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

Last updated: April 20, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Hypertriglyceridemia

Obesity

Diabetes Prevention

Treatment

Semaglutide

Placebo semaglutide

Placebo cagrilintide

Clinical Study ID

NCT05394519
NN9838-4609
U1111-1267-4287
jRCT2031220671
2021-005121-24
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 beforescreening

  • Treatment with either lifestyle intervention, or treatment with 1-3 marketed oralantidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides,sodium-glucose co-transporter 2 inhibitor (SGLT2i), thiazolidinediones, orsulphonylureas (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 anddosing frequency) for at least 90 days before screening

  • HbA1c 7%-10% (53-86 mmol/mol) (both inclusive) as measured by the central laboratoryat screening

Exclusion

Exclusion Criteria:

  • Clinically significant or severe hypoglycaemia within 6 months before screening orhistory of hypoglycaemia unawareness

  • Renal impairment with estimated glomerular filtration rate (eGFR) below 30mL/min/1.73 m^2, as measured by the central laboratory at screening

  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verifiedby a fundus examination performed within 90 days before screening or in the periodbetween screening and randomisation. Pharmacological pupil-dilation is a requirementunless using a digital fundus photography camera specified for non-dilatedexamination.

Study Design

Total Participants: 1200
Treatment Group(s): 4
Primary Treatment: Semaglutide
Phase: 3
Study Start date:
February 01, 2023
Estimated Completion Date:
February 03, 2025

Connect with a study center

  • Novo Nordisk Investigational Site

    Graz, 8036
    Austria

    Site Not Available

  • Universitätsklinik für Innere Medizin

    Graz, 8036
    Austria

    Site Not Available

  • Universitätsklinik für Innere Medizin Graz

    Graz, 8036
    Austria

    Site Not Available

  • Barmh. Brüder Linz, Konventspital

    Linz, 4021
    Austria

    Site Not Available

  • Novo Nordisk Investigational Site

    Linz, 4021
    Austria

    Site Not Available

  • Fließer-Görzer [Ordination]

    Saint Stefan, 8511
    Austria

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint Stefan, 8511
    Austria

    Site Not Available

  • Imed 19- privat

    Wien, 1190
    Austria

    Site Not Available

  • Klinik Landstraße

    Wien, 1030
    Austria

    Site Not Available

  • Novo Nordisk Investigational Site

    Wien, A 1190
    Austria

    Site Not Available

  • Universitätsklinikum AKH Wien

    Wien, 1090
    Austria

    Site Not Available

  • C-endo Diab Endo Clin Calgery

    Calgary, Alberta T2V 4J2
    Canada

    Site Not Available

  • LMC Clin Res Inc. Calgary

    Calgary, Alberta T2H 2G4
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Calgary, Alberta T2V 4J2
    Canada

    Site Not Available

  • Dr. M.B. Jones Inc

    Victoria, British Columbia V8V 4A1
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Victoria, British Columbia V8V 4A1
    Canada

    Site Not Available

  • Commonwealth Medical Clinic

    Mount Pearl, Newfoundland and Labrador A1N 1W7
    Canada

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    Mount Pearl, Newfoundland and Labrador A1N 1W7
    Canada

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  • Dr. Harpreet Bajaj

    Brampton, Ontario L6S 0C6
    Canada

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    Brampton, Ontario L6S 0C6
    Canada

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  • Centricity Research Etobicoke

    Etobicoke, Ontario M9R 4E1
    Canada

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    Etobicoke, Ontario M9R 4E1
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    Hamilton, Ontario L8L 5G8
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    Canada

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    Canada

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    Nepean, Ontario K2J 0V2
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  • Diabetes Heart Research Centre

    Toronto, Ontario M6G 1M2
    Canada

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    Pointe-Claire, Quebec H9R 4S3
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    Saint-Laurent, Quebec H4T 1Z9
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    Saint-Laurent, Quebec H4T 1Z9
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    Ville Saint-Laurent, Quebec H4T 1Z9
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    Bad Mergentheim, 97980
    Germany

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    Elsterwerda, 04910
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    Germany

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    Essen, 45136
    Germany

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    Hamburg, 22607
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    Leipzig, 04107
    Germany

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    Leipzig, 04107
    Germany

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    Münster, 48145
    Germany

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    Saint Ingbert-Oberwürzbach, 66386
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    Germany

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    Stuttgart, 70378
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    Wangen, 88239
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    Szeged, Csongrád-Csanád H-6725
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    Szeged, Csongrád-Csanád 6725
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    Debrecen, Hajdu-Bihar 4032
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    Nagpur, Maharashtra 440010
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    Jaipur, Rajasthan 302004
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    India

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  • Apollo Research & Innovation (ARI)

    Chennai, Tamil Nadu 600006
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  • Madras Diabetes Research Foundation

    Chennai, Tamil Nadu 600086
    India

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    Kolkata, West Bengal 700054
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    Kolkata, West Bengal 700054
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  • Lady Hardinge Medical College

    New Delhi, 110001
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    New Delhi, 110001
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  • CRF - Galway

    Galway, Connaght H91 YR71
    Ireland

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    Galway, Connaght H91 YR71
    Ireland

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  • Clinical Research Centre, St. Vincent's University Hospital,

    Dublin, Leinster D04 T6F4
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    Dublin, Leinster DUBLIN 15
    Ireland

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    Dublin, Leinster D07 XAO9
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    Dublin, Leinster D08 A978
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    Dublin, Leinster D08 A978
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    Aichi, 468-0009
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    Aichi, 468-0009
    Japan

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    Chiba, 261-0004
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    Chiba, 261-0004
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    Ibaraki, 311-0113
    Japan

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    Ibaraki, 311-0113
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  • AMC NISHI-UMEDA Clinic_Diabetes Internal Medicine

    Osaka, 530-0001
    Japan

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    Osaka, 569-1045
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  • Osaka Nishiumeda Clinic_Diabetes Internal Medicine

    Osaka, 530-0001
    Japan

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  • Osaka University Hospital

    Osaka, 565-0871
    Japan

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  • Takatsuki Red Cross Hospital

    Osaka, 569-1045
    Japan

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  • Novo Nordisk Investigational Site

    Kota Bharu, Kelantan 16150
    Malaysia

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    Cheras, Kuala Lumpur 56000
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    Cheras, Kuala Lumpur 56000
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    Sarawak, Miri 98000
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    Sarawak, Miri 98000
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    Seri Manjung, Perak 32040
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    Seri Manjung, Perak 32040
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    Kuching, Sarawak 93586
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    Kuching, Sarawak 93586
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    Ampang, Selangor, Selangor 68000
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    Sungai Buloh, Selangor 47000
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  • University Technology MARA (UiTM) - Puncak Alam

    Sungai Buloh, Selangor 47000
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  • University Technology MARA (UiTM) - Sg Buloh

    Sungai Buloh, Selangor 47000
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    Putrajaya, Wilayah Persekutuan Putrajaya 62250
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    Putrajaya, Wilayah Persekutuan Putrajaya 62250
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    Kota Bharu, Kelantan, 16150
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    Melaka, 75400
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    Melaka, 75400
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    Seremban, 70300
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    Seremban, 70300
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    Wilayah Persekutuan Putrajaya, 62250
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  • Beata Mikłaszewicz & Dariusz Dąbrowski "CARDIAMED" s.j.

    Legnica, Dolnośląskie 59-220
    Poland

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    Legnica, Dolnośląskie 59-220
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    Bygdoszcz, Kuyavian-Pomeranian Voivodeship 85-796
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  • Terpa Sp. z o.o. Sp. k.

    Lublin, Lubelskie Voivodeship 20-333
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    Warszawa, Mazovian Voivodeship 02-117
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    Warszawa, Mazowieckie 02-798
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    Warszawa, Mazowieckie 02-798
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  • Samodzielny Publiczny Szpital Kliniczny Im. Prof. W. Orłowskiego Centrum Medycznego Kształcenia Podyplomowego

    Warszawa, Mazowieckie 00-416
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    Kraków, Małopolskie 30-721
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    Bialystok, Podlaskie 15-281
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    Bialystok, Podlaskie Voivodeship 15-281
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    Bangkoknoi, Bangkok, Bangkok 10700
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    Muang, Khon Kaen 40002
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    Bristol, BS10 5NB
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    Chippenham, SN14 6GT
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    Chippenham, SN14 6GT
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    Hounslow,, TW5 9ER
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    Leicester, LE5 4PW
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    Leicester, LE5 4PW
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    Nantwich, CW5 5NX
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    Nantwich, CW5 5NX
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    Rotherham, S65 1DA
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    Rotherham, S651DA
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    Sandbach, CW11 1EQ
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    Sandbach, CW11 1EQ
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    Soham, CB7 5JD
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    Soham, CB7 5JD
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    Swansea, SA2 8PP
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    Swansea, SA2 8PP
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    Taunton, TA1 5DA
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    Taunton, TA1 5DA
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    Truro, TR1 3LJ
    United Kingdom

    Site Not Available

  • Royal Cornwall Hospital (Treliske)

    Truro, TR1 3LJ
    United Kingdom

    Site Not Available

  • Albany House Medical Centre

    Wellingborough, NN8 4RW
    United Kingdom

    Site Not Available

  • Novo Nordisk Investigational Site

    Wellingborough, NN8 4RW
    United Kingdom

    Site Not Available

  • John Muir Physician Network

    Concord, California 94520
    United States

    Site Not Available

  • John Muir Physicians Network

    Concord, California 94520
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Concord, California 94520
    United States

    Site Not Available

  • AMCR Institute Inc

    Escondido, California 92025
    United States

    Site Not Available

  • Headlands Research California, LLC

    Escondido, California 92025
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Escondido, California 92025
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Fullerton, California 92835
    United States

    Site Not Available

  • St. Jos Heritage Hlthcr_Fllrtn

    Fullerton, California 92835
    United States

    Site Not Available

  • Diabetes/Lipid Mgmt & Res Ctr

    Huntington Beach, California 92648
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Huntington Beach, California 92648
    United States

    Site Not Available

  • Clinical Trials Research

    Lincoln, California 95648
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lincoln, California 95648
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Los Angeles, California 90057
    United States

    Active - Recruiting

  • Velocity Clin Res Los Angeles

    Los Angeles, California 90017
    United States

    Site Not Available

  • Velocity Clin Res Wstlke

    Los Angeles, California 90057
    United States

    Site Not Available

  • Desert Oasis Hlthcr Med Group

    Palm Springs, California 92262
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Palm Springs, California 92262
    United States

    Active - Recruiting

  • Diablo Clinical Research, Inc.

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Walnut Creek, California 94598
    United States

    Site Not Available

  • New West Physicians,Inc.

    Golden, Colorado 80401
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Golden, Colorado 80401
    United States

    Site Not Available

  • Clinical Res Of W Florida Inc

    Clearwater, Florida 33765
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Clearwater, Florida 33765
    United States

    Site Not Available

  • Northeast Research Institute

    Fleming Island, Florida 32003
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Fleming Island, Florida 32003
    United States

    Site Not Available

  • Jacksonville Ctr For Clin Res

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Ocala, Florida 34470
    United States

    Site Not Available

  • Renstar Medical Research

    Ocala, Florida 34470
    United States

    Site Not Available

  • AdventHealth Diab Inst

    Orlando, Florida 32804
    United States

    Site Not Available

  • Florida Institute for Clinical Research, LLC

    Orlando, Florida 32825
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Orlando, Florida 32825
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Oviedo, Florida 32765
    United States

    Site Not Available

  • Oviedo Medical Research, LLC

    Oviedo, Florida 32765
    United States

    Site Not Available

  • Endo Res Solutions Inc

    Roswell, Georgia 30076
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Roswell, Georgia 30076
    United States

    Site Not Available

  • East West Med Res Inst

    Honolulu, Hawaii 96814
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Honolulu, Hawaii 96814
    United States

    Site Not Available

  • Cedar-Crosse Research Center

    Chicago, Illinois 60607
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chicago, Illinois 60607
    United States

    Site Not Available

  • Iowa Diab & Endo Res Center

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    West Des Moines, Iowa 50265
    United States

    Site Not Available

  • Cotton-Oneill Diabetes and End

    Topeka, Kansas 66606-2806
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Topeka, Kansas 66606-2806
    United States

    Site Not Available

  • L-MARC Research Center

    Louisville, Kentucky 40213
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Louisville, Kentucky 40213
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Baton Rouge, Louisiana 70808
    United States

    Site Not Available

  • Pennington Biom Res Ctr

    Baton Rouge, Louisiana 70808
    United States

    Site Not Available

  • Northern Pines Hlth Ctr, PC

    Buckley, Michigan 49620
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Buckley, Michigan 49620
    United States

    Site Not Available

  • International Diabetes Center

    Minneapolis, Minnesota 55416
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Minneapolis, Minnesota 55416
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint Peters, Missouri 63303
    United States

    Site Not Available

  • StudyMetrix Research LLC

    Saint Peters, Missouri 63303
    United States

    Site Not Available

  • Mercury Str Med Grp, PLLC

    Butte, Montana 59701
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Butte, Montana 59701
    United States

    Site Not Available

  • Albany Medical College - Endo

    Albany, New York 12203
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Albany, New York 12203
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    West Seneca, New York 14224
    United States

    Site Not Available

  • Southgate Medical Group, LLP

    West Seneca, New York 14224
    United States

    Site Not Available

  • Great Lakes Medical Research

    Westfield, New York 14787
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Westfield, New York 14787
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • PharmQuest Life Sciences LLC

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • Hillcrest Clinical Research

    Simpsonville, South Carolina 29681-1538
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Simpsonville, South Carolina 29681-1538
    United States

    Site Not Available

  • Holston Medical Group

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • Amarillo Med Spec LLP

    Amarillo, Texas 79106
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Amarillo, Texas 79106
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Austin, Texas 78731
    United States

    Site Not Available

  • Texas Diab & Endo, P.A.

    Austin, Texas 78749
    United States

    Site Not Available

  • North Texas Endocrine Center

    Dallas, Texas 75231
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Dallas, Texas 75390-9302
    United States

    Site Not Available

  • UT Southwestern Med Cntr

    Dallas, Texas 75390-9302
    United States

    Site Not Available

  • Velocity Clinical Res-Dallas

    Dallas, Texas 75230
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Houston, Texas 77079
    United States

    Site Not Available

  • PlanIt Research, PLLC

    Houston, Texas 77079
    United States

    Site Not Available

  • DCOL Ctr for Clin Res

    Longview, Texas 75605
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Longview, Texas 75605
    United States

    Site Not Available

  • Consano Clinical Research, LLC

    Shavano Park, Texas 78231
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Shavano Park, Texas 78231
    United States

    Site Not Available

  • Chrysalis Clinical Research

    Saint George, Utah 84790
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint George, Utah 84790
    United States

    Site Not Available

  • National Clin Res Inc.

    Richmond, Virginia 23294
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Richmond, Virginia 23294
    United States

    Site Not Available

  • Amherst Family Practice P.C.

    Winchester, Virginia 22601
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Winchester, Virginia 22601
    United States

    Site Not Available

  • Selma Medical Associates

    Winchester, Virginia 22601-3834
    United States

    Site Not Available

  • Capital Clin Res Ctr,LLC

    Olympia, Washington 98502
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Olympia, Washington 98502
    United States

    Site Not Available

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