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NCT06221969CompletedPhase 3

A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor

Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) 2.4 mg/2.4 mg s.c. Once Weekly Versus Tirzepatide 15 mg s.c. Once Weekly in Participants With Type 2 Diabetes Inadequately Controlled on Metformin With or Without an SGLT2 Inhibitor

Source: ClinicalTrials.gov · Last updated 19 Oct 2026

Brief summary (registry, in English)

This study will look at how well CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide that doctors may prescribe in some countries. Participants will get either CagriSema or tirzepatide. Which treatment participant get is decided by chance like flipping a coin. Participant will have an equal chance of receiving either drug. For each participant, the study will last for up to one and a half years.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1024 (actual)
First submitted
15 Jan 2024
Start date
16 Jan 2024
Primary completion date
4 Mar 2026
Lead sponsor
Novo Nordisk A/S
NCT number
NCT06221969
EU CT number
2023-503789-21-00

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 1024
  • From 16 Jan 2024 to the primary completion date, 4 Mar 2026
  • 195 sites in 8 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Lab values

  • Renal impairment with estimated Glomerular Filtration Rate \< 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) as determined by central laboratory at screening.

Other

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.

Who the study is looking for

  • Male or female (sex at birth).
  • Age 18 years or above at the time of signing the informed consent.
  • Diagnosed with type 2 diabetes ≥ 180 days before screening.
  • Stable daily dose(s) ≥ 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without an sodium-glucose co-transporter-2 (SGLT2) inhibitor.
  • HbA1c 7.0-10.5% (53-91 mmol/mol) (both inclusive) as determined by central laboratory at screening.
  • Body mass index (BMI) of ≥ 30.0 kilogram per square meter (kg/m\^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (195)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
OMI- Organización Médica de Investigación
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Buenos AiresArgentinaUnknown status
CICEMO- Consultorio de Investigación Clínica EMO
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Buenos AiresArgentinaUnknown status
Instituto de Investigaciones Metabolicas (IDIM)
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Buenos AiresArgentinaUnknown status
Cedic - Centro de Investigacion Clinica
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CABAArgentinaUnknown status
Centro de Investigación Clínica
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CABAArgentinaUnknown status
Buenos Aires Mácula
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Ciudad Autonoma de Buenos AiresArgentinaUnknown status
CICEMO- Consultorio de Investigación Clínica EMO
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Ciudad Autonoma de Buenos AiresArgentinaUnknown status
Instituto Medico Especializado_Capital Federal
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Ciudad de Buenos AiresArgentinaUnknown status
Instituto de Investigaciones Clinicas Mar del Plata
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Mar del PlataArgentinaUnknown status
CEDIR - Centro de diagnóstico y rehabilitación Santa Fe
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Santa FeArgentinaUnknown status
Paratus Clinical
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BlacktownAustraliaUnknown status
Townsville University Hospital
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DouglasAustraliaUnknown status
Paratus Clinical
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KanwalAustraliaUnknown status
Hunter Diabetes Centre
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MerewetherAustraliaUnknown status
University of Sunshine Coast - Morayfield
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MorayfieldAustraliaUnknown status
Southern Adelaide Diabetes & Endocrine Services
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Oaklands ParkAustraliaUnknown status
The Royal Melbourne Hospital
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ParkvilleAustraliaUnknown status
The Royal Melbourne Hospital - Diabetes & Endocrinology Department
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ParkvilleAustraliaUnknown status
Austrials
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St AlbansAustraliaUnknown status
Momentum Clinical Research Sunshine
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St AlbansAustraliaUnknown status
Royal North Shore Hospital
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St LeonardsAustraliaUnknown status
Momentum Clinical Research Taringa
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TaringaAustraliaUnknown status
Centricity Research Oshawa
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BarrieCanadaUnknown status
Centricity Research Brampton Endocrinology
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BramptonCanadaUnknown status
Centricity Research Calgary Endocrinology
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CalgaryCanadaUnknown status
Western Univ. Cnt for Studies in Fam Med
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LondonCanadaUnknown status
Milestone Research
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LondonCanadaUnknown status
G.A. Research Associates, Ltd.
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MonctonCanadaUnknown status
Centre Medical Acadie
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MontrealCanadaUnknown status
Clinique des Maladies Lipidiques de Quebec Inc.
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QuébecCanadaUnknown status
Centre de Recherche Saint-Louis
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QuébecCanadaUnknown status
Clin des Mal Lipid de Quebec
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QuébecCanadaUnknown status
Alpha Recherche Clinique
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QuébecCanadaUnknown status
London Road Diagnostic Clinic and Medical Centre
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SarniaCanadaUnknown status
Guilford Med Clinic
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SurreyCanadaUnknown status
Ocean West Research Clinic
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SurreyCanadaUnknown status
Hilltop Medical Clinic
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SurreyCanadaUnknown status
TLC Diabetes and Endocrinology
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SurreyCanadaUnknown status
Ctr de Med Metab de Lanaudiere
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TerrebonneCanadaUnknown status
Centricity Research Toronto
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TorontoCanadaUnknown status
Diabetes Heart Research Centre
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TorontoCanadaUnknown status
Diex Recherche Victoriaville
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VictoriavilleCanadaUnknown status
Clinica De La Costa
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BarranquillaColombiaUnknown status
Cimedical
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BarranquillaColombiaUnknown status
UNIENDO
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BogotáColombiaUnknown status
Centro de Investigación en Reumatología y Especialidades Médicas S.A.S. CIREEM S.A.S.
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BogotáColombiaUnknown status
FOSCAL
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FloridablancaColombiaUnknown status
Rajiv Gandhi Centre for Diabetes and Endocrinology, J.N Medical College, Aligarh Muslim University
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AligarhIndiaUnknown status
Belgaum Diabetes Centre
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BelagaviIndiaUnknown status
SRM Centre for Clinical Trials & Research
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ChennaiIndiaUnknown status
Maulana Azad Medical College
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DelhiIndiaUnknown status
AIG Hospitals,Hyderabad
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HyderabadIndiaUnknown status
SMS Medical College & Hospital
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JaipurIndiaUnknown status
Diabetes, Thyroid and Endocrine Centre
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JaipurIndiaUnknown status
BP Poddar Hospital
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KolkataIndiaUnknown status
Government Medical College, Kozhikode
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KozhikodeIndiaUnknown status
Seth GS Medical College & KEM Hospital
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MumbaiIndiaUnknown status
BSES MG hospital
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MumbaiIndiaUnknown status
Government Institute of Medical Sciences
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NoidaIndiaUnknown status
Chellaram Diabetes Institute
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PuneIndiaUnknown status
Grant Medical Foundation Ruby Hall Clinic
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PuneIndiaUnknown status
Nirmal Hospital Pvt Ltd.
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SuratIndiaUnknown status
Indian Institute of Diabetes
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ThiruvnanthapuramIndiaUnknown status
Jothydev's Diabetes & Research Center
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ThriruvananthapuramIndiaUnknown status
SSG Hospital, Baroda
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VadodaraIndiaUnknown status
Christian Medical College Hospital, Vellore
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VelloreIndiaUnknown status
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
Chung Shan Medical University Hospital
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TaichungTaiwanUnknown status
Taichung Veterans General Hospital
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TaichungTaiwanUnknown status
Kuang Tien General Hospital
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TaichungTaiwanUnknown status
National Cheng Kung University Hospital
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TainanTaiwanUnknown status
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status
National Taiwan University Hospital_main
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TaipeiTaiwanUnknown status
AMC Community Endocrinology
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AlbanyUnited StatesUnknown status
Velocity Clin Res Albuquerque
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AlbuquerqueUnited StatesUnknown status
Velocity Clinical Res-Anderson
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AndersonUnited StatesUnknown status
Arlington Family Res. Ctr Inc
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ArlingtonUnited StatesUnknown status
University of Colorado Hospital
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AuroraUnited StatesUnknown status
Velocity Clin Res
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AustinUnited StatesUnknown status
AM Diabetes And Endocrinology Center
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BartlettUnited StatesUnknown status
UT Health University of Texas
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BellaireUnited StatesUnknown status
Belzoni Clinical Research
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BelzoniUnited StatesUnknown status
Univ of Alabama Birmingham
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BirminghamUnited StatesUnknown status
Synexus Clin Res-Birmingham
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BirminghamUnited StatesUnknown status
St. Luke's Health System
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BoiseUnited StatesUnknown status
Joslin Diabetes Center
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BostonUnited StatesUnknown status
Holston Medical Group Pc
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BristolUnited StatesUnknown status
UNC Eastowne Clinical Research Unit
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Chapel HillUnited StatesUnknown status
Univ Diab & Endo Consultants
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ChattanoogaUnited StatesUnknown status
Diabetes & Endo Specialists Inc
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ChesterfieldUnited StatesUnknown status
Cedar Crosse Research Center
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ChicagoUnited StatesUnknown status
Velocity Clin Res-Chula Vista
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Chula VistaUnited StatesUnknown status
StudyMetrix Research, LLC
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City of Saint PetersUnited StatesUnknown status
Optumcare Clinical Trials,LLC-Golden
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Colorado SpringsUnited StatesUnknown status
Remington Davis, Inc.
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ColumbusUnited StatesUnknown status
Hope Clin Res & Wellness
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ConyersUnited StatesUnknown status
Clinical Res Collaborative
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CumberlandUnited StatesUnknown status
Synexus Clin Res Dallas
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DallasUnited StatesUnknown status
Velocity Clin Res, Dallas
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DallasUnited StatesUnknown status
Cedar Health Research
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DallasUnited StatesUnknown status
North Texas Endocrine Center
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DallasUnited StatesUnknown status
Velocity Clin Res Providence
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East GreenwichUnited StatesUnknown status
Velocity Clin Res Syracuse
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East SyracuseUnited StatesUnknown status
Neighborhood Healthcare
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EscondidoUnited StatesUnknown status
Headlands Research California, LLC
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EscondidoUnited StatesUnknown status
Plains Clinical Research Center, LLC
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FargoUnited StatesUnknown status
St. Jude Heritage Yorba Linda - Pediatric Ste D
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FullertonUnited StatesUnknown status
Center for Adv Res & Education
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GainesvilleUnited StatesUnknown status
Prime Medical Group, LLC
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GilbertUnited StatesUnknown status
Prevea Health
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Green BayUnited StatesUnknown status
American Health Network of Indiana, LLC_Greenfield
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GreenfieldUnited StatesUnknown status
PharmQuest Life Sciences LLC
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GreensboroUnited StatesUnknown status
Velocity Clin Res Gulfport
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GulfportUnited StatesUnknown status
Clinical Invest Special_Gurnee
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GurneeUnited StatesUnknown status
Pacific Diabetes & Endo Ctr
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HonoluluUnited StatesUnknown status
CCT Research
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HorshamUnited StatesUnknown status
Discovery MM Services, Inc
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HoustonUnited StatesUnknown status
Amir Ali Hassan, MD, PA
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HoustonUnited StatesUnknown status
JCCT- Juno NW Houston
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HoustonUnited StatesUnknown status
Primecare Medical Group
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HoustonUnited StatesUnknown status
PlanIt Research, PLLC
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HoustonUnited StatesUnknown status
MedStar Hlth Res Institute
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HyattsvilleUnited StatesUnknown status
Jackson Clinic
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JacksonUnited StatesUnknown status
Northeast Res Inst. Inc.
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JacksonvilleUnited StatesUnknown status
Holston Medical Group.
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KingsportUnited StatesUnknown status
Velocity Clin Res Lafayette
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LafayetteUnited StatesUnknown status
Velocity Clin Res San Diego
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La MesaUnited StatesUnknown status
Diabetes and Endocrine Specialists - La Mesa
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La MesaUnited StatesUnknown status
Diabetes & Endocrine Specialists - La Mesa
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La MesaUnited StatesUnknown status
Fmc Science, Llc
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LampasasUnited StatesUnknown status
Headlands Research CTR Lincoln
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LincolnUnited StatesUnknown status
Arkansas Clinical Research
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Little RockUnited StatesUnknown status
Loma Linda Univ Hlth Cr Endo
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Loma LindaUnited StatesUnknown status
Urban Family Practice Assoc
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MariettaUnited StatesUnknown status
Advanced Medical Research
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MaumeeUnited StatesUnknown status
Clinical Neuroscience Solutions
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MemphisUnited StatesUnknown status
Solaris Clinical Research
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MeridianUnited StatesUnknown status
New Horizon Research Center
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MiamiUnited StatesUnknown status
Bioclinical Research Alliance
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MiamiUnited StatesUnknown status
International Diabetes Center
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MinneapolisUnited StatesUnknown status
South Broward Research LLC
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MiramarUnited StatesUnknown status
Centricity Rsrch MHCity Multi
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Morehead CityUnited StatesUnknown status
Carteret Medical Group
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Trial Management Associates
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Clinical Research Associates
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TPMG Clinical Research
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Lynn Institute of Norman
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Valley Clinical Trials, Inc.
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NorthridgeUnited StatesUnknown status
West Orange Endocrinology
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OcoeeUnited StatesUnknown status
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Orange CityUnited StatesUnknown status
Trans Res Inst for Met & Diab
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OrlandoUnited StatesUnknown status
Oviedo Medical Research, LLC
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OviedoUnited StatesUnknown status
Desert Oasis Healthcare
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Velocity Clin Res - Panorama
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Center for Diab,Obes & Metab
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Velocity Clinical Research, Phoenix
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Synexus Rsch /Cnt Phnx Med C
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Western University of Health Sciences
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Rainier Clin Res Ctr Inc
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RentonUnited StatesUnknown status
Endocrine Research Solutions
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RoswellUnited StatesUnknown status
Foothill Family Clinic South
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NE Clin Res of San Antonio
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San AntonioUnited StatesUnknown status
Quality Clinical Research, Inc.
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University of Texas San Antonio
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Mills-Peninsula Medical Center
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NorCal Endocrinology and Internal Medicine
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Unity Health-Searcy Medical Center
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SearcyUnited StatesUnknown status
Consano Clinical Research, LLC
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Hillcrest Clinical Research
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Endeavor Health
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Evanston Premier Hlthcr Res
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J.Lewis Research Inc
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Spartanburg Medical Research
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Piedmont Healthcare/Research
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Mt Olympus Medical Research, LLC
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Premier Medical Center, Inc.
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DM Clin Rsrch/Fam Diag Clinic
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TomballUnited StatesUnknown status
Cotton O'Neil Diab & Endo Ctr
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Velocity Clin Res - Panorama
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New Venture Medical Research
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Diablo Clinical Research, Inc.
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Iowa Diabetes & Endo Res Ctr
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Velocity Clin Res-Salt Lk City
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West JordanUnited StatesUnknown status
Southgate Medical Group, LLP
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Accellacare
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Dr Wilhase's rooms
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Dr J Reddy
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Ubuntu Clinical Research
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Krugersdorp Medical Centre
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KrugersdorpSouth AfricaUnknown status

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