A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight

Last updated: April 17, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Not Recruiting

Phase

3

Condition

Hypertriglyceridemia

Knee Injuries

Diabetes Prevention

Treatment

Placebo

Retatrutide

Clinical Study ID

NCT05929066
18557
2023-503657-35-00
J1I-MC-GZBJ
J1I-MC-GSA1
J1I-MC-GOA1
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants who have obesity or overweight (J1I-MC-GZBJ master protocol) including subsets of participants who have knee osteoarthritis (OA) (J1I-MC-GOA1) or who have obstructive sleep apnea (OSA) (J1I-MC-GSA1). This study will last about 89 weeks and will include up to 24 visits. Addendum (2) is optional and available to approximately 500 participants to continue treatment with retatrutide for up to an additional 24 weeks.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have body mass index (BMI) ≥30.0 kilograms per square meter (kg/m²), or ≥27.0 kg/m²with at least one of the following:

  • hypertension

  • dyslipidemia

  • obstructive sleep apnea, or

  • cardiovascular disease

  • History of of at least one unsuccessful dietary effort to reduce body weight

GOA1 Inclusion Criteria:

  • Have index knee pain for >12 weeks prior to screening, and presence of index kneepain for >15 days over the previous month

  • Have knee X-ray with moderate radiographic changes (Kellgren-Lawrence Grade 2 or 3)per central reading at screening

  • Currently meets American College of Rheumatology (ACR) Criteria (clinical andradiological) for OA.

GSA1 Inclusion Criteria:

  • Previously diagnosed with OSA

  • Have AHI ≥15 on polysomnography at screening (definition of moderate-to-severe OSA)

  • For participants not on positive airway pressure (PAP) therapy: unable or unwillingto use PAP therapy and have not used PAP for at least 4 weeks prior to screening.

  • If on PAP therapy, have been on PAP therapy for at least 3 consecutive months priorto screening, and willing to temporarily stop using PAP therapy for approximately 7days prior to each of the sleep study (PSG) visits.

GZBJ Addenda (2) inclusion criteria:

  • Have completed the final treatment visit of GZBJ Week 80.

Exclusion

Exclusion Criteria:

  • Have a self-reported or documented change in body weight >5 kg (11 pounds) within 90days.

  • Have taken weight loss drugs, including over-the-counter medications, within 90 daysprior to screening.

  • Have a prior or planned surgical treatment for obesity.

  • Have diabetes mellitus.

  • Have family or personal history of medullary thyroid carcinoma (MTC) or multipleendocrine neoplasia syndrome type 2 (MEN-2)

  • Have had pancreatitis.

GOA1 exclusion criteria

  • Have had steroid joint injections within 90 days of screening.

  • Have had other joint injections and procedures within 6 months of screening.

  • Have joint disease other than osteoarthritis.

GSA1 exclusion criteria

  • Use stimulants (for example, modafinil, armodafinil, solriamfetol, pitolisant,amphetamine) less than 3 months prior to screening.

  • Use hypnotics, mirtazapine, opioids, trazodone, and zonisamide less than 3 monthsprior to screening.

  • Use a dental appliance or other device to treat OSA other than PAP therapy.

GZBJ Addenda (2) exclusion criteria

  • Have had study intervention discontinuation.

  • Have had permanent dose reduction.

Study Design

Total Participants: 2300
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
July 10, 2023
Estimated Completion Date:
May 31, 2026

Connect with a study center

  • Emeritus Research

    Botany, New South Wales 2019
    Australia

    Site Not Available

  • Optimus Clinical Research

    Botany, New South Wales 2019
    Australia

    Active - Recruiting

  • The AIM Centre / Hunter Diabetes Centre

    Merewether, New South Wales 2291
    Australia

    Site Not Available

  • Logan Hospital

    Meadowbrook, Queensland 4131
    Australia

    Site Not Available

  • Nightingale Research

    Adelaide, South Aust 5000
    Australia

    Site Not Available

  • Fusion Clinical Research

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Emeritus Research

    Camberwell, Victoria 3124
    Australia

    Site Not Available

  • Barwon Health

    Geelong, Victoria 3220
    Australia

    Site Not Available

  • One Clinical Research

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • CPCLIN

    Natal, Rio Grande Do Norte 59025-050
    Brazil

    Site Not Available

  • CPCLIN

    Sao Paulo, São Paulo 01228-200
    Brazil

    Site Not Available

  • CEPIC - Centro Paulista de Investigação Clínica

    São Paulo, 04266-010
    Brazil

    Site Not Available

  • CPQuali Pesquisa Clínica

    São Paulo, 01228-000
    Brazil

    Site Not Available

  • Hospital das Clinicas FMUSP

    São Paulo, 04266-010
    Brazil

    Active - Recruiting

  • Aggarwal and Associates Limited

    Brampton, Ontario L6T 0G1
    Canada

    Site Not Available

  • Dr. Steven V. Zizzo Medicine Professional Corporation

    Hamilton, Ontario L8J 0B6
    Canada

    Site Not Available

  • Wharton Medical Clinic

    Hamilton, Ontario L8L 5G8
    Canada

    Site Not Available

  • Your Research Network

    Niagara Falls, Ontario L2H 1H5
    Canada

    Site Not Available

  • Bluewater Clinical Research Group Inc.

    Sarnia, Ontario N7T 4X3
    Canada

    Site Not Available

  • Canadian Phase Onward

    Toronto, Ontario M3J 0K2
    Canada

    Site Not Available

  • Centre de Recherche Clinique de Laval

    Laval, Quebec H7T 2P5
    Canada

    Site Not Available

  • Clinique de médecine Urbaine du Quartier Latin

    Montreal, Quebec H2L 4E9
    Canada

    Site Not Available

  • C.I.C. Mauricie inc.

    Trois-Rivières, Quebec G8T 7A1
    Canada

    Site Not Available

  • Beijing Friendship Hospital

    Beijing, Beijing 100050
    China

    Site Not Available

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    Beijing, Beijing 100050
    China

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  • The Fourth Hospital of Harbin Medical University

    Harbin, Heilongjiang 150001
    China

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  • The First Affiliated Hospital of Henan University of Science &Technology

    Luoyang, Henan 471003
    China

    Site Not Available

  • The First Affiliated Hospital of Henan University of Science &Technology

    Luoyang Shi, Henan 471003
    China

    Site Not Available

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450014
    China

    Site Not Available

  • Nanjing First Hospital

    Nanjing, Jiangsu 210006
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu 210011
    China

    Site Not Available

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu 212000
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, Jilin 130021
    China

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    Xi'an, Shaanxi 710077
    China

    Site Not Available

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    Shanghai, Shanghai
    China

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    Shanghai, Shanghai 200065
    China

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    Chengdu, Sichuan 610041
    China

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    Chengdu, Sichuan 610041
    China

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    Tianjin, Tianjin 300052
    China

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    Urumchi, Xinjiang 830054
    China

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    Urumqi, Xinjiang 830000
    China

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    Ürümqi, Xinjiang 830054
    China

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    Ningbo, Zhejiang 315010
    China

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    Wenzhou, Zhejiang 325000
    China

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    Szeged, Csongrád 6725
    Hungary

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    Szekesfehervar, Fejér 8000
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    Nyiregyhaza, Nyíregyháza 4400
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    Debrecen, 4031
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    Debrecen, 4032
    Hungary

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    Debrecen, 4031
    Hungary

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    Guntur, Andhra Pradesh 522001
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    India

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    New Delhi, Delhi 110001
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    Ahmedabad, Gujarat 380013
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    Surat, Gujarat 395002
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    Hubli, Karnataka 580021
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    Thiruvananthapuram, Kerala 695031
    India

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    Trivandrum, Kerala 695032
    India

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    Mumbai, Maharashtra 400008
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    Mumbai, Maharashtra 400011
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    Nagpur, Maharashtra 440015
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    Nagpur, Maharashtra 440009
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  • Chellaram Diabetes Institute

    Pune, Maharashtra 411021
    India

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    Pune, Maharashtra 411004
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    Pune, Maharashtra 411057
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    Bhubaneswar, Odisha 751019
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    Jaipur, Rajasthan 302020
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    Vellore, Tamil Nadu 632004
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    Namdong, Incheon-gw 21565
    Korea, Republic of

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    Namdong-gu, Incheon-gw 21565
    Korea, Republic of

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  • Korea University Ansan Hospital

    Ansan-si, Kyǒnggi-do 15355
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    Anyang-si, Kyǒnggi-do 14068
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  • Hanyang University Guri Hospital

    Guri-si, Kyǒnggi-do 11923
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  • Seoul National University Bundang Hospital

    Seongnam, Kyǒnggi-do 13620
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  • Ajou University Hospital

    Suwon, Kyǒnggi-do 16499
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  • Pusan National University Yangsan Hospital

    Busan, Kyǒngsangnam-do 50612
    Korea, Republic of

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  • Kangbuk Samsung Hospital

    Seoul, Seoul-teukbyeolsi [Seoul] 03181
    Korea, Republic of

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  • Korea University Guro Hospital

    Seoul, Seoul-teukbyeolsi [Seoul] 08308
    Korea, Republic of

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  • Nowon Eulji Medical Center, Eulji University

    Seoul, Seoul-teukbyeolsi [Seoul] 01830
    Korea, Republic of

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  • Kyungpook National University Hospital

    Jung-gu, Taegu-Kwan 41944
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  • Kyungpook National University Hospital

    Junggu, Taegu-Kwangyǒkshi 41944
    Korea, Republic of

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  • Eulji University Hospital

    Daejeon, Taejǒn-Kwangyǒkshi 01830
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  • Konyang University Hospital

    Seo-gu, Taejǒn-Kwangyǒkshi 35365
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  • Konyang University Hospital

    Seogu, Taejǒn-Kwangyǒkshi 35365
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  • Ulsan University Hospital

    Ulsan, Ulsan-Kwangyǒkshi 44033
    Korea, Republic of

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  • Centro de Investigacion en Artritis y Osteoporosis SC

    Mexicali, Baja California 21200
    Mexico

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  • Clinica Omega

    Mexico City, Distrito Federal 06700
    Mexico

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  • RM Pharma Specialists

    Mexico City, Distrito Federal 03100
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  • Clinica de Investigacion en Reumatologia y Obesidad S. C.

    Guadalajara, Jalisco 44650
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  • Diseno y Planeacion en Investigacion Medica

    Guadalajara, Jalisco 44130
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  • Private Practice - Dr. Arechavaleta Granell Maria del Rosario

    Guadalajara, Jalisco 44670
    Mexico

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  • Unidad de Investigación Clínica y Atención Médica HEPA

    Guadalajara, Jalisco 44670
    Mexico

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  • Instituto de Diabetes, Obesidad y Nutricion

    Cuernavaca, Morelos 62250
    Mexico

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  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León 66460
    Mexico

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  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey, Nuevo León 66460
    Mexico

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  • Unidad biomedica avanzada monterrey

    Monterrey, Nuevo León 64460
    Mexico

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  • EME RED Hospitalaria

    Mérida, Yucatán 97000
    Mexico

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  • Kohler and Milstein Research S.A. de C.V.

    Mérida, Yucatán 97070
    Mexico

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  • Köhler & Milstein Research

    Mérida, Yucatán 97070
    Mexico

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  • Centro de Atención e Investigación Clínica

    Aguascalientes, 20119
    Mexico

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  • Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos

    Chihuahua, 31110
    Mexico

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  • Arké SMO S.A de C.V

    Veracruz, 91910
    Mexico

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  • INTERCOR

    Bydgoszcz, Kujawsko-pomorskie 85-605
    Poland

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  • CenterMed Lublin NZOZ

    Lublin, Lubelskie 20-044
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  • Gabinety TERPA

    Lublin, Lubelskie 20-333
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  • MICS Centrum Medyczne Warszawa

    Warszawa, Mazowieckie 00-874
    Poland

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  • Medycyna Kliniczna

    Warszawa, Mazowieckie 00-874
    Poland

    Active - Recruiting

  • Private Practice - Dr. Robert Witek

    Tarnów, Małopolskie 33-100
    Poland

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  • Centrum Zdrowia Tuchów

    Wierzchosławice, Małopolskie 33-122
    Poland

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  • Uniwersytecki Szpital Kliniczny w Białymstoku

    Białystok, Podlaskie 15-276
    Poland

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  • Centrum Badan Klinicznych PI-House sp. z o.o.

    Gdansk, Pomorskie 80-546
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  • Centrum Kliniczno-Badawcze

    Elblag, Warmińsko-mazurskie 82-300
    Poland

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  • Ambulatorium Barbara Bazela

    Elbląg, Warmińsko-mazurskie 82-300
    Poland

    Active - Recruiting

  • Ambulatorium Sp. z o.o.

    Elbląg, Warmińsko-mazurskie 82-300
    Poland

    Site Not Available

  • Centrum Zdrowia Metabolicznego Pawel Bogdanski

    Poznań, Wielkopolskie 60-589
    Poland

    Site Not Available

  • NZOZ Salvia CM

    Katowice, Śląskie 40-772
    Poland

    Site Not Available

  • Specjalistyczna Praktyka Lekarska Diabetologia, Leczenie Cukrzycy i Otylosci

    Kielce, Świętokrzyskie 25-355
    Poland

    Site Not Available

  • Ponce Medical School Foundation Inc.

    Ponce, 00716
    Puerto Rico

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  • Diabdana

    Oradea, Bihor 410147
    Romania

    Site Not Available

  • C.M.D.T.A. Neomed

    Brasov, Brașov 500283
    Romania

    Site Not Available

  • Hightech Medical Services SRL-Centrul pentru Studiul Metabolismului

    Bucharest, București 011053
    Romania

    Site Not Available

  • Gama Diamed

    Mangalia, Constanța 905500
    Romania

    Site Not Available

  • Cabinet Medical Dr.Geru

    Timisoara, Timiș 300288
    Romania

    Site Not Available

  • SC Minimed SRL

    Bacău, 600274
    Romania

    Site Not Available

  • Diamed Obesity

    Galați, 800291
    Romania

    Site Not Available

  • Centrul Medical Consultmed

    Iași, 700547
    Romania

    Site Not Available

  • Clinica Korall

    Satu Mare, 440055
    Romania

    Site Not Available

  • Policlinica Astra Sibiu

    Sibiu, 550371
    Romania

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  • CHUAC-Complejo Hospitalario Universitario A Coruña

    A Coruña, A Coruña [La Coruña] 15006
    Spain

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  • Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval

    Ferrol, A Coruña [La Coruña] 15405
    Spain

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  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona] 08035
    Spain

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  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria 39008
    Spain

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    Valencia, Valenciana, Comunitat 46014
    Spain

    Site Not Available

  • Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)

    Sevilla, 41003
    Spain

    Site Not Available

  • Changhua Christian Hospital

    Changhua County, Changhua 50006
    Taiwan

    Site Not Available

  • Changhua Christian Hospital

    Changhua, 50006
    Taiwan

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  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung, 807
    Taiwan

    Active - Recruiting

  • Kaohsiung Medical University Hospital

    Kaohsiung, 807
    Taiwan

    Site Not Available

  • China Medical University Hospital

    Taichung, 404332
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan, 704
    Taiwan

    Site Not Available

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    Tainan, 704
    Taiwan

    Site Not Available

  • Rowden Surgery

    Chippenham, England SN15 2SB
    United Kingdom

    Site Not Available

  • Layton Medical Centre

    Blackpool, Lancashire FY3 7EN
    United Kingdom

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  • Leicester General Hospital

    Leicester, Leicestershire LE5 4PW
    United Kingdom

    Site Not Available

  • Panthera Biopartners - North London

    Enfield, London, City Of EN3 4GS
    United Kingdom

    Site Not Available

  • Panthera Biopartners - North London

    Enfield Town, London, City Of EN3 4GS
    United Kingdom

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  • Glasgow Royal Infirmary

    Glasgow, Scotland G31 2ER
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    Birmingham, B9 5SS
    United Kingdom

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    Liverpool, L9 7AL
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    Penzance, TR18 3DX
    United Kingdom

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    Sheffield, S2 5FX
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  • Arizona Research Center

    Phoenix, Arizona 85053
    United States

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    Phoenix, Arizona 85020
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    Little Rock, Arkansas 72211
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    Fresno, California 93710
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    San Diego, California 92103
    United States

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    Aurora, Colorado 80045
    United States

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    New Haven, Connecticut 06519
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    Waterbury, Connecticut 06708
    United States

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  • Teradan Clinical Trials, LLC

    Brandon, Florida 33511
    United States

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    Miami, Florida 33165
    United States

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  • Suncoast Research Group

    Miami, Florida 33135
    United States

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    Orlando, Florida 32801
    United States

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    Orlando, Florida 32801
    United States

    Site Not Available

  • Progressive Medical Research

    Port Orange, Florida 32127
    United States

    Site Not Available

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    Atlanta, Georgia 30328
    United States

    Site Not Available

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    Woodstock, Georgia 30189
    United States

    Site Not Available

  • East-West Medical Research Institute

    Honolulu, Hawaii 96814
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative

    Springfield, Illinois 62711
    United States

    Site Not Available

  • Brengle Family Medicine

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • Cotton O'Neil Clinical Research Center

    Topeka, Kansas 66606
    United States

    Active - Recruiting

  • Cotton O'Neil Diabetes & Endocrinology

    Topeka, Kansas 66606
    United States

    Site Not Available

  • MedVadis Research Corporation

    Waltham, Massachusetts 02451
    United States

    Site Not Available

  • Great Lakes Research Group, Inc.

    Bay City, Michigan 48706
    United States

    Site Not Available

  • StudyMetrix Research

    Saint Peters, Missouri 63303
    United States

    Site Not Available

  • Clinvest Headlands Llc

    Springfield, Missouri 65807
    United States

    Active - Recruiting

  • Clinvest Research LLC

    Springfield, Missouri 65807
    United States

    Site Not Available

  • Palm Research Center Tenaya

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • Rochester Clinical Research, Inc.

    Rochester, New York 14609
    United States

    Active - Recruiting

  • Rochester Clinical Research, LLC

    Rochester, New York 14609
    United States

    Site Not Available

  • Carteret Medical Group

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • Trial Management Associates - Wilmington - Floral Parkway

    Wilmington, North Carolina 28403
    United States

    Site Not Available

  • Lillestol Research

    Fargo, North Dakota 58104
    United States

    Site Not Available

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Tribe Clinical Research, LLC

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • Tribe Clinical Research - Spartanburg

    Spartanburg, South Carolina 29301
    United States

    Site Not Available

  • Vanderbilt Health One Hundred Oaks

    Nashville, Tennessee 37204
    United States

    Site Not Available

  • FutureSearch Trials of Neurology

    Austin, Texas 78731
    United States

    Site Not Available

  • Juno Research

    Houston, Texas 77040
    United States

    Site Not Available

  • Advanced Research Institute

    Ogden, Utah 84405
    United States

    Site Not Available

  • Northwest Clinical Research Center

    Bellevue, Washington 98007
    United States

    Site Not Available

  • Rainier Clinical Research Center

    Renton, Washington 98057
    United States

    Site Not Available

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