Efficacy and Safety of MET097 Once-Weekly in People With Overweight or Obesity (VESPER-4)

Evaluating The Efficacy and Safety of MET097, a Fully-Biased, Ultra Long-Acting GLP-1RA, In People With Overweight or Obesity: A Phase 3, Multi-Center Randomized, Controlled Trial (VESPER-4)

This study investigates the efficacy and safety of once weekly injectable MET097 in adult participants with obesity or overweight with weight-related comorbidities excluding T2D. This trial will last for a duration of 84 weeks. The primary endpoint will be assessed after 64 weeks of treatment with the secondary at 84 weeks.

Study Overview

• Status: Recruiting
• Conditions: Obesity and Overweight
• Intervention / Treatment: Drug: MET097; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 3501
• 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 Médico Viamonte
  • Buenos Aires, Argentina, C1056ABI
    • Not yet recruiting
    • CINME
  • Buenos Aires, Argentina, C1060
    • Not yet recruiting
    • CEDIC
  • Córdoba, Argentina, 5000
    • Not yet recruiting
    • Clínica Privada Vélez Sarsfield
  • 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 Médico Privado de Reumatología
  • 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, 4004
    • Not yet recruiting
    • MHAT Sveta Karidad EAD
  • Plovdiv, Bulgaria, 4000
    • Not yet recruiting
    • Medical Center Futuremeds EOOD
  • Sofia, Bulgaria, 1510
    • Not yet recruiting
    • Medical Center Hera EOOD
  • Sofia, Bulgaria, 1431
    • Not yet recruiting
    • Diagnostic Consultative Center Aleksandrovska
  • 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
  • Alberta
    • Edmonton, Alberta, Canada, T6H 2L4
      • Not yet recruiting
      • C-health Research
    • Sherwood Park, Alberta, Canada, T8H 0N2
      • Not yet recruiting
      • Synergy Medical Clinic
  • Ontario
    • Etobicoke, Ontario, Canada, M9R 4E1
      • Not yet recruiting
      • Centricity Research Etobicoke Endocrinology
    • Hamilton, Ontario, Canada, L8L 5G8
      • Not yet recruiting
      • The Wharton Medical Clinic Clinical Trials Inc
    • Toronto, Ontario, Canada, M4G 3E8
      • Not yet recruiting
      • LMC Diabetes & Endocrinology - Bayview (Centricity Research Toronto LMC Multispecialty)
  • Quebec
    • Mirabel, Quebec, Canada, J7J 2K8
      • Not yet recruiting
      • Centricity Research Mirabel Multispecialty (Centricity Research)
• Czechia
  • Brno, Czechia, 60200
    • Not yet recruiting
    • Pratia Brno,s.r.o
  • 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.
  • Olomouc, Czechia, 77900
    • Not yet recruiting
    • Agentura science pro 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
    • Fakultni nemocnice Kralovske Vinohrady
  • Prague, Czechia, 18100
    • Not yet recruiting
    • ResTrial s.r.o.
  • Prague, Czechia, 120 00
    • Not yet recruiting
    • Synexus/Trialmed Prague
• Germany
  • Bad Homburg, Germany, 61348
    • Not yet recruiting
    • Kardiologische Praxis Dr. med. univ. Wolfgang Jungmair
  • 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
    • Zentrum für 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
    • DZHW
  • Holstein, Germany, 23858
    • Not yet recruiting
    • Praxis Reinfeld Mitte
  • Karlsruhe, Germany, 76137
    • Not yet recruiting
    • Klinische Forschung Karlsruhe GmbH
  • Leipzig, Germany, 4107
    • Not yet recruiting
    • AmBeNet GmbH
  • Münster, Germany, 48145
    • Not yet recruiting
    • IDFM GmbH
  • Naunhof, Germany, 4683
    • Not yet recruiting
    • Gemeinschaftspraxis PD Dr. med. habil. Holger Kittner & Dr. 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, 4179
      • 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, 81-384
    • Not yet recruiting
    • FutureMeds 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
  • Krakow, Poland, 31-501
    • Not yet recruiting
    • FutureMeds Krakow
  • 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
  • Lodz, Poland, 91-393
    • Not yet recruiting
    • FutureMeds Lodz
  • 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, 00-215
    • Not yet recruiting
    • FutureMeds Warszawa Centrum
  • 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
  • Warsaw, Poland, 03-291
    • Not yet recruiting
    • FutureMeds Warszawa Targowek
  • Wroclaw, Poland, 50-381
    • Not yet recruiting
    • Synexus Polska Sp. z o.o., Oddział we Wrocławiu
  • Wroclaw, Poland, 53-673
    • Not yet recruiting
    • FutureMeds Wroclaw
  • Łódź Voivodeship
    • Lodz, Łódź Voivodeship, Poland, 90-302
      • Not yet recruiting
      • Santa Familia PTG Lodz
• Romania
  • Bacau, Romania
    • Not yet recruiting
    • Minimed S.R.L.
  • Brasov, Romania, 500388
    • Not yet recruiting
    • Futuremeds S.R.L., Brasov
  • Bucharest, Romania
    • 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
    • Not yet recruiting
    • Institutul National de Endocrinologie "C.I. Parhon"
  • Craiova, Romania, 200115
    • Not yet recruiting
    • Futuremeds S.R.L., Craiova
  • Galati, Romania
    • Not yet recruiting
    • Futuremeds S.R.L., Galati
  • Oradea, Romania
    • 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, Bratislava
    • 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.
  • Sabinov, Slovakia, 083 01
    • Not yet recruiting
    • MEDI-DIA 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 Cádiz
  • 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
    • Not yet recruiting
    • Synexus Glasgow Clinical Research Centre
  • Birmingham, United Kingdom, B15 2SQ
    • Not yet recruiting
    • Synexus Midlands Clinical Research Centre
  • Birmingham, United Kingdom, B21 9RY
    • Not yet recruiting
    • FutureMeds Birmingham
  • Birmingham, United Kingdom, B4 7TA
    • Not yet recruiting
    • Civia Health_Boots Birmingham
  • Bristol, United Kingdom, BS10 5NB
    • Not yet recruiting
    • Southmead Hospital
  • Bromborough, United Kingdom, CH62 6EE
    • Not yet recruiting
    • FutureMeds Liverpool
  • Cardiff, United Kingdom, CF15 9SS
    • Not yet recruiting
    • Synexus/Trialmed Cardiff
  • Enfield, United Kingdom, EN3 4GS
    • Not yet recruiting
    • Panthera Biopartners Limited - Enfield
  • Glasgow, United Kingdom, G51 4TY
    • Not yet recruiting
    • Panthera Biopartners Limited - Glasgow
  • Liverpool, United Kingdom, L224QQ
    • Not yet recruiting
    • Bodyline Medical Clinic Crosby
  • London, United Kingdom, NW10 2PB
    • Not yet recruiting
    • FutureMeds London
  • Manchester, United Kingdom, M15 6SE
    • Not yet recruiting
    • Synexus Manchester Clinical Research Centre
  • Nantwich, United Kingdom, CW5 5NX
    • Not yet recruiting
    • Kiltearn Medical Centre
  • Newcastle upon Tyne, United Kingdom, NE6 1SG
    • Not yet recruiting
    • FutureMeds Newcastle upon Tyne
  • Northampton, United Kingdom, NN1 5PH
    • Not yet recruiting
    • DANES Medical Centre
  • Nottingham, United Kingdom, NG1 3QS,
    • Not yet recruiting
    • Civia Health_Boots Nottingham
  • Preston, United Kingdom, PR2 9QB
    • Not yet recruiting
    • Panthera Biopartners Limited - Preston
  • Rochdale, United Kingdom, OL11 4AU
    • Not yet recruiting
    • Panthera Biopartners Limited - Rochdale
  • Rotherham, United Kingdom, S65 2EN
    • Not yet recruiting
    • Clifton Medical Centre
  • Sandbach, United Kingdom, CW11 1EQ
    • Not yet recruiting
    • Sandbach GPs
  • Sheffield, United Kingdom, S2 5FX
    • Not yet recruiting
    • Panthera Biopartners Limited - Sheffield
  • Soham, United Kingdom, ELY CB75JD
    • Not yet recruiting
    • Staploe Medical Centre
  • Stockton-on-Tees, United Kingdom, TS19 8PE
    • Not yet recruiting
    • FutureMeds Teesside
  • Stoke-on-Trent, United Kingdom, ST1 5TL
    • Not yet recruiting
    • Bodyline Medical Clinic Stoke on Trent
  • York, United Kingdom, YO24 4LJ
    • Not yet recruiting
    • Panthera Biopartners Limited - York
  • CITY of Sunderland
    • Hendon, CITY of Sunderland, United Kingdom, SR1 1PB
      • Not yet recruiting
      • Civia Health Sunderland
  • Cambridgeshire
    • Peterborough, Cambridgeshire, United Kingdom, PE1 1NW
      • Not yet recruiting
      • Boots Peterborough
  • Cheshire EAST
    • Warrington, Cheshire EAST, United Kingdom, WA1 3TZ
      • Not yet recruiting
      • Bodyline Medical Clinic Warrington
  • EAST Sussex
    • Brighton, EAST Sussex, United Kingdom, BN1 2BE
      • Not yet recruiting
      • Boots Brighton
  • Liverpool
    • St Helens, Liverpool, United Kingdom, WA9 1AF
      • Not yet recruiting
      • Bodyline Medical Clinic St Helens
  • Manchester
    • Openshaw, Manchester, United Kingdom, M11 1AA
      • Not yet recruiting
      • Bodyline Medical Research Openshaw
  • Scotland
    • Glasgow, Scotland, United Kingdom, G20 7BE
      • Not yet recruiting
      • FutureMeds Glasgow McCafferty House
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85260
      • Recruiting
      • Headlands Research
  • California
    • Canoga Park, California, United States, 91304
      • Recruiting
      • Alliance Research Institute
    • Riverside, California, United States, 92506
      • Recruiting
      • Clinical Innovations, Inc dba CITrials
    • Rolling Hills, California, United States, 90274
      • Recruiting
      • Peninsula Headlands LLC
    • Torrance, California, United States, 90504
      • Recruiting
      • Collaborative Neuroscience Research, LLC
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Recruiting
      • CenExcel Rocky Mountain Clinical Research, LLC
  • Florida
    • Hollywood, Florida, United States, 33024
      • Recruiting
      • Research Centers of America
    • 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 @ Springer Wellness and Restorative Health
    • Savannah, Georgia, United States, 31405
      • Recruiting
      • CenExel iResearch, LLC
  • Maryland
    • Gaithersburg, Maryland, United States, 20877
      • Recruiting
      • CenExel CBH Health
  • Michigan
    • Shelby, Michigan, United States, 48315
      • Not yet recruiting
      • Civia Health Shelby
  • Missouri
    • Chesterfield, Missouri, United States, 63005
      • Recruiting
      • Clinical Research Professionals
    • Creve Coeur, Missouri, United States, 63141
      • Not yet recruiting
      • Civia Health St. Louis
    • Independence, Missouri, United States, 64055
      • Not yet recruiting
      • Civia Health Independence
  • 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
    • Durham, North Carolina, United States, 27704
      • Recruiting
      • Eximia EquiHealth Research
    • Wilmington, North Carolina, United States, 28403
      • Recruiting
      • TMA Headlands LLC
  • Oregon
    • Portland, Oregon, United States, 97210
      • Recruiting
      • Summit Headlands LLC
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Recruiting
      • Tribe Clinical Research, LLC
    • Spartanburg, South Carolina, United States, 29301
      • Recruiting
      • Tribe Clinical Research, LLC
  • Tennessee
    • Goodlettsville, Tennessee, United States, 37072
      • Recruiting
      • Civia Health Goodlettsville
    • La Vergne, Tennessee, United States, 37086
      • Recruiting
      • Civia Health Nashville
    • Memphis, Tennessee, United States, 38117
      • Not yet recruiting
      • Civia Health Memphis
  • Texas
    • Austin, Texas, United States, 78758
      • Recruiting
      • Forum Austin (Civia Health)
    • Dallas, Texas, United States, 75251
      • Recruiting
      • Cedar Health Research
    • 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

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• BMI ≥ 30 kg/m2 or BMI ≥ 27.0 kg/m2 to <30.0 kg/m2 and presence of at least 1 of the following weight- related comorbidities: Hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease)

Exclusion Criteria:

• Have any form of diabetes
• Have a self-reported body weight change > 5 kg (11 pounds) within 3 months prior to Screening
• Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
• History of chronic pancreatitis or presence of acute pancreatitis within the past 180 days prior to the Screening visit; or active/current, symptomatic gallbladder disease

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: MET097 Dose 1; Participants will receive MET097 administered subcutaneously	Drug: MET097; Once-weekly MET097 administered via subcutaneous injection; Other Names: PF-08653944
Experimental: MET097 Dose 2; Participants will receive MET097 administered subcutaneously	Drug: MET097; Once-weekly MET097 administered via subcutaneous injection; Other Names: PF-08653944
Experimental: MET097 Dose 3; Participants will receive MET097 administered subcutaneously	Drug: MET097; Once-weekly MET097 administered via subcutaneous injection; Other Names: PF-08653944
Placebo Comparator: Placebo; Once-weekly placebo administered via subcutaneous injection	Drug: Placebo; Once-weekly placebo administered via subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent change from baseline in body weight	Baseline (Day 0) to Week 64

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants who achieve ≥5% of reduction from baseline body weight	Baseline (Day 0) to Week 64
Percentage of Participants who achieve ≥10% of reduction from baseline body weight	Baseline (Day 0) to Week 64
Percentage of Participants who achieve ≥15% of reduction from baseline body weight	Baseline (Day 0) to Week 64
Percentage of Participants who achieve ≥20% of reduction from baseline body weight	Baseline (Day 0) to Week 64
Change from baseline in Fasting triglycerides	Baseline (Day 0) to Week 64
Change from baseline in non-high-density lipoprotein-cholesterol (non-HDL-C) (mg/dL)	Baseline (Day 0) to Week 64
Change from baseline in the Short Form 36 health survey (SF-36) physical function domain score	Baseline (Day 0) to Week 64
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 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
Change from baseline in systolic blood pressure	Baseline (Day 0) to Week 64
Change from baseline in body weight	Baseline (Day 0) to Week 84
Percentage of Participants who achieve ≥5% of reduction from baseline body weight	Baseline (Day 0) to Week 84
Percentage of Participants who achieve ≥10% of reduction from baseline body weight	Baseline (Day 0) to Week 84
Percentage of Participants who achieve ≥15% of reduction from baseline body weight	Baseline (Day 0) to Week 84
Percentage of Participants who achieve ≥20% of reduction from baseline body weight	Baseline (Day 0) to Week 84
Change from baseline in Fasting triglycerides	Baseline (Day 0) to Week 84
Change from baseline in non-high-density lipoprotein-cholesterol (non-HDL-C)	Baseline (Day 0) to Week 84
Change from baseline in systolic blood pressure (mmHg)	Baseline (Day 0) to Week 84
Change from baseline in the Short Form 36 health survey (SF-36) physical function domain score	Baseline (Day 0) to Week 84
Change from baseline in waist circumference (cm)	Baseline (Day 0) to Week 64 and Week 84
Change from baseline in glycated hemoglobin (HbA1c)	Baseline (Day 0) to Week 64 and Week 84
Change from baseline in fasting plasma glucose (FPG)	Baseline (Day 0) to Week 64 and Week 84
Change from baseline in fasting insulin	Baseline (Day 0) to Week 64 and Week 84
Change from baseline in total cholesterol	Baseline (Day 0) to Week 64 and Week 84
Change from baseline in low-density lipoprotein-cholesterol (LDL-C)	Baseline (Day 0) to Week 64 and Week 84
Change from baseline in very low-density lipoprotein-cholesterol (VLDL-C)	Baseline (Day 0) to Week 64 and Week 84
Change from baseline in high-density lipoprotein-cholesterol (HDL-C)	Baseline (Day 0) to Week 64 and Week 84
Change from baseline in DBP	Baseline (Day 0) to Week 64 and Week 84
Percent change from baseline in high-sensitivity C-reactive protein (hs-CRP)	Baseline (Day 0) to Week 64 and Week 84
Change from baseline in EuroQoL 5-Dimension 5-Level (EQ5D-5L)	Baseline (Day 0) to Week 64 and Week 84
Change from baseline in Control of Eating Questionnaire (CoEQ)	Baseline (Day 0) to Week 64 and Week 84
Change from baseline in Food Noise Questionnaire (FNQ)	Baseline (Day 0) to Week 64 and Week 84
Number of Participants with Adverse Events of Clinical Interest (AECIs	Week 84
Change from baseline in body weight	Baseline (Day 0) to Week 64
Percent change from baseline in body weight	Baseline (Day 0) to Week 84

Collaborators and Investigators

• Sponsor: Metsera, a wholly owned subsidiary of 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): December 19, 2025
• Primary Completion (Estimated): September 21, 2027
• Study Completion (Estimated): April 25, 2028

Study Registration Dates

• First Submitted: December 29, 2025
• First Submitted That Met QC Criteria: December 29, 2025
• First Posted (Actual): December 31, 2025

Study Record Updates

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

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: VESPER-4 (MET097-25-301); C6491007 (Other Identifier: Alias Study Number); 2025-523974-18-00 (Registry Identifier: CTIS (EU))

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