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Recruiting Phase 3 NCT07400653

A Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D)

Phase 3 – large-scale trial before approval
Conditions: Obesity Overweight and/or Obesity Overweight Diabetes, Type 2 Type 2 Diabetes

Sponsor: Pfizer

trial.available_in: БГ
Overview
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.
Who can participate
Inclusion Criteria: * 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. Exclusion Criteria: * Female who is breastfeeding, or who is pregnant * Unwilling or unable to follow contraceptive requirements * Diagnosis of Type 1 diabetes, or any other types of diabetes except T2DM. * Severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to Screening * Poorly controlled hypertension * Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed \>1 year prior to screening) * Have taken within 3 months prior to randomization, medications (prescribed or over-the counter) intended to promote weight loss * Are receiving or have received within 3 months prior to screening chronic (\>2 weeks or 14 days) systemic glucocorticoid therapy
Interventions
PF-08653944
DRUG
Placebo
OTHER
Locations 184
Argentina (12)
CINME
Buenos Aires
NOT_YET_RECRUITING
CEDIC
Buenos Aires
NOT_YET_RECRUITING
Centro Medico Viamonte
Buenos Aires
NOT_YET_RECRUITING
Centro Diabetologico Dr Waitman
Córdoba
NOT_YET_RECRUITING
Clinica Privada Velez Sarsfield
Córdoba
NOT_YET_RECRUITING
Instituto de Investigaciones Clinicas Cordoba
Córdoba
NOT_YET_RECRUITING
CIDIM
Córdoba
NOT_YET_RECRUITING
CIPADI - Centro Integral de Prevencion Y Atencion en Diabetes
Godoy Cruz
NOT_YET_RECRUITING
IIC Mar del Plata
Mar del Plata
NOT_YET_RECRUITING
CIAD Moron
Morón
NOT_YET_RECRUITING
Centro Medico Privado de Reumatologia
San Miguel de Tucumán
NOT_YET_RECRUITING
Instituto Medico Catamarca (IMEC)
Santa Fe
NOT_YET_RECRUITING
Bulgaria (15)
MHAT Botevgrad
Botevgrad
NOT_YET_RECRUITING
4 Life EOOD
Burgas
NOT_YET_RECRUITING
Multiprofile Hospital for Active Treatment Dobrich AD (MHAT Dobrich AD)
Dobrich
NOT_YET_RECRUITING
Medical Center New Polyclinic Gabrovo Ltd.
Gabrovo
NOT_YET_RECRUITING
Medical Center Zdrave 1
Kozloduy
NOT_YET_RECRUITING
FutureMeds Plovdiv
Plovdiv
NOT_YET_RECRUITING
MHAT Sveta Karidad EAD
Plovdiv
NOT_YET_RECRUITING
Diagnostic Consultative Center Aleksandrovska
Sofia
NOT_YET_RECRUITING
Medical Center Hera EOOD
Sofia
NOT_YET_RECRUITING
Prevencia - 2000 - Medical Center for Prehospital Medical Care OOD
Stara Zagora
NOT_YET_RECRUITING
UMHAT "Prof. Dr. Stoyan Kirkovich"AD
Stara Zagora
NOT_YET_RECRUITING
MC Nova Clinic
Varna
NOT_YET_RECRUITING
Medical Centre Pratia Clinic EOOD
Varna
NOT_YET_RECRUITING
MC Nevromedics Ltd.
Veliko Tarnovo
NOT_YET_RECRUITING
Medical Center Berbatov
Yambol
NOT_YET_RECRUITING
Canada (4)
Centricity Research Etobicoke Endocrinology
Etobicoke , Ontario
NOT_YET_RECRUITING
The Wharton Medical Clinic Clinical Trials Inc
Hamilton , Ontario
NOT_YET_RECRUITING
Centricity Research Mirabel Multispecialty (Centricity Research)
Mirabel , Quebec
NOT_YET_RECRUITING
LMC Diabetes & Endocrinology - Bayview (Centricity Research Toronto LMC Multispecialty)
Toronto , Ontario
NOT_YET_RECRUITING
Czech Republic (9)
Diacentrum Brandys n.L.
Brandys Nad Lebem
NOT_YET_RECRUITING
Nemocnice Jihlava
Jihlava
NOT_YET_RECRUITING
Edumed s.r.o.
Náchod
NOT_YET_RECRUITING
PreventaMed s.r.o.
Olomouc
NOT_YET_RECRUITING
CCR Ostrava
Ostrava
NOT_YET_RECRUITING
Pratia Pardubice
Pardubice
NOT_YET_RECRUITING
Fakultní nemocnice Královské Vinohrady
Prague
NOT_YET_RECRUITING
Synexus/Trialmed Prague
Prague
NOT_YET_RECRUITING
ResTrial s.r.o.
Prague
NOT_YET_RECRUITING
Germany (20)
Klinische Forschung Berlin-Mitte GmbH
Berlin
NOT_YET_RECRUITING
FutureMeds Berlin
Berlin
NOT_YET_RECRUITING
Velocity Clinical Research Germany, Berlin
Berlin
NOT_YET_RECRUITING
Diabetespraxis Dr. Braun
Berlin
NOT_YET_RECRUITING
Pratia
Dresden
NOT_YET_RECRUITING
Medizentrum Essen Borbeck
Essen
NOT_YET_RECRUITING
Praxis am Markt - Dr. Bernd Becker
Essen
NOT_YET_RECRUITING
Klinische Forschung Hamburg GmbH / Pratia
Hamburg
NOT_YET_RECRUITING
Diabetes Studienzentrum Wilhelmsburg
Hamburg
NOT_YET_RECRUITING
DZHW
Hamburg
NOT_YET_RECRUITING
Praxis Reinfeld Mitte
Holstein
NOT_YET_RECRUITING
Zentrum fuer klinische Forschung Koeln Duennwald
Kaln
NOT_YET_RECRUITING
Klinische Forschung Karlsruhe GmbH
Karlsruhe
NOT_YET_RECRUITING
Studienzentrum FMZ Radowsky
Leipzig , Saxony
NOT_YET_RECRUITING
CDG Studienambulanz Hartard
Munich , Bavaria
NOT_YET_RECRUITING
IDFM GmbH
Münster
NOT_YET_RECRUITING
Gemeinschaftspraxis PD Dr. med. habil. Holger Kittner & Dr. Hartig
Naunhof
NOT_YET_RECRUITING
FutureMeds Frankfurt/Offenbach
Offenbach
NOT_YET_RECRUITING
Zentrum für kliniche Studien Allgäu-Oberschwaben
Wangen
NOT_YET_RECRUITING
Medislim GmbH
Weinheim
NOT_YET_RECRUITING
Poland (27)
Zdrowie Osteo Medic sc L i A Racewicz, A i J Supronik
Bialystok
NOT_YET_RECRUITING
NZOZ Centrum Medyczne KERmed
Bydgoszcz
NOT_YET_RECRUITING
Centrum medyczne Pratia Bydgoszcz
Bydgoszcz
NOT_YET_RECRUITING
Pratia Chojnice
Chojnice
NOT_YET_RECRUITING
Synexus Polska Sp. z o.o., Oddzial w Czestochowie
Częstochowa
NOT_YET_RECRUITING
Synexus Polska Sp z o.o.
Gdansk
NOT_YET_RECRUITING
Centrum Badan Klinicznych PI-House Sp. z o.o.
Gdansk
NOT_YET_RECRUITING
Centrum Medyczne Pratia Gdynia
Gdynia
NOT_YET_RECRUITING
Synexus Polska Sp. z o.o. Oddzial w Gdyni
Gdynia
NOT_YET_RECRUITING
Synexus Polska Sp. Z O.O. Oddzial W Katowicach
Katowice
NOT_YET_RECRUITING
Centrum Medyczne Pratia Katowice
Katowice
NOT_YET_RECRUITING
Synexus Polska Sp. z o.o., Oddzial w Lodzi
Lodz
NOT_YET_RECRUITING
Santa Sp. z.o.o.
Lodz
NOT_YET_RECRUITING
Centrum Terapii Współczesnej J.M. Jasnorzewska Spółka Komandytowo-Akcyjna
Lodz
NOT_YET_RECRUITING
Ekamed Sp. z o. o.
Lublin
NOT_YET_RECRUITING
FutureMeds Olsztyn
Olsztyn
NOT_YET_RECRUITING
Medicome Sp. z o.o. Oświęcimskie Centrum Badań Klinicznych
Oświęcim
NOT_YET_RECRUITING
IRMED
Piotrkow Trybunalski
NOT_YET_RECRUITING
Trialmed CRS
Piotrkow Trybunalski
NOT_YET_RECRUITING
Synexus Polska Sp. z o.o., Oddział w Poznaniu
Poznan
NOT_YET_RECRUITING
Praktyka Lekarska Ewa Krzyzagorska
Poznan
NOT_YET_RECRUITING
ETG Siedlce
Siedlce
NOT_YET_RECRUITING
Metabolica Sp. z o.o., NZOZ METABOLICA Ośrodek Badań Klinicznych
Tarnów
NOT_YET_RECRUITING
Instytut Diabetologii.sp.z.o.o.
Warsaw
NOT_YET_RECRUITING
Synexus Polska Sp. z o.o., Oddzial w Warszawie
Warsaw
NOT_YET_RECRUITING
Etg Warszawa
Warsaw
NOT_YET_RECRUITING
Synexus Polska Sp. z o.o., Oddział we Wrocławiu
Wroclaw
NOT_YET_RECRUITING
Romania (11)
Minimed S.R.L.
Bacau
NOT_YET_RECRUITING
Futuremeds S.R.L., Brasov
Brasov
NOT_YET_RECRUITING
Hightech Medical Services S.R.L (Centrul pentru Studiul Metabolismului)
Bucharest
NOT_YET_RECRUITING
Fundatia Dr Victor Babes
Bucharest
NOT_YET_RECRUITING
Institutul Clinic Fundeni
Bucharest
NOT_YET_RECRUITING
Institutul National de Endocrinologie "C.I. Parhon"
Bucharest
NOT_YET_RECRUITING
Futuremeds S.R.L., Craiova
Craiova
NOT_YET_RECRUITING
Futuremeds S.R.L., Galati
Galati
NOT_YET_RECRUITING
Centru Medical "GRANDMED"
Oradea
NOT_YET_RECRUITING
Sc Gensan Srl/Policlinica Astra
Sibiu
NOT_YET_RECRUITING
Centrul Medical Mediab - Mediab Srl
Târgu Mureş
NOT_YET_RECRUITING
Slovakia (8)
DIABEDA s.r.o.
Bratislava
NOT_YET_RECRUITING
Medispektrum
Bratislava
NOT_YET_RECRUITING
Poliklinika Váš Lekár
Bratislava - Ružinov
NOT_YET_RECRUITING
Cardio D&R Košice
Košice
NOT_YET_RECRUITING
Medical group Kosice s.r.o.
Košice
NOT_YET_RECRUITING
Tatratrial s.r.o.
Rožňava
NOT_YET_RECRUITING
JAL s.r.o.
Trnava
NOT_YET_RECRUITING
Medivasa s.r.o
Žilina
NOT_YET_RECRUITING
Spain (11)
Hospital Universitario Torrecárdenas (CPE Bola Azul)
Almería
NOT_YET_RECRUITING
Hospital Universitari Vall d'Hebron
Barcelona
NOT_YET_RECRUITING
Hospital Vithas Sevilla
Castilleja de la Cuesta
NOT_YET_RECRUITING
Futuremeds Spain Cadiz
Chiclana de la Frontera
NOT_YET_RECRUITING
Futuremeds Spain Madrid
Madrid
NOT_YET_RECRUITING
Hospital Universitario Virgen de la Victoria
Málaga
NOT_YET_RECRUITING
Hospital Universitari Son Espases
Palma de Mallorca
NOT_YET_RECRUITING
Hospital Virgen del Camino
Sanlúcar de Barrameda
NOT_YET_RECRUITING
Nuevas Tecnologías en Diabetes y Endocrinología S.L.
Seville
NOT_YET_RECRUITING
Futuremeds Spain Sevilla
Seville
NOT_YET_RECRUITING
Ecg Médica S.L.
Valencia
NOT_YET_RECRUITING
United Kingdom (32)
Synexus Glasgow Clinical Research Centre
Bellshill
NOT_YET_RECRUITING
Synexus Midlands Clinical Research Centre
Birmingham
NOT_YET_RECRUITING
FutureMeds Birmingham
Birmingham
NOT_YET_RECRUITING
Civia Health_Boots Birmingham
Birmingham
NOT_YET_RECRUITING
Civia Health_Boots Brighton
Brighton
NOT_YET_RECRUITING
Southmead Hospital
Bristol
NOT_YET_RECRUITING
FutureMeds Liverpool
Bromborough
NOT_YET_RECRUITING
Synexus/Trialmed Cardiff
Cardiff
NOT_YET_RECRUITING
Panthera Biopartners Limited - Enfield
Enfield
NOT_YET_RECRUITING
FutureMeds Glasgow McCafferty House
Glasgow , Scotland
NOT_YET_RECRUITING
Panthera Biopartners Limited - Glasgow
Glasgow
NOT_YET_RECRUITING
Civia Health Sunderland
Hendon , CITY of Sunderland
NOT_YET_RECRUITING
Bodyline Medical Clinic Crosby
Liverpool
NOT_YET_RECRUITING
FutureMeds London
London
NOT_YET_RECRUITING
Synexus Manchester Clinical Research Centre
Manchester
NOT_YET_RECRUITING
Kiltearn Medical Centre
Nantwich
NOT_YET_RECRUITING
FutureMeds Newcastle
Newcastle upon Tyne
NOT_YET_RECRUITING
Danes Camp Medical Centre
Northampton
NOT_YET_RECRUITING
Civia Health_Boots Nottingham
Nottingham
NOT_YET_RECRUITING
Bodyline Medical Research Openshaw
Openshaw , Manchester
NOT_YET_RECRUITING
Bodyline Medical Clinic Warrington Civia Health
Paddington
NOT_YET_RECRUITING
Civia Health_Boots Peterborough
Peterborough
NOT_YET_RECRUITING
Panthera Biopartners Limited - Preston
Preston
NOT_YET_RECRUITING
Panthera Biopartners Limited - Rochdale
Rochdale
NOT_YET_RECRUITING
Clifton Medical Centre
Rotherham
NOT_YET_RECRUITING
Ashfields Primary Care Centre
Sandbach
NOT_YET_RECRUITING
Panthera Biopartners Limited - Sheffield
Sheffield
NOT_YET_RECRUITING
Staploe Medical Centre
Soham
NOT_YET_RECRUITING
Bodyline Medical Clinic St Helens
St Helens , Liverpool
NOT_YET_RECRUITING
FutureMeds Teesside
Stockton-on-Tees
NOT_YET_RECRUITING
Bodyline Medical Clinic Stoke on Trent
Stoke-on-Trent , Staffordshire
NOT_YET_RECRUITING
Panthera Biopartners Limited - York
York
NOT_YET_RECRUITING
United States (35)
CenExel Anaheim Clinical Trials
Anaheim , California
DelRicht Research
Atlanta , Georgia
Forum Austin (Civia Health)
Austin , Texas
Pantheon Clinical Research
Bountiful , Utah
Alliance Research Institute
Canoga Park , California
Forum Health Cary
Cary , North Carolina
Core Healthcare Group
Cerritos , California
Civia Health St. Louis
Creve Coeur , Missouri
NOT_YET_RECRUITING
CenExel iResearch, LLC
Decatur , Georgia
Eximia EquiHealth Research
Durham , North Carolina
GLRI El Paso Research
El Paso , Texas
CenExel Denver CO (Rocky Mountain Clinical Research)
Englewood , Colorado
Civia Health Goodlettsville
Goodlettsville , Tennessee
NOT_YET_RECRUITING
Miami Eye Institute
Hollywood , Florida
Research Centers of America
Hollywood , Florida
Civia Health Independence
Independence , Missouri
NOT_YET_RECRUITING
Civia Health Nashville
La Vergne , Tennessee
NOT_YET_RECRUITING
Future Medical Research (Civia Health)
Longwood , Florida
CenExel CNS - Collaborative Neuroscience Research
Los Alamitos , California
Patient First Clinical Trials (PFCTRIALS)
Lutherville , Maryland
CenExel HRI - Hassman Research Institute
Marlton , New Jersey
Civia Health Memphis
Memphis , Tennessee
NOT_YET_RECRUITING
Advanced Clinical Research
Miami , Florida
Quality Clinical Research Inc
Omaha , Nebraska
Cure Clinical Research
Orange , California
Oviedo Medical Research
Oviedo , Florida
Primary Care Research (Civia Health)
Papillion , Nebraska
Eximia Research - NC, LLC
Raleigh , North Carolina
Dallas Clinical Research Center (Pillar Clinical Research)
Richardson , Texas
CenExel CIT
Riverside , California
CenExel Salt Lake City UT (JBR Clinical Research)
Salt Lake City , Utah
Murray Vision Center PC
Salt Lake City , Utah
CenExel iResearch, LLC
Savannah , Georgia
DelRicht Research @ Command Family Medicine
Springfield , Missouri
CenExel FCR - ForCare Clinical Research
Tampa , Florida
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
24.02.2026
Completion date
16.05.2028
Registry ID
NCT07400653
Source
clinicaltrials.gov
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.