NCT07311850

Brief 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. The primary endpoint will be assessed after 64 weeks of treatment with the secondary at 84 weeks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
3,578

participants targeted

Target at P75+ for phase_3

Timeline
21mo left

Started Dec 2025

Geographic Reach
10 countries

170 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Dec 2025Apr 2028

Study Start

First participant enrolled

December 19, 2025

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 31, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2028

Last Updated

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

1.8 years

First QC Date

December 29, 2025

Last Update Submit

July 23, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percent change from baseline in body weight

    Baseline (Day 0) to Week 64

Secondary Outcomes (38)

  • 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

  • +33 more secondary outcomes

Study Arms (4)

MET097 Dose 1

EXPERIMENTAL

Participants will receive MET097 administered subcutaneously

Drug: MET097

MET097 Dose 2

EXPERIMENTAL

Participants will receive MET097 administered subcutaneously

Drug: MET097

MET097 Dose 3

EXPERIMENTAL

Participants will receive MET097 administered subcutaneously

Drug: MET097

Placebo

PLACEBO COMPARATOR

Once-weekly placebo administered via subcutaneous injection

Drug: Placebo

Interventions

Once-weekly placebo administered via subcutaneous injection

Placebo
MET097DRUG

Once-weekly MET097 administered via subcutaneous injection

Also known as: PF-08653944
MET097 Dose 1MET097 Dose 2MET097 Dose 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (170)

Headlands Research

Scottsdale, Arizona, 85260, United States

Location

Alliance Research Institute

Canoga Park, California, 91304, United States

Location

Collaborative Neuroscience Research, LLC

Garden Grove, California, 92845, United States

Location

Clinical Innovations, Inc dba CITrials

Riverside, California, 92506, United States

Location

Peninsula Headlands LLC

Rolling Hills, California, 90274, United States

Location

CenExcel Rocky Mountain Clinical Research, LLC

Englewood, Colorado, 80113, United States

Location

Research Centers of America

Hollywood, Florida, 33024, United States

Location

Future Medical Research (Civia Health)

Longwood, Florida, 32750, United States

Location

Advanced Clinical Research

Miami, Florida, 33156, United States

Location

Oviedo Medical Research

Oviedo, Florida, 32765, United States

Location

CenExel FCR - ForCare Clinical Research

Tampa, Florida, 33613, United States

Location

DelRicht Research

Atlanta, Georgia, 30329, United States

Location

CenExel iResearch, LLC

Savannah, Georgia, 31405, United States

Location

CenExel CBH Health

Gaithersburg, Maryland, 20877, United States

Location

Clinical Research Professionals

Chesterfield, Missouri, 63005, United States

Location

Upgrade Performance Institute

Elkhorn, Nebraska, 68022, United States

Location

Quality Clinical Research Inc

Omaha, Nebraska, 68114, United States

Location

Primary clinical Research

Papillion, Nebraska, 68046, United States

Location

Hassman Research Institute

Marlton, New Jersey, 08053, United States

Location

Forum Health Cary

Cary, North Carolina, 27511, United States

Location

Eximia EquiHealth Research

Durham, North Carolina, 27704, United States

Location

Sahana Optometry PLLC dba Family Eye Wellness

Holly Springs, North Carolina, 27540, United States

Location

TMA Headlands LLC - Wilmington

Wilmington, North Carolina, 28403, United States

Location

TMA Headlands LLC

Wilmington, North Carolina, 28403, United States

Location

Summit Headlands LLC

Portland, Oregon, 97210, United States

Location

Tribe Clinical Research LLC.- Greenville

Greenville, South Carolina, 29607, United States

Location

Palmetto Internal Medicine

Mauldin, South Carolina, 29662, United States

Location

Tribe Clinical Research LLC. - Spartanburg

Spartanburg, South Carolina, 29301, United States

Location

Civia Health Goodlettsville

Goodlettsville, Tennessee, 37072, United States

Location

Civia Health Nashville

La Vergne, Tennessee, 37086, United States

Location

Civia Health Memphis

Memphis, Tennessee, 38117, United States

Location

Forum Austin (Civia Health)

Austin, Texas, 78758, United States

Location

Cedar Health Research

Dallas, Texas, 75251, United States

Location

GLRI El Paso Research

El Paso, Texas, 79936, United States

Location

Dallas Clinical Research Center (Pillar Clinical Research)

Richardson, Texas, 75080, United States

Location

Pantheon Clinical Research

Bountiful, Utah, 84010, United States

Location

MHAT Botevgrad

Botevgrad, 2140, Bulgaria

Location

Medical Center 4Life EOOD

Burgas, 8018, Bulgaria

Location

Multiprofile Hospital for Active Treatment Dobrich AD (MHAT Dobrich AD)

Dobrich, 9300, Bulgaria

Location

Medical Center New Polyclinic Gabrovo Ltd.

Gabrovo, 5300, Bulgaria

Location

Medical Center Zdrave 1

Kozloduy, 3320, Bulgaria

Location

Medical Center Futuremeds EOOD

Plovdiv, 4000, Bulgaria

Location

MHAT Sveta Karidad EAD

Plovdiv, 4004, Bulgaria

Location

Diagnostic Consultative Center Aleksandrovska

Sofia, 1431, Bulgaria

Location

Medical Center Hera EOOD

Sofia, 1510, Bulgaria

Location

Prevencia - 2000 - Medical Center for Prehospital Medical Care OOD

Stara Zagora, 6000, Bulgaria

Location

Medical Center - Clinic Nova EOOD

Varna, 9020, Bulgaria

Location

Medical Centre Pratia Clinic EOOD

Varna, 9020, Bulgaria

Location

MC Nevromedics Ltd.

Veliko Tarnovo, 5005, Bulgaria

Location

Medical Center Berbatov

Yambol, 8600, Bulgaria

Location

Centricity Research Etobicoke Endocrinology

Etobicoke, Ontario, M9R 4E1, Canada

Location

The Wharton Medical Clinic Clinical Trials Inc

Hamilton, Ontario, L8L 5G8, Canada

Location

LMC Diabetes & Endocrinology - Bayview (Centricity Research Toronto LMC Multispecialty)

Toronto, Ontario, M4G 3E8, Canada

Location

Centricity Research Mirabel Multispecialty (Centricity Research)

Mirabel, Quebec, J7J 2K8, Canada

Location

Pratia Brno,s.r.o

Brno, 60200, Czechia

Location

Nemocnice Jihlava

Jihlava, 58601, Czechia

Location

Edumed s.r.o.

Náchod, 54701, Czechia

Location

Agentura science pro s.r.o.

Olomouc, 77900, Czechia

Location

CCR Ostrava

Ostrava, 702 00, Czechia

Location

Pratia Pardubice

Pardubice, 53002, Czechia

Location

Fakultní nemocnice Královské Vinohrady

Prague, 100 34, Czechia

Location

Synexus/Trialmed Prague

Prague, 120 00, Czechia

Location

ResTrial s.r.o.

Prague, 18100, Czechia

Location

CDG Studienambulanz Hartard

Munich, Bavaria, 80809, Germany

Location

Studienzentrum FMZ Radowsky

Leipzig, Saxony, 4179, Germany

Location

Zentrum für klinische Studien Bad Homburg

Bad Homburg, 61348, Germany

Location

Klinische Forschung Berlin-Mitte GmbH

Berlin, 10117, Germany

Location

FutureMeds Berlin

Berlin, 10629, Germany

Location

Velocity Clinical Research Germany

Berlin, 10787, Germany

Location

Diabetespraxis Dr. Braun

Berlin, 13187, Germany

Location

Zentrum für klinische Forschung

Cologne, 51069, Germany

Location

Klinische Forschung Dresden GmbH / Pratia

Dresden, 01069, Germany

Location

Medizentrum Essen Borbeck

Essen, 45355, Germany

Location

Praxis am Markt - Dr. Bernd Becker

Essen, 45355, Germany

Location

Klinische Forschung Hamburg GmbH / Pratia

Hamburg, 20253, Germany

Location

Diabeteszentrum Hamburg-West

Hamburg, 22607, Germany

Location

Praxis Reinfeld Mitte

Holstein, 23858, Germany

Location

Klinische Forschung Karlsruhe GmbH

Karlsruhe, 76137, Germany

Location

AmBeNet GmbH

Leipzig, 4107, Germany

Location

Gemeinschaftspraxis Dres. H.Kittner und K.Hartig

Naunhof, 04683, Germany

Location

FutureMeds Frankfurt/Offenbach

Offenbach, 63065, Germany

Location

Zentrum für klinische Forschung Allgäu-Oberschwaben

Wangen, 88239, Germany

Location

Medislim GmbH

Weinheim, 69469, Germany

Location

Zdrowie Osteo Medic sc L i A Racewicz, A i J Supronik

Bialystok, 15-351, Poland

Location

NZOZ Centrum Medyczne KERmed

Bydgoszcz, 85-231, Poland

Location

Centrum medyczne Pratia Bydgoszcz

Bydgoszcz, 85-796, Poland

Location

Pratia Chojnice

Chojnice, 89-600, Poland

Location

Synexus Polska Sp. z o.o., Oddzial w Czestochowie

Częstochowa, 42-202, Poland

Location

Synexus Polska Sp z o.o.

Gdansk, 80-382, Poland

Location

Centrum Badan Klinicznych PI-House Sp. z o.o.

Gdansk, 80-546, Poland

Location

Centrum Medyczne Pratia Gdynia

Gdynia, 81-338, Poland

Location

FutureMeds Gdynia

Gdynia, 81-384, Poland

Location

Synexus Polska Sp. z o.o. Oddzial w Gdyni

Gdynia, 81-537, Poland

Location

Synexus Polska Sp. Z O.O. Oddzial W Katowicach

Katowice, 40-040, Poland

Location

Centrum Medyczne Pratia Katowice

Katowice, 40-081, Poland

Location

FutureMeds Krakow

Krakow, 31-501, Poland

Location

Synexus Polska Sp. z o.o., Oddzial w Lodzi

Lodz, 90-127, Poland

Location

Centrum Terapii Współczesnej J.M. Jasnorzewska Spółka Komandytowo-Akcyjna

Lodz, 90-338, Poland

Location

FutureMeds Lodz

Lodz, 91-393, Poland

Location

Ekamed Sp. z o. o.

Lublin, 20-718, Poland

Location

FutureMeds Olsztyn

Olsztyn, 10-165, Poland

Location

Medicome Sp. z o.o. Oświęcimskie Centrum Badań Klinicznych

Oświęcim, 32-600, Poland

Location

IRMED

Piotrkow Trybunalski, 97-300, Poland

Location

Trialmed CRS

Piotrkow Trybunalski, 97-300, Poland

Location

Synexus Polska Sp. z o.o., Oddział w Poznaniu

Poznan, 60-702, Poland

Location

Praktyka Lekarska Ewa Krzyzagorska

Poznan, 61-655, Poland

Location

ETG Siedlce

Siedlce, 08-110, Poland

Location

Metabolica Sp. z o.o., NZOZ METABOLICA Ośrodek Badań Klinicznych

Tarnów, 33-100, Poland

Location

FutureMeds Warszawa Centrum

Warsaw, 00-215, Poland

Location

Instytut Diabetologii.sp.z.o.o.

Warsaw, 02-117, Poland

Location

Synexus Polska Sp. z o.o., Oddzial w Warszawie

Warsaw, 02-672, Poland

Location

Etg Warszawa

Warsaw, 02-677, Poland

Location

FutureMeds Warszawa Targowek

Warsaw, 03-291, Poland

Location

Synexus Polska Sp. z o.o., Oddział we Wrocławiu

Wroclaw, 50-381, Poland

Location

FutureMeds Wroclaw

Wroclaw, 53-673, Poland

Location

Santa Familia PTG Lodz

Lodz, Łódź Voivodeship, 90-302, Poland

Location

Minimed S.R.L.

Bacau, 600237, Romania

Location

Futuremeds S.R.L., Brasov

Brasov, 500388, Romania

Location

Hightech Medical Services S.R.L (Centrul pentru Studiul Metabolismului)

Bucharest, 011053, Romania

Location

Institutul National de Endocrinologie "C.I. Parhon"

Bucharest, 011863, Romania

Location

Institutul Clinic Fundeni

Bucharest, 022328, Romania

Location

Fundatia Dr Victor Babes

Bucharest, 30303, Romania

Location

Futuremeds S.R.L., Craiova

Criaova, 200115, Romania

Location

Futuremeds S.R.L., Galati

Galati, 800183, Romania

Location

Centru Medical "GRANDMED"

Oradea, 410032, Romania

Location

Sc Gensan Srl/Policlinica Astra

Sibiu, 550371, Romania

Location

Centrul Medical Mediab - Mediab Srl

Târgu Mureş, 540142, Romania

Location

DIABEDA s.r.o.

Bratislava, 831 06, Slovakia

Location

Medispektrum s.r.o.

Bratislava, 85101, Slovakia

Location

Poliklinika Váš Lekár

Bratislava - Ružinov, 91109, Slovakia

Location

Cardio D&R Košice

Košice, 040 22, Slovakia

Location

Medical group Kosice s.r.o.

Košice, 04001, Slovakia

Location

Tatratrial s.r.o.

Rožňava, 048 01, Slovakia

Location

MEDI-DIA s.r.o

Sabinov, 083 01, Slovakia

Location

JAL s.r.o

Trnava, 91701, Slovakia

Location

Medivasa s.r.o

Žilina, 010 01, Slovakia

Location

Hospital Universitario Virgen de la Victoria

Málaga, Málaga, 29010, Spain

Location

Hospital Vithas Sevilla

Castilleja de la Cuesta, 41950, Spain

Location

Futuremeds Spain Cadiz

Chiclana de la Frontera, 11139, Spain

Location

Futuremeds Spain Madrid

Madrid, 28003, Spain

Location

Hospital Virgen del Camino

Sanlúcar de Barrameda, 11540, Spain

Location

Nuevas Tecnologías en Diabetes y Endocrinología S.L.

Seville, 41003, Spain

Location

Futuremeds Spain Sevilla

Seville, 41012, Spain

Location

Ecg Médica S.L.

Valencia, 46015, Spain

Location

Ashfields Primary Care Center

Sandbach, Cheshire, CW11 1EQ, United Kingdom

Location

Civia Health Sunderland

Hendon, CITY of Sunderland, SR1 1PB, United Kingdom

Location

FutureMeds Glasgow McCafferty House

Glasgow, Scotland, G20 7BE, United Kingdom

Location

Synexus Glasgow Clinical Research Centre

Bellshill, ML4 3NJ, United Kingdom

Location

Synexus Midlands Clinical Research Centre

Birmingham, B15 2SQ, United Kingdom

Location

FutureMeds Birmingham

Birmingham, B21 9RY, United Kingdom

Location

Civia Health_Boots Birmingham

Birmingham, B4 7TA, United Kingdom

Location

Southmead Hospital

Bristol, BS10 5NB, United Kingdom

Location

FutureMeds Liverpool

Bromborough, CH62 6EE, United Kingdom

Location

Panthera Biopartners Limited - Enfield

Enfield, EN3 4GS, United Kingdom

Location

Panthera Biopartners Limited - Glasgow

Glasgow, G51 4TY, United Kingdom

Location

Bodyline Medical Clinic, Crosby Civia Health

Liverpool, L22 4QQ, United Kingdom

Location

FutureMeds London

London, NW10 2PB, United Kingdom

Location

Synexus Manchester Clinical Research Centre

Manchester, M15 6SE, United Kingdom

Location

Kiltearn Medical Centre

Nantwich, CW5 5NX, United Kingdom

Location

FutureMeds Newcastle upon Tyne

Newcastle upon Tyne, NE6 1SG, United Kingdom

Location

Civia Health_Boots Nottingham

Nottingham, NG1 3QS,, United Kingdom

Location

Bodyline Medical Clinic Warrington Civia Health

Paddington, WA1 3TZ, United Kingdom

Location

Panthera Biopartners Limited - Preston

Preston, PR2 9QB, United Kingdom

Location

Panthera Biopartners Limited - Rochdale

Rochdale, OL11 4AU, United Kingdom

Location

Clifton Medical Centre

Rotherham, S651DA, United Kingdom

Location

Panthera Biopartners Limited - Sheffield

Sheffield, S2 5FX, United Kingdom

Location

Bodyline Medical Clinic, St Helens Civia Health

St Helens, WA9 1AF, United Kingdom

Location

FutureMeds Teesside

Stockton-on-Tees, TS19 8PE, United Kingdom

Location

Bodyline Medical Clinic, Stoke-on-Trent Civia Health

Stoke-on-Trent, ST1 5TL, United Kingdom

Location

Panthera Biopartners Limited - York

York, YO24 4LJ, United Kingdom

Location

Related Links

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2025

First Posted

December 31, 2025

Study Start

December 19, 2025

Primary Completion (Estimated)

September 21, 2027

Study Completion (Estimated)

April 25, 2028

Last Updated

July 24, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

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.

More information

Locations