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, C1056ABI
    • Recruiting
    • Centro de Investigaciones Metabolicas (CINME)
  • Buenos Aires, Argentina, C1060
    • Recruiting
    • CEDIC
  • Buenos Aires, Argentina
    • Recruiting
    • Centro Medico Viamonte
  • Córdoba, Argentina, 5000
    • Recruiting
    • Clínica Privada Vélez Sarsfield
  • Córdoba, Argentina, X5000AAW
    • Recruiting
    • Instituto de Investigaciones Clínicas Córdoba
  • Córdoba, Argentina, X5000AVE
    • Recruiting
    • CIDIM
  • Godoy Cruz, Argentina, M5501ARP
    • Recruiting
    • CIPADI - Centro Integral de Prevencion y Atencion en Diabetes
  • San Miguel de Tucumán, Argentina, T4000AXL
    • Recruiting
    • Centro de Investigaciones Medicas Tucuman
  • Santa Fe, Argentina, S2000
    • Recruiting
    • Instituto Medico Catamarca (IMEC)
• Bulgaria
  • Botevgrad, Bulgaria, 2140
    • Recruiting
    • MHAT Botevgrad
  • Burgas, Bulgaria, 8018
    • Recruiting
    • Medical Center 4Life EOOD
  • Dobrich, Bulgaria, 9300
    • Recruiting
    • Multiprofile Hospital for Active Treatment Dobrich AD (MHAT Dobrich AD)
  • Gabrovo, Bulgaria, 5300
    • Recruiting
    • Medical Center New Polyclinic Gabrovo Ltd.
  • Kozloduy, Bulgaria, 3320
    • Recruiting
    • Medical Center Zdrave 1
  • Plovdiv, Bulgaria, 4004
    • Recruiting
    • MHAT Sveta Karidad EAD
  • Plovdiv, Bulgaria, 4000
    • Recruiting
    • FutureMeds Plovdiv
  • Sofia, Bulgaria, 1431
    • Recruiting
    • Diagnostic Consultative Center Aleksandrovska
  • Sofia, Bulgaria, 1710
    • Recruiting
    • Medical Center Hera EOOD
  • Stara Zagora, Bulgaria, 6000
    • Recruiting
    • Prevencia - 2000 - Medical Center for Prehospital Medical Care OOD
  • Varna, Bulgaria, 9020
    • Recruiting
    • Medical Centre Pratia Clinic EOOD
  • Varna, Bulgaria, 9020
    • Recruiting
    • Medical Center - Clinic Nova EOOD
  • Veliko Tarnovo, Bulgaria, 5005
    • Recruiting
    • MC Nevromedics Ltd.
  • Yambol, Bulgaria, 8600
    • 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
    • Recruiting
    • Diacentrum Brandys n.L.
  • Jihlava, Czechia, 58601
    • Recruiting
    • Nemocnice Jihlava
  • Náchod, Czechia, 54701
    • Recruiting
    • Edumed s.r.o.
  • Ostrava, Czechia, 702 00
    • Recruiting
    • CCR Ostrava
  • Pardubice, Czechia, 53002
    • Recruiting
    • Pratia Pardubice
  • Prague, Czechia, 100 34
    • Recruiting
    • Fakultni nemocnice Kralovske Vinohrady
  • Prague, Czechia, 18100
    • Recruiting
    • ResTrial s.r.o.
  • Prague, Czechia, 120 00
    • Recruiting
    • Synexus/Trialmed Prague
• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Klinische Forschung Berlin-Mitte GmbH
  • Berlin, Germany, 13187
    • Recruiting
    • Diabetespraxis Dr. Braun
  • Berlin, Germany, 10629
    • Recruiting
    • FutureMeds Berlin
  • Berlin, Germany, 10787
    • Recruiting
    • Velocity Clinical Research Germany
  • Cologne, Germany, 51069
    • Recruiting
    • Practice Dr. Kirsch and Colleague, Zentrum fur klinische Forschung
  • Dresden, Germany, 01069
    • Recruiting
    • Klinische Forschung Dresden GmbH / Pratia
  • Essen, Germany, 45355
    • Recruiting
    • Medizentrum Essen Borbeck
  • Essen, Germany, 45355
    • Recruiting
    • Praxis am Markt - Dr. Bernd Becker
  • Hamburg, Germany, 20253
    • Recruiting
    • Klinische Forschung Hamburg GmbH / Pratia
  • Hamburg, Germany, 21109
    • Recruiting
    • Diabetes Studienzentrum Wilhelmsburg
  • Hamburg, Germany, 22607
    • Recruiting
    • Diabeteszentrum Hamburg-West
  • Holstein, Germany, 23858
    • Recruiting
    • Praxis Reinfeld Mitte
  • Karlsruhe, Germany, 76137
    • Recruiting
    • Klinische Forschung Karlsruhe GmbH
  • Naunhof, Germany, 04683
    • Recruiting
    • Gemeinschaftspraxis Dres. H.Kittner und K.Hartig
  • Offenbach, Germany, 63065
    • Recruiting
    • FutureMeds Frankfurt/Offenbach
  • Wangen, Germany, 88239
    • Recruiting
    • Zentrum für klinische Forschung Allgäu-Oberschwaben
  • Weinheim, Germany, 69469
    • Recruiting
    • Medislim GmbH
  • Bavaria
    • Munich, Bavaria, Germany, 80809
      • Recruiting
      • CDG Studienambulanz Hartard
  • Saxony
    • Leipzig, Saxony, Germany, 04179
      • Recruiting
      • Studienzentrum FMZ Radowsky
• Poland
  • Bialystok, Poland, 15-351
    • Recruiting
    • Zdrowie Osteo Medic sc L i A Racewicz, A i J Supronik
  • Bydgoszcz, Poland, 85-796
    • Recruiting
    • Centrum Medyczne Pratia Bydgoszcz
  • Bydgoszcz, Poland, 85-231
    • Recruiting
    • NZOZ Centrum Medyczne KERmed
  • Chojnice, Poland, 89-600
    • Recruiting
    • Pratia Chojnice
  • Częstochowa, Poland, 42-202
    • Recruiting
    • Synexus Polska Sp. z o.o., Oddzial w Czestochowie
  • Gdansk, Poland, 80-546
    • Recruiting
    • Centrum Badan Klinicznych Pi-House Sp. Z O.O.
  • Gdansk, Poland, 80-382
    • Recruiting
    • Synexus Polska Sp z o.o.
  • Gdynia, Poland, 81-537
    • Recruiting
    • Synexus Polska Sp. z o.o. Oddzial w Gdyni
  • Gdynia, Poland, 81-338
    • Recruiting
    • Centrum Medyczne Pratia Gdynia
  • Katowice, Poland, 40-040
    • Recruiting
    • Synexus Polska Sp. Z O.O. Oddzial W Katowicach
  • Katowice, Poland, 40-081
    • Recruiting
    • Centrum Medyczne Pratia Katowice
  • Lodz, Poland, 90-127
    • Recruiting
    • Synexus Polska Sp. z o.o., Oddzial w Lodzi
  • Lodz, Poland, 90-338
    • Recruiting
    • Centrum Terapii Współczesnej J.M. Jasnorzewska Spółka Komandytowo-Akcyjna
  • Lublin, Poland, 20-718
    • Recruiting
    • Ekamed Sp. z o. o.
  • Olsztyn, Poland, 10-165
    • Recruiting
    • Futuremeds Olsztyn
  • Oświęcim, Poland, 32-600
    • Recruiting
    • Medicome Sp. z o.o. Oświęcimskie Centrum Badań Klinicznych
  • Piotrkow Trybunalski, Poland, 97-300
    • Recruiting
    • Trialmed CRS
  • Piotrkow Trybunalski, Poland, 97-300
    • Recruiting
    • IRMED
  • Poznan, Poland, 61-655
    • Recruiting
    • Praktyka Lekarska Ewa Krzyzagorska
  • Poznan, Poland, 60-702
    • Recruiting
    • Synexus Polska Sp. z o.o., Oddział w Poznaniu
  • Siedlce, Poland, 08-110
    • Recruiting
    • ETG Siedlce
  • Tarnów, Poland, 33-100
    • Recruiting
    • Metabolica Sp. z o.o., NZOZ METABOLICA Ośrodek Badań Klinicznych
  • Warsaw, Poland, 02-677
    • Recruiting
    • ETG Warszawa
  • Warsaw, Poland, 02-117
    • Recruiting
    • Instytut Diabetologii.sp.z.o.o.
  • Warsaw, Poland, 02-672
    • Recruiting
    • Synexus Polska Sp. z o.o., Oddzial w Warszawie
  • Wroclaw, Poland, 50-381
    • Recruiting
    • Synexus Polska Sp. z o.o., Oddział we Wrocławiu
  • WOJ Lodzkie
    • Lodz, WOJ Lodzkie, Poland, 90-302
      • Recruiting
      • Santa Familia PTG Lodz
• Romania
  • Bacau, Romania, 600274
    • Recruiting
    • Minimed S.R.L.
  • Brasov, Romania, 500388
    • Recruiting
    • Futuremeds S.R.L., Brasov
  • Bucharest, Romania, 022328
    • Recruiting
    • Institutul Clinic Fundeni
  • Bucharest, Romania, 011863
    • Recruiting
    • Institutul National de Endocrinologie "C.I. Parhon"
  • Bucharest, Romania, 011053
    • Recruiting
    • Hightech Medical Services S.R.L (Centrul pentru Studiul Metabolismului)
  • Bucharest, Romania, 30303
    • Recruiting
    • Fundatia Dr Victor Babes
  • Craiova, Romania, 200115
    • Recruiting
    • Futuremeds S.R.L., Craiova
  • Galati, Romania, 800183
    • Recruiting
    • Futuremeds S.R.L., Galati
  • Oradea, Romania, 410032
    • Recruiting
    • Centru Medical "GRANDMED"
  • Sibiu, Romania, 550371
    • Recruiting
    • Sc Gensan Srl/Policlinica Astra
  • Târgu Mureş, Romania, 540142
    • Recruiting
    • Centrul Medical Mediab - Mediab Srl
• Slovakia
  • Bratislava, Slovakia, 831 06
    • Recruiting
    • DIABEDA s.r.o.
  • Bratislava, Slovakia, 85101
    • Recruiting
    • MEDISPEKTRUM s.r.o.
  • Bratislava - Ružinov, Slovakia, 91109
    • Recruiting
    • Poliklinika Váš Lekár
  • Košice, Slovakia, 040 22
    • Recruiting
    • Cardio D&R Košice
  • Košice, Slovakia, 04001
    • Recruiting
    • Medical group Kosice s.r.o.
  • Rožňava, Slovakia, 048 01
    • Recruiting
    • Tatratrial s.r.o.
  • Trnava, Slovakia, 91701
    • Recruiting
    • JAL s.r.o.
  • Žilina, Slovakia, 010 01
    • Recruiting
    • Medivasa s.r.o
• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitari Vall d'Hebron
  • Castilleja de la Cuesta, Spain, 41950
    • Recruiting
    • Hospital Vithas Sevilla
  • Chiclana de la Frontera, Spain, 11139
    • Recruiting
    • FutureMeds Spain Cádiz
  • Madrid, Spain, 28003
    • Recruiting
    • Futuremeds Spain Madrid
  • Sanlúcar de Barrameda, Spain, 11540
    • Recruiting
    • Hospital Virgen del Camino
  • Seville, Spain, 41003
    • Recruiting
    • Nuevas Tecnologías en Diabetes y Endocrinología S.L.
  • Seville, Spain, 41012
    • Recruiting
    • Futuremeds Spain Sevilla
  • Valencia, Spain, 46015
    • Recruiting
    • Ecg Médica S.L.
  • Málaga
    • Málaga, Málaga, Spain, 29010
      • Recruiting
      • Hospital Universitario Virgen de La Victoria
• United Kingdom
  • Bellshill, United Kingdom, ML4 3NJ
    • Recruiting
    • Synexus Glasgow Clinical Research Centre
  • Birmingham, United Kingdom, B15 2SQ
    • Recruiting
    • Synexus Midlands Clinical Research Centre
  • Birmingham, United Kingdom, B21 9RY
    • Recruiting
    • FutureMeds Birmingham
  • Birmingham, United Kingdom, B4 7TA
    • Recruiting
    • Civia Health_Boots Birmingham
  • Bristol, United Kingdom, BS10 5NB
    • Recruiting
    • Southmead Hospital
  • Bromborough, United Kingdom, CH62 6EE
    • Recruiting
    • FutureMeds Liverpool
  • Enfield, United Kingdom, EN3 4GS
    • Recruiting
    • Panthera Biopartners Limited - Enfield
  • Glasgow, United Kingdom, G51 4RY
    • Recruiting
    • Panthera Biopartners Limited - Glasgow
  • Liverpool, United Kingdom, L22 4QQ
    • Recruiting
    • Bodyline Medical Clinic, Crosby Civia Health
  • London, United Kingdom, NW10 2PB
    • Recruiting
    • FutureMeds London
  • Manchester, United Kingdom, M15 6SE
    • Recruiting
    • Synexus Manchester Clinical Research Centre
  • Nantwich, United Kingdom, CW5 5NX
    • Recruiting
    • Kiltearn Medical Centre
  • Newcastle upon Tyne, United Kingdom, NE6 1SG
    • Recruiting
    • FutureMeds Newcastle
  • Northampton, United Kingdom, NN4 0NY
    • Recruiting
    • Danes Camp Medical Centre
  • Nottingham, United Kingdom, NG1 3QS,
    • Recruiting
    • Civia Health_Boots Nottingham
  • Paddington, United Kingdom, WA1 3TZ
    • Recruiting
    • Bodyline Medical Clinic Warrington Civia Health
  • Preston, United Kingdom, PR2 9QB
    • Recruiting
    • Panthera Biopartners Limited - Preston
  • Rochdale, United Kingdom, OL11 4AU
    • Recruiting
    • Panthera Biopartners Limited - Rochdale
  • Rotherham, United Kingdom, S651DA
    • Recruiting
    • Clifton Medical Centre
  • Sandbach, United Kingdom, CW11 1EQ
    • Recruiting
    • Ashfields Primary Care Centre
  • Sheffield, United Kingdom, S2 5FX
    • Recruiting
    • Panthera Biopartners Limited - Sheffield
  • St Helens, United Kingdom, WA9 1AF
    • Recruiting
    • Bodyline Medical Clinic, St Helens Civia Health
  • 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
      • Recruiting
      • Civia Health Sunderland
  • Scotland
    • Glasgow, Scotland, United Kingdom, G20 7BE
      • Recruiting
      • FutureMeds Glasgow McCafferty House
• 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
    • Montclair, California, United States, 91763
      • Recruiting
      • Catalina Research Institute, LLC
    • Orange, California, United States, 92866
      • Recruiting
      • Cure Clinical Research
    • Riverside, California, United States, 92506
      • Recruiting
      • CenExel CIT
    • Torrance, California, United States, 90502
      • Recruiting
      • Lundquist Institute for Biomedical Innovation at Harbor- UCLA Medical Center
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Recruiting
      • CenExel Denver CO (Rocky Mountain Clinical Research)
  • Florida
    • Fort Myers, Florida, United States, 33912
      • Recruiting
      • AMR Clinical
    • Fort Myers, Florida, United States, 33912
      • Recruiting
      • Pedro P. Ylisastigui, MD
    • Hialeah, Florida, United States, 33014
      • Recruiting
      • Private Practice Adjacent to For Eyes Optical
    • 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
    • Miami Lakes, Florida, United States, 33016
      • Recruiting
      • Indago Research & Health Center, Inc
    • Orange City, Florida, United States, 32763
      • Recruiting
      • Optimal Research Sites, LLC
    • 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
    • Springfield, Missouri, United States, 65807
      • Recruiting
      • Delricht Research
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Recruiting
      • Quality Clinical Research Inc
    • Papillion, Nebraska, United States, 68046
      • Recruiting
      • Primary Clinical Research
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • Recruiting
      • 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
    • Holly Springs, North Carolina, United States, 27540
      • Recruiting
      • Sahana Optometry PLLC dba Family Eye Wellness
    • Morganton, North Carolina, United States, 28655
      • Recruiting
      • Burke Primary Care
    • Raleigh, North Carolina, United States, 27607
      • Recruiting
      • Eximia Research - NC, LLC
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Recruiting
      • Tribe Clinical Research LLC.- Greenville
    • Spartanburg, South Carolina, United States, 29301
      • Recruiting
      • Tribe Clinical Research LLC. - Spartanburg
  • Tennessee
    • Goodlettsville, Tennessee, United States, 37072
      • Recruiting
      • Civia Health Goodlettsville
    • La Vergne, Tennessee, United States, 37086
      • Recruiting
      • Civia Health Nashville
  • Texas
    • Amarillo, Texas, United States, 79124
      • Recruiting
      • Amarillo Medical Specialists LLP
    • Austin, Texas, United States, 78578
      • Recruiting
      • Forum Austin (Civia Health)
    • El Paso, Texas, United States, 79936
      • Recruiting
      • GLRI El Paso Research
    • Houston, Texas, United States, 77070
      • Recruiting
      • Cardiovascular Specialists of Willowbrook
    • 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
  • Washington
    • Redmond, Washington, United States, 98052
      • Recruiting
      • Era Health Research

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): July 8, 2026
• Last Update Submitted That Met QC Criteria: July 7, 2026
• Last Verified: July 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