Recruiting
Katowice, Poland
Centrum Medyczne Pratia KatowiceNot Yet Recruiting
Katowice, Poland
Synexus Polska Sp. z o.o., Oddzial w LodziNot Yet Recruiting
Lodz, Poland
Centrum Terapii Współczesnej J.M. Jasnorzewska Spółka Komandytowo-AkcyjnaNot Yet Recruiting
Lodz, Poland
Ekamed Sp. z o. o.Not Yet Recruiting
Lublin, Poland
FutureMeds OlsztynNot Yet Recruiting
Olsztyn, Poland
Medicome Sp. z o.o. Oświęcimskie Centrum Badań KlinicznychNot Yet Recruiting
Oświęcim, Poland
IRMEDNot Yet Recruiting
Piotrkow Trybunalski, Poland
Trialmed CRSNot Yet Recruiting
Piotrkow Trybunalski, Poland
Synexus Polska Sp. z o.o., Oddział w PoznaniuNot Yet Recruiting
Poznan, Poland
Praktyka Lekarska Ewa KrzyzagorskaNot Yet Recruiting
Poznan, Poland
ETG SiedlceNot Yet Recruiting
Siedlce, Poland
Metabolica Sp. z o.o., NZOZ METABOLICA Ośrodek Badań KlinicznychNot Yet Recruiting
Tarnów, Poland
Instytut Diabetologii.sp.z.o.o.Not Yet Recruiting
Warsaw, Poland
Synexus Polska Sp. z o.o., Oddzial w WarszawieNot Yet Recruiting
Warsaw, Poland
Etg WarszawaNot Yet Recruiting
Warsaw, Poland
Synexus Polska Sp. z o.o., Oddział we WrocławiuNot Yet Recruiting
Wroclaw, Poland
Minimed S.R.L.Not Yet Recruiting
Bacau, Romania
Futuremeds S.R.L., BrasovNot Yet Recruiting
Brasov, Romania
Hightech Medical Services S.R.L (Centrul pentru Studiul Metabolismului)Not Yet Recruiting
Bucharest, Romania
Institutul National de Endocrinologie "C.I. Parhon"Not Yet Recruiting
Bucharest, Romania
Institutul Clinic FundeniNot Yet Recruiting
Bucharest, Romania
Fundatia Dr Victor BabesNot Yet Recruiting
Bucharest, Romania
Futuremeds S.R.L., CraiovaNot Yet Recruiting
Craiova, Romania
Futuremeds S.R.L., GalatiNot Yet Recruiting
Galati, Romania
Centru Medical "GRANDMED"Not Yet Recruiting
Oradea, Romania
Sc Gensan Srl/Policlinica AstraNot Yet Recruiting
Sibiu, Romania
Centrul Medical Mediab - Mediab SrlNot Yet Recruiting
Târgu Mureş, Romania
DIABEDA s.r.o.Not Yet Recruiting
Bratislava, Slovakia
MedispektrumNot Yet Recruiting
Bratislava, Slovakia
Poliklinika Váš LekárNot Yet Recruiting
Bratislava - Ružinov, Slovakia
Cardio D&R KošiceNot Yet Recruiting
Košice, Slovakia
Medical group Kosice s.r.o.Not Yet Recruiting
Košice, Slovakia
Tatratrial s.r.o.Not Yet Recruiting
Rožňava, Slovakia
JAL s.r.o.Not Yet Recruiting
Trnava, Slovakia
Medivasa s.r.oNot Yet Recruiting
Žilina, Slovakia
Hospital Universitario Virgen de la VictoriaNot Yet Recruiting
Málaga, Málaga, Spain
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
Castilleja de la Cuesta, Spain
Futuremeds Spain CadizNot Yet Recruiting
Chiclana de la Frontera, Spain
Futuremeds Spain MadridNot Yet Recruiting
Madrid, Spain
Hospital Universitari Son EspasesNot Yet Recruiting
Palma de Mallorca, 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
Valencia, Spain
Civia Health SunderlandNot Yet Recruiting
Hendon, CITY of Sunderland, United Kingdom
Bodyline Medical Clinic St HelensNot Yet Recruiting
St Helens, Liverpool, United Kingdom
FutureMeds Glasgow McCafferty HouseRecruiting
Glasgow, Scotland, United Kingdom
Bodyline Medical Clinic Stoke on TrentNot Yet Recruiting
Stoke-on-Trent, Staffordshire, United Kingdom
Synexus Glasgow Clinical Research CentreRecruiting
Bellshill, United Kingdom
Synexus Midlands Clinical Research CentreNot Yet Recruiting
Birmingham, United Kingdom
FutureMeds BirminghamRecruiting
Birmingham, United Kingdom
Civia Health_Boots BirminghamNot Yet Recruiting
Birmingham, United Kingdom
Civia Health_Boots BrightonNot Yet Recruiting
Brighton, United Kingdom
Southmead HospitalNot Yet Recruiting
Bristol, United Kingdom
FutureMeds LiverpoolRecruiting
Bromborough, United Kingdom
Synexus/Trialmed CardiffNot Yet Recruiting
Cardiff, United Kingdom
Panthera Biopartners Limited - EnfieldRecruiting
Enfield, United Kingdom
Panthera Biopartners Limited - GlasgowRecruiting
Glasgow, United Kingdom
Bodyline Medical Clinic CrosbyNot Yet Recruiting
Liverpool, United Kingdom
FutureMeds LondonRecruiting
London, United Kingdom
Synexus Manchester Clinical Research CentreRecruiting
Manchester, United Kingdom
Kiltearn Medical CentreNot Yet Recruiting
Nantwich, United Kingdom
FutureMeds NewcastleRecruiting
Newcastle upon Tyne, United Kingdom
Danes Camp Medical CentreNot Yet Recruiting
Northampton, United Kingdom
Civia Health_Boots NottinghamNot Yet Recruiting
Nottingham, United Kingdom
Bodyline Medical Clinic Warrington Civia HealthNot Yet Recruiting
Paddington, United Kingdom
Civia Health_Boots PeterboroughNot Yet Recruiting
Peterborough, United Kingdom
Panthera Biopartners Limited - PrestonNot Yet Recruiting
Preston, United Kingdom
Panthera Biopartners Limited - RochdaleRecruiting
Rochdale, United Kingdom
Clifton Medical CentreNot Yet Recruiting
Rotherham, United Kingdom
Ashfields Primary Care CentreNot Yet Recruiting
Sandbach, United Kingdom
Panthera Biopartners Limited - SheffieldRecruiting
Sheffield, United Kingdom
Staploe Medical CentreNot Yet Recruiting
Soham, United Kingdom
FutureMeds TeessideRecruiting
Stockton-on-Tees, United Kingdom
Panthera Biopartners Limited - YorkRecruiting
York, United Kingdom
A Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D) · TrialPath