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

July 2, 2026 updated by: Pfizer

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

Study Type

Interventional

Enrollment (Estimated)

3501

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Study Locations

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
    - Medical Center Futuremeds EOOD
  - Sofia, Bulgaria, 1431
    - Recruiting
    - Diagnostic Consultative Center Aleksandrovska
  - Sofia, Bulgaria, 1510
    - Recruiting
    - Medical Center Hera EOOD
  - Stara Zagora, Bulgaria, 6000
    - Recruiting
    - Prevencia - 2000 - Medical Center for Prehospital Medical Care OOD
  - Varna, Bulgaria, 9000
    - Recruiting
    - Medical Center - Clinic Nova EOOD
  - Varna, Bulgaria, 9020
    - Recruiting
    - Medical Centre Pratia Clinic 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
- - Brno, Czechia, 60200
    - Recruiting
    - Pratia Brno,s.r.o
  - Jihlava, Czechia, 58601
    - Recruiting
    - Nemocnice Jihlava
  - Náchod, Czechia, 54701
    - Recruiting
    - EDUMED s.r.o.
  - Olomouc, Czechia, 77900
    - Recruiting
    - Agentura science pro 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
- - Bad Homburg, Germany, 61348
    - Recruiting
    - Zentrum für klinische Studien Bad Homburg
  - 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
    - Zentrum für 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
  - Leipzig, Germany, 4107
    - Recruiting
    - AmBeNet 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, 4179
    - 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
  - Gdynia, Poland, 81-384
    - Recruiting
    - FutureMeds Gdynia
  - Katowice, Poland, 40-040
    - Recruiting
    - Synexus Polska Sp. Z O.O. Oddzial W Katowicach
  - Katowice, Poland, 40-081
    - Recruiting
    - Centrum Medyczne Pratia Katowice
  - Krakow, Poland, 31-501
    - Recruiting
    - FutureMeds Krakow
  - 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
  - Lodz, Poland, 91-393
    - Recruiting
    - FutureMeds Lodz
  - 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, 00-215
    - Recruiting
    - FutureMeds Warszawa Centrum
  - 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
  - Warsaw, Poland, 03-291
    - Recruiting
    - FutureMeds Warszawa Targowek
  - Wroclaw, Poland, 53-673
    - Recruiting
    - FutureMeds Wroclaw
  - Wroclaw, Poland, 50-381
    - Recruiting
    - Synexus Polska Sp. z o.o., Oddział we Wrocławiu
- Łódź Voivodeship
  - Lodz, Łódź Voivodeship, Poland, 90-302
    - Recruiting
    - Santa Familia PTG Lodz
Romania
- - Bacau, Romania, 600237
    - 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
  - Criaova, Romania, 200115
    - Recruiting
    - Futuremeds S.R.L., Craiova
  - Galati, Romania
    - 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, 85101
    - Recruiting
    - Medispektrum s.r.o.
  - Bratislava, Slovakia, 82109
    - Recruiting
    - Poliklinika Váš Lekár
  - Bratislava, Slovakia, Bratislava
    - Recruiting
    - DIABEDA s.r.o.
  - 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.
  - Sabinov, Slovakia, 083 01
    - Recruiting
    - MEDI-DIA s.r.o
  - Trnava, Slovakia, 91701
    - Recruiting
    - JAL s.r.o.
  - Žilina, Slovakia, 010 01
    - Recruiting
    - Medivasa s.r.o
Spain
- - 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 4TY
    - 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 upon Tyne
  - 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
  - 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
  - Stoke-on-Trent, United Kingdom, ST1 5TL
    - Recruiting
    - Bodyline Medical Clinic, Stoke-on-Trent Civia Health
  - 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
- Cheshire
  - Sandbach, Cheshire, United Kingdom, CW11 1EQ
    - Recruiting
    - Ashfields Primary Care Center
- Scotland
  - Glasgow, Scotland, United Kingdom, G20 7BE
    - 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
  - Garden Grove, California, United States, 92845
    - Recruiting
    - Collaborative Neuroscience Research, LLC
  - Riverside, California, United States, 92506
    - Recruiting
    - Clinical Innovations, Inc dba CITrials
  - Rolling Hills, California, United States, 90274
    - Recruiting
    - Peninsula Headlands 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
- 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
  - Elkhorn, Nebraska, United States, 68022
    - Recruiting
    - Upgrade Performance Institute
  - 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
    - 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
  - Holly Springs, North Carolina, United States, 27540
    - Recruiting
    - Sahana Optometry PLLC dba Family Eye Wellness
  - Wilmington, North Carolina, United States, 28403
    - Recruiting
    - TMA Headlands LLC
  - Wilmington, North Carolina, United States, 28403
    - Recruiting
    - TMA Headlands LLC - Wilmington
- Oregon
  - Portland, Oregon, United States, 97210
    - Recruiting
    - Summit Headlands LLC
- South Carolina
  - 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Number of Arms

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 Time Frame: Baseline (Day 0) to Week 64	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 Time Frame: Baseline (Day 0) to Week 64	Baseline (Day 0) to Week 64
Percentage of Participants who achieve ≥10% of reduction from baseline body weight Time Frame: Baseline (Day 0) to Week 64	Baseline (Day 0) to Week 64
Percentage of Participants who achieve ≥15% of reduction from baseline body weight Time Frame: Baseline (Day 0) to Week 64	Baseline (Day 0) to Week 64
Percentage of Participants who achieve ≥20% of reduction from baseline body weight Time Frame: Baseline (Day 0) to Week 64	Baseline (Day 0) to Week 64
Change from baseline in Fasting triglycerides Time Frame: Baseline (Day 0) to Week 64	Baseline (Day 0) to Week 64
Change from baseline in non-high-density lipoprotein-cholesterol (non-HDL-C) (mg/dL) Time Frame: Baseline (Day 0) to Week 64	Baseline (Day 0) to Week 64
Change from baseline in the Short Form 36 health survey (SF-36) physical function domain score Time Frame: Baseline (Day 0) to Week 64	Baseline (Day 0) to Week 64
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Time Frame: Week 84	Week 84
Number of Participants with Serious adverse events (SAEs) Time Frame: Week 84	Week 84
Number of Participants With Clinical Laboratory Abnormalities Time Frame: Week 84	Week 84
Number of participants with anti-drug antibodies (ADAs) Time Frame: Week 84	Week 84
Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of PF-08653944 Time Frame: Week 84	Week 84
Change from baseline in systolic blood pressure Time Frame: Baseline (Day 0) to Week 64	Baseline (Day 0) to Week 64
Change from baseline in body weight Time Frame: Baseline (Day 0) to Week 84	Baseline (Day 0) to Week 84
Percentage of Participants who achieve ≥5% of reduction from baseline body weight Time Frame: Baseline (Day 0) to Week 84	Baseline (Day 0) to Week 84
Percentage of Participants who achieve ≥10% of reduction from baseline body weight Time Frame: Baseline (Day 0) to Week 84	Baseline (Day 0) to Week 84
Percentage of Participants who achieve ≥15% of reduction from baseline body weight Time Frame: Baseline (Day 0) to Week 84	Baseline (Day 0) to Week 84
Percentage of Participants who achieve ≥20% of reduction from baseline body weight Time Frame: Baseline (Day 0) to Week 84	Baseline (Day 0) to Week 84
Change from baseline in Fasting triglycerides Time Frame: Baseline (Day 0) to Week 84	Baseline (Day 0) to Week 84
Change from baseline in non-high-density lipoprotein-cholesterol (non-HDL-C) Time Frame: Baseline (Day 0) to Week 84	Baseline (Day 0) to Week 84
Change from baseline in systolic blood pressure (mmHg) Time Frame: Baseline (Day 0) to Week 84	Baseline (Day 0) to Week 84
Change from baseline in the Short Form 36 health survey (SF-36) physical function domain score Time Frame: Baseline (Day 0) to Week 84	Baseline (Day 0) to Week 84
Change from baseline in waist circumference (cm) Time Frame: Baseline (Day 0) to Week 64 and Week 84	Baseline (Day 0) to Week 64 and Week 84
Change from baseline in glycated hemoglobin (HbA1c) Time Frame: Baseline (Day 0) to Week 64 and Week 84	Baseline (Day 0) to Week 64 and Week 84
Change from baseline in fasting plasma glucose (FPG) Time Frame: Baseline (Day 0) to Week 64 and Week 84	Baseline (Day 0) to Week 64 and Week 84
Change from baseline in fasting insulin Time Frame: Baseline (Day 0) to Week 64 and Week 84	Baseline (Day 0) to Week 64 and Week 84
Change from baseline in total cholesterol Time Frame: Baseline (Day 0) to Week 64 and Week 84	Baseline (Day 0) to Week 64 and Week 84
Change from baseline in low-density lipoprotein-cholesterol (LDL-C) Time Frame: Baseline (Day 0) to Week 64 and Week 84	Baseline (Day 0) to Week 64 and Week 84
Change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) Time Frame: Baseline (Day 0) to Week 64 and Week 84	Baseline (Day 0) to Week 64 and Week 84
Change from baseline in high-density lipoprotein-cholesterol (HDL-C) Time Frame: Baseline (Day 0) to Week 64 and Week 84	Baseline (Day 0) to Week 64 and Week 84
Change from baseline in DBP Time Frame: Baseline (Day 0) to Week 64 and Week 84	Baseline (Day 0) to Week 64 and Week 84
Percent change from baseline in high-sensitivity C-reactive protein (hs-CRP) Time Frame: Baseline (Day 0) to Week 64 and Week 84	Baseline (Day 0) to Week 64 and Week 84
Change from baseline in EuroQoL 5-Dimension 5-Level (EQ5D-5L) Time Frame: Baseline (Day 0) to Week 64 and Week 84	Baseline (Day 0) to Week 64 and Week 84
Change from baseline in Control of Eating Questionnaire (CoEQ) Time Frame: Baseline (Day 0) to Week 64 and Week 84	Baseline (Day 0) to Week 64 and Week 84
Change from baseline in Food Noise Questionnaire (FNQ) Time Frame: Baseline (Day 0) to Week 64 and Week 84	Baseline (Day 0) to Week 64 and Week 84
Number of Participants with Adverse Events of Clinical Interest (AECIs Time Frame: Week 84	Week 84
Change from baseline in body weight Time Frame: Baseline (Day 0) to Week 64	Baseline (Day 0) to Week 64
Percent change from baseline in body weight Time Frame: Baseline (Day 0) to Week 84	Baseline (Day 0) to Week 84

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

July 6, 2026

Last Update Submitted That Met QC Criteria

July 2, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

VESPER-4 (MET097-25-301)
C6491007 (Other Identifier: Alias Study Number)
2025-523974-18-00 (Registry Identifier: CTIS (EU))
VESPER-4 (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

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Obesity and Overweight

Clinical Trials on MET097

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