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NCT06131372CompletedPhase 2

A Research Study to See if Kidney Damage in People With Chronic Kidney Disease and Type 2 Diabetes Living With Overweight or Obesity Can be Reduced by CagriSema Compared to Semaglutide, Cagrilintide and Placebo

Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema 2.4 mg/2.4 mg) Once Weekly Versus Semaglutide 2.4 mg, Cagrilintide 2.4 mg and Placebo in People With Chronic Kidney Disease and Type 2 Diabetes Living With Overweight or Obesity

Source: ClinicalTrials.gov · Last updated 24 Sept 2026

Brief summary (registry, in English)

This study will look if CagriSema can lower kidney damage in people with chronic kidney disease (CKD), type 2 diabetes (T2D) and overweight or obesity. CagriSema is a new investigational medicine. CagriSema cannot yet be prescribed by doctors. The study will compare CagriSema to the 2 medicines semaglutide and cagrilintide, when they are taken alone. It will also compare CagriSema to a "dummy" medicine (also called placebo) without any active ingredient. Participant will either get CagriSema, semaglutide, cagrilintide or placebo. Which treatment participant will get is decided by chance (like flipping a coin). Study doctor will not know which of the study medicines participant will get. For each participant, the study will last for about 35 weeks.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
626 (actual)
First submitted
9 Nov 2023
Start date
1 Apr 2024
Primary completion date
24 Sept 2025
Lead sponsor
Novo Nordisk A/S
NCT number
NCT06131372
EU CT number
2023-505857-42-00
EudraCT number
2023-505857-42

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 626
  • From 1 Apr 2024 to the primary completion date, 24 Sept 2025
  • 117 sites in 13 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

  • Use of any glucagon-like peptide-1 receptor agonist (GLP-1RA) (including medication with GLP-1RA activity, e.g., GIP/GLP-1RA) or amylin analogue within 60 days prior to screening.
  • Myocardial infarction, stroke, transient ischaemic attack, or hospitalization for unstable angina pectoris within 60 days before screening.
  • Chronic or intermittent haemodialysis or peritoneal dialysis within 90 days before screening.
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Other illness

  • Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations.
  • Presence or history of malignant neoplasms or in situ carcinomas (other than basal or squamous cell skin cancer, low-risk prostate cancer, or in-situ carcinomas of the cervix or carcinoma in situ/high grade prostatic intraepithelial neoplasia (PIN) within 5 years before screening.

Other

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.

Who the study is looking for

  • Male or female.
  • Age 18 years or above at the time of signing the informed consent.
  • Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening.
  • Body mass index (BMI) ≥ 27.0 kilograms per meter square (kg/m\^2) at screening. BMI will be calculated in the eCRF (electronic case report form) based on height and body weight at screening.
  • HbA1c less than or equal to (≤) 10.5% (91 millimoles per mole \[mmol/mol\]) as assessed by central laboratory at screening.
  • Kidney impairment defined by serum creatinine and cystatin C-based eGFR ≥ 15 and \< 90 milliliters per minutes per 1.73\^m\^2 (mL/min/1.73 m\^2) (CKD-EPI 2021) as assessed by central laboratory at screening.
  • Albuminuria defined by UACR ≥ 100 and \< 5000 milligram per gram (mg/g) as assessed by central laboratory at screening.
  • Treatment with maximum labelled or tolerated dose of an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated, in the opinion of the investigator. Treatment dose must be stable for at least 30 days prior to screening.

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

Full criteria on ClinicalTrials.gov

Sites (117)

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

SiteCityCountrySite status
Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
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Buenos AiresArgentinaUnknown status
Mautalen- Salud e Investigacion
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CABAArgentinaUnknown status
Centro Medico Privado San Vicente Diabetes
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CórdobaArgentinaUnknown status
Centro de Investigaciones Medicas Mar Del Plata
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Mar del PlataArgentinaUnknown status
Fundación CESIM
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Santa RosaArgentinaUnknown status
Instituto Pro Renal Brasil
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CuritibaBrazilUnknown status
Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
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Porto AlegreBrazilUnknown status
CPCLIN - Centro de Pesquisas Clínicas
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São PauloBrazilUnknown status
Hospital do Rim e Hipertensao Fundacao Oswaldo Ramos
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São PauloBrazilUnknown status
Centricity Research Brampton Endocrinology
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BramptonCanadaUnknown status
Centricity Research Calgary Endocrinology
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CalgaryCanadaUnknown status
Centricity Research Vaughn Endocrinology
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ConcordCanadaUnknown status
Centricity Research Etobicoke Endocrinology
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EtobicokeCanadaUnknown status
Hamilton Medical Research Group
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HamiltonCanadaUnknown status
Ctr de recherche Clinique de Laval
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LavalCanadaUnknown status
Centre Medical Acadie
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MontrealCanadaUnknown status
Bluewater Clin Res Group Inc
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SarniaCanadaUnknown status
UHN-Toronto General Hospital
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TorontoCanadaUnknown status
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca
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BarcelonaSpainCompleted
Hospital Universitario De Canarias
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La LagunaSpainCompleted
Bellvitge University Hospital
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L'hospitalet De LlobregatSpainCompleted
Hospital General Universitario Gregorio Marañón
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MadridSpainCompleted
Hospital Universitario Fundacion Alcorcon
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MadridSpainCompleted
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainCompleted
Hospital Clinico Universitario de Valencia
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ValenciaSpainCompleted
Groupe Sos Sante
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Le CreusotFranceCompleted
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
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Paris Cedex 14FranceCompleted
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceCompleted
Centre Hospitalier Universitaire Reims
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Reims CedexFranceCompleted
Centre Hospitalier Universitaire de Nantes
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Saint-HerblainFranceCompleted
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceCompleted
Centre de Recherche Clinique Portes Du Sud
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VénissieuxFranceCompleted
Laiko General Hospital of Athens
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AthensGreeceCompleted
General Hospital of Athens "G. Gennimatas"
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AthensGreeceCompleted
University General Hospital of Heraklion
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HeraklionGreeceCompleted
Athens Medical Center S.A.
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Paleo FaliroGreeceCompleted
General University Hospital Of Patras
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PatrasGreeceCompleted
Hippokration Hospital
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ThessalonikiGreeceCompleted
General Hospital Of Thessloniki G Gennimatas
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ThessalonikiGreeceCompleted
Ippokratio General Hospital of Thessaloniki
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ThessalonikiGreeceCompleted
Geniko Nosokomeio Thessalonikis George Papanikolaou
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ThessalonikiGreeceCompleted
Lausmed Kft
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BajaHungaryCompleted
Szent Margit Rendelointezet Nonprofit Kft.
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Budapest IIIHungaryCompleted
Belinus Bt.
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DebrecenHungaryCompleted
Bekes Varmegyei Koezponti Korhaz
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GyulaHungaryCompleted
Borbanya Praxis Egeszsegugyi Kft
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NyíregyházaHungaryCompleted
University of Pecs
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PécsHungaryCompleted
Siofoki Korhaz-Rendelointezet
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SiofokHungaryCompleted
Lifecare Hospital and Research Centre
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BengaluruIndiaUnknown status
Madras Diabetes Research Foundation
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ChennaiIndiaUnknown status
Shri Mahant Indiresh Hospital
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DehradunIndiaUnknown status
Maulana Azad Medical College
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DelhiIndiaUnknown status
Endolife Specialty Hospitals
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GunturIndiaUnknown status
Nizam's Institute of Medical Sciences
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HyderabadIndiaUnknown status
Seth GS Medical College & KEM Hospital
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MumbaiIndiaUnknown status
King Edward Memorial Hospital
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Pune- MaharashtraIndiaUnknown status
Sunrise Hospital
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VijayawadaIndiaUnknown status
Nippon Kokan Fukuyama Hospital_Diabetology
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Fukuyama-shi, HiroshimaJapanUnknown status
Sasaki Internal Medicine
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HokkaidoJapanUnknown status
Nishiyamado Keiwa Hospital_Internal Medicine
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IbarakiJapanUnknown status
Seino Internal Medicine Clinic_Internal medicine
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Koriyama-shi, FukushimaJapanUnknown status
Kanno Naika_Internal Medicine
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Mitaka-shi, TokyoJapanUnknown status
Minami Akatsuka Clinic
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Mito-shi, IbarakiJapanUnknown status
Minami Akatsuka Clinic_internal medicine
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Mito-shi, IbarakiJapanUnknown status
Tokyo-Eki Center-building Clinic_Internal Medicine
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TokyoJapanUnknown status
Fukuwa Clinic_Internal Medicine
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TokyoJapanUnknown status
Fukuwa Clinic
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TokyoJapanUnknown status
Kresmed Sp. z o. o.
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BialystokPolandCompleted
Niepublicznego Zakladu Opieki Zdrowotnej Specjalistyczny Osrodek Internistyczno Diabetologiczny
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BialystokPolandCompleted
ZDROWIE OSTEO-MEDIC s.c.
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BialystokPolandCompleted
M2M Med. Sp. z o.o. Sp. j.
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ChorzowPolandCompleted
Pratia S.A.
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GdyniaPolandCompleted
Pratia S.A.
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KatowicePolandCompleted
Gabinet Lekarski Malgorzata Saryusz-Wolska
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LodzPolandCompleted
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
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OlsztynPolandCompleted
Gaja Poradnie Lekarskie
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PoznanPolandCompleted
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
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WarsawPolandCompleted
Centrum Medyczne Oporow
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WroclawPolandCompleted
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
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ZabrzePolandCompleted
Kardio-Sanus spol. s r.o.
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Devinska Nova VesSlovakiaCompleted
Univerzitna nemocnica L. Pasteura Kosice
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KošiceSlovakiaCompleted
Vysokospecializovany Odborny ustav Geriatricky sv. Lukasa v Kosiciach n.o.
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KošiceSlovakiaCompleted
Human-Care s.r.o.
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Kosice 1SlovakiaCompleted
Medispektrum s.r.o.
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PetrzalkaSlovakiaCompleted
Tatratrial s.r.o.
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RožňavaSlovakiaCompleted
King Chulalongkorn Memorial Hospital
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BangkokThailandUnknown status
Siriraj Hospital
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BangkokThailandUnknown status
Phramongkutklao Hospital
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BangkokThailandUnknown status
Siriraj Hospital
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Bangkok NoiThailandUnknown status
Maharaj Nakorn Chiang Mai Hospital_Nephrology
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Chiang MaiThailandUnknown status
Thammasat University Hospital
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Klong LuangThailandUnknown status
Thammasat Hospital_CRC
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Pathum ThaniThailandUnknown status
Albany Medical College
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AlbanyUnited StatesUnknown status
Heritage Valley Multispeciality Group Inc
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BeaverUnited StatesUnknown status
John Muir Physicians Network
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ConcordUnited StatesUnknown status
Osvaldo A. Brusco MD
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Corpus ChristiUnited StatesUnknown status
Northeast Research Institute
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Fleming IslandUnited StatesUnknown status
Elite Research Center
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FlintUnited StatesUnknown status
Valley Research
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FresnoUnited StatesUnknown status
Southwest Houston Research Ltd
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HoustonUnited StatesUnknown status
Clinical Investigation Specialists Inc, Kenosha
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KenoshaUnited StatesUnknown status
Main Street Physician's Care
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Little RiverUnited StatesUnknown status
Ohio- Advanced Medical Research
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MaumeeUnited StatesUnknown status
Life Spring Research Foundation, LLC
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MiamiUnited StatesUnknown status
NYU Langone Nephrology Associates
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MineolaUnited StatesUnknown status
Carteret Medical Group
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Morehead CityUnited StatesUnknown status
Eastern Nephrology Associates, PLLC
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New BernUnited StatesUnknown status
New York University Grossman School of Medicine
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New YorkUnited StatesUnknown status
Univ. of Nebraska Medical Center_Omaha
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OmahaUnited StatesUnknown status
Advent Health Translational Research Institute
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OrlandoUnited StatesUnknown status
Desert Oasis Hlthcr Med Group
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Palm SpringsUnited StatesUnknown status
Clinical Advancement Center
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San AntonioUnited StatesUnknown status
North America Research Institute
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San DimasUnited StatesUnknown status
NorCal Endocrinology and Internal Medicine
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San RamonUnited StatesUnknown status
Velocity Clin. Res Valparaiso
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ValparaisoUnited StatesUnknown status
Southgate Medical Group, LLP
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West SenecaUnited StatesUnknown status
Brookview Hills Research Associates, LLC
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Winston-SalemUnited StatesUnknown status

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