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NCT05394519CompletedPhase 3

A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight

Efficacy and Safety of Cagrilintide s.c. 2.4 mg in Combination With Semaglutide s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) Once-weekly in Participants With Overweight or Obesity and Type 2 Diabetes

Source: ClinicalTrials.gov · Last updated 28 Jan 2026

Brief summary (registry, in English)

This study will look at how well the new medicine CagriSema helps people living with excess body weight and type 2 diabetes losing weight. Participants will either get CagriSema or a dummy medicine. Which treatment they get is decided by chance. The study will last for about 1½ years. Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1200 (actual)
First submitted
24 May 2022
Start date
1 Feb 2023
Primary completion date
28 Jan 2025
Lead sponsor
Novo Nordisk A/S
NCT number
NCT05394519
EU CT number
2023-506931-13-00
EudraCT number
2021-005121-24

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 1200
  • From 1 Feb 2023 to the primary completion date, 28 Jan 2025
  • 163 sites in 13 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

  • Clinically significant or severe hypoglycaemia within 6 months before screening or history of hypoglycaemia unawareness
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus 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 (eGFR) below 30 mL/min/1.73 m\^2, as measured by the central laboratory at screening

Who the study is looking for

  • Male or female
  • Age above or equal to 18 years at the time of signing informed consent
  • BMI greather than or equal to 27.0 kg/m\^2
  • Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening
  • Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitor (SGLT2i), thiazolidinediones, or sulphonylureas (SU)s as a single agent or in combination) according to local label
  • Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 90 days before screening
  • HbA1c 7%-10% (53-86 mmol/mol) (both inclusive) as measured by the central laboratory at screening

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

Full criteria on ClinicalTrials.gov

Sites (163)

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

SiteCityCountrySite status
University Hospital Graz
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GrazAustriaCompleted
Ordination Dr. Evelyn Fliesser-Görzer
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St. Stefan ob StainzAustriaCompleted
Imed19-privat
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ViennaAustriaCompleted
Klinik Landstrabe
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ViennaAustriaCompleted
Medical University of Vienna
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ViennaAustriaCompleted
Dr. Harpreet Bajaj
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BramptonCanadaUnknown status
LMC Clin Res Inc. Calgary
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CalgaryCanadaUnknown status
C-endo Diab Endo Clin Calgery
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CalgaryCanadaUnknown status
Centricity Research Etobicoke Endocrinology
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EtobicokeCanadaUnknown status
Wharton Med Clin Trials
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HamiltonCanadaUnknown status
Milestone Research
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LondonCanadaUnknown status
Centre Medical Acadie
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MontrealCanadaUnknown status
Commonwealth Medical Clinic
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Mount PearlCanadaUnknown status
LMC Research Inc. Ottawa
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NepeanCanadaUnknown status
Centricity Res Pointe-Claire
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Pointe-ClaireCanadaUnknown status
LMC Clin Rsrch Inc. (Montreal)
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Saint-LaurentCanadaUnknown status
Diabetes Heart Research Centre
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TorontoCanadaUnknown status
Dr. M.B. Jones Inc
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VictoriaCanadaUnknown status
MVZ DiaMedicum Bad Mergentheim GmbH
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Bad MergentheimGermanyCompleted
Zentrum fuer klinische Studien Suedbrandenburg GmbH
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ElsterwerdaGermanyCompleted
InnoDiab Forschung Gmbh
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EssenGermanyCompleted
Wendisch/Dahl Hamburg
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HamburgGermanyCompleted
Ambenet GmbH Das Ambulante Behandlungsnetz
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LeipzigGermanyCompleted
Institut fuer Diabetesforschung Muenster GmbH
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MuensterGermanyCompleted
Zentrum für klinische Studien Alexander Segner
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St. Ingbert-OberwürzbachGermanyCompleted
Erlinger
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StuttgartGermanyCompleted
Zentrum für klinische Forschung Allgäu-Oberschwaben
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WangenGermanyCompleted
Crouch Oak Family Practice
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AddlestoneUnited KingdomUnknown status
Antrim Area Hospital
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AntrimUnited KingdomUnknown status
Layton Medical Centre
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BlackpoolUnited KingdomUnknown status
The Health Centre
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Bradford on AvonUnited KingdomUnknown status
Southmead Hospital
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BristolUnited KingdomUnknown status
Hathaway Medical Centre
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ChippenhamUnited KingdomUnknown status
Harrogate District Hospital
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HarrogateUnited KingdomUnknown status
HMC Health - Heston
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HounslowUnited KingdomUnknown status
Leicester General Hospital
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LeicesterUnited KingdomUnknown status
Kiltearn Medical Centre
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NantwichUnited KingdomUnknown status
Clifton Medical Centre
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RotherhamUnited KingdomUnknown status
Ashfields Primary Care Centre
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SandbachUnited KingdomUnknown status
Staploe Medical Centre
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SohamUnited KingdomUnknown status
Joint Clinical Research Facility - Swansea
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SwanseaUnited KingdomUnknown status
Musgrove Park Hospital
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TauntonUnited KingdomUnknown status
Royal Cornwall Hospital (Treliske)
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TruroUnited KingdomUnknown status
Albany House Medical Centre
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WellingboroughUnited KingdomUnknown status
Szőcs Depot Egészségügyi Szolgáltató Kft.
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BudapestHungaryCompleted
Budapesti Bajcsy-Zsilinszky Korhaz Es Rendelointezet
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BudapestHungaryCompleted
Clinexpert Kft.
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Budapest IIIHungaryCompleted
University of Debrecen
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DebrecenHungaryCompleted
Komaromi Selye Janos Korhaz
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KomáromHungaryCompleted
University of Szeged
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SzegedHungaryCompleted
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointézet
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SzolnokHungaryCompleted
Connolly Hospital
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Dublin 15IrelandCompleted
St Vincent's University Hospital
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Dublin 4IrelandCompleted
Mater Misericordiae University Hospital
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Dublin 7IrelandCompleted
St James's Hospital
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Dublin 8IrelandCompleted
National University Of Ireland
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GalwayIrelandCompleted
HCG Hospitals
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AhmedabadIndiaUnknown status
All India Institute of Medical Sciences_Delhi
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AnsārinagarIndiaUnknown status
Ramaiah Memorial Hospital
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BangaloreIndiaUnknown status
Post Graduate Institute of Medical Education & Research_Chandigarh
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ChandigarhIndiaUnknown status
Apollo Research & Innovation (ARI)
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ChennaiIndiaUnknown status
Madras Diabetes Research Foundation
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ChennaiIndiaUnknown status
Gleneagles Hospitals
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HyderabadIndiaUnknown status
SMS Medical College & Hospital
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JaipurIndiaUnknown status
J K Lon Hospital, SMS Medical College & Attached Hospitals
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JaipurIndiaUnknown status
Excel Endocrine Centre
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KolhāpurIndiaUnknown status
Apollo Multispeciality Hospitals limited
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KolkataIndiaUnknown status
Apollo Multispeciality Hospital, Kolkata
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KolkataIndiaUnknown status
Calicut Medical College
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KozhikodeIndiaUnknown status
BYL Nair Hospital and T N Medical College Department of endo
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MumbaiIndiaUnknown status
Seth GS medical college and KEM Hospital
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MumbaiIndiaUnknown status
Sunil's Diabetes Care n' Research Centre Pvt Ltd
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NagpurIndiaUnknown status
Lady Hardinge Medical College
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New DelhiIndiaUnknown status
Noble Hospitals Pvt Ltd.
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PuneIndiaUnknown status
Indian Institute of Diabetes
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ThiruvnanthapuramIndiaUnknown status
TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
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AichiJapanUnknown status
Tokuyama clinic_Diabetic internal medicine
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ChibaJapanUnknown status
Naka Kinen Clinic_Internal medicine
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IbarakiJapanUnknown status
Osaka Nishiumeda Clinic_Diabetes Internal Medicine
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OsakaJapanUnknown status
Takatsuki Red Cross Hospital
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OsakaJapanUnknown status
Osaka University Hospital_Metabolic Medicine
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OsakaJapanUnknown status
Hospital Ampang
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Ampang, SelangorMalaysiaUnknown status
Hospital Canselor Tuanku Muhriz UKM
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CherasMalaysiaUnknown status
Hospital Universiti Sains Malaysia
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Kota BharuMalaysiaUnknown status
Sarawak General Hospital
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KuchingMalaysiaUnknown status
Hospital Melaka
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MalaccaMalaysiaUnknown status
Hospital Miri
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MiriMalaysiaUnknown status
Hospital Putrajaya
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PutrajayaMalaysiaUnknown status
Hospital Tuanku Jaafar
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SerembanMalaysiaUnknown status
Hospital Seri Manjung
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Seri ManjungMalaysiaUnknown status
University Technology MARA (UiTM) - Sg Buloh
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Sungai BulohMalaysiaUnknown status
Uniwersytecki Szpital Kliniczny w Bialymstoku
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BialystokPolandCompleted
Gabinet Leczenia Otyłości i Chorób Dietozależnych
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BiałystokPolandCompleted
Centrum Kardiometaboliczne Gierach-Med Marcin Gierach
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BydgoszczPolandCompleted
Linden Sp. z o.o. sp.k.
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CracowPolandCompleted
Klinika Bellamed
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ElblagPolandCompleted
Uniwersyteckie Centrum Kliniczne
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GdanskPolandCompleted
Salvia Lekston I Madej Sp. J.
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KatowicePolandCompleted
Beata Miklaszewicz & Dariusz Dabrowski Cardiamed Sp. j.
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LegnicaPolandCompleted
Terpa Sp. z o.o. S.K.
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LublinPolandCompleted
Trialmed Sp. z o. o.
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Piotrkow TrybunalskiPolandCompleted
Centrum Zdrowia Metabolicznego
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PoznanPolandCompleted
Instytut Diabetologii.sp.z.o.o.
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WarsawPolandCompleted
Samodzielny Publiczny Szpital Kliniczny Im. Prof. W. Orlowskiego CMKP
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WarsawPolandCompleted
Med Sp. z o.o.
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WarsawPolandCompleted
Ponce Med School Found Inc
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PoncePuerto RicoUnknown status
Ramathibodi Hospital
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BangkokThailandUnknown status
King Chulalongkorn Memorial Hospital_Bangkok
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BangkokThailandUnknown status
Rajavithi Hospital_Diabetes and Endocrinology
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BangkokThailandUnknown status
King Chulalongkorn Memorial Hospital_Endocrinology
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BangkokThailandUnknown status
Siriraj Hospital_Dept Endocrinology
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BangkokThailandUnknown status
Rajavithi Hospital
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BangkokThailandUnknown status
Siriraj Hospital_Bangkoknoi, Bangkok
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Bangkoknoi, BangkokThailandUnknown status
Srinagarind Hospital
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Khon KaenThailandUnknown status
Thammasat Hospital_Cardiology
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Pathum ThaniThailandUnknown status
AMC Community Endocrinology
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AlbanyUnited StatesUnknown status
Amarillo Med Spec LLP
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AmarilloUnited StatesUnknown status
Texas Diab & Endo, P.A.
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AustinUnited StatesUnknown status
Pennington Biom Res Ctr
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Baton RougeUnited StatesUnknown status
Northern Pines Hlth Ctr, PC
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BuckleyUnited StatesUnknown status
Mercury Str Med Grp, PLLC
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ButteUnited StatesUnknown status
Cedar Crosse Research Center
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ChicagoUnited StatesUnknown status
StudyMetrix Research, LLC
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City of Saint PetersUnited StatesUnknown status
Clinical Res Of W Florida Inc
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ClearwaterUnited StatesUnknown status
John Muir Physicians Network
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ConcordUnited StatesUnknown status
Velocity Clinical Res-Dallas
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DallasUnited StatesUnknown status
North Texas Endocrine Center
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DallasUnited StatesUnknown status
UT Southwestern Med Cntr
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DallasUnited StatesUnknown status
Headlands Research California, LLC
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EscondidoUnited StatesUnknown status
Northeast Research Institute
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Fleming IslandUnited StatesUnknown status
St. Jos Heritage Hlthcr_Fllrtn
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FullertonUnited StatesUnknown status
Providence Medical Foundation
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FullertonUnited StatesUnknown status
New West Physicians,Inc.
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GoldenUnited StatesUnknown status
PharmQuest Life Sciences LLC
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GreensboroUnited StatesUnknown status
East West Med Res Inst
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HonoluluUnited StatesUnknown status
PlanIt Research, PLLC
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HoustonUnited StatesUnknown status
Diabetes/Lipid Mgmt & Res Ctr
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Huntington BeachUnited StatesUnknown status
Jacksonville Ctr for Clin Res
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JacksonvilleUnited StatesUnknown status
Holston Medical Group.
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KingsportUnited StatesUnknown status
Clinical Trials Research
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LincolnUnited StatesUnknown status
DCOL Ctr for Clin Res
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LongviewUnited StatesUnknown status
Velocity Clin Res Los Angeles
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Los AngelesUnited StatesUnknown status
Velocity Clin Res Wstlke
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Los AngelesUnited StatesUnknown status
L-MARC Research Center
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LouisvilleUnited StatesUnknown status
International Diabetes Center
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MinneapolisUnited StatesUnknown status
Renstar Medical Research
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OcalaUnited StatesUnknown status
Capital Clin Res Ctr,LLC
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OlympiaUnited StatesUnknown status
AdventHealth Diab Inst
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OrlandoUnited StatesUnknown status
Florida Institute For Clinical Research, LLC
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OrlandoUnited StatesUnknown status
Oviedo Medical Research, LLC
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OviedoUnited StatesUnknown status
Desert Oasis Hlthcr Med Group
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Palm SpringsUnited StatesUnknown status
National Clin Res Inc.
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RichmondUnited StatesUnknown status
Endo Res Solutions Inc
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RoswellUnited StatesUnknown status
Consano Clinical Research, LLC
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Shavano ParkUnited StatesUnknown status
Hillcrest Clinical Research
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SimpsonvilleUnited StatesUnknown status
Chrysalis Clinical Research
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St. GeorgeUnited StatesUnknown status
Cotton-Oneill Diabetes and End
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TopekaUnited StatesUnknown status
Diablo Clinical Research, Inc.
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Walnut CreekUnited StatesUnknown status
Iowa Diab & Endo Res Center
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West Des MoinesUnited StatesUnknown status
Great Lakes Medical Research
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WestfieldUnited StatesUnknown status
Southgate Medical Group, LLP
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West SenecaUnited StatesUnknown status
Amherst Family Practice P.C.
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WinchesterUnited StatesUnknown status
Selma Medical Associates
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WinchesterUnited StatesUnknown status

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