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)
4 other identifiers
interventional
1,044
11 countries
183
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 obesity
Started Feb 2026
Typical duration for phase_3 obesity
183 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2026
CompletedFirst Posted
Study publicly available on registry
February 10, 2026
CompletedStudy Start
First participant enrolled
February 24, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 12, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 16, 2028
July 27, 2026
July 1, 2026
1.6 years
February 3, 2026
July 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change from baseline in body weight
Baseline, Week 64
Secondary Outcomes (32)
Change from baseline in body weight
Baseline, Week 64 and 84
Change in HbA1c (%) from baseline
Baseline, Week 64 and 84
Percentage of Participants achieving ≥5% of body weight reduction from baseline
Baseline, Week 64 and 84
Percentage of Participants achieving ≥10% of body weight reduction from baseline
Baseline, Week 64 and 84
Percentage of Participants achieving ≥15% of body weight reduction from baseline
Baseline, Week 64 and 84
- +27 more secondary outcomes
Study Arms (4)
Placebo
PLACEBO COMPARATORParticipants will receive matching placebo by Subcutaneous Injection.
Treatment Arm 1
EXPERIMENTALParticipants will receive PF-08653944 by Subcutaneous Injection.
Treatment Arm 2
EXPERIMENTALParticipants will receive PF-08653944 by Subcutaneous Injection.
Treatment Arm 3
EXPERIMENTALParticipants will receive PF-08653944 by Subcutaneous Injection.
Interventions
By Subcutaneous Injection
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (183)
CenExel Anaheim Clinical Trials
Anaheim, California, 92801, United States
Alliance Research Institute
Canoga Park, California, 91304, United States
Core Healthcare Group
Cerritos, California, 90703, United States
CenExel CNS - Collaborative Neuroscience Research
Los Alamitos, California, 90720, United States
Catalina Research Institute, LLC
Montclair, California, 91763, United States
Cure Clinical Research
Orange, California, 92866, United States
CenExel CIT
Riverside, California, 92506, United States
Lundquist Institute for Biomedical Innovation at Harbor- UCLA Medical Center
Torrance, California, 90502, United States
CenExcel Rocky Mountain Clinical Research, LLC
Englewood, Colorado, 80113, United States
CenExel Denver CO (Rocky Mountain Clinical Research)
Englewood, Colorado, 80113, United States
Neuro-Sight Vision Care
Lakewood, Colorado, 80226, United States
AMR Clinical
Fort Myers, Florida, 33912, United States
Pedro P. Ylisastigui, MD
Fort Myers, Florida, 33912, United States
Private Practice Adjacent to For Eyes Optical
Hialeah, Florida, 33014, United States
Miami Eye Institute
Hollywood, Florida, 33024, United States
Research Centers of America
Hollywood, Florida, 33024, United States
Future Medical Research (Civia Health)
Longwood, Florida, 32750, United States
Advanced Clinical Research
Miami, Florida, 33156, United States
Indago Research & Health Center, Inc
Miami Lakes, Florida, 33016, United States
Optimal Research Sites, LLC
Orange City, Florida, 32763, United States
Oviedo Medical Research
Oviedo, Florida, 32765, United States
CenExel FCR - ForCare Clinical Research
Tampa, Florida, 33613, United States
DelRicht Research
Atlanta, Georgia, 30329, United States
CenExel iResearch, LLC
Decatur, Georgia, 30030, United States
CenExel iResearch, LLC
Savannah, Georgia, 31405, United States
Patient First Clinical Trials (PFCTRIALS)
Lutherville, Maryland, 21093, United States
DelRicht Research
Springfield, Missouri, 65807, United States
Quality Clinical Research Inc
Omaha, Nebraska, 68114, United States
Primary clinical Research
Papillion, Nebraska, 68046, United States
Hassman Research Institute
Marlton, New Jersey, 08053, United States
Forum Health_Cary (Civia)
Cary, North Carolina, 27511, United States
Eximia EquiHealth Research
Durham, North Carolina, 27704, United States
Sahana Optometry PLLC dba Family Eye Wellness
Holly Springs, North Carolina, 27540, United States
Burke Primary Care
Morganton, North Carolina, 28655, United States
Eximia Research - NC, LLC
Raleigh, North Carolina, 27607, United States
Tribe Clinical Research LLC.- Greenville
Greenville, South Carolina, 29607, United States
Tribe Clinical Research LLC. - Spartanburg
Spartanburg, South Carolina, 29301, United States
Civia Health Goodlettsville
Goodlettsville, Tennessee, 37072, United States
Civia Health Nashville
La Vergne, Tennessee, 37086, United States
Amarillo Medical Specialists LLP
Amarillo, Texas, 79124, United States
Forum Austin (Civia Health)
Austin, Texas, 78578, United States
GLRI El Paso Research
El Paso, Texas, 79936, United States
Cardiovascular Specialists of Willowbrook
Houston, Texas, 77070, United States
Dallas Clinical Research Center (Pillar Clinical Research)
Richardson, Texas, 75080, United States
Pantheon Clinical Research
Bountiful, Utah, 84010, United States
CenExel Salt Lake City UT (JBR Clinical Research)
Salt Lake City, Utah, 84107, United States
Murray Vision Center PC
Salt Lake City, Utah, 84107, United States
ERA Health Research
Redmond, Washington, 98052, United States
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, C1056ABI, Argentina
CEDIC
Buenos Aires, C1060, Argentina
Centro Medico Viamonte
Buenos Aires, Argentina
Clinica Privada Velez Sarsfield
Córdoba, 5000, Argentina
Instituto de Investigaciones Clinicas Cordoba
Córdoba, X5000AAW, Argentina
CIDIM
Córdoba, X5000AVE, Argentina
CIPADI - Centro Integral de Prevencion Y Atencion en Diabetes
Godoy Cruz, M5501ARP, Argentina
Centro de Investigaciones Médicas Tucuman
San Miguel de Tucumán, T4000AXL, Argentina
Instituto Medico Catamarca (IMEC)
Santa Fe, S2000, Argentina
MHAT Botevgrad
Botevgrad, 2140, Bulgaria
Medical Center 4Life EOOD
Burgas, 8018, Bulgaria
Multiprofile Hospital for Active Treatment Dobrich AD (MHAT Dobrich AD)
Dobrich, 9300, Bulgaria
Medical Center New Polyclinic Gabrovo Ltd.
Gabrovo, 5300, Bulgaria
Medical Center Zdrave 1
Kozloduy, 3320, Bulgaria
FutureMeds Plovdiv
Plovdiv, 4000, Bulgaria
MHAT Sveta Karidad EAD
Plovdiv, 4004, Bulgaria
Diagnostic Consultative Center Aleksandrovska
Sofia, 1431, Bulgaria
Medical Center Hera EOOD
Sofia, 1710, Bulgaria
Prevencia - 2000 - Medical Center for Prehospital Medical Care OOD
Stara Zagora, 6000, Bulgaria
Medical Center - Clinic Nova EOOD
Varna, 9020, Bulgaria
Medical Centre Pratia Clinic EOOD
Varna, 9020, Bulgaria
MC Nevromedics Ltd.
Veliko Tarnovo, 5005, Bulgaria
Medical Center Berbatov
Yambol, 8600, Bulgaria
Centricity Research Etobicoke Endocrinology
Etobicoke, Ontario, M9R 4E1, Canada
The Wharton Medical Clinic Clinical Trials Inc
Hamilton, Ontario, L8L 5G8, Canada
LMC Diabetes & Endocrinology - Bayview (Centricity Research Toronto LMC Multispecialty)
Toronto, Ontario, M4G 3E8, Canada
Centricity Research Mirabel Multispecialty (Centricity Research)
Mirabel, Quebec, J7J 2K8, Canada
Diacentrum Brandys n.L.
Brandys Nad Lebem, 25001, Czechia
Nemocnice Jihlava
Jihlava, 58601, Czechia
Edumed s.r.o.
Náchod, 54701, Czechia
CCR Ostrava
Ostrava, 702 00, Czechia
Pratia Pardubice
Pardubice, 53002, Czechia
Fakultní nemocnice Královské Vinohrady
Prague, 100 34, Czechia
Synexus/Trialmed Prague
Prague, 120 00, Czechia
ResTrial s.r.o.
Prague, 18100, Czechia
CDG Studienambulanz Hartard
Munich, Bavaria, 80809, Germany
Studienzentrum FMZ Radowsky
Leipzig, Saxony, 04179, Germany
Klinische Forschung Berlin-Mitte GmbH
Berlin, 10117, Germany
FutureMeds Berlin
Berlin, 10629, Germany
Velocity Clinical Research Germany
Berlin, 10787, Germany
Diabetespraxis Dr. Braun
Berlin, 13187, Germany
Practice Dr. Kirsch and Colleague, Zentrum fur klinische Forschung
Cologne, 51069, Germany
Klinische Forschung Dresden GmbH / Pratia
Dresden, 01069, Germany
Medizentrum Essen Borbeck
Essen, 45355, Germany
Praxis am Markt - Dr. Bernd Becker
Essen, 45355, Germany
Klinische Forschung Hamburg GmbH / Pratia
Hamburg, 20253, Germany
Diabetes Studienzentrum Wilhelmsburg
Hamburg, 21109, Germany
Diabeteszentrum Hamburg-West
Hamburg, 22607, Germany
Praxis Reinfeld Mitte
Holstein, 23858, Germany
Klinische Forschung Karlsruhe GmbH
Karlsruhe, 76137, Germany
Gemeinschaftspraxis Dres. H.Kittner und K.Hartig
Naunhof, 04683, Germany
FutureMeds Frankfurt/Offenbach
Offenbach, 63065, Germany
Zentrum für klinische Forschung Allgäu-Oberschwaben
Wangen, 88239, Germany
Medislim GmbH
Weinheim, 69469, Germany
Santa Familia PTG Lodz
Lodz, WOJ Lodzkie, 90-302, Poland
Zdrowie Osteo Medic sc L i A Racewicz, A i J Supronik
Bialystok, 15-351, Poland
NZOZ Centrum Medyczne KERmed
Bydgoszcz, 85-231, Poland
Centrum medyczne Pratia Bydgoszcz
Bydgoszcz, 85-796, Poland
Pratia Chojnice
Chojnice, 89-600, Poland
Synexus Polska Sp. z o.o., Oddzial w Czestochowie
Częstochowa, 42-202, Poland
Synexus Polska Sp z o.o.
Gdansk, 80-382, Poland
Centrum Badan Klinicznych PI-House Sp. z o.o.
Gdansk, 80-546, Poland
Centrum Medyczne Pratia Gdynia
Gdynia, 81-338, Poland
Synexus Polska Sp. z o.o. Oddzial w Gdyni
Gdynia, 81-537, Poland
Synexus Polska Sp. Z O.O. Oddzial W Katowicach
Katowice, 40-040, Poland
Centrum Medyczne Pratia Katowice
Katowice, 40-081, Poland
Synexus Polska Sp. z o.o., Oddzial w Lodzi
Lodz, 90-127, Poland
Centrum Terapii Współczesnej J.M. Jasnorzewska Spółka Komandytowo-Akcyjna
Lodz, 90-338, Poland
Ekamed Sp. z o. o.
Lublin, 20-718, Poland
FutureMeds Olsztyn
Olsztyn, 10-165, Poland
Medicome Sp. z o.o. Oświęcimskie Centrum Badań Klinicznych
Oświęcim, 32-600, Poland
IRMED
Piotrkow Trybunalski, 97-300, Poland
Trialmed CRS
Piotrkow Trybunalski, 97-300, Poland
Synexus Polska Sp. z o.o., Oddział w Poznaniu
Poznan, 60-702, Poland
Praktyka Lekarska Ewa Krzyzagorska
Poznan, 61-655, Poland
ETG Siedlce
Siedlce, 08-110, Poland
Metabolica Sp. z o.o., NZOZ METABOLICA Ośrodek Badań Klinicznych
Tarnów, 33-100, Poland
Instytut Diabetologii.sp.z.o.o.
Warsaw, 02-117, Poland
Synexus Polska Sp. z o.o., Oddzial w Warszawie
Warsaw, 02-672, Poland
Etg Warszawa
Warsaw, 02-677, Poland
Synexus Polska Sp. z o.o., Oddział we Wrocławiu
Wroclaw, 50-381, Poland
Minimed S.R.L.
Bacau, 600274, Romania
Futuremeds S.R.L., Brasov
Brasov, 500388, Romania
Hightech Medical Services S.R.L (Centrul pentru Studiul Metabolismului)
Bucharest, 011053, Romania
Institutul National de Endocrinologie "C.I. Parhon"
Bucharest, 011863, Romania
Institutul Clinic Fundeni
Bucharest, 022328, Romania
Fundatia Dr Victor Babes
Bucharest, 30303, Romania
Futuremeds S.R.L., Craiova
Craiova, 200115, Romania
Futuremeds S.R.L., Galati
Galati, 800183, Romania
Centru Medical "GRANDMED"
Oradea, 410032, Romania
Sc Gensan Srl/Policlinica Astra
Sibiu, 550371, Romania
Centrul Medical Mediab - Mediab Srl
Târgu Mureş, 540142, Romania
DIABEDA s.r.o.
Bratislava, 831 06, Slovakia
Medispektrum s.r.o.
Bratislava, 85101, Slovakia
Poliklinika Váš Lekár
Bratislava - Ružinov, 91109, Slovakia
Cardio D&R Košice
Košice, 040 22, Slovakia
Medical group Kosice s.r.o.
Košice, 04001, Slovakia
Tatratrial s.r.o.
Rožňava, 048 01, Slovakia
JAL s.r.o.
Trnava, 91701, Slovakia
Medivasa s.r.o
Žilina, 010 01, Slovakia
Hospital Universitario Virgen de la Victoria
Málaga, Málaga, 29010, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Vithas Sevilla
Castilleja de la Cuesta, 41950, Spain
Futuremeds Spain Cadiz
Chiclana de la Frontera, 11139, Spain
Futuremeds Spain Madrid
Madrid, 28003, Spain
Hospital Virgen del Camino
Sanlúcar de Barrameda, 11540, Spain
Nuevas Tecnologías en Diabetes y Endocrinología S.L.
Seville, 41003, Spain
Futuremeds Spain Sevilla
Seville, 41012, Spain
Ecg Médica S.L.
Valencia, 46015, Spain
Civia Health Sunderland
Hendon, CITY of Sunderland, SR1 1PB, United Kingdom
FutureMeds Glasgow McCafferty House
Glasgow, Scotland, G20 7BE, United Kingdom
Synexus Glasgow Clinical Research Centre
Bellshill, ML4 3NJ, United Kingdom
Synexus Midlands Clinical Research Centre
Birmingham, B15 2SQ, United Kingdom
FutureMeds Birmingham
Birmingham, B21 9RY, United Kingdom
Civia Health_Boots Birmingham
Birmingham, B4 7TA, United Kingdom
Southmead Hospital
Bristol, BS10 5NB, United Kingdom
FutureMeds Liverpool
Bromborough, CH62 6EE, United Kingdom
Panthera Biopartners Limited - Enfield
Enfield, EN3 4GS, United Kingdom
Panthera Biopartners Limited - Glasgow
Glasgow, G51 4RY, United Kingdom
Bodyline Medical Clinic, Crosby Civia Health
Liverpool, L22 4QQ, United Kingdom
FutureMeds London
London, NW10 2PB, United Kingdom
Synexus Manchester Clinical Research Centre
Manchester, M15 6SE, United Kingdom
Kiltearn Medical Centre
Nantwich, CW5 5NX, United Kingdom
FutureMeds Newcastle
Newcastle upon Tyne, NE6 1SG, United Kingdom
Danes Camp Medical Centre
Northampton, NN4 0NY, United Kingdom
Civia Health_Boots Nottingham
Nottingham, NG1 3QS,, United Kingdom
Bodyline Medical Clinic Warrington Civia Health
Paddington, WA1 3TZ, United Kingdom
Panthera Biopartners Limited - Preston
Preston, PR2 9QB, United Kingdom
Panthera Biopartners Limited - Rochdale
Rochdale, OL11 4AU, United Kingdom
Clifton Medical Centre
Rotherham, S651DA, United Kingdom
Ashfields Primary Care Centre
Sandbach, CW11 1EQ, United Kingdom
Panthera Biopartners Limited - Sheffield
Sheffield, S2 5FX, United Kingdom
Bodyline Medical Clinic, St Helens Civia Health
St Helens, WA9 1AF, United Kingdom
FutureMeds Teesside
Stockton-on-Tees, TS19 8PE, United Kingdom
Panthera Biopartners Limited - York
York, YO24 4LJ, United Kingdom
Related Links
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2026
First Posted
February 10, 2026
Study Start
February 24, 2026
Primary Completion (Estimated)
October 12, 2027
Study Completion (Estimated)
May 16, 2028
Last Updated
July 27, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.