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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
In plain English

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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: 2026-07-08
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 (181)
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
Catalina Research Institute, LLCRecruiting
Montclair, California, United States
Cure Clinical ResearchRecruiting
Orange, California, United States
CenExel CITRecruiting
Riverside, California, United States
Lundquist Institute for Biomedical Innovation at Harbor- UCLA Medical CenterRecruiting
Torrance, California, United States
CenExel Denver CO (Rocky Mountain Clinical Research)Recruiting
Englewood, Colorado, United States
AMR ClinicalRecruiting
Fort Myers, Florida, United States
Pedro P. Ylisastigui, MDRecruiting
Fort Myers, Florida, United States
Private Practice Adjacent to For Eyes OpticalRecruiting
Hialeah, Florida, 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
Indago Research & Health Center, IncRecruiting
Miami Lakes, Florida, United States
Optimal Research Sites, LLCRecruiting
Orange City, 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
DelRicht ResearchRecruiting
Springfield, Missouri, United States
Quality Clinical Research IncRecruiting
Omaha, Nebraska, United States
Primary clinical ResearchRecruiting
Papillion, Nebraska, United States
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
Sahana Optometry PLLC dba Family Eye WellnessRecruiting
Holly Springs, North Carolina, United States
Burke Primary CareRecruiting
Morganton, North Carolina, United States
Eximia Research - NC, LLCRecruiting
Raleigh, North Carolina, United States
Tribe Clinical Research LLC.- GreenvilleRecruiting
Greenville, South Carolina, United States
Tribe Clinical Research LLC. - SpartanburgRecruiting
Spartanburg, South Carolina, United States
Civia Health GoodlettsvilleRecruiting
Goodlettsville, Tennessee, United States
Civia Health NashvilleRecruiting
La Vergne, Tennessee, United States
Amarillo Medical Specialists LLPRecruiting
Amarillo, Texas, United States
Forum Austin (Civia Health)Recruiting
Austin, Texas, United States
GLRI El Paso ResearchRecruiting
El Paso, Texas, United States
Cardiovascular Specialists of WillowbrookRecruiting
Houston, 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
ERA Health ResearchRecruiting
Redmond, Washington, United States
Centro de Investigaciones Metabólicas (CINME)Recruiting
Buenos Aires, Argentina
CEDICRecruiting
Buenos Aires, Argentina
Centro Medico ViamonteRecruiting
Buenos Aires, Argentina
Clinica Privada Velez SarsfieldRecruiting
Córdoba, Argentina
Instituto de Investigaciones Clinicas CordobaRecruiting
Córdoba, Argentina
CIDIMRecruiting
Córdoba, Argentina
CIPADI - Centro Integral de Prevencion Y Atencion en DiabetesRecruiting
Godoy Cruz, Argentina
Centro de Investigaciones Médicas TucumanRecruiting
San Miguel de Tucumán, Argentina
Instituto Medico Catamarca (IMEC)Recruiting
Santa Fe, Argentina
MHAT BotevgradRecruiting
Botevgrad, Bulgaria
Medical Center 4Life EOODRecruiting
Burgas, Bulgaria
Multiprofile Hospital for Active Treatment Dobrich AD (MHAT Dobrich AD)Recruiting
Dobrich, Bulgaria
Medical Center New Polyclinic Gabrovo Ltd.Recruiting
Gabrovo, Bulgaria
Medical Center Zdrave 1Recruiting
Kozloduy, Bulgaria
FutureMeds PlovdivRecruiting
Plovdiv, Bulgaria
MHAT Sveta Karidad EADRecruiting
Plovdiv, Bulgaria
Diagnostic Consultative Center AleksandrovskaRecruiting
Sofia, Bulgaria
Medical Center Hera EOODRecruiting
Sofia, Bulgaria
Prevencia - 2000 - Medical Center for Prehospital Medical Care OODRecruiting
Stara Zagora, Bulgaria
Medical Center - Clinic Nova EOODRecruiting
Varna, Bulgaria
Medical Centre Pratia Clinic EOODRecruiting
Varna, Bulgaria
MC Nevromedics Ltd.Recruiting
Veliko Tarnovo, Bulgaria
Medical Center BerbatovRecruiting
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.Recruiting
Brandys Nad Lebem, Czechia
Nemocnice JihlavaRecruiting
Jihlava, Czechia
Edumed s.r.o.Recruiting
Náchod, Czechia
CCR OstravaRecruiting
Ostrava, Czechia
Pratia PardubiceRecruiting
Pardubice, Czechia
Fakultní nemocnice Královské VinohradyRecruiting
Prague, Czechia
Synexus/Trialmed PragueRecruiting
Prague, Czechia
ResTrial s.r.o.Recruiting
Prague, Czechia
CDG Studienambulanz HartardRecruiting
Munich, Bavaria, Germany
Studienzentrum FMZ RadowskyRecruiting
Leipzig, Saxony, Germany
Klinische Forschung Berlin-Mitte GmbHRecruiting
Berlin, Germany
FutureMeds BerlinRecruiting
Berlin, Germany
Velocity Clinical Research GermanyRecruiting
Berlin, Germany
Diabetespraxis Dr. BraunRecruiting
Berlin, Germany
Practice Dr. Kirsch and Colleague, Zentrum fur klinische ForschungRecruiting
Cologne, Germany
Klinische Forschung Dresden GmbH / PratiaRecruiting
Dresden, Germany
Medizentrum Essen BorbeckRecruiting
Essen, Germany
Praxis am Markt - Dr. Bernd BeckerRecruiting
Essen, Germany
Klinische Forschung Hamburg GmbH / PratiaRecruiting
Hamburg, Germany
Diabetes Studienzentrum WilhelmsburgRecruiting
Hamburg, Germany
Diabeteszentrum Hamburg-WestRecruiting
Hamburg, Germany
Praxis Reinfeld MitteRecruiting
Holstein, Germany
Klinische Forschung Karlsruhe GmbHRecruiting
Karlsruhe, Germany
Gemeinschaftspraxis Dres. H.Kittner und K.HartigRecruiting
Naunhof, Germany
FutureMeds Frankfurt/OffenbachRecruiting
Offenbach, Germany
Zentrum für klinische Forschung Allgäu-OberschwabenRecruiting
Wangen, Germany
Medislim GmbHRecruiting
Weinheim, Germany
Santa Familia PTG LodzRecruiting
Lodz, WOJ Lodzkie, Poland
Zdrowie Osteo Medic sc L i A Racewicz, A i J SupronikRecruiting
Bialystok, Poland
NZOZ Centrum Medyczne KERmedRecruiting
Bydgoszcz, Poland
Centrum medyczne Pratia BydgoszczRecruiting
Bydgoszcz, Poland
Pratia ChojniceRecruiting
Chojnice, Poland
Synexus Polska Sp. z o.o., Oddzial w CzestochowieRecruiting
Częstochowa, Poland
Synexus Polska Sp z o.o.Recruiting
Gdansk, Poland
Centrum Badan Klinicznych PI-House Sp. z o.o.Recruiting
Gdansk, Poland
Centrum Medyczne Pratia GdyniaRecruiting
Gdynia, Poland
Synexus Polska Sp. z o.o. Oddzial w GdyniRecruiting
Gdynia, Poland
Synexus Polska Sp. Z O.O. Oddzial W KatowicachRecruiting
Katowice, Poland
Centrum Medyczne Pratia KatowiceRecruiting
Katowice, Poland
Synexus Polska Sp. z o.o., Oddzial w LodziRecruiting
Lodz, Poland
Centrum Terapii Współczesnej J.M. Jasnorzewska Spółka Komandytowo-AkcyjnaRecruiting
Lodz, Poland
Ekamed Sp. z o. o.Recruiting
Lublin, Poland
FutureMeds OlsztynRecruiting
Olsztyn, Poland
Medicome Sp. z o.o. Oświęcimskie Centrum Badań KlinicznychRecruiting
Oświęcim, Poland
IRMEDRecruiting
Piotrkow Trybunalski, Poland
Trialmed CRSRecruiting
Piotrkow Trybunalski, Poland
Synexus Polska Sp. z o.o., Oddział w PoznaniuRecruiting
Poznan, Poland
Praktyka Lekarska Ewa KrzyzagorskaRecruiting
Poznan, Poland
ETG SiedlceRecruiting
Siedlce, Poland
Metabolica Sp. z o.o., NZOZ METABOLICA Ośrodek Badań KlinicznychRecruiting
Tarnów, Poland
Instytut Diabetologii.sp.z.o.o.Recruiting
Warsaw, Poland
Synexus Polska Sp. z o.o., Oddzial w WarszawieRecruiting
Warsaw, Poland
Etg WarszawaRecruiting
Warsaw, Poland
Synexus Polska Sp. z o.o., Oddział we WrocławiuRecruiting
Wroclaw, Poland
Minimed S.R.L.Recruiting
Bacau, Romania
Futuremeds S.R.L., BrasovRecruiting
Brasov, Romania
Hightech Medical Services S.R.L (Centrul pentru Studiul Metabolismului)Recruiting
Bucharest, Romania
Institutul National de Endocrinologie "C.I. Parhon"Recruiting
Bucharest, Romania
Institutul Clinic FundeniRecruiting
Bucharest, Romania
Fundatia Dr Victor BabesRecruiting
Bucharest, Romania
Futuremeds S.R.L., CraiovaRecruiting
Craiova, Romania
Futuremeds S.R.L., GalatiRecruiting
Galati, Romania
Centru Medical "GRANDMED"Recruiting
Oradea, Romania
Sc Gensan Srl/Policlinica AstraRecruiting
Sibiu, Romania
Centrul Medical Mediab - Mediab SrlRecruiting
Târgu Mureş, Romania
DIABEDA s.r.o.Recruiting
Bratislava, Slovakia
Medispektrum s.r.o.Recruiting
Bratislava, Slovakia
Poliklinika Váš LekárRecruiting
Bratislava - Ružinov, Slovakia
Cardio D&R KošiceRecruiting
Košice, Slovakia
Medical group Kosice s.r.o.Recruiting
Košice, Slovakia
Tatratrial s.r.o.Recruiting
Rožňava, Slovakia
JAL s.r.o.Recruiting
Trnava, Slovakia
Medivasa s.r.oRecruiting
Žilina, Slovakia
Hospital Universitario Virgen de la VictoriaRecruiting
Málaga, Málaga, Spain
Hospital Universitari Vall d'HebronRecruiting
Barcelona, Spain
Hospital Vithas SevillaRecruiting
Castilleja de la Cuesta, Spain
Futuremeds Spain CadizRecruiting
Chiclana de la Frontera, Spain
Futuremeds Spain MadridRecruiting
Madrid, Spain
Hospital Virgen del CaminoRecruiting
Sanlúcar de Barrameda, Spain
Nuevas Tecnologías en Diabetes y Endocrinología S.L.Recruiting
Seville, Spain
Futuremeds Spain SevillaRecruiting
Seville, Spain
Ecg Médica S.L.Recruiting
Valencia, Spain
Civia Health SunderlandRecruiting
Hendon, CITY of Sunderland, United Kingdom
FutureMeds Glasgow McCafferty HouseRecruiting
Glasgow, Scotland, United Kingdom
Synexus Glasgow Clinical Research CentreRecruiting
Bellshill, United Kingdom
Synexus Midlands Clinical Research CentreRecruiting
Birmingham, United Kingdom
FutureMeds BirminghamRecruiting
Birmingham, United Kingdom
Civia Health_Boots BirminghamRecruiting
Birmingham, United Kingdom
Southmead HospitalRecruiting
Bristol, United Kingdom
FutureMeds LiverpoolRecruiting
Bromborough, United Kingdom
Panthera Biopartners Limited - EnfieldRecruiting
Enfield, United Kingdom
Panthera Biopartners Limited - GlasgowRecruiting
Glasgow, United Kingdom
Bodyline Medical Clinic, Crosby Civia HealthRecruiting
Liverpool, United Kingdom
FutureMeds LondonRecruiting
London, United Kingdom
Synexus Manchester Clinical Research CentreRecruiting
Manchester, United Kingdom
Kiltearn Medical CentreRecruiting
Nantwich, United Kingdom
FutureMeds NewcastleRecruiting
Newcastle upon Tyne, United Kingdom
Danes Camp Medical CentreRecruiting
Northampton, United Kingdom
Civia Health_Boots NottinghamRecruiting
Nottingham, United Kingdom
Bodyline Medical Clinic Warrington Civia HealthRecruiting
Paddington, United Kingdom
Panthera Biopartners Limited - PrestonRecruiting
Preston, United Kingdom
Panthera Biopartners Limited - RochdaleRecruiting
Rochdale, United Kingdom
Clifton Medical CentreRecruiting
Rotherham, United Kingdom
Ashfields Primary Care CentreRecruiting
Sandbach, United Kingdom
Panthera Biopartners Limited - SheffieldRecruiting
Sheffield, United Kingdom
Bodyline Medical Clinic, St Helens Civia HealthRecruiting
St Helens, 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