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NCT06534411CompletedPhase 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, SGLT2 Inhibitor or Both

Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) 1.0 mg/1.0 mg s.c. Once Weekly Versus Tirzepatide 5 mg s.c. Once Weekly in Participants With Type 2 Diabetes Inadequately Controlled on Metformin, SGLT2 Inhibitor or Both

Source: ClinicalTrials.gov · Last updated 19 Oct 2026

Brief summary (registry, in English)

This study will look at how much CagriSema lowers blood sugar and body weight in people with type 2 diabetes. CagriSema is a new investigational medicine. Doctors cannot yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide. Doctors can prescribe tirzepatide in some countries. Participants will either receive CagriSema or tirzepatide. Which treatment the participant will receive is decided by chance. For each participant, the study will last for up to 1 year and 4 months.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1023 (actual)
First submitted
30 Jul 2024
Start date
5 Nov 2024
Primary completion date
2 Jun 2026
Lead sponsor
Novo Nordisk A/S
NCT number
NCT06534411
EU CT number
2023-509600-15-00
EudraCT number
2023-509600-15

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 1023
  • From 5 Nov 2024 to the primary completion date, 2 Jun 2026
  • 161 sites in 14 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 design.

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 anti-diabetic or anti-obesity medication (irrespective of indication) other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days is 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 less than \< 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 mellitus greater than or equal to (\>=) 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
  • sodium-glucose co-transporter 2 inhibitor (SGLT2i)
  • Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mol \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening.
  • Body mass index (BMI) \>= 30 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 (161)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
IMOBA
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City of Buenos AiresArgentinaUnknown status
Centro de Investigaciones Metabólicas
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City of Buenos AiresArgentinaUnknown status
Centro Médico CIMEL
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Lanús EsteArgentinaUnknown status
Centro de Investigaciones Medicas Mar Del Plata
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Mar del PlataArgentinaUnknown status
Centro de Investigaciones Médicas Tucumán
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San Miguel de TucuimánArgentinaUnknown status
Instituto de Investigaciones Clinicas San Nicolás
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San NicolásArgentinaUnknown status
Fundación CESIM
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Santa RosaArgentinaUnknown status
Paratus Clinical
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BruceAustraliaUnknown status
Townsville University Hospital
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DouglasAustraliaUnknown status
Paratus Clinical
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HerstonAustraliaUnknown status
Hunter Diabetes Centre
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MerewetherAustraliaUnknown status
Austrials
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St LeonardsAustraliaUnknown status
Momentum Clinical Research St Leonards
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St LeonardsAustraliaUnknown status
Roger Chih Yu Chen
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SydneyAustraliaUnknown status
Centro de Diabetes Curitiba
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CuritibaBrazilUnknown status
Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
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Porto AlegreBrazilUnknown status
CPQuali Pesquisa Clínica Ltda
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São PauloBrazilUnknown status
Centricity Research Brampton Endocrinology
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BramptonCanadaUnknown status
Centricity Research Etobicoke Endocrinology
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EtobicokeCanadaUnknown status
Wharton Medical Clinic Clinical Trials (Hamilton)
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HamiltonCanadaUnknown status
Ctr de recherche Clinique de Laval
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LavalCanadaUnknown status
Alpha Recherche Clinique - Clinique de Levis
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LévisCanadaUnknown status
G.A. Research Associates, Ltd.
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MonctonCanadaUnknown status
Centre Medical Acadie
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MontrealCanadaUnknown status
Centre de Recherche Saint-Louis
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QuébecCanadaUnknown status
London Road Diagnostic Clinic and Medical Centre
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SarniaCanadaUnknown status
Hilltop Medical Clinic
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SurreyCanadaUnknown status
Ctr de Med Metab de Lanaudiere
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TerrebonneCanadaUnknown status
Diabetes Heart Research Centre
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TorontoCanadaUnknown status
Diex Recherche Victoriaville
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VictoriavilleCanadaUnknown status
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum
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Bad OeynhausenGermanyCompleted
Universitaetsklinikum Essen (AoR)
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EssenGermanyCompleted
Praxis am Markt Dr. Becker
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EssenGermanyCompleted
Medical Center- University of Freiburg
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Freiburg im BreisgauGermanyCompleted
Wendisch/Dahl Hamburg
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HamburgGermanyCompleted
Medicover Neuroendokrinologie MVZ
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MuenchenGermanyCompleted
Schwerpunktpraxis für Diabetes und Ernährungsmedizin
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MünsterGermanyCompleted
Zentrum für klinische Forschung Allgäu-Oberschwaben
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WangenGermanyCompleted
Centro Periférico de Especialidades Bola Azul
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AlmeríaSpainCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Hospital Universitario Clínico San Cecilio
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GranadaSpainCompleted
Clínica Universidad de navarra
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PamplonaSpainCompleted
Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional
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SevillaSpainCompleted
Hospital Clínico Universitario de Valladolid
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ValladolidSpainCompleted
Evangelismos S A
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AthensGreeceCompleted
Alexandra Hospital
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AthensGreeceCompleted
Laiko General Hospital of Athens
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AthensGreeceCompleted
General Hospital Venizeleio
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HeraklionGreeceCompleted
University General Hospital of Ioannina
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IoanninaGreeceCompleted
Athens Medical Center S.A.
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Paleo FaliroGreeceCompleted
General Hospital Of Thessloniki G Gennimatas
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ThessalonikiGreeceCompleted
Ippokratio General Hospital of Thessaloniki
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ThessalonikiGreeceCompleted
Szőcs Depot Egészségügyi Szolgáltató Kft.
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BudapestHungaryCompleted
Qualiclinic Kft.
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BudapestHungaryCompleted
Obudai Egeszseguegyi Centrum Kft.
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Budapest IIIHungaryCompleted
Semmelweis University
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Budapest VIIIHungaryCompleted
ClinDiab Kft.
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Budapest VIIIHungaryCompleted
PVN Kutato Kft.
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Budapest XHungaryCompleted
Med-Tima Kft.
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Budapest XIIIHungaryCompleted
Central Hospital Of Northern Pest Military Hospital
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Budapest XIIIHungaryCompleted
Komaromi Selye Janos Korhaz
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KomáromHungaryCompleted
University of Szeged
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SzegedHungaryCompleted
Rambam MC - Diabetes and obesity center of excellence
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HaifaIsraelUnknown status
Clalit sick fund Herzeliya
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HerzeliyaIsraelUnknown status
Wolfson MC - Diabetes Clinic
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HolonIsraelUnknown status
Hadassah Ein Karam MC - Diabetes Unit
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JerusalemIsraelUnknown status
Rabin MC Beilinson - Endo unit
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Petah TikvaIsraelUnknown status
Sourasky MC - Institute of Endocrinology, metabolism and hypertension
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Tel AvivIsraelUnknown status
Sheba MC - Endocrinology Clinic
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Tel HaShomerIsraelUnknown status
Jawahar Lal Nehru Govt. Medical College
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AjmerIndiaUnknown status
Ramaiah Memorial Hospital
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BengaluruIndiaUnknown status
Endolife Specialty Hospitals
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GunturIndiaUnknown status
AIG Hospitals,Hyderabad
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HyderabadIndiaUnknown status
Diabetes, Thyroid and Endocrine Centre
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JaipurIndiaUnknown status
SMS Hospital
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JaipurIndiaUnknown status
Excel Endocrine Centre
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KolhāpurIndiaUnknown status
IPGME&R and SSKM Hospital
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KolkataIndiaUnknown status
Udyaan Health Care
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LucknowIndiaUnknown status
Arthur Asirvatham hospital,
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MaduraiIndiaUnknown status
All India Institute of Medical Sciences(AIIMS)
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New DelhiIndiaUnknown status
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
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PuducherryIndiaUnknown status
Acharya Vinoba Bhave Rural Hospital, Sawangi Meghe, Wardha
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WardhaIndiaUnknown status
Uniwersytecki Szpital Kliniczny w Bialymstoku
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BialystokPolandCompleted
Diab Serwis Popenda Sp. j.
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ChorzowPolandCompleted
Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski
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Gorzów WielkopolskiPolandCompleted
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
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LodzPolandCompleted
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
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OlsztynPolandCompleted
Kiepury Clinic MALGORZATA JARNOT SPECJALISTYCZNA PRAKTYKA GINEKOLOGICZNO-POLOZNICZA
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SosnowiecPolandCompleted
Centrum Medyczne Oporow
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WroclawPolandCompleted
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
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ZabrzePolandCompleted
Cabinet Medical Individual Diabet, Nutritie, Boli Metabolice Dr. Pop Lavinia
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Baia MareRomaniaCompleted
Nutrilife S.R.L.
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BucharestRomaniaCompleted
Diabet Med S.R.L.
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BucharestRomaniaCompleted
Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti
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BucharestRomaniaCompleted
Sanamed Hospital S.R.L.
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BucharestRomaniaCompleted
Diabdana S.R.L.
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OradeaRomaniaCompleted
Clinica Korall S.R.L.
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Satu MareRomaniaCompleted
Mediab S.R.L.
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Târgu MureşRomaniaCompleted
Chang Gung Memorial Hospital - Kaohsiung Branch
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Kaohsiung CityTaiwanUnknown status
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
Kaohsiung Medical University Chung-Ho Memorial Hospital
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KaoshiungTaiwanUnknown status
Taichung Veterans General Hospital
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TaichungTaiwanUnknown status
China Medical University 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
Chang Gung Memorial Hospital, Linkou
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TaoyuanTaiwanUnknown status
Chang Gung Memorial Hospital Linkou
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Taoyuan CityTaiwanUnknown status
Albany Medical College
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AlbanyUnited StatesUnknown status
Velocity Clin Res Albuquerque
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AlbuquerqueUnited StatesUnknown status
Velocity Clin Res Austin
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AustinUnited StatesUnknown status
Velocity Clin Res-Chula Vista
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Chula VistaUnited StatesUnknown status
Tampa Bay Medical Research
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ClearwaterUnited StatesUnknown status
Optumcare Clinical Trials,LLC-Golden
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Colorado SpringsUnited StatesUnknown status
John Muir Physicians Network
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ConcordUnited StatesUnknown status
Clinical Res Collaborative
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CumberlandUnited StatesUnknown status
Synexus Clin Res Dallas
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DallasUnited StatesUnknown status
UT Southwestern Med Center
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DallasUnited StatesUnknown status
Velocity Clin Res Providence
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East GreenwichUnited StatesUnknown status
Lillestol Research, LLC
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FargoUnited StatesUnknown status
Javara Inc. / Privia Medical Group Georgia LLC
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FayettevilleUnited StatesUnknown status
Velocity Clin Res Gaffney
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GaffneyUnited StatesUnknown status
Velocity Clin Res Gulfport
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GulfportUnited StatesUnknown status
Clinical Invest Special_Gurnee
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GurneeUnited StatesUnknown status
AGA Clinical Trial
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HialeahUnited StatesUnknown status
PlanIt Research, PLLC
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HoustonUnited StatesUnknown status
Synergy Groups Medical
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HoustonUnited StatesUnknown status
JCCT- Juno NW Houston
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HoustonUnited StatesUnknown status
Sante Clinical Research
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KerrvilleUnited StatesUnknown status
Holston Medical Group.
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KingsportUnited StatesUnknown status
Diabetes & Endocrine Specialists - La Mesa
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La MesaUnited StatesUnknown status
Aeres Clinical Research
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LaredoUnited StatesUnknown status
Woodland Int. Research Group
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Little RockUnited StatesUnknown status
Velocity Clin Research LA
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Los AngelesUnited StatesUnknown status
Biopharma Informatic, LLC
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McAllenUnited StatesUnknown status
Bioclinical Research Alliance
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MiamiUnited StatesUnknown status
New Horizon Research Center
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MiamiUnited StatesUnknown status
South Broward Research LLC
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MiramarUnited StatesUnknown status
Carteret Medical Group
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Morehead CityUnited StatesUnknown status
Clinical Research Associates
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NashvilleUnited StatesUnknown status
TPMG Clinical Research
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Newport NewsUnited StatesUnknown status
Triad Research Institute
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NormanUnited StatesUnknown status
West Orange Endocrinology
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OcoeeUnited StatesUnknown status
Univ of Nebraska Medical CTR
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OmahaUnited StatesUnknown status
-
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Orange CityUnited StatesUnknown status
Desert Oasis Healthcare
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Palm SpringsUnited StatesUnknown status
Cahaba Research
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PelhamUnited StatesUnknown status
Center for Diab,Obes & Metab
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Pembroke PinesUnited StatesUnknown status
Velocity Clinical Research, Phoenix
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PhoenixUnited StatesUnknown status
Circuit Clinical - PMSI
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PottstownUnited StatesUnknown status
AES Minneapolis DRS
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RichfieldUnited StatesUnknown status
J.Lewis Research Inc
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Salt Lake CityUnited StatesUnknown status
Velocity Clin Res Santa Ana
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Santa AnaUnited StatesUnknown status
Piedmont Healthcare/Research
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StatesvilleUnited StatesUnknown status
Privia Health Javara Clin Res.
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StephenvilleUnited StatesUnknown status
Chrysalis Clinical Research
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St. GeorgeUnited StatesUnknown status
AES St. Louis DRS
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St LouisUnited StatesUnknown status
Cotton-Oneill Diabetes and End
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TopekaUnited StatesUnknown status
AES Tucson DRS
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TucsonUnited StatesUnknown status
Velocity Clin Res - Panorama
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Van NuysUnited StatesUnknown status
FEME Medical LLC
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Washington D.C.United StatesUnknown status
Iowa Diabetes & Endo Res Ctr
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West Des MoinesUnited StatesUnknown status

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