Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes

Last updated: October 8, 2024
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Diabetes Mellitus, Type 2

Hyponatremia

Diabetes And Hypertension

Treatment

Placebo (Semaglutide)

Semaglutide

Clinical Study ID

NCT04916470
EX9536-4773
2020-004170-22
U1111-1257-5069
  • Ages > 18
  • All Genders

Study Summary

This study will look at how participants' daily life is affected by their heart failure. The study will also look at the change in participants' body weight.

This study will compare the effect of semaglutide (a new medicine) compared to "dummy" medicine on body weight and heart failure symptoms.

Participants will either get semaglutide or "dummy" medicine, which treatment participants get is decided by chance.

Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach area, thigh or upper arm.

During the study participants will have talks with the study staff about healthy lifestyle and physical activity.

The study will last for about 59 weeks, that is a little more than 1 year. Participants will have 12 clinic visits with the study doctor.

  • At 6 of the visits participants will have blood samples taken.

  • At 5 of the visits participants will be asked to fill in a questionnaire

  • At 4 of the visits participants will have to do a 6-minute walking test

  • At 3 of the visits participants will have a test to check the heart.

  • participants will have their eyes checked before or at the start of the study and at the end of the study

Women cannot take part if pregnant, breast-feeding or plan to become 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 informedconsent.

  • Body mass index (BMI) greater than or equal to 30.0 kg/m^2

  • New York Heart Association (NYHA) Class II-IV

  • Left ventricular ejection fraction (LVEF) greater than or equal to 45% at screening

  • Diagnosed with T2D greater than or equal to 90 days prior to the day of screening

  • HbA1c of below or equal to 10.0% as measured at the screening visit

Exclusion

Exclusion Criteria:

  • A self-reported change in body weight greater than 5 kg (11 lbs) within 90 daysbefore screening irrespective of medical records

  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verifiedby a fundus examination performed within 90 days prior to 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: 617
Treatment Group(s): 2
Primary Treatment: Placebo (Semaglutide)
Phase: 3
Study Start date:
June 15, 2021
Estimated Completion Date:
October 11, 2023

Connect with a study center

  • CEMEDIC

    Caba, Buenos Aires C1440CFD
    Argentina

    Site Not Available

  • Centro de Investigación y Prevención Cardiovascular

    Caba, C1119ACN
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Caba, C1061AAS.
    Argentina

    Site Not Available

  • Cardiología Palermo

    Ciudad Autónoma de Buenos Aire, 1425
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Ciudad Autónoma de Buenos Aire, 1425
    Argentina

    Site Not Available

  • Instituto de Cardiología de Corrientes

    Corrientes, W3400AMZ
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Corrientes, W3400AMZ
    Argentina

    Site Not Available

  • Consultorio Integral de Atención al Diabético

    Morón, B1708IFF
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Morón, B1708IFF
    Argentina

    Site Not Available

  • Novo Nordisk Investigational Site

    Rosario, Santa Fe, S2000CVB
    Argentina

    Site Not Available

  • Sanatorio Britanico S.A.

    Rosario, Santa Fe, S2000CVB
    Argentina

    Site Not Available

  • Krankenhaus St. Josef Braunau

    Braunau, A 5280
    Austria

    Site Not Available

  • Novo Nordisk Investigational Site

    Braunau, A 5280
    Austria

    Site Not Available

  • Medizinische Universität Graz

    Graz, A 8036
    Austria

    Site Not Available

  • Novo Nordisk Investigational Site

    Graz, A 8036
    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

  • Novo Nordisk Investigational Site

    Wien, A 1090
    Austria

    Site Not Available

  • Universitätsklinik für Innere Medizin II

    Wien, A 1090
    Austria

    Site Not Available

  • Novo Nordisk Investigational Site

    Calgary, Alberta T2N 4Z6
    Canada

    Site Not Available

  • University of Calgary_Calgary

    Calgary, Alberta T2N 4Z6
    Canada

    Site Not Available

  • Cambridge Cardiac Care Centre

    Cambridge, Ontario N1R 6V6
    Canada

    Site Not Available

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    Cambridge, Ontario N1R 6V6
    Canada

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  • Novo Nordisk Investigational Site

    Newmarket, Ontario L3Y 2P6
    Canada

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  • Partnrs Adv Cardio Eval (PACE)

    Newmarket, Ontario L3Y 2P6
    Canada

    Site Not Available

  • Heart Health Institute Research, Inc.

    Scarborough, Ontario M1B 4Z8
    Canada

    Site Not Available

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    Scarborough, Ontario M1B 4Z8
    Canada

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    Toronto, Ontario M9N 1W4
    Canada

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    Weston, Ontario M9N 1W4
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    Montreal, Quebec H4A 3T2
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    Terrebonne, Quebec J6X 4P7
    Canada

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    Terrebonne, Quebec J6X 4P7
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    Quebec, G1V 4G5
    Canada

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    Quebec, G1V 4G5
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    Czechia

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    Praha 7, 170 00
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    Praha 7, 170 00
    Czechia

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    Berlin, 13353
    Germany

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    Berlin, 13353
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    Dresden, 01277
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    Dresden, 01277
    Germany

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    Germany

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    Frankfurt, 60389
    Germany

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    Frankfurt, 60389
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    Freiburg, 79106
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    Kassel, 34121
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    Leipzig, 04103
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    Leipzig, 04103
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    Leipzig, 04103
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    Mainz, 55131
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    Würzburg, 97078
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    Budapest, 1096
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    Budapest, 1122
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  • Szent Margit Rendelőintézet Nonprofit Kft.

    Budapest, 1032
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    Debrecen, 4032
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    Miskolc, 3526
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    Zalaegerszeg, 8900
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  • G B Pant Institute of Postgraduate Medical Education and Research

    New Delhi, Delhi 110002
    India

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  • Max Super Speciality Hospital, Saket

    New Delhi, Delhi 110017
    India

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    New Delhi, Delhi 110017
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    Kochi, Kerala 682018
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    Kochi, Kerala 682018
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    Nashik, Maharashtra 422005
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  • Vijan Cardiac & Critical Care

    Nashik, Maharashtra 422005
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  • Vijan Hospital & Research Centre

    Nashik, Maharashtra 422005
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  • Novo Nordisk Investigational Site

    New Dehli, New Delhi 110029
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  • VMMC & Safdarjung Hospital

    New Dehli, New Delhi 110029
    India

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    Bikaner, Rajasthan 334003
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  • SP Medical College

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    Bikaner, Rajasthan 334003
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    Chennai, Tamil Nadu 600006
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  • Gandhi Memorial Hospital- King George's Medical University

    Lucknow, Uttar Pradesh 226003
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    New Delhi, 110017
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    New Delhi, 110060
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  • Hadassah Ein Kerem MC - Cardio

    Jerusalem, 91120
    Israel

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    Jerusalem, 91120
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    Nahariya, 22100
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Nahariya, 22100
    Israel

    Site Not Available

  • Heart Failure Unit, Rabin Medical Center - Beilinson Campus

    Petah-Tikva, 49100
    Israel

    Site Not Available

  • Novo Nordisk Investigational Site

    Petah-Tikva, 49100
    Israel

    Site Not Available

  • Cardio Vascular Research Center Sourasky MC

    Tel Aviv, 6423906
    Israel

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    Tel Aviv, 6423906
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    Tel Hashomer, 5265601
    Israel

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  • Sheba Medica Center - Clinical Research Unit

    Tel Hashomer, 5265601
    Israel

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    Bergamo, Bg 24127
    Italy

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    Bergamo, Bg 24127
    Italy

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    Brescia, Bs 25123
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  • Spedali Civili Brescia

    Brescia, Bs 25123
    Italy

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  • A.O.U. Ferrara, Sant'Anna

    Cona (Ferrara), Fe 44124
    Italy

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  • Novo Nordisk Investigational Site

    Cona (Ferrara), Fe 44124
    Italy

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  • Centro Cardiologico Monzino. Istituto di Ricovero e Cura

    Milano, 20138
    Italy

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    Milano, 20138
    Italy

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    Padova, 35128
    Italy

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  • A.O.U. Policlinico Umberto I

    Roma, 00161
    Italy

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  • Novo Nordisk Investigational Site

    Roma, 00161
    Italy

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  • Novo Nordisk Investigational Site

    Rome, 00168
    Italy

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  • Policlinico A. Gemelli IRCCS

    Rome, 00168
    Italy

    Site Not Available

  • Hyogo Prefectural HarimaHimeji General Medical Center_Cardiology

    Himeji-shi, Hyogo, 670-8560
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Himeji-shi, Hyogo, 670-8560
    Japan

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  • Kokura Memorial Hospital, Cardiology

    Kitakyushu-shi,Fukuoka, 802-8555
    Japan

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  • Novo Nordisk Investigational Site

    Kitakyushu-shi,Fukuoka, 802-8555
    Japan

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  • Novo Nordisk Investigational Site

    Okayama-shi, Okayama, 700-8558
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  • Novo Nordisk Investigational Site

    Omihachiman-shi, Siga, 523-0082
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    Omihachiman-shi, Siga, 523-0082
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    Osaka, 534-0021
    Japan

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    Osaka, 534-0021
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    Osaka-shi, Osaka, 530-8480
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    Sapporo-shi, Hokkaido, 062-0003
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    Sapporo-shi, Hokkaido, 062-0003
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    Tokyo, 140-8522
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  • Tokyo Shinagawa Hospital Social Medical Corporation Association Tokyokyojuno-kai

    Tokyo, 140-8522
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    Apeldoorn, 7334 DZ
    Netherlands

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    Arnhem, 6815 AD
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    Beverwijk, 1942 LE
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    Beverwijk, 1942 LE
    Netherlands

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    Groningen, 9713 GZ
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    Groningen, 9713 GZ
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    Hardenberg, 7772 SE
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    Leeuwarden, 8934 AD
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    Leeuwarden, 8934 AD
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    Roosendaal, 4708 AE
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    Lodz, Lodzkie 90-549
    Poland

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    Lodz, Lodzkie 90-549
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    Chrzanow, Malopolskie 32-500
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    Bialystok, Podlaskie 15-276
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    Katowice, Śląskie 40-648
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    Gdynia, 81-157
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    Uppsala, 751 85
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    Dundee, DD1 9SY
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    Glasgow, G31 2ER
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    Swindon, SN3 6BB
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    Jacksonville, Florida 32258
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    Miami, Florida 33173
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    Arlington Heights, Illinois 60005
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    Arlington Heights, Illinois 60005
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    Arlington Heights, Illinois 60005
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    Chicago, Illinois 60611
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    Evanston, Illinois 60208
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    Hazel Crest, Illinois 60429
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    Indianapolis, Indiana 46260
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    Munster, Indiana 46321
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    Topeka, Kansas 66606
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    Topeka, Kansas 66606
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    Elizabethtown, Kentucky 42701
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    Elizabethtown, Kentucky 42701
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    Lexington, Kentucky 40503
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    Louisville, Kentucky 40207
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    Louisville, Kentucky 40207
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    Bossier City, Louisiana 71111
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    Bossier City, Louisiana 71111
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    Shreveport, Louisiana 71105
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    Slidell, Louisiana 70458
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  • John Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Univ of Mississippi Med Ctr

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint Louis, Missouri 63136
    United States

    Site Not Available

  • St Louis Heart & Vascular, P.C.

    Saint Louis, Missouri 63136
    United States

    Site Not Available

  • Bryan Heart

    Lincoln, Nebraska 68506
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Lincoln, Nebraska 68506
    United States

    Site Not Available

  • CHI Health Clinic Cardiology (CUMC - Bergan Mercy)

    Omaha, Nebraska 68124
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Omaha, Nebraska 68124
    United States

    Site Not Available

  • Carteret Medical Group

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Dallas, Texas 75390
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Houston, Texas 77025
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Richmond, Virginia 23298-5058
    United States

    Site Not Available

  • Virginia Commonwealth University

    Richmond, Virginia 23298-5058
    United States

    Site Not Available

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