Obesity and OverweightPhase 3VESPER-4NCT07311850
Efficacy and Safety of MET097 Once-Weekly in People With Overweight or Obesity
A Phase 3 study testing MET097 in people with Obesity and Overweight, run by Pfizer at 161 sites in 10 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity and Overweight
- What is being tested?
- MET097
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,578 participants
- Where
- 161 sitesin 10 countries
- Study dates
- 19 Dec 2025to 25 Apr 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
161 sites in 10 countries.
161 sites in 10 countries
United States37 sites
DelRicht Research
Atlanta, Georgia, 30329
Forum Austin (Civia Health)
Austin, Texas, 78758
Pantheon Clinical Research
Bountiful, Utah, 84010
Alliance Research Institute
Canoga Park, California, 91304
Forum Health_Cary (Civia)
Cary, North Carolina, 27511
Clinical Research Professionals
Chesterfield, Missouri, 63005
Cedar Health Research
Dallas, Texas, 75251
Eximia EquiHealth Research
Durham, North Carolina, 27704
GLRI El Paso Research
El Paso, Texas, 79936
Upgrade Performance Institute
Elkhorn, Nebraska, 68022
CenExcel Rocky Mountain Clinical Research, LLC
Englewood, Colorado, 80113
CenExel CBH Health
Gaithersburg, Maryland, 20877
Civia Health Goodlettsville
Goodlettsville, Tennessee, 37072
Tribe Clinical Research LLC.- Greenville
Greenville, South Carolina, 29607
Sahana Optometry PLLC dba Family Eye Wellness
Holly Springs, North Carolina, 27540
Research Centers of America
Hollywood, Florida, 33024
Civia Health Nashville
La Vergne, Tennessee, 37086
Future Medical Research (Civia Health)
Longwood, Florida, 32750
Hassman Research Institute
Marlton, New Jersey, 08053
Palmetto Internal Medicine
Mauldin, South Carolina, 29662
Civia Health Memphis
Memphis, Tennessee, 38117
Advanced Clinical Research
Miami, Florida, 33156
Quality Clinical Research Inc
Omaha, Nebraska, 68114
Oviedo Medical Research
Oviedo, Florida, 32765
Rolling Oaks Radiology -Palms
Oxnard, California, 93036
Primary Care Research (Civia Health)
Papillion, Nebraska, 68046
Summit Headlands LLC
Portland, Oregon, 97210
Dallas Clinical Research Center (Pillar Clinical Research)
Richardson, Texas, 75080
Clinical Innovations, Inc dba CITrials
Riverside, California, 92506
Peninsula Headlands LLC
Rolling Hills, California, 90274
CenExel iResearch, LLC
Savannah, Georgia, 31405
Headlands Research
Scottsdale, Arizona, 85260
Tribe Clinical Research LLC. - Spartanburg
Spartanburg, South Carolina, 29301
CenExel FCR - ForCare Clinical Research
Tampa, Florida, 33613
Collaborative Neuroscience Research, LLC
Torrance, California, 90504
TMA Headlands LLC - Wilmington
Wilmington, North Carolina, 28403
TMA Headlands LLC
Wilmington, North Carolina, 28403
Poland31 sites
Zdrowie Osteo Medic sc L i A Racewicz, A i J Supronik
Bialystok, 15-351
NZOZ Centrum Medyczne KERmed
Bydgoszcz, 85-231
Centrum medyczne Pratia Bydgoszcz
Bydgoszcz, 85-796
Pratia Chojnice
Chojnice, 89-600
Synexus Polska Sp. z o.o., Oddzial w Czestochowie
Częstochowa, 42-202
Synexus Polska Sp z o.o.
Gdansk, 80-382
Centrum Badan Klinicznych PI-House Sp. z o.o.
Gdansk, 80-546
Centrum Medyczne Pratia Gdynia
Gdynia, 81-338
FutureMeds Gdynia
Gdynia, 81-384
Synexus Polska Sp. z o.o. Oddzial w Gdyni
Gdynia, 81-537
Synexus Polska Sp. Z O.O. Oddzial W Katowicach
Katowice, 40-040
Centrum Medyczne Pratia Katowice
Katowice, 40-081
FutureMeds Krakow
Krakow, 31-501
Synexus Polska Sp. z o.o., Oddzial w Lodzi
Lodz, 90-127
FutureMeds Lodz
Lodz, 91-393
Santa Familia PTG Lodz
Lodz, Łódź Voivodeship, 90-302
Ekamed Sp. z o. o.
Lublin, 20-718
FutureMeds Olsztyn
Olsztyn, 10-165
Medicome Sp. z o.o. Oświęcimskie Centrum Badań Klinicznych
Oświęcim, 32-600
IRMED
Piotrkow Trybunalski, 97-300
Trialmed CRS
Piotrkow Trybunalski, 97-300
Synexus Polska Sp. z o.o., Oddział w Poznaniu
Poznan, 60-702
ETG Siedlce
Siedlce, 08-110
Metabolica Sp. z o.o., NZOZ METABOLICA Ośrodek Badań Klinicznych
Tarnów, 33-100
FutureMeds Warszawa Centrum
Warsaw, 00-215
Instytut Diabetologii.sp.z.o.o.
Warsaw, 02-117
Synexus Polska Sp. z o.o., Oddzial w Warszawie
Warsaw, 02-672
Etg Warszawa
Warsaw, 02-677
FutureMeds Warszawa Targowek
Warsaw, 03-291
Synexus Polska Sp. z o.o., Oddział we Wrocławiu
Wroclaw, 50-381
FutureMeds Wroclaw
Wroclaw, 53-673
United Kingdom21 sites
Synexus Glasgow Clinical Research Centre
Bellshill, ML4 3NJ
FutureMeds Birmingham
Birmingham, B21 9RY
Civia Health_Boots Birmingham
Birmingham, B4 7TA
Southmead Hospital
Bristol, BS10 5NB
FutureMeds Liverpool
Bromborough, CH62 6EE
Synexus Midlands Clinical Research Centre
Edgbaston, B16 8QQ
Panthera Biopartners Limited - Enfield
Enfield, EN3 4GS
FutureMeds Glasgow McCafferty House
Glasgow, Scotland, G20 7BE
Panthera Biopartners Limited - Glasgow
Glasgow, G51 4TY
Civia Health Sunderland
Hendon, CITY of Sunderland, SR1 1PB
FutureMeds London
London, NW10 2PB
Synexus Manchester Clinical Research Centre
Manchester, M15 6SE
Kiltearn Medical Centre
Nantwich, CW5 5NX
FutureMeds Newcastle upon Tyne
Newcastle upon Tyne, NE6 1SG
Civia Health_Boots Nottingham
Nottingham, NG1 3QS,
Panthera Biopartners Limited - Preston
Preston, PR2 9QB
Panthera Biopartners Limited - Rochdale
Rochdale, OL11 4AU
Ashfields Primary Care Center
Sandbach, Cheshire, CW11 1EQ
Panthera Biopartners Limited - Sheffield
Sheffield, S2 5FX
FutureMeds Teesside
Stockton, TS19 8PE
Panthera Biopartners Limited - York
York, YO24 4LJ
Germany19 sites
Zentrum für klinische Studien Bad Homburg
Bad Homburg, 61348
Klinische Forschung Berlin-Mitte GmbH
Berlin, 10117
FutureMeds Berlin
Berlin, 10629
Velocity Clinical Research Germany
Berlin, 10787
Diabetes Practice Dr. Braun
Berlin, 13187
Klinische Forschung Dresden GmbH / Pratia
Dresden, 01069
Medizentrum Essen Borbeck
Essen, 45355
Praxis am Markt - Dr. Bernd Becker
Essen, 45355
Klinische Forschung Hamburg GmbH / Pratia
Hamburg, 20253
Diabeteszentrum Hamburg-West
Hamburg, 22607
Praxis Reinfeld Mitte
Holstein, 23858
Klinische Forschung Karlsruhe GmbH
Karlsruhe, 76137
Studienzentrum FMZ Radowsky
Leipzig, Saxony, 4179
AmBeNet GmbH
Leipzig, 4107
CDG Studienambulanz Hartard
Munich, Bavaria, 80809
Gemeinschaftspraxis Dres. H.Kittner und K.Hartig
Naunhof, 04683
FutureMeds Frankfurt/Offenbach
Offenbach, 63065
Zentrum für klinische Forschung Allgäu-Oberschwaben
Wangen, 88239
Medislim GmbH
Weinheim, 69469
Bulgaria14 sites
MHAT Botevgrad
Botevgrad, 2140
Medical Center 4Life EOOD
Burgas, 8018
Multiprofile Hospital for Active Treatment Dobrich AD (MHAT Dobrich AD)
Dobrich, 9300
Medical Center New Polyclinic Gabrovo Ltd.
Gabrovo, 5300
Medical Center Zdrave 1
Kozloduy, 3320
Medical Center Futuremeds EOOD
Plovdiv, 4000
MHAT Sveta Karidad EAD
Plovdiv, 4004
Diagnostic Consultative Center Aleksandrovska
Sofia, 1431
Medical Center Hera EOOD
Sofia, 1510
Prevencia - 2000 - Medical Center for Prehospital Medical Care OOD
Stara Zagora, 6000
Medical Center - Clinic Nova EOOD
Varna, 9020
Medical Centre Pratia Clinic EOOD
Varna, 9020
MC Nevromedics Ltd.
Veliko Tarnovo, 5005
Medical Center Berbatov
Yambol, 8600
Romania11 sites
Minimed S.R.L.
Bacau, 600237
Futuremeds S.R.L., Brasov
Brasov, 500388
Hightech Medical Services S.R.L (Centrul pentru Studiul Metabolismului)
Bucharest, 011053
Institutul National de Endocrinologie "C.I. Parhon"
Bucharest, 011863
Institutul Clinic Fundeni
Bucharest, 022328
Fundatia Dr Victor Babes
Bucharest, 30303
Futuremeds S.R.L., Craiova
Criaova, 200115
Futuremeds S.R.L., Galati
Galati, 800183
Centru Medical "GRANDMED"
Oradea, 410032
Sc Gensan Srl/Policlinica Astra
Sibiu, 550371
Centrul Medical Mediab - Mediab Srl
Târgu Mureş, 540142
Slovakia9 sites
DIABEDA s.r.o.
Bratislava, 831 06
Medispektrum s.r.o.
Bratislava, 85101
Poliklinika Váš Lekár
Bratislava - Ružinov, 91109
Cardio D&R Košice
Košice, 040 22
Medical group Kosice s.r.o.
Košice, 04001
Tatratrial s.r.o.
Rožňava, 048 01
MEDI-DIA s.r.o
Sabinov, 083 01
JAL s.r.o
Trnava, 91701
Medivasa s.r.o
Žilina, 010 01
Spain8 sites
Hospital Vithas Sevilla
Castilleja de la Cuesta, 41950
Futuremeds Spain Cadiz
Chiclana de la Frontera, 11139
Futuremeds Spain Madrid
Madrid, 28003
Hospital Universitario Virgen de la Victoria
Málaga, Málaga, 29010
Hospital Virgen del Camino
Sanlúcar de Barrameda, 11540
Nuevas Tecnologías en Diabetes y Endocrinología S.L.
Seville, 41003
Futuremeds Spain Sevilla
Seville, 41012
Ecg Médica S.L.
Valencia, 46015
Czechia7 sites
Pratia Brno,s.r.o
Brno, 60200
Edumed s.r.o.
Náchod, 54701
CCR Ostrava
Ostrava, 702 00
Pratia Pardubice
Pardubice, 53002
Fakultní nemocnice Královské Vinohrady
Prague, 100 34
Synexus/Trialmed Prague
Prague, 120 00
ResTrial s.r.o.
Prague, 18100
Canada4 sites
Centricity Research Etobicoke Endocrinology
Etobicoke, Ontario, M9R 4E1
The Wharton Medical Clinic Clinical Trials Inc
Hamilton, Ontario, L8L 5G8
Centricity Research Mirabel Multispecialty (Centricity Research)
Mirabel, Quebec, J7J 2K8
LMC Diabetes & Endocrinology - Bayview (Centricity Research Toronto LMC Multispecialty)
Toronto, Ontario, M4G 3E8
About this study
Official title: 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.
- Conditions
- Obesity and Overweight
- Being tested
- MET097, Placebo
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MET097Drug
Also called PF-08653944
Once-weekly MET097 administered via subcutaneous injection
PlaceboDrug
Once-weekly placebo administered via subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| MET097 Dose 1 | Experimental | Participants will receive MET097 administered subcutaneously Receives: Drug: MET097 |
| MET097 Dose 2 | Experimental | Participants will receive MET097 administered subcutaneously Receives: Drug: MET097 |
| MET097 Dose 3 | Experimental | Participants will receive MET097 administered subcutaneously Receives: Drug: MET097 |
| Placebo | Placebo comparator | Once-weekly placebo administered via subcutaneous injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline in body weight
Measured: Baseline (Day 0) to Week 64
Secondary outcomes (38)
Percentage of Participants who achieve ≥5% of reduction from baseline body weight
Measured: Baseline (Day 0) to Week 64
Percentage of Participants who achieve ≥10% of reduction from baseline body weight
Measured: Baseline (Day 0) to Week 64
Percentage of Participants who achieve ≥15% of reduction from baseline body weight
Measured: Baseline (Day 0) to Week 64
Percentage of Participants who achieve ≥20% of reduction from baseline body weight
Measured: Baseline (Day 0) to Week 64
Change from baseline in Fasting triglycerides
Measured: Baseline (Day 0) to Week 64
Change from baseline in non-high-density lipoprotein-cholesterol (non-HDL-C) (mg/dL)
Measured: Baseline (Day 0) to Week 64
Change from baseline in systolic blood pressure
Measured: Baseline (Day 0) to Week 64
Change from baseline in the Short Form 36 health survey (SF-36) physical function domain score
Measured: Baseline (Day 0) to Week 64
Change from baseline in body weight
Measured: Baseline (Day 0) to Week 84
Percentage of Participants who achieve ≥5% of reduction from baseline body weight
Measured: Baseline (Day 0) to Week 84
Percentage of Participants who achieve ≥10% of reduction from baseline body weight
Measured: Baseline (Day 0) to Week 84
Percentage of Participants who achieve ≥15% of reduction from baseline body weight
Measured: Baseline (Day 0) to Week 84
Percentage of Participants who achieve ≥20% of reduction from baseline body weight
Measured: Baseline (Day 0) to Week 84
Change from baseline in Fasting triglycerides
Measured: Baseline (Day 0) to Week 84
Change from baseline in non-high-density lipoprotein-cholesterol (non-HDL-C)
Measured: Baseline (Day 0) to Week 84
Change from baseline in systolic blood pressure (mmHg)
Measured: Baseline (Day 0) to Week 84
Change from baseline in the Short Form 36 health survey (SF-36) physical function domain score
Measured: Baseline (Day 0) to Week 84
Change from baseline in waist circumference (cm)
Measured: Baseline (Day 0) to Week 64 and Week 84
Change from baseline in glycated hemoglobin (HbA1c)
Measured: Baseline (Day 0) to Week 64 and Week 84
Change from baseline in fasting plasma glucose (FPG)
Measured: Baseline (Day 0) to Week 64 and Week 84
Change from baseline in fasting insulin
Measured: Baseline (Day 0) to Week 64 and Week 84
Change from baseline in total cholesterol
Measured: Baseline (Day 0) to Week 64 and Week 84
Change from baseline in low-density lipoprotein-cholesterol (LDL-C)
Measured: Baseline (Day 0) to Week 64 and Week 84
Change from baseline in very low-density lipoprotein-cholesterol (VLDL-C)
Measured: Baseline (Day 0) to Week 64 and Week 84
Change from baseline in high-density lipoprotein-cholesterol (HDL-C)
Measured: Baseline (Day 0) to Week 64 and Week 84
Change from baseline in DBP
Measured: Baseline (Day 0) to Week 64 and Week 84
Percent change from baseline in high-sensitivity C-reactive protein (hs-CRP)
Measured: Baseline (Day 0) to Week 64 and Week 84
Change from baseline in EuroQoL 5-Dimension 5-Level (EQ5D-5L)
Measured: Baseline (Day 0) to Week 64 and Week 84
Change from baseline in Control of Eating Questionnaire (CoEQ)
Measured: Baseline (Day 0) to Week 64 and Week 84
Change from baseline in Food Noise Questionnaire (FNQ)
Measured: Baseline (Day 0) to Week 64 and Week 84
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Measured: Week 84
Number of Participants with Serious adverse events (SAEs)
Measured: Week 84
Number of Participants with Adverse Events of Clinical Interest (AECIs
Measured: Week 84
Number of Participants With Clinical Laboratory Abnormalities
Measured: Week 84
Number of participants with anti-drug antibodies (ADAs)
Measured: Week 84
Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of PF-08653944
Measured: Week 84
Change from baseline in body weight
Measured: Baseline (Day 0) to Week 64
Percent change from baseline in body weight
Measured: Baseline (Day 0) to Week 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start19 Dec 2025
- Primary completion21 Sep 2027 (estimated)
- Study completion25 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3,578 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311850
- Sponsor's protocol ID
- VESPER-4 (MET097-25-301)
- Other IDs
- C6491007, 2025-523974-18-00, VESPER-4, 2025
- Acronym
- VESPER-4
- Status last verified
- Oct 2026
- First submitted
- 29 Dec 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07311850
- Acronym / sponsor ID
- VESPER-4 / VESPER-4 (MET097-25-301)
- Conditions
- Obesity and Overweight
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,578 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2025 (actual)
- Primary completion
- 21 Sep 2027 (estimated)
- Study completion
- 25 Apr 2028 (estimated)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MET097 Dose 1 | Experimental | Drug: MET097Participants will receive MET097 administered subcutaneously |
| MET097 Dose 2 | Experimental | Drug: MET097Participants will receive MET097 administered subcutaneously |
| MET097 Dose 3 | Experimental | Drug: MET097Participants will receive MET097 administered subcutaneously |
| Placebo | Placebo comparator | Drug: PlaceboOnce-weekly placebo administered via subcutaneous injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MET097Also: PF-08653944Once-weekly MET097 administered via subcutaneous injection | Drug | MET097 Dose 1, MET097 Dose 2, MET097 Dose 3 |
| PlaceboOnce-weekly placebo administered via subcutaneous injection | Drug | Placebo |
Primary outcome
Percent change from baseline in body weight
Time frame: Baseline (Day 0) to Week 64
38 secondary outcomes
Percentage of Participants who achieve ≥5% of reduction from baseline body weight
Time frame: 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
Percentage of Participants who achieve ≥15% of reduction from baseline body weight
Time frame: 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
Change from baseline in Fasting triglycerides
Time frame: 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
Change from baseline in systolic blood pressure
Time frame: 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
Change from baseline in body weight
Time frame: 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
Percentage of Participants who achieve ≥10% of reduction from baseline body weight
Time frame: 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
Percentage of Participants who achieve ≥20% of reduction from baseline body weight
Time frame: Baseline (Day 0) to Week 84
Change from baseline in Fasting triglycerides
Time frame: 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
Change from baseline in systolic blood pressure (mmHg)
Time frame: 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
Change from baseline in waist circumference (cm)
Time frame: 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
Change from baseline in fasting plasma glucose (FPG)
Time frame: 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
Change from baseline in total cholesterol
Time frame: 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
Change from baseline in very low-density lipoprotein-cholesterol (VLDL-C)
Time frame: 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
Change from baseline in DBP
Time frame: 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
Change from baseline in EuroQoL 5-Dimension 5-Level (EQ5D-5L)
Time frame: 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
Change from baseline in Food Noise Questionnaire (FNQ)
Time frame: Baseline (Day 0) to Week 64 and Week 84
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Week 84
Number of Participants with Serious adverse events (SAEs)
Time frame: Week 84
Number of Participants with Adverse Events of Clinical Interest (AECIs
Time frame: Week 84
Number of Participants With Clinical Laboratory Abnormalities
Time frame: Week 84
Number of participants with anti-drug antibodies (ADAs)
Time frame: Week 84
Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of PF-08653944
Time frame: Week 84
Change from baseline in body weight
Time frame: Baseline (Day 0) to Week 64
Percent change from baseline in body weight
Time frame: Baseline (Day 0) to Week 84
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
161 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MET097 in people with Obesity and Overweight, run by Pfizer at 161 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 161 sites in United States, Poland, United Kingdom, Germany, Bulgaria and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change from baseline in body weight (time frame: Baseline (Day 0) to Week 64). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.