Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight

Last updated: July 24, 2025
Sponsor: Amgen
Overall Status: Active - Recruiting

Phase

3

Condition

Obesity

Diabetes Mellitus, Type 2

Diabetes Prevention

Treatment

Maridebart cafraglutide

Placebo

Clinical Study ID

NCT06858878
20210184
  • Ages 18-99
  • All Genders

Study Summary

The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years.

  • Body mass index ≥ 27 kg/m^2.

  • History of at least 1 self-reported unsuccessful attempt at weight loss by diet andexercise.

  • Diagnosis of T2DM.

Exclusion

Exclusion Criteria:

  • Type 1 diabetes mellitus.

  • Self-reported change in body weight > 5 kg within 90 days before screening.

  • Proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferativediabetic retinopathy that requires acute treatment.

  • Obesity induced by other endocrinologic disorders.

  • Family (first-degree relative[s]) or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2.

  • History of chronic pancreatitis or history of acute pancreatitis within 180 daysbefore screening.

  • History of unstable major depressive disorder (MDD) or other severe psychiatricdisorder within 2 years before screening.

  • Lifetime history of suicide attempt.

Study Design

Total Participants: 999
Treatment Group(s): 2
Primary Treatment: Maridebart cafraglutide
Phase: 3
Study Start date:
March 17, 2025
Estimated Completion Date:
April 16, 2027

Connect with a study center

  • Cedic Centro de Investigacion Clinica

    Caba, Buenos Aires C1060ABN
    Argentina

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  • Cemedic Centro de Especialidades Medicas

    Caba, Buenos Aires C1407GTN
    Argentina

    Active - Recruiting

  • Centro Medico Viamonte

    Caba, Buenos Aires 1120
    Argentina

    Active - Recruiting

  • Maffei Centro Medico

    Caba, Buenos Aires C1425AGC
    Argentina

    Active - Recruiting

  • Cinme - Centro de Investigaciones Metabolicas

    Ciudad Autonoma de Buenos Aires, Buenos Aires C1056ABI
    Argentina

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  • Ciprec Centro de Investigacion y Prevencion Cardiovascular

    Ciudad Autonoma de Buenos Aires, Buenos Aires C1061AAT
    Argentina

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  • Ambulatory for specialized outpatient medical aid in endocrinology-Dr Albena Dinkova EOOD

    Pleven, 5801
    Bulgaria

    Active - Recruiting

  • Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD

    Sofia, 1407
    Bulgaria

    Active - Recruiting

  • Diagnostic - Consultative Center XX - Sofia EOOD

    Sofia, 1404
    Bulgaria

    Active - Recruiting

  • University Multiprofile Hospital for Active Treatment Sofiamed OOD

    Sofia, 1750
    Bulgaria

    Active - Recruiting

  • Prevencia-2000-Medical center for outpatient medical aid OOD

    Stara Zagora, 6000
    Bulgaria

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  • Medical Center Berbatov EOOD

    Yambol, 8600
    Bulgaria

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  • tlc Diabetes and Endocrinology

    Surrey, British Columbia V3T 2V6
    Canada

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  • Chronic Disease Innovation Centre

    Winnipeg, Manitoba R2V 3M3
    Canada

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  • Nova Scotia Health Authority, Queen Elizabeth ii Health Sciences Centre

    Halifax, Nova Scotia B3H 2Y9
    Canada

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  • Aggarwal and Associates Ltd

    Brampton, Ontario L6T 0G1
    Canada

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  • Centricity Research Brampton

    Brampton, Ontario L6S 0C6
    Canada

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  • Centricity Research Vaughan

    Concord, Ontario L4K 4M2
    Canada

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  • Premier Clinical Trial Network

    Hamilton, Ontario L8L 5G4
    Canada

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    Hamilton, Ontario L8J 0B6
    Canada

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  • Milestone Research

    London, Ontario N5W 6A2
    Canada

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  • Centricity Research Ottawa LMC

    Nepean, Ontario K2J 0V2
    Canada

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  • Your Research Network Inc.

    Niagara Falls, Ontario L2H 1H5
    Canada

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  • North York Diagnostic and Cardiac Centre

    North York, Ontario M6B 3H7
    Canada

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  • Bluewater Clinical Research Group Incorporated

    Sarnia, Ontario N7T 4X3
    Canada

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  • Albion Finch Medical Centre

    Toronto, Ontario M9V 4B4
    Canada

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    Levis, Quebec G6W 0M5
    Canada

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    Montreal, Quebec H4N 2W2
    Canada

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  • Institut de recherches cliniques de Montreal

    Montreal, Quebec H2W 1R7
    Canada

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    Pointe-Claire, Quebec H9R 4S3
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  • Diex Recherche Trois Rivieres

    Trois-Rivieres, Quebec G9A 4P3
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    Brno, 625 00
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    Ostrava, 702 00
    Czechia

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    Pardubice, 530 02
    Czechia

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    Pardubice, 530 02
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    Praha, 128 08
    Czechia

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    Praha 10, 100 34
    Czechia

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    Pribram VIII, 261 01
    Czechia

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    Aachen, 52074
    Germany

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    Bad Krozingen, 79189
    Germany

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    Bad Mergentheim, 97980
    Germany

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    Bad Oeynhausen, 32545
    Germany

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  • Charite - Universitaetsmedizin Berlin, Campus Mitte

    Berlin, 10117
    Germany

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  • Diabetespraxis Dr. Hermann Braun

    Berlin, 13187
    Germany

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  • Mvz am Bahnhof Spandau

    Berlin, 13597
    Germany

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  • Velocity Clinical Research GmbH

    Berlin, 10787
    Germany

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  • Zentrum fuer Klinische Studien Suedbrandenburg GmbH

    Elsterwerda, 04910
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  • InnoDiab Forschung

    Essen, 45136
    Germany

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  • Schwerpunktpraxis fuer Diabetes, Gefaess- & Ernaehrungsmedizin

    Falkensee, 14612
    Germany

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    Hamburg, 22607
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    Hamburg, 22767
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    Hohenmoelsen, 06679
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    Leipzig, 04107
    Germany

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    Leipzig, 04103
    Germany

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    Markkleeberg, 04416
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  • Centrum für Diagnostik und Gesundheit

    Muenchen, 80809
    Germany

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    Muenster, 48145
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  • Red-Institut GmbH

    Oldenburg, 23758
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    Baja, 6500
    Hungary

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    Balatonfured, 8230
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    Budapest, 1036
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  • Borvo Clinic Kft

    Debrecen, 4025
    Hungary

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  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032
    Hungary

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  • Komaromi Selye Janos Korhaz

    Komarom, 2900
    Hungary

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  • Borbanya Praxis Egeszsegugyi Kft

    Nyiregyhaza, 4405
    Hungary

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  • Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz

    Szombathely, 9700
    Hungary

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  • IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola

    Bologna, 40138
    Italy

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  • Universita degli Studi Gabriele D Annunzio di Chieti e Pescara

    Chieti, 66100
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Careggi

    Firenze, 50134
    Italy

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  • Azienda Socio Sanitaria Territoriale Fatebenefratelli Sacco

    Milano, 20157
    Italy

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  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milano, 20122
    Italy

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  • IRCCS Centro Cardiologico Monzino

    Milano, 20138
    Italy

    Active - Recruiting

  • Mikannohana Clinic, Diabetes, Endocrinology and Metabolism

    Matsuyama-shi, Ehime 790-0034
    Japan

    Active - Recruiting

  • Morizono Medical Clinic

    Kitakyusyu-shi, Fukuoka 807-0072
    Japan

    Active - Recruiting

  • Mazda Hospital of Mazda Motor Corporation

    Aki-gun, Hiroshima 735-8585
    Japan

    Active - Recruiting

  • Nakamoto Medical Clinic

    Mito-shi, Ibaraki 310-0826
    Japan

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  • Nakakinen Clinic

    Naka-shi, Ibaraki 311-0113
    Japan

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  • Ohishi Naika Clinic

    Tsuchiura-shi, Ibaraki 300-0835
    Japan

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  • Morinaga Ueno Clinic

    Kumamoto-shi, Kumamoto 860-0863
    Japan

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  • Shiraiwa Medical Clinic

    Kashiwara-shi, Osaka 582-0005
    Japan

    Active - Recruiting

  • Suruga Clinic

    Shizuoka-shi, Shizuoka 424-0855
    Japan

    Active - Recruiting

  • Yutenji Medical Clinic

    Meguro-ku, Tokyo 153-0053
    Japan

    Active - Recruiting

  • Medical Corporation Ouitsukai Kanno Naika

    Mitaka-shi, Tokyo 181-0013
    Japan

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  • Korea University Ansan Hospital

    Ansan-si, Gyeonggi-do, 15355
    Korea, Republic of

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  • Yeungnam University Medical Center

    Daegu, 42415
    Korea, Republic of

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  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620
    Korea, Republic of

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  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

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  • Hallym University Kangnam Sacred Heart Hospital

    Seoul, 07441
    Korea, Republic of

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  • Kangbuk Samsung Hospital

    Seoul, 03181
    Korea, Republic of

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  • Korea University Anam Hospital

    Seoul, 02841
    Korea, Republic of

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  • KyungHee University Gangdong Hospital

    Seoul, 05278
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

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  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591
    Korea, Republic of

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  • Yonsei University Wonju Severance Christian Hospital

    Wonju-si, Gangwon-do, 26426
    Korea, Republic of

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  • Salvia-Lekston i Madej Spolka Jawna

    Katowice, 40-772
    Poland

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  • Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna

    Lodz, 90-338
    Poland

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  • Clinical Best Solutions Sp zoo Spolka Komandytowa Gabinet Lekarski

    Lublin, 20-011
    Poland

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  • Ekamed Spolka z Ograniczona Odpowiedzialnoscia

    Lublin, 20-718
    Poland

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  • Medicome Spolka z Ograniczona Odpowiedzialnoscia

    Oswiecim, 32-600
    Poland

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  • Velocity Nova Sp zoo Velocity Pulawy

    Pulawy, 24-100
    Poland

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  • NZOZ Przychodnia Specjalistyczna A Wittek H Rudzki spolka jawna

    Ruda Slaska, 41-709
    Poland

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  • Velocity Nova Sp zoo Velocity Staszow

    Staszow, 28-200
    Poland

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  • Tomasz Blicharski Lubelskie Centrum Diagnostyczne

    Swidnik, 21-040
    Poland

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  • Nbr Polska Tomasz Klodawski

    Warszawa, 00-710
    Poland

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  • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji

    Warszawa, 02-507
    Poland

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  • Wromedica I Bielicka A Strzalkowska SC

    Wroclaw, 51-685
    Poland

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  • Latin Clinical Trial Center

    San Juan, 00909
    Puerto Rico

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  • Ormeau Clinical Trials Ltd

    Belfast, BT28BG
    United Kingdom

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    Birmingham, B21 9RY
    United Kingdom

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  • Layton Medical Centre

    Blackpool, FY3 7EN
    United Kingdom

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    Blackpool, FY4 3AD
    United Kingdom

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  • Southmead Hospital

    Bristol, BS10 5NB
    United Kingdom

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  • Staploe Medical Centre

    Ely, CB7 5JD
    United Kingdom

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    Glasgow, G20 7BE
    United Kingdom

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  • Hull Royal Infirmary

    Hull, HU3 2JZ
    United Kingdom

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  • NIHR Leicestershire & Northamptonshire Commercial Research Delivery Centre

    Leicester, LE5 4PW
    United Kingdom

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    Liverpool, L9 7AL
    United Kingdom

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  • Clifton Medical Centre

    Rotherham, S65 1DA
    United Kingdom

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  • Alliance for Multispecialty Research Mobile

    Mobile, Alabama 36608
    United States

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    Gilbert, Arizona 85296
    United States

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    Mesa, Arizona 85213
    United States

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    Phoenix, Arizona 85044
    United States

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  • San Fernando Valley Health Institute

    Canoga Park, California 91304
    United States

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  • Core Healthcare Group

    Cerritos, California 90703
    United States

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    Chula Vista, California 91911
    United States

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    Escondido, California 92025
    United States

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  • Paradigm Clinical Research

    Modesto, California 95355
    United States

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    Northridge, California 91325
    United States

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  • University of California Irvine

    Orange, California 92868
    United States

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    Pomona, California 91767
    United States

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    United States

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  • Greenwich Clinical Trials

    Riverside, Connecticut 06878
    United States

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  • Indago Research and Health Center

    Hialeah, Florida 33012
    United States

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  • New Horizon Research Center

    Miami, Florida 33165
    United States

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  • Optimus U Corporation

    Miami, Florida 33135
    United States

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  • San Marcus Research Clinic Inc

    Miami Lakes, Florida 33014
    United States

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  • Florida Institute for Clinical Research

    Orlando, Florida 32825
    United States

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  • Encore Medical Research of Weston LLC

    Weston, Florida 33331
    United States

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  • Conquest Research - Winter Park

    Winter Park, Florida 32789
    United States

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  • Alliance For Multispecialty Research - Oak Brook

    Oak Brook, Illinois 60523
    United States

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  • Alliance for Multispecialty Research, LLC - Park Ridge

    Park Ridge, Illinois 66068
    United States

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  • Endeavor Health Medical Group - Endocrinology and Diabetes- Skokie

    Skokie, Illinois 60077
    United States

    Active - Recruiting

  • Indiana Medical Research Institute

    Merrillville, Indiana 46410
    United States

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  • Iowa Diabetes Research

    West Des Moines, Iowa 50266
    United States

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  • Alliance for Multispecialty Research Newton

    Newton, Kansas 67114
    United States

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  • Alliance for Multispecialty Research LLC

    Wichita, Kansas 67207
    United States

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  • Advanced Internal Medicine

    Paducah, Kentucky 42001
    United States

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  • Ima Clinical Research- Monroe

    Monroe, Louisiana 71201
    United States

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  • Annapolis Internal Medicine, LLC

    Annapolis, Maryland 21401
    United States

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  • Brigham and Womens Hospital

    Boston, Massachusetts 02115
    United States

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  • International Diabetes Center - HealthPartners Institute

    Minneapolis, Minnesota 55416
    United States

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  • Alliance for Multispecialty Research - Kansas City

    Kansas City, Missouri 64114
    United States

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  • Palm Research Center Inc

    Las Vegas, Nevada 89128
    United States

    Active - Recruiting

  • Vector Clinical Trials

    Sparks, Nevada 89436
    United States

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  • Premier Research

    Trenton, New Jersey 08611
    United States

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  • Albany Medical College

    Albany, New York 12203
    United States

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  • Asheville Clinical Research

    Asheville, North Carolina 28803
    United States

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  • Physicians East

    Greenville, North Carolina 27834
    United States

    Active - Recruiting

  • Carteret Medical Group

    Morehead City, North Carolina 28557
    United States

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  • West Clinical Research

    Morehead City, North Carolina 28557
    United States

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  • Velocity Clinical Research - Cincinnati

    Blue Ash, Ohio 45242
    United States

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  • Velocity Clinical Research - Springdale

    Cincinnati, Ohio 45246
    United States

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  • Velocity Clinical Research - Providence

    East Greenwich, Rhode Island 02818
    United States

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  • Medical Care LLC

    Elizabethton, Tennessee 37643
    United States

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  • Elligo Clinical Research Center

    Austin, Texas 78704
    United States

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  • Osvaldo A Brusco MD PA

    Corpus Christi, Texas 78414
    United States

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  • Cedar Health Research, LLC

    Dallas, Texas 75251
    United States

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    Denison, Texas 75020
    United States

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    Euless, Texas 76040
    United States

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    Euless, Texas 76040
    United States

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    Houston, Texas 77054
    United States

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    McKinney, Texas 75069
    United States

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    San Antonio, Texas 78233
    United States

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  • Alliance for Multispecialty Research - Layton

    Layton, Utah 84041
    United States

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    Manassas, Virginia 20110
    United States

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    Seattle, Washington 98108
    United States

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  • Ima Clinical Research - West Virginia

    Morgantown, West Virginia 26505
    United States

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