EVALUATING THE EFFICACY AND SAFETY OF MET097, A FULLY-BIASED ULTRA LONG-ACTING GLP-1RA, IN PEOPLE WITH OVERWEIGHT OR OBESITY AND TYPE 2 DIABETES: A PHASE 3, MULTI-CENTER RANDOMIZED PLACEBO-CONTROLLED TRIAL (VESPER-5)
Status: Recruiting
Location: See all (175) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this clinical study is to learn about the safety and effects of the study medicine to help adults with obesity or overweight and type 2 diabetes lose weight. Being overweight or obese means carrying too much body weight. Type 2 diabetes is a condition where there is too much sugar in the blood. The study medicine is given by a shot under the skin in the belly area. The participants will be trained to do this at home once every week. About 660 out of 1000 adults will also receive the study medicine and about 330 out of 1000 adults will receive placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. The investigators will compare the experiences of people receiving the study medicine to those of the people who do not. This will help us assess if the study medicine is safe and effective. People will take part in this study for about 21 months. During this time, they will have about 14 study visits at the site and 5 over the phone.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Provision of signed and dated informed consent form (ICF)
• Male or female adults, aged ≥18 years
• Have a BMI at Screening of ≥27.0 kg/m2
• Have T2DM for at least 6 months before Screening based on participant reported history or documentation of the disease diagnostic criteria
• Have HbA1c value between ≥6.5% (48 mmol/mol) and ≤10.0% (86.0 mmol/mol) at Screening with stable therapy for at least 90 days prior to Screening/Visit 1. T2DM may be treated with:
⁃ -Diet and exercise alone or in combination with: Any oral antidiabetic therapy per local labeling EXCEPT DPP-4 inhibitors. Participant may NOT be on GLP-1 agonists or insulin
• Participants must be motivated and willing to:
‣ Self-inject study medication (or be aided by caregiver if needed),
⁃ Perform finger-stick glucose monitoring as required.
• Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
Locations
United States
California
CenExel Anaheim Clinical Trials
RECRUITING
Anaheim
Alliance Research Institute
RECRUITING
Canoga Park
Core Healthcare Group
RECRUITING
Cerritos
CenExel CNS - Collaborative Neuroscience Research
RECRUITING
Los Alamitos
Cure Clinical Research
RECRUITING
Orange
CenExel CIT
RECRUITING
Riverside
Colorado
CenExel Denver CO (Rocky Mountain Clinical Research)
NOT_YET_RECRUITING
Englewood
Florida
Miami Eye Institute
RECRUITING
Hollywood
Research Centers of America
RECRUITING
Hollywood
Future Medical Research (Civia Health)
RECRUITING
Longwood
Advanced Clinical Research
RECRUITING
Miami
Oviedo Medical Research
NOT_YET_RECRUITING
Oviedo
CenExel FCR - ForCare Clinical Research
NOT_YET_RECRUITING
Tampa
Georgia
CenExel Atlanta GA (Atlanta Center for Medical Research)
NOT_YET_RECRUITING
Atlanta
DelRicht Research
RECRUITING
Atlanta
CenExel iResearch, LLC
NOT_YET_RECRUITING
Decatur
CenExel iResearch, LLC
NOT_YET_RECRUITING
Savannah
Kansas
Tekton Research
NOT_YET_RECRUITING
Wichita
Maryland
Patient First Clinical Trials (PFCTRIALS)
RECRUITING
Lutherville
Missouri
Civia Health St. Louis
NOT_YET_RECRUITING
Creve Coeur
Civia Health Independence
NOT_YET_RECRUITING
Independence
DelRicht Research @ Command Family Medicine
RECRUITING
Springfield
North Carolina
Forum Health Cary
RECRUITING
Cary
Eximia EquiHealth Research
RECRUITING
Durham
Eximia Research - NC, LLC
RECRUITING
Raleigh
Nebraska
Quality Clinical Research Inc
RECRUITING
Omaha
Primary Care Research (Civia Health)
RECRUITING
Papillion
New Jersey
CenExel HRI - Hassman Research Institute
NOT_YET_RECRUITING
Marlton
Tennessee
Civia Health Goodlettsville
NOT_YET_RECRUITING
Goodlettsville
Civia Health Nashville
NOT_YET_RECRUITING
La Vergne
Civia Health Memphis
NOT_YET_RECRUITING
Memphis
Texas
Forum Austin (Civia Health)
RECRUITING
Austin
GLRI El Paso Research
RECRUITING
El Paso
Dallas Clinical Research Center (Pillar Clinical Research)
NOT_YET_RECRUITING
Richardson
Utah
Pantheon Clinical Research
NOT_YET_RECRUITING
Bountiful
CenExel Salt Lake City UT (JBR Clinical Research)
NOT_YET_RECRUITING
Salt Lake City
Other Locations
Argentina
CEDIC
NOT_YET_RECRUITING
Buenos Aires
Centro Medico Viamonte
NOT_YET_RECRUITING
Buenos Aires
CINME
NOT_YET_RECRUITING
Buenos Aires
CIDIM
NOT_YET_RECRUITING
Córdoba
Clinica Privada Velez Sarsfield
NOT_YET_RECRUITING
Córdoba
Instituto de Investigaciones Clinicas Cordoba
NOT_YET_RECRUITING
Córdoba
CIPADI - Centro Integral de Prevencion Y Atencion en Diabetes
NOT_YET_RECRUITING
Godoy Cruz
IIC Mar del Plata
NOT_YET_RECRUITING
Mar Del Plata
CIAD Moron
NOT_YET_RECRUITING
Morón
Centro Medico Privado de Reumatologia
NOT_YET_RECRUITING
San Miguel De Tucumán
Instituto Medico Catamarca (IMEC)
NOT_YET_RECRUITING
Santa Fe
Bulgaria
MHAT Botevgrad
NOT_YET_RECRUITING
Botevgrad
4 Life EOOD
NOT_YET_RECRUITING
Burgas
Multiprofile Hospital for Active Treatment Dobrich AD (MHAT Dobrich AD)
NOT_YET_RECRUITING
Dobrich
Medical Center New Polyclinic Gabrovo Ltd.
NOT_YET_RECRUITING
Gabrovo
Medical Center Zdrave 1
NOT_YET_RECRUITING
Kozloduy
FutureMeds Plovdiv
NOT_YET_RECRUITING
Plovdiv
MHAT Sveta Karidad EAD
NOT_YET_RECRUITING
Plovdiv
Diagnostic Consultative Center Aleksandrovska
NOT_YET_RECRUITING
Sofia
Medical Center Hera EOOD
NOT_YET_RECRUITING
Sofia
Prevencia - 2000 - Medical Center for Prehospital Medical Care OOD
NOT_YET_RECRUITING
Stara Zagora
UMHAT Prof. Dr. Stoyan KirkovichAD
NOT_YET_RECRUITING
Stara Zagora
MC Nova Clinic
NOT_YET_RECRUITING
Varna
Medical Centre Pratia Clinic EOOD
NOT_YET_RECRUITING
Varna
MC Nevromedics Ltd.
NOT_YET_RECRUITING
Veliko Tarnovo
Medical Center Berbatov
NOT_YET_RECRUITING
Yambol
Canada
LMC Etobicoke
NOT_YET_RECRUITING
Etobicoke
The Wharton Medical Clinic Clinical Trials Inc
NOT_YET_RECRUITING
Hamilton
Manna Research Mirabel
NOT_YET_RECRUITING
Mirabel
LMC Diabetes & Endocrinology - Bayview (Centricity Research Toronto LMC Multispecialty)
NOT_YET_RECRUITING
Toronto
Germany
Diabetespraxis Dr. Braun
NOT_YET_RECRUITING
Berlin
FutureMeds Berlin
NOT_YET_RECRUITING
Berlin
Klinische Forschung Berlin-Mitte GmbH
NOT_YET_RECRUITING
Berlin
Velocity Clinical Research Germany, Berlin
NOT_YET_RECRUITING
Berlin
Pratia
NOT_YET_RECRUITING
Dresden
Medizentrum Essen Borbeck
NOT_YET_RECRUITING
Essen
Praxis am Markt - Dr. Bernd Becker
NOT_YET_RECRUITING
Essen
Diabetes Studienzentrum Wilhelmsburg
NOT_YET_RECRUITING
Hamburg
DZHW
NOT_YET_RECRUITING
Hamburg
Klinische Forschung Hamburg GmbH / Pratia
NOT_YET_RECRUITING
Hamburg
Praxis Reinfeld Mitte
NOT_YET_RECRUITING
Holstein
Zentrum fuer klinische Forschung Koeln Duennwald
NOT_YET_RECRUITING
Kaln
Klinische Forschung Karlsruhe GmbH
NOT_YET_RECRUITING
Karlsruhe
Studienzentrum FMZ Radowsky
NOT_YET_RECRUITING
Leipzig
CDG Studienambulanz Hartard
NOT_YET_RECRUITING
Munich
IDFM GmbH
NOT_YET_RECRUITING
Münster
Gemeinschaftspraxis PD Dr. med. habil. Holger Kittner & Dr. Hartig
NOT_YET_RECRUITING
Naunhof
FutureMeds Frankfurt/Offenbach
NOT_YET_RECRUITING
Offenbach
Zentrum für kliniche Studien Allgäu-Oberschwaben
NOT_YET_RECRUITING
Wangen
Medislim GmbH
NOT_YET_RECRUITING
Weinheim
Poland
Zdrowie Osteo Medic sc L i A Racewicz, A i J Supronik
NOT_YET_RECRUITING
Bialystok
Centrum medyczne Pratia Bydgoszcz
NOT_YET_RECRUITING
Bydgoszcz
NZOZ Centrum Medyczne KERmed
NOT_YET_RECRUITING
Bydgoszcz
Pratia Chojnice
NOT_YET_RECRUITING
Chojnice
Synexus Polska Sp. z o.o., Oddzial w Czestochowie
NOT_YET_RECRUITING
Częstochowa
Centrum Badan Klinicznych PI-House Sp. z o.o.
NOT_YET_RECRUITING
Gdansk
Synexus Polska Sp z o.o.
NOT_YET_RECRUITING
Gdansk
Centrum Medyczne Pratia Gdynia
NOT_YET_RECRUITING
Gdynia
Synexus Polska Sp. z o.o. Oddzial w Gdyni
NOT_YET_RECRUITING
Gdynia
Centrum Medyczne Pratia Katowice
NOT_YET_RECRUITING
Katowice
Synexus Polska Sp. Z O.O. Oddzial W Katowicach
NOT_YET_RECRUITING
Katowice
Centrum Terapii Współczesnej J.M. Jasnorzewska Spółka Komandytowo-Akcyjna
NOT_YET_RECRUITING
Lodz
Santa Sp. z.o.o.
NOT_YET_RECRUITING
Lodz
Synexus Polska Sp. z o.o., Oddzial w Lodzi
NOT_YET_RECRUITING
Lodz
Ekamed Sp. z o. o.
NOT_YET_RECRUITING
Lublin
FutureMeds Olsztyn
NOT_YET_RECRUITING
Olsztyn
Medicome Sp. z o.o. Oświęcimskie Centrum Badań Klinicznych
NOT_YET_RECRUITING
Oświęcim
IRMED
NOT_YET_RECRUITING
Piotrkow Trybunalski
Trialmed CRS
NOT_YET_RECRUITING
Piotrkow Trybunalski
Praktyka Lekarska Ewa Krzyzagorska
NOT_YET_RECRUITING
Poznan
Synexus Polska Sp. z o.o., Oddział w Poznaniu
NOT_YET_RECRUITING
Poznan
ETG Siedlce
NOT_YET_RECRUITING
Siedlce
Metabolica Sp. z o.o., NZOZ METABOLICA Ośrodek Badań Klinicznych
NOT_YET_RECRUITING
Tarnów
Etg Warszawa
NOT_YET_RECRUITING
Warsaw
Instytut Diabetologii.sp.z.o.o.
NOT_YET_RECRUITING
Warsaw
Synexus Polska Sp. z o.o., Oddzial w Warszawie
NOT_YET_RECRUITING
Warsaw
Synexus Polska Sp. z o.o., Oddział we Wrocławiu
NOT_YET_RECRUITING
Wroclaw
Romania
Minimed S.R.L.
NOT_YET_RECRUITING
Bacau
Futuremeds S.R.L., Brasov
NOT_YET_RECRUITING
Brasov
Fundatia Dr Victor Babes
NOT_YET_RECRUITING
Bucharest
Hightech Medical Services S.R.L (Centrul pentru Studiul Metabolismului)
NOT_YET_RECRUITING
Bucharest
Institutul Clinic Fundeni
NOT_YET_RECRUITING
Bucharest
Institutul National de Endocrinologie C.I. Parhon
NOT_YET_RECRUITING
Bucharest
Futuremeds S.R.L., Craiova
NOT_YET_RECRUITING
Craiova
Futuremeds S.R.L., Galati
NOT_YET_RECRUITING
Galati
Centru Medical GRANDMED
NOT_YET_RECRUITING
Oradea
Sc Gensan Srl/Policlinica Astra
NOT_YET_RECRUITING
Sibiu
Centrul Medical Mediab - Mediab Srl
NOT_YET_RECRUITING
Târgu Mureş
Slovakia
DIABEDA s.r.o.
NOT_YET_RECRUITING
Bratislava
Medispektrum
NOT_YET_RECRUITING
Bratislava
Poliklinika Váš Lekár
NOT_YET_RECRUITING
Bratislava - Ružinov
Cardio D&R Košice
NOT_YET_RECRUITING
Košice
Medical group Kosice s.r.o.
NOT_YET_RECRUITING
Košice
Tatratrial s.r.o.
NOT_YET_RECRUITING
Rožňava
JAL s.r.o.
NOT_YET_RECRUITING
Trnava
Medivasa sro
NOT_YET_RECRUITING
Žilina
Spain
Hospital Universitario Torrecárdenas (CPE Bola Azul)
NOT_YET_RECRUITING
Almería
Hospital Universitari Vall d'Hebron
NOT_YET_RECRUITING
Barcelona
Hospital Vithas Sevilla
NOT_YET_RECRUITING
Castilleja De La Cuesta
Futuremeds Spain Cadiz
NOT_YET_RECRUITING
Chiclana De La Frontera
Futuremeds Spain Madrid
NOT_YET_RECRUITING
Madrid
Hospital Universitario Virgen de la Victoria
NOT_YET_RECRUITING
Málaga
Hospital Universitari Son Espases
NOT_YET_RECRUITING
Palma
Hospital Virgen del Camino
NOT_YET_RECRUITING
Sanlúcar De Barrameda
Futuremeds Spain Sevilla
NOT_YET_RECRUITING
Seville
Nuevas Tecnologías en Diabetes y Endocrinología S.L.
NOT_YET_RECRUITING
Seville
Ecg Médica S.L.
NOT_YET_RECRUITING
Valencia
United Kingdom
Synexus/Trialmed Glasgow
NOT_YET_RECRUITING
Bellshill
Boots Birmingham
NOT_YET_RECRUITING
Birmingham
FutureMeds Birmingham
NOT_YET_RECRUITING
Birmingham
Synexus/Trialmed Midlands
NOT_YET_RECRUITING
Birmingham
Civia Health_Boots Brighton
NOT_YET_RECRUITING
Brighton
Southmead Hospital
NOT_YET_RECRUITING
Bristol
FutureMeds Liverpool
NOT_YET_RECRUITING
Bromborough
Synexus/Trialmed Cardiff
NOT_YET_RECRUITING
Cardiff
Panthera Biopartners Limited - Enfield
NOT_YET_RECRUITING
Enfield
FutureMeds Glasgow McCafferty House
NOT_YET_RECRUITING
Glasgow
Panthera Biopartners Limited - Glasgow
NOT_YET_RECRUITING
Glasgow
Civia Health Sunderland
NOT_YET_RECRUITING
Hendon
Bodyline Medical Clinic Crosby
NOT_YET_RECRUITING
Liverpool
FutureMeds London
NOT_YET_RECRUITING
London
Synexus/Trialmed Manchester
NOT_YET_RECRUITING
Manchester
Kiltearn Medical Centre
NOT_YET_RECRUITING
Nantwich
FutureMeds Newcastle
NOT_YET_RECRUITING
Newcastle Upon Tyne
DANES Medical Centre
NOT_YET_RECRUITING
Northampton
Boots Nottingham
NOT_YET_RECRUITING
Nottingham
Bodyline Medical Research Openshaw
NOT_YET_RECRUITING
Openshaw
Civia Health_Boots Peterborough
NOT_YET_RECRUITING
Peterborough
Panthera Biopartners Limited - Preston
NOT_YET_RECRUITING
Preston
Panthera Biopartners Limited - Rochdale
NOT_YET_RECRUITING
Rochdale
Clifton Medical Centre
NOT_YET_RECRUITING
Rotherham
Sandbach GPs
NOT_YET_RECRUITING
Sandbach
Panthera Biopartners Limited - Sheffield
NOT_YET_RECRUITING
Sheffield
Staploe Medical Centre
NOT_YET_RECRUITING
Soham
Bodyline Medical Clinic St Helens
NOT_YET_RECRUITING
St Helens
FutureMeds Teesside
NOT_YET_RECRUITING
Stockton-on-tees
Bodyline Medical Clinic Stoke on Trent
NOT_YET_RECRUITING
Stoke-on-trent
Bodyline Medical Clinic Warrington
NOT_YET_RECRUITING
Warrington
Panthera Biopartners Limited - York
NOT_YET_RECRUITING
York
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2026-02-24
Estimated Completion Date: 2028-05-16
Participants
Target number of participants: 999
Treatments
Experimental: Treatment Arm 1
Participants will receive PF-08653944 by Subcutaneous Injection.
Experimental: Treatment Arm 2
Participants will receive PF-08653944 by Subcutaneous Injection.
Experimental: Treatment Arm 3
Participants will receive PF-08653944 by Subcutaneous Injection.
Placebo_comparator: Placebo
Participants will receive matching placebo by Subcutaneous Injection.
Related Therapeutic Areas
Sponsors
Leads: Pfizer