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)

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Overweight; Type 2 Diabetes; Overweight and/or Obesity; Diabetes, Type 2
• Intervention / Treatment: Drug: PF-08653944; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 999
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1120AAC
    • Not yet recruiting
    • Centro Medico Viamonte
  • Buenos Aires, Argentina, C1056ABI
    • Not yet recruiting
    • CINME
  • Buenos Aires, Argentina, C1060
    • Not yet recruiting
    • CEDIC
  • Córdoba, Argentina, 5000
    • Not yet recruiting
    • Clinica Privada Velez Sarsfield
  • Córdoba, Argentina, 5000
    • Not yet recruiting
    • Centro Diabetologico Dr Waitman
  • Córdoba, Argentina, X5000AAW
    • Not yet recruiting
    • Instituto de Investigaciones Clínicas Córdoba
  • Córdoba, Argentina, X5000AVE
    • Not yet recruiting
    • CIDIM
  • Godoy Cruz, Argentina, M5501ARP
    • Not yet recruiting
    • CIPADI - Centro Integral de Prevencion y Atencion en Diabetes
  • Mar del Plata, Argentina, 7600
    • Not yet recruiting
    • IIC Mar del Plata
  • Morón, Argentina, B1708EPE
    • Not yet recruiting
    • CIAD Moron
  • San Miguel de Tucumán, Argentina, T4000AXA
    • Not yet recruiting
    • Centro Medico Privado de Reumatologia
  • Santa Fe, Argentina, S2000
    • Not yet recruiting
    • Instituto Medico Catamarca (IMEC)
• Bulgaria
  • Botevgrad, Bulgaria, 2140
    • Not yet recruiting
    • MHAT Botevgrad
  • Burgas, Bulgaria, 8018
    • Not yet recruiting
    • 4 Life EOOD
  • Dobrich, Bulgaria, 9300
    • Not yet recruiting
    • Multiprofile Hospital for Active Treatment Dobrich AD (MHAT Dobrich AD)
  • Gabrovo, Bulgaria, 5300
    • Not yet recruiting
    • Medical Center New Polyclinic Gabrovo Ltd.
  • Kozloduy, Bulgaria, 3320
    • Not yet recruiting
    • Medical Center Zdrave 1
  • Plovdiv, Bulgaria, 4000
    • Not yet recruiting
    • FutureMeds Plovdiv
  • Plovdiv, Bulgaria, 4004
    • Not yet recruiting
    • MHAT Sveta Karidad EAD
  • Sofia, Bulgaria, 1431
    • Not yet recruiting
    • Diagnostic Consultative Center Aleksandrovska
  • Sofia, Bulgaria, 1710
    • Not yet recruiting
    • Medical Center Hera Eood
  • Stara Zagora, Bulgaria, 6003
    • Not yet recruiting
    • UMHAT "Prof. Dr. Stoyan Kirkovich"AD
  • Stara Zagora, Bulgaria, 6000
    • Not yet recruiting
    • Prevencia - 2000 - Medical Center for Prehospital Medical Care OOD
  • Varna, Bulgaria, 9020
    • Not yet recruiting
    • Medical Centre Pratia Clinic EOOD
  • Varna, Bulgaria, 9020
    • Not yet recruiting
    • Medical Center - Clinic Nova EOOD
  • Veliko Tarnovo, Bulgaria, 5005
    • Not yet recruiting
    • MC Nevromedics Ltd.
  • Yambol, Bulgaria, 8600
    • Not yet recruiting
    • Medical Center Berbatov
• Canada
  • Ontario
    • Etobicoke, Ontario, Canada, M9R 4E1
      • Recruiting
      • Centricity Research Etobicoke Endocrinology
    • Hamilton, Ontario, Canada, L8L 5G8
      • Recruiting
      • The Wharton Medical Clinic Clinical Trials Inc
    • Toronto, Ontario, Canada, M4G 3E8
      • Recruiting
      • LMC Diabetes & Endocrinology - Bayview (Centricity Research Toronto LMC Multispecialty)
  • Quebec
    • Mirabel, Quebec, Canada, J7J 2K8
      • Recruiting
      • Centricity Research Mirabel Multispecialty (Centricity Research)
• Czechia
  • Brandys Nad Lebem, Czechia, 25001
    • Not yet recruiting
    • Diacentrum Brandys n.L.
  • Jihlava, Czechia, 58601
    • Not yet recruiting
    • Nemocnice Jihlava
  • Náchod, Czechia, 54701
    • Not yet recruiting
    • EDUMED s.r.o.
  • Olomouc, Czechia, 77900
    • Not yet recruiting
    • PreventaMed s.r.o.
  • Ostrava, Czechia, 702 00
    • Not yet recruiting
    • CCR Ostrava
  • Pardubice, Czechia, 53002
    • Not yet recruiting
    • Pratia Pardubice
  • Prague, Czechia, 100 34
    • Not yet recruiting
    • Fakultní Nemocnice Královské Vinohrady
  • Prague, Czechia, 18100
    • Not yet recruiting
    • ResTrial s.r.o.
  • Prague, Czechia, 120 00
    • Not yet recruiting
    • Synexus/Trialmed Prague
• Germany
  • Berlin, Germany, 10117
    • Not yet recruiting
    • Klinische Forschung Berlin-Mitte GmbH
  • Berlin, Germany, 13187
    • Not yet recruiting
    • Diabetespraxis Dr. Braun
  • Berlin, Germany, 10629
    • Not yet recruiting
    • FutureMeds Berlin
  • Berlin, Germany, 10787
    • Not yet recruiting
    • Velocity Clinical Research Germany
  • Cologne, Germany, 51069
    • Not yet recruiting
    • Practice Dr. Kirsch and Colleague, Zentrum fur klinische Forschung
  • Dresden, Germany, 1069
    • Not yet recruiting
    • Pratia
  • Essen, Germany, 45355
    • Not yet recruiting
    • Praxis am Markt - Dr. Bernd Becker
  • Essen, Germany, 45355
    • Not yet recruiting
    • Medizentrum Essen Borbeck
  • Hamburg, Germany, 20253
    • Not yet recruiting
    • Klinische Forschung Hamburg GmbH / Pratia
  • Hamburg, Germany, 21109
    • Not yet recruiting
    • Diabetes Studienzentrum Wilhelmsburg
  • Hamburg, Germany, 22607
    • Not yet recruiting
    • Diabeteszentrum Hamburg-West
  • Holstein, Germany, 23858
    • Not yet recruiting
    • Praxis Reinfeld Mitte
  • Karlsruhe, Germany, 76137
    • Not yet recruiting
    • Klinische Forschung Karlsruhe GmbH
  • Münster, Germany, 48145
    • Not yet recruiting
    • IDFM GmbH
  • Naunhof, Germany, 04683
    • Not yet recruiting
    • Gemeinschaftspraxis Dres. H.Kittner und K.Hartig
  • Offenbach, Germany, 63065
    • Not yet recruiting
    • FutureMeds Frankfurt/Offenbach
  • Wangen, Germany, 88239
    • Not yet recruiting
    • Zentrum für klinische Forschung Allgäu-Oberschwaben
  • Weinheim, Germany, 69469
    • Not yet recruiting
    • Medislim GmbH
  • Bavaria
    • Munich, Bavaria, Germany, 80809
      • Not yet recruiting
      • CDG Studienambulanz Hartard
  • Saxony
    • Leipzig, Saxony, Germany, 04179
      • Not yet recruiting
      • Studienzentrum FMZ Radowsky
• Poland
  • Bialystok, Poland, 15-351
    • Not yet recruiting
    • Zdrowie Osteo Medic sc L i A Racewicz, A i J Supronik
  • Bydgoszcz, Poland, 85-796
    • Not yet recruiting
    • Centrum medyczne Pratia Bydgoszcz
  • Bydgoszcz, Poland, 85-231
    • Not yet recruiting
    • NZOZ Centrum Medyczne KERmed
  • Chojnice, Poland, 89-600
    • Not yet recruiting
    • Pratia Chojnice
  • Częstochowa, Poland, 42-202
    • Not yet recruiting
    • Synexus Polska Sp. z o.o., Oddzial w Czestochowie
  • Gdansk, Poland, 80-546
    • Not yet recruiting
    • Centrum Badan Klinicznych PI-House sp. z o.o.
  • Gdansk, Poland, 80-382
    • Not yet recruiting
    • Synexus Polska Sp z o.o.
  • Gdynia, Poland, 81-338
    • Not yet recruiting
    • Centrum Medyczne Pratia Gdynia
  • Gdynia, Poland, 81-537
    • Not yet recruiting
    • Synexus Polska Sp. z o.o. Oddzial w Gdyni
  • Katowice, Poland, 40-081
    • Not yet recruiting
    • Centrum Medyczne Pratia Katowice
  • Katowice, Poland, 40-040
    • Not yet recruiting
    • Synexus Polska Sp. Z O.O. Oddzial W Katowicach
  • Lodz, Poland, 90-127
    • Not yet recruiting
    • Synexus Polska Sp. z o.o., Oddzial w Lodzi
  • Lodz, Poland, 90-338
    • Not yet recruiting
    • Centrum Terapii Współczesnej J.M. Jasnorzewska Spółka Komandytowo-Akcyjna
  • Lublin, Poland, 20-718
    • Not yet recruiting
    • Ekamed Sp. z o. o.
  • Olsztyn, Poland, 10-165
    • Not yet recruiting
    • FutureMeds Olsztyn
  • Oświęcim, Poland, 32-600
    • Not yet recruiting
    • Medicome Sp. z o.o. Oświęcimskie Centrum Badań Klinicznych
  • Piotrkow Trybunalski, Poland, 97-300
    • Not yet recruiting
    • IRMED
  • Piotrkow Trybunalski, Poland, 97-300
    • Not yet recruiting
    • Trialmed CRS
  • Poznan, Poland, 60-702
    • Not yet recruiting
    • Synexus Polska Sp. z o.o., Oddział w Poznaniu
  • Poznan, Poland, 61-655
    • Not yet recruiting
    • Praktyka Lekarska Ewa Krzyzagorska
  • Siedlce, Poland, 08-110
    • Not yet recruiting
    • ETG Siedlce
  • Tarnów, Poland, 33-100
    • Not yet recruiting
    • Metabolica Sp. z o.o., NZOZ METABOLICA Ośrodek Badań Klinicznych
  • Warsaw, Poland, 02-677
    • Not yet recruiting
    • ETG Warszawa
  • Warsaw, Poland, 02-117
    • Not yet recruiting
    • Instytut Diabetologii.sp.z.o.o.
  • Warsaw, Poland, 02-672
    • Not yet recruiting
    • Synexus Polska Sp. z o.o., Oddzial w Warszawie
  • Wroclaw, Poland, 50-381
    • Not yet recruiting
    • Synexus Polska Sp. z o.o., Oddział we Wrocławiu
  • WOJ Lodzkie
    • Lodz, WOJ Lodzkie, Poland, 90-302
      • Not yet recruiting
      • Santa Familia PTG Lodz
• Romania
  • Bacau, Romania, 600274
    • Not yet recruiting
    • Minimed S.R.L.
  • Brasov, Romania, 500388
    • Not yet recruiting
    • Futuremeds S.R.L., Brasov
  • Bucharest, Romania, 022328
    • Not yet recruiting
    • Institutul Clinic Fundeni
  • Bucharest, Romania, 011053
    • Not yet recruiting
    • Hightech Medical Services S.R.L (Centrul pentru Studiul Metabolismului)
  • Bucharest, Romania, 30303
    • Not yet recruiting
    • Fundatia Dr Victor Babes
  • Bucharest, Romania, 011863
    • Not yet recruiting
    • Institutul National de Endocrinologie "C.I. Parhon"
  • Craiova, Romania, 200115
    • Not yet recruiting
    • Futuremeds S.R.L., Craiova
  • Galati, Romania, 800183
    • Not yet recruiting
    • Futuremeds S.R.L., Galati
  • Oradea, Romania, 410032
    • Not yet recruiting
    • Centru Medical "GRANDMED"
  • Sibiu, Romania, 550371
    • Not yet recruiting
    • Sc Gensan Srl/Policlinica Astra
  • Târgu Mureş, Romania, 540142
    • Not yet recruiting
    • Centrul Medical Mediab - Mediab Srl
• Slovakia
  • Bratislava, Slovakia, 85101
    • Not yet recruiting
    • Medispektrum
  • Bratislava, Slovakia, 831 06
    • Not yet recruiting
    • DIABEDA s.r.o.
  • Bratislava - Ružinov, Slovakia, 91109
    • Not yet recruiting
    • Poliklinika Váš Lekár
  • Košice, Slovakia, 040 22
    • Not yet recruiting
    • Cardio D&R Košice
  • Košice, Slovakia, 04001
    • Not yet recruiting
    • Medical group Kosice s.r.o.
  • Rožňava, Slovakia, 048 01
    • Not yet recruiting
    • Tatratrial s.r.o.
  • Trnava, Slovakia, 91701
    • Not yet recruiting
    • JAL s.r.o.
  • Žilina, Slovakia, 010 01
    • Not yet recruiting
    • Medivasa s.r.o
• Spain
  • Almería, Spain, 04009
    • Not yet recruiting
    • Hospital Universitario Torrecárdenas (CPE Bola Azul)
  • Barcelona, Spain, 08035
    • Not yet recruiting
    • Hospital Universitari Vall d'Hebron
  • Castilleja de la Cuesta, Spain, 41950
    • Not yet recruiting
    • Hospital Vithas Sevilla
  • Chiclana de la Frontera, Spain, 11139
    • Not yet recruiting
    • Futuremeds Spain Cadiz
  • Madrid, Spain, 28003
    • Not yet recruiting
    • Futuremeds Spain Madrid
  • Palma de Mallorca, Spain, 07120
    • Not yet recruiting
    • Hospital Universitari Son Espases
  • Sanlúcar de Barrameda, Spain, 11540
    • Not yet recruiting
    • Hospital Virgen del Camino
  • Seville, Spain, 41003
    • Not yet recruiting
    • Nuevas Tecnologías en Diabetes y Endocrinología S.L.
  • Seville, Spain, 41012
    • Not yet recruiting
    • Futuremeds Spain Sevilla
  • Valencia, Spain, 46015
    • Not yet recruiting
    • Ecg Médica S.L.
  • Málaga
    • Málaga, Málaga, Spain, 29010
      • Not yet recruiting
      • Hospital Universitario Virgen de la Victoria
• United Kingdom
  • Bellshill, United Kingdom, ML4 3NJ
    • Recruiting
    • Synexus Glasgow Clinical Research Centre
  • Birmingham, United Kingdom, B21 9RY
    • Recruiting
    • FutureMeds Birmingham
  • Birmingham, United Kingdom, B15 2SQ
    • Not yet recruiting
    • Synexus Midlands Clinical Research Centre
  • Birmingham, United Kingdom, B4 7TA
    • Not yet recruiting
    • Civia Health_Boots Birmingham
  • Brighton, United Kingdom, BN1 2BE
    • Not yet recruiting
    • Civia Health_Boots Brighton
  • Bristol, United Kingdom, BS10 5NB
    • Not yet recruiting
    • Southmead Hospital
  • Bromborough, United Kingdom, CH62 6EE
    • Recruiting
    • FutureMeds Liverpool
  • Cardiff, United Kingdom, CF15 9SS
    • Not yet recruiting
    • Synexus/Trialmed Cardiff
  • Enfield, United Kingdom, EN3 4GS
    • Recruiting
    • Panthera Biopartners Limited - Enfield
  • Glasgow, United Kingdom, G51 4RY
    • Recruiting
    • Panthera Biopartners Limited - Glasgow
  • Liverpool, United Kingdom, L224QQ
    • Not yet recruiting
    • Bodyline Medical Clinic Crosby
  • London, United Kingdom, NW10 2PB
    • Recruiting
    • FutureMeds London
  • Manchester, United Kingdom, M15 6SE
    • Recruiting
    • Synexus Manchester Clinical Research Centre
  • Nantwich, United Kingdom, CW5 5NX
    • Not yet recruiting
    • Kiltearn Medical Centre
  • Newcastle upon Tyne, United Kingdom, NE6 1SG
    • Recruiting
    • FutureMeds Newcastle
  • Northampton, United Kingdom, NN4 0NY
    • Not yet recruiting
    • Danes Camp Medical Centre
  • Nottingham, United Kingdom, NG1 3QS,
    • Not yet recruiting
    • Civia Health_Boots Nottingham
  • Paddington, United Kingdom, WA1 3TZ
    • Not yet recruiting
    • Bodyline Medical Clinic Warrington Civia Health
  • Peterborough, United Kingdom, PE1 1NW
    • Not yet recruiting
    • Civia Health_Boots Peterborough
  • Preston, United Kingdom, PR2 9QB
    • Not yet recruiting
    • Panthera Biopartners Limited - Preston
  • Rochdale, United Kingdom, OL11 4AU
    • Recruiting
    • Panthera Biopartners Limited - Rochdale
  • Rotherham, United Kingdom, S651DA
    • Not yet recruiting
    • Clifton Medical Centre
  • Sandbach, United Kingdom, CW11 1EQ
    • Not yet recruiting
    • Ashfields Primary Care Centre
  • Sheffield, United Kingdom, S2 5FX
    • Recruiting
    • Panthera Biopartners Limited - Sheffield
  • Soham, United Kingdom, ELY CB75JD
    • Not yet recruiting
    • Staploe Medical Centre
  • Stockton-on-Tees, United Kingdom, TS19 8PE
    • Recruiting
    • FutureMeds Teesside
  • York, United Kingdom, YO24 4LJ
    • Recruiting
    • Panthera Biopartners Limited - York
  • CITY of Sunderland
    • Hendon, CITY of Sunderland, United Kingdom, SR1 1PB
      • Not yet recruiting
      • Civia Health Sunderland
  • Liverpool
    • St Helens, Liverpool, United Kingdom, WA9 1AF
      • Not yet recruiting
      • Bodyline Medical Clinic St Helens
  • Scotland
    • Glasgow, Scotland, United Kingdom, G20 7BE
      • Recruiting
      • FutureMeds Glasgow McCafferty House
  • Staffordshire
    • Stoke-on-Trent, Staffordshire, United Kingdom, ST1 5TL
      • Not yet recruiting
      • Bodyline Medical Clinic Stoke on Trent
• United States
  • California
    • Anaheim, California, United States, 92801
      • Recruiting
      • CenExel Anaheim Clinical Trials
    • Canoga Park, California, United States, 91304
      • Recruiting
      • Alliance Research Institute
    • Cerritos, California, United States, 90703
      • Recruiting
      • Core Healthcare Group
    • Los Alamitos, California, United States, 90720
      • Recruiting
      • CenExel CNS - Collaborative Neuroscience Research
    • Orange, California, United States, 92866
      • Recruiting
      • Cure Clinical Research
    • Riverside, California, United States, 92506
      • Recruiting
      • CenExel CIT
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Recruiting
      • CenExel Denver CO (Rocky Mountain Clinical Research)
  • Florida
    • Hollywood, Florida, United States, 33024
      • Recruiting
      • Research Centers of America
    • Hollywood, Florida, United States, 33024
      • Recruiting
      • Miami Eye Institute
    • Longwood, Florida, United States, 32750
      • Recruiting
      • Future Medical Research (Civia Health)
    • Miami, Florida, United States, 33156
      • Recruiting
      • Advanced Clinical Research
    • Oviedo, Florida, United States, 32765
      • Recruiting
      • Oviedo Medical Research
    • Tampa, Florida, United States, 33613
      • Recruiting
      • CenExel FCR - ForCare Clinical Research
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Recruiting
      • DelRicht Research
    • Decatur, Georgia, United States, 30030
      • Recruiting
      • CenExel iResearch, LLC
    • Savannah, Georgia, United States, 31405
      • Recruiting
      • CenExel iResearch, LLC
  • Maryland
    • Lutherville, Maryland, United States, 21093
      • Recruiting
      • Patient First Clinical Trials (PFCTRIALS)
  • Missouri
    • Creve Coeur, Missouri, United States, 63141
      • Not yet recruiting
      • Civia Health St. Louis
    • Independence, Missouri, United States, 64055
      • Not yet recruiting
      • Civia Health Independence
    • Springfield, Missouri, United States, 65807
      • Recruiting
      • DelRicht Research @ Command Family Medicine
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Recruiting
      • Quality Clinical Research Inc
    • Papillion, Nebraska, United States, 68046
      • Recruiting
      • Primary Care Research (Civia Health)
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • Recruiting
      • CenExel HRI - Hassman Research Institute
  • North Carolina
    • Cary, North Carolina, United States, 27511
      • Recruiting
      • Forum Health_Cary (Civia)
    • Durham, North Carolina, United States, 27704
      • Recruiting
      • Eximia EquiHealth Research
    • Raleigh, North Carolina, United States, 27607
      • Recruiting
      • Eximia Research - NC, LLC
  • Tennessee
    • Goodlettsville, Tennessee, United States, 37072
      • Not yet recruiting
      • Civia Health Goodlettsville
    • La Vergne, Tennessee, United States, 37086
      • Not yet recruiting
      • Civia Health Nashville
    • Memphis, Tennessee, United States, 38117
      • Not yet recruiting
      • Civia Health Memphis
  • Texas
    • Austin, Texas, United States, 78578
      • Recruiting
      • Forum Austin (Civia Health)
    • El Paso, Texas, United States, 79936
      • Recruiting
      • GLRI El Paso Research
    • Richardson, Texas, United States, 75080
      • Recruiting
      • Dallas Clinical Research Center (Pillar Clinical Research)
  • Utah
    • Bountiful, Utah, United States, 84010
      • Recruiting
      • Pantheon Clinical Research
    • Salt Lake City, Utah, United States, 84107
      • Recruiting
      • CenExel Salt Lake City UT (JBR Clinical Research)
    • Salt Lake City, Utah, United States, 84107
      • Recruiting
      • Murray Vision Center PC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm 1; Participants will receive PF-08653944 by Subcutaneous Injection.	Drug: PF-08653944; By Subcutaneous Injection; Other Names: MET097
Experimental: Treatment Arm 2; Participants will receive PF-08653944 by Subcutaneous Injection.	Drug: PF-08653944; By Subcutaneous Injection; Other Names: MET097
Experimental: Treatment Arm 3; Participants will receive PF-08653944 by Subcutaneous Injection.	Drug: PF-08653944; By Subcutaneous Injection; Other Names: MET097
Placebo Comparator: Placebo; Participants will receive matching placebo by Subcutaneous Injection.	Other: Placebo; By Subcutaneous Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent Change from baseline in body weight	Baseline, Week 64

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Percentage of Participants achieving ≥20% of body weight reduction from baseline	Baseline, Week 64 and 84
Change from baseline in Fasting triglycerides	Baseline, Week 64 and 84
Change from baseline in Non-high-density lipoprotein cholesterol (non-HDL-C)	Baseline, Week 64 and 84
Change from baseline in Systolic Blood Pressure (SBP)	Baseline, Week 64 and 84
Change from baseline in Short Form 36 health survey (SF-36) physical function domain score	Baseline, Week 64 and 84
Percent change from baseline in body weight	Baseline, Week 84
Change from baseline in waist circumference	Baseline, Week 64 and 84
Percentage of Participants Achieving HbA1c <7%	Week 64 and Week 84
Percentage of Participants Achieving HbA1c ≤6.5%	Week 64 and Week 84
Percentage of Participants Achieving HbA1c <5.7%	Week 64 and Week 84
Change from Baseline in Fasting Glucose	Baseline, Week 64 and 84
Change from Baseline in Fasting insulin	Baseline, Week 64 and 84
Change from baseline in Total Cholesterol	Baseline, Week 64 and 84
Change from baseline in Low-density lipoprotein cholesterol	Baseline, Week 64 and 84
Change from baseline in Very low-density lipoprotein cholesterol	Baseline, Week 64 and 84
Change from baseline in High-density lipoprotein cholesterol	Baseline, Week 64 and 84
Change from Baseline in Diastolic Blood Pressure (DBP)	Baseline, Week 64 and 84
Percent change from baseline in high-sensitivity C-reactive protein	Baseline, Week 64 and 84
Change from Baseline in EuroQoL 5-Dimension 5-Level (EQ5D-5L)	Baseline, Week 64 and 84
Change from Baseline in Control of Eating Questionnaire (CoEQ)	Baseline, Week 64 and 84
Change from Baseline in Food Noise Questionnaire (FNQ)	Baseline, Week 64 and 84
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	Week 84
Number of Participants with Serious adverse events (SAEs)	Week 84
Number of Participants with Adverse Events of Clinical Interest (AECIs)	Week 84
Number of Participants With Clinical Laboratory Abnormalities	Week 84
Number of participants with anti-drug antibodies (ADAs)	Week 84
Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of PF-08653944	Week 84

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2026
• Primary Completion (Estimated): October 12, 2027
• Study Completion (Estimated): May 16, 2028

Study Registration Dates

• First Submitted: February 3, 2026
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Obesity; Diabetes Mellitus; Overweight; Diabetes Mellitus, Type 2; Body Weight; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Nutrition Disorders; Signs and Symptoms; Overnutrition; Nutritional and Metabolic Diseases; Pathological Conditions, Signs and Symptoms
• Additional Relevant MeSH Terms: Overweight; Obesity; Diabetes Mellitus, Type 2; Body Weight; Diabetes Mellitus; Metabolic Diseases; Nutrition Disorders; Glucose Metabolism Disorders; Endocrine System Diseases; Overnutrition; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases
• Other Study ID Numbers: C6491008; 2025-523975-48-00 (Registry Identifier: CTIS (EU)); VESPER-5 (MET097-25-302) (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No