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NCT05929066CompletedPhase 3

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

A Master Protocol to Investigate the Efficacy and Safety of LY3437943 Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial (TRIUMPH-1)

Source: ClinicalTrials.gov · Last updated 21 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
2335 (actual)
First submitted
26 Jun 2023
Start date
10 Jul 2023
Primary completion date
6 Apr 2026
Lead sponsor
Eli Lilly and Company
NCT number
NCT05929066
EU CT number
2023-503657-35-00

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 2335
  • From 10 Jul 2023 to the primary completion date, 6 Apr 2026
  • 133 sites in 12 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

  • Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
  • Have a prior or planned surgical treatment for obesity.
  • Have had steroid joint injections within 90 days of screening.
  • 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 months prior to screening.
  • Use a dental appliance or other device to treat OSA other than PAP therapy.
    • GZBJ Addenda (2) exclusion criteria

Other illness

  • Have diabetes mellitus.
  • Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
  • Have joint disease other than osteoarthritis.
    • GSA1 exclusion criteria

Other

  • Have a self-reported or documented change in body weight \>5 kg (11 pounds) within 90 days.
  • Have had pancreatitis.
    • GOA1 exclusion criteria
  • Have had other joint injections and procedures within 6 months of screening.
  • Have had study intervention discontinuation.
  • Have had permanent dose reduction.

Who the study is looking for

  • Have body mass index (BMI) ≥30.0 kilograms per square meter (kg/m²), or ≥27.0 kg/m² with at least one of the following:
    • hypertension
    • dyslipidemia
    • obstructive sleep apnea, or
    • cardiovascular disease
  • History 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 knee pain 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 and radiological) 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 unwilling to 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 prior to screening, and willing to temporarily stop using PAP therapy for approximately 7 days prior to each of the sleep study (PSG) visits.
    • GZBJ Addenda (2) inclusion criteria:
  • Have completed the final treatment visit of GZBJ Week 80.

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

Full criteria on ClinicalTrials.gov

Sites (133)

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

SiteCityCountrySite status
Fusion Clinical Research
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AdelaideAustraliaUnknown status
Nightingale Research
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AdelaideAustraliaUnknown status
Emeritus Research
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BotanyAustraliaUnknown status
Emeritus Research
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CamberwellAustraliaUnknown status
Barwon Health
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GeelongAustraliaUnknown status
Logan Hospital
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MeadowbrookAustraliaUnknown status
The AIM Centre / Hunter Diabetes Centre
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MerewetherAustraliaUnknown status
One Clinical Research
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NedlandsAustraliaUnknown status
CPCLIN
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São PauloBrazilUnknown status
CEPIC - Centro Paulista de Investigação Clínica
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São PauloBrazilUnknown status
CPQuali Pesquisa Clínica
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São PauloBrazilUnknown status
Aggarwal and Associates Limited
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BramptonCanadaUnknown status
Dr. Steven V. Zizzo Medicine Professional Corporation
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HamiltonCanadaUnknown status
Wharton Medical Clinic
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HamiltonCanadaUnknown status
Centre de recherche Clinique de Laval
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LavalCanadaUnknown status
Clinique de médecine Urbaine du Quartier Latin
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MontrealCanadaUnknown status
Your Research Network
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Niagara FallsCanadaUnknown status
Bluewater Clinical Research Group Inc.
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SarniaCanadaUnknown status
Canadian Phase Onward
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TorontoCanadaUnknown status
C.I.C. Mauricie inc.
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Trois-RivièresCanadaUnknown status
CHUAC-Complejo Hospitalario Universitario A Coruña
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A CoruñaSpainUnknown status
Hospital Universitari Vall d'Hebron
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BarcelonaSpainUnknown status
Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval
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FerrolSpainUnknown status
Hospital Universitario Marqués de Valdecilla
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SantanderSpainUnknown status
Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
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SevilleSpainUnknown status
Hospital General Universitario de Valencia
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ValenciaSpainUnknown status
Heartlands Hospital
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BirminghamUnited KingdomUnknown status
Layton Medical Centre
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BlackpoolUnited KingdomUnknown status
Rowden Surgery
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ChippenhamUnited KingdomUnknown status
Panthera Biopartners - North London
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EnfieldUnited KingdomUnknown status
Glasgow Royal Infirmary
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GlasgowUnited KingdomUnknown status
Leicester General Hospital
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LeicesterUnited KingdomUnknown status
Aintree University Hospital NHS Foundation Trust
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LiverpoolUnited KingdomUnknown status
St Clare Medical Centre
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PenzanceUnited KingdomUnknown status
Panthera Biopartners - Sheffield
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SheffieldUnited KingdomUnknown status
DRC Gyógyszervizsgáló Központ
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BalatonfüredHungaryUnknown status
Óbudai Egészségügyi Centrum
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BudapestHungaryUnknown status
ClinDiab Kft.
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BudapestHungaryUnknown status
Debreceni Egyetem Klinikai Kozpont
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DebrecenHungaryUnknown status
Medifarma-98 Kft.
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NyíregyházaHungaryUnknown status
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
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SzegedHungaryUnknown status
Regia Med Kft
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SzékesfehérvárHungaryUnknown status
Avron Hospitals
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AhmedabadIndiaUnknown status
All India Institute of Medical Sciences
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BhubaneswarIndiaUnknown status
Endolife Speciality Hospitals
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GunturIndiaUnknown status
Karnataka Institute of Medical Sciences
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HubliIndiaUnknown status
Eternal Heart Care Center and Research Institute
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JaipurIndiaUnknown status
ILS Hospitals
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KolkataIndiaUnknown status
Wockhardt Hospital - Mumbai Central
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MumbaiIndiaUnknown status
Deenanath Mangeshkar Hospital & Research Centre
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PuneIndiaUnknown status
Lifepoint Multispeciality Hospital
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PuneIndiaUnknown status
Chellaram Diabetes Institute
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PuneIndiaUnknown status
Surat Institute of Digestive Sciences Hospitals
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SuratIndiaUnknown status
Indian Institute of Diabetes
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ThiruvananthapuramIndiaUnknown status
Jothydev's Diabetes and Research Center
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TrivandrumIndiaUnknown status
Christian Medical College Vellore
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VelloreIndiaUnknown status
Centro de Atención e Investigación Clínica
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AguascalientesMexicoUnknown status
Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos
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Chihuahua CityMexicoUnknown status
Instituto de Diabetes, Obesidad y Nutricion
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CuernavacaMexicoUnknown status
Clinica de Investigacion en Reumatologia y Obesidad S. C.
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GuadalajaraMexicoUnknown status
Unidad de Investigación Clinica y atencion Medica HEPA
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GuadalajaraMexicoUnknown status
Diseno y Planeacion en Investigacion Medica
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GuadalajaraMexicoUnknown status
Private Practice - Dr. Arechavaleta Granell Maria del Rosario
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GuadalajaraMexicoUnknown status
Kohler and Milstein Research S.A. de C.V.
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MéridaMexicoUnknown status
Eme Red Hospitalaria
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MéridaMexicoUnknown status
Centro de Investigacion en Artritis y Osteoporosis SC
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MexicaliMexicoUnknown status
RM Pharma Specialists
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Mexico CityMexicoUnknown status
Clinica Omega
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Mexico CityMexicoUnknown status
Unidad Biomedica Avanzada Monterrey
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MonterreyMexicoUnknown status
Hospital Universitario Dr. Jose Eleuterio González
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MonterreyMexicoUnknown status
Arké SMO S.A de C.V
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VeracruzMexicoUnknown status
Uniwersytecki Szpital Kliniczny w Białymstoku
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BialystokPolandUnknown status
INTERCOR
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BydgoszczPolandUnknown status
Centrum Kliniczno-Badawcze
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ElblagPolandUnknown status
Ambulatorium Sp. z o.o.
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ElblagPolandUnknown status
Centrum Badan Klinicznych PI-House sp. z o.o.
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GdanskPolandUnknown status
NZOZ Salvia CM
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KatowicePolandUnknown status
Specjalistyczna Praktyka Lekarska Diabetologia, Leczenie Cukrzycy i Otylosci
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KielcePolandUnknown status
CenterMed Lublin NZOZ
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LublinPolandUnknown status
Gabinety TERPA
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LublinPolandUnknown status
Centrum Zdrowia Metabolicznego Pawel Bogdanski
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PoznanPolandUnknown status
Private Practice - Dr. Robert Witek
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TarnówPolandUnknown status
MICS Centrum Medyczne Warszawa
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WarsawPolandUnknown status
Ponce Medical School Foundation Inc.
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PoncePuerto RicoUnknown status
SC Minimed SRL
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BacauRomaniaUnknown status
C.M.D.T.A. Neomed
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BrasovRomaniaUnknown status
Hightech Medical Services SRL-Centrul pentru Studiul Metabolismului
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BucharestRomaniaUnknown status
Diamed Obesity
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GalațiRomaniaUnknown status
Centrul Medical Consultmed
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IașiRomaniaUnknown status
Gama Diamed
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MangaliaRomaniaUnknown status
Diabdana
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OradeaRomaniaUnknown status
Clinica Korall
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Satu MareRomaniaUnknown status
Policlinica Astra Sibiu
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SibiuRomaniaUnknown status
Cabinet Medical Dr.Geru
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TimișoaraRomaniaUnknown status
NeuroTrials Research Inc
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AtlantaUnited StatesUnknown status
University of Colorado Anschutz Medical Campus
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AuroraUnited StatesUnknown status
FutureSearch Trials of Neurology
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AustinUnited StatesUnknown status
Great Lakes Research Group, Inc.
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Bay CityUnited StatesUnknown status
Northwest Clinical Research Center
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BellevueUnited StatesUnknown status
Teradan Clinical trials LLC
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BrandonUnited StatesUnknown status
Northwestern University
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ChicagoUnited StatesUnknown status
StudyMetrix Research
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City of Saint PetersUnited StatesUnknown status
Altoona Center For Clinical Research
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DuncansvilleUnited StatesUnknown status
Lillestol Research
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FargoUnited StatesUnknown status
Valley Research
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FresnoUnited StatesUnknown status
Neuro-Pain Medical Center
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FresnoUnited StatesUnknown status
Tribe Clinical Research LLC
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GreenvilleUnited StatesUnknown status
East-West Medical Research Institute
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HonoluluUnited StatesUnknown status
Juno Research
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HoustonUnited StatesUnknown status
Brengle Family Medicine
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IndianapolisUnited StatesUnknown status
Palm Research Center Tenaya
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Las VegasUnited StatesUnknown status
Medical Investigations
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Little RockUnited StatesUnknown status
Suncoast Research Group
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MiamiUnited StatesUnknown status
New Horizon Research Center
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MiamiUnited StatesUnknown status
Carteret Medical Group
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Morehead CityUnited StatesUnknown status
Vanderbilt Health One Hundred Oaks
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NashvilleUnited StatesUnknown status
Yale University School Of Medicine
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New HavenUnited StatesUnknown status
Advanced Research Institute
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OgdenUnited StatesUnknown status
Clinical Neuroscience Solutions
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OrlandoUnited StatesUnknown status
Central Phoenix Medical Clinic
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PhoenixUnited StatesUnknown status
Arizona Research Center
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PhoenixUnited StatesUnknown status
Progressive Medical Research
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Port OrangeUnited StatesUnknown status
Rainier Clinical Research Center
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RentonUnited StatesUnknown status
Rochester Clinical Research, LLC
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RochesterUnited StatesUnknown status
Artemis Institute for Clinical Research
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San DiegoUnited StatesUnknown status
Tribe Clinical Research - Spartanburg
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SpartanburgUnited StatesUnknown status
Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative
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SpringfieldUnited StatesUnknown status
Clinvest Research, LLC
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SpringfieldUnited StatesUnknown status
Cotton O'Neil Diabetes & Endocrinology
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TopekaUnited StatesUnknown status
MedVadis Research Corporation
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WalthamUnited StatesUnknown status
Chase Medical Research, LLC
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WaterburyUnited StatesUnknown status
Trial Management Associates - Wilmington - Floral Parkway
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WilmingtonUnited StatesUnknown status
North Georgia Clinical Research
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WoodstockUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.