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NCT06979362RecruitingPhase 2

A Research Study Comparing Different Doses of CDR132L With Placebo on the Structure and Function of the Heart in People With Heart Failure With Preserved Ejection Fraction and Left Ventricular Hypertrophy

Phase 2, Multicentre, Randomised, Double-blind, Placebo-controlled Safety and Efficacy Study of CDR132L on Reverse Cardiac Remodelling in Participants With Heart Failure With Preserved Ejection Fraction and Left Ventricular Hypertrophy

Source: ClinicalTrials.gov · Last updated 5 Oct 2026

Brief summary (registry, in English)

This study will look into how CDR132L (a potential new medicine) works on the structure and function of the heart in people living with heart failure. Participants will either get CDR132L or placebo (a medicine which has no effect on the body), which treatment the participants get is decided by chance. The study will last for about 60 weeks.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
200 (estimated)
First submitted
16 May 2025
Start date
27 Jun 2025
Primary completion date
16 Nov 2027
Lead sponsor
Novo Nordisk A/S
NCT number
NCT06979362
EU CT number
2024-515796-35-00
EudraCT number
2024-515796-35

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 200
  • From 27 Jun 2025 to the primary completion date, 16 Nov 2027
  • 109 sites in 9 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

  • Participants with an episode of acute kidney failure or acute kidney injury, at the discretion of the investigator, within 90 days prior to randomisation
  • Myocardial infarction, unstable angina pectoris or HF hospitalisation within 30 days prior to screening
  • Participants receiving intravenous HF medications within 45 days prior to randomisation
  • Stroke or transient ischemic attack within 12 months prior to randomisation

Other illness

  • Planned coronary revascularisation, pacemaker/cardioverter-defibrillator/CRT implantation, ablation of cardiac arrythmias and valve repair/replacement at the time of randomisation
  • Known genetic (or highly suspected due to family history) cause of increased cardiac mass (including dilated cardiomyopathy, Fabry disease and likely pathogenic or pathogenic variants within hypertrophic cardiomyopathy \[HCM\]).
  • Participants with suspected or diagnosed cardiac amyloidosis or sarcoidosis.

Lab values

  • Estimated glomerular filtration rate lesser than (\<) 30 milliliter per minute (mL/min)/1.73 square meter (m\^2) at time of screening, measured by central laboratory
  • Known history of severe liver disease and/or alanine aminotransferase or aspartate aminotransferase \>2.5 x upper limit of normal at screening, measured by central laboratory

Other

  • Participants with CRT, pacemaker or implantable cardioverter-defibrillator
  • Participants with potential disruption of the blood-brain barrier (e.g., multiple sclerosis), in the opinion of the investigator

Who the study is looking for

  • Age 40-84 years (both inclusive) at the time of signing the informed consent
  • Documented symptomatic chronic heart failure (HF) diagnosed greater than or equal to (≥) 90 days prior to screening with at least weekly need for oral diuretic treatment, and/or a sodium-glucose cotransporter-2 inhibitor (SGLT2i), and New York Heart Association class II-III at screening
  • Clinically stable and on optimised doses and unchanged drug classes of guideline-directed HF therapy ≥45 days prior to randomisation
  • Left ventricular ejection fraction ≥40% as assessed by echocardiography at screening, measured by central laboratory
  • Left ventricular hypertrophy assessed by echocardiography at screening measured by central laboratory with any of the following:
    • LVMi (greater than) \>88 gram per square meter (g/m\^2) for female participants and \>102 g/m\^2 for male participants, using the truncated ellipsoid method measured by central laboratory
    • LVMi \>95 g/m2 for female participants and \>115 g/m2 for male participants using the linear method (cube formula).
    • Interventricular septum diameter measured in diastole (IVSd) in the parasternal long axis view ≥1.1 cm for female participants and ≥1.2 cm for male participants.
  • Body mass index 18.5-45 kilogram per square meter (kg/m\^2) (both inclusive) and body weight less than or equal to (≤) 140 kilogram (kg). Body mass index is calculated in the electronic case report form based on height and body weight at the screening visit (visit 1)
  • NT-proBNP ≥300 picograms per milliliter (pg/mL); NT-proBNP ≥600 pg/mL if atrial fibrillation/flutter is present at time of screening, measured by central laboratory

Age in the registry: 40 years to 84 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (109)

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

SiteCityCountrySite status
William Osler Hel Bra Civic Hs
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BramptonCanadaNot yet recruiting
Cardio Health Clinical Trials
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HamiltonCanadaNot yet recruiting
Hamilton Hlth Sc. - General Site
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HamiltonCanadaNot yet recruiting
Hamilton General Hospital
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HamiltonCanadaCompleted
Premier Clinical Trial Research Network (PCTRN)
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HamiltonCanadaNot yet recruiting
Cardio Health Clinical Trials
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MississaugaCanadaRecruiting
University of Ottawa Heart Institute (UOHI)
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OttawaCanadaRecruiting
IUCPQ-Universite Laval
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QuébecCanadaRecruiting
St. Michael's Hospital
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TorontoCanadaNot yet recruiting
Women's College Hospital
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TorontoCanadaNot yet recruiting
St Pauls Hospital
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VancouverCanadaCompleted
Winchester Dist Memorial Hosp
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WinchesterCanadaRecruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyRecruiting
Herzzentrum Dresden GmbH Universitaetsklinik
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DresdenGermanyRecruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyRecruiting
Universitaetsklinikum Frankfurt AöR
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Frankfurt Am MainGermanyRecruiting
Universitaetsklinikum Halle (Saale) AöR
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Halle SaaleGermanyRecruiting
Medizinische Hochschule Hannover
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HanoverGermanyRecruiting
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyRecruiting
Universitaetsklinikum Schleswig-Holstein AöR
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KielGermanyRecruiting
Hospital del Mar
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BarcelonaSpainRecruiting
Hospital Universitario Clínico San Cecilio
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GranadaSpainRecruiting
El Hospital Universitario De Gran Canaria Dr. Negrin
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Las Palmas De Gran CanariaSpainRecruiting
Hospital Universitario La Paz
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MadridSpainRecruiting
Hospital Universitario Ramón y Cajal
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MadridSpainRecruiting
University Clinical Hospital Virgen De La Arrixaca
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MurciaSpainRecruiting
Hospital Clinico Universitario de Valencia
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ValenciaSpainRecruiting
Trialmed - Midlands
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BirminghamUnited KingdomRecruiting
Wycombe General Hospital
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High WycombeUnited KingdomRecruiting
The Royal Brompton Hospital - Respiratory CRF
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LondonUnited KingdomRecruiting
St Bartholomew's Hospital - Cardiology
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LondonUnited KingdomRecruiting
St Bartholomew's Hospital - Cardiac Research Office
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LondonUnited KingdomNot yet recruiting
King's College Hospital
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LondonUnited KingdomRecruiting
The James Cook University Hospital - Cardiology
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MiddlesbroughUnited KingdomRecruiting
Southampton General Hospital
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SouthamptonUnited KingdomRecruiting
Apollo Hospital Chennai
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ChennaiIndiaRecruiting
Shri Mahant Indiresh Hospital
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DehradunIndiaRecruiting
Osmania General Hospital
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HyderabadIndiaRecruiting
IPGME&R and SSKM Hospital
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KolkataIndiaRecruiting
Sengupta Hospital and Research Institute
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NagpurIndiaRecruiting
All India Institute of Medical Sciences (AIIMS) - Nagpur
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NagpurIndiaRecruiting
VMMC & Safdarjung Hospital
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New DehliIndiaRecruiting
Sir Ganga Ram Hospital-Cardiology
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New DelhiIndiaRecruiting
G B Pant Institute of Postgraduate Medical Education and Research
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New DelhiIndiaRecruiting
Rhythm Heart Institute - A unit of Synergy Lifecare Pvt
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VadodaraIndiaRecruiting
Government Siddhartha Medical College & Government General Hospital, Vijayawada
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VijayawadaIndiaRecruiting
NIPPON MEDICAL SCHOOL HOSPITAL_Cardiovascular medicine
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Bunkyo-ku, TokyoJapanRecruiting
Fukuokaken Saiseikai Futsukaichi Hospital_Cardiology
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Chikushino-shi, FukuokaJapanNot yet recruiting
Hyogo Prefectural HarimaHimeji General Medical Center_Cardiology
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Himeji-shi, HyogoJapanRecruiting
National Hospital Organization Mito Medical Center_Cardiovascular medicine
Coordinator of this site? Confirm its status
IbarakiJapanRecruiting
Mitoyo General Hospital_Cardiovascular medicine
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KagawaJapanNot yet recruiting
Yokohama City University Medical Center_Cardiovascular Center
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KanagawaJapanRecruiting
Kagawa University Hospital_Cardiology
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Kita-gun, KagawaJapanCompleted
Kobe City Medical Center General Hospital_Cardiology
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Kobe-shi, HyogoJapanRecruiting
Ome medical center_Cardiology
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Ome-shi, TokyoJapanRecruiting
Medical Research Institute KITANO HOSPITAL_Cardiovascular Medicine
Coordinator of this site? Confirm its status
Osaka-shi, OsakaJapanRecruiting
Osaka Metropolitan University Hospital_Cardiovascular Medicine
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Osaka-Shi, OsakaJapanRecruiting
Sapporo Medical University Hospital_Cardiovascular, Kidney, Metabolism Endocrinology
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Sapporo-shi, HokkaidoJapanRecruiting
National Hospital Organization Yokohama Medical Center_Cardiology
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Yokohama-shi, KanagawaJapanRecruiting
Chungbuk National University Hospital
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Cheongju-siSouth KoreaRecruiting
Keimyung University Dongsan Hospital
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DaeguSouth KoreaRecruiting
Wonju Severance Christian Hospital
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Gangwon-doSouth KoreaRecruiting
Seoul National University Bundang Hospital
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Seongnam-si, Gyeonggi-doSouth KoreaCompleted
Korea University Anam Hospital
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SeoulSouth KoreaRecruiting
Korea University Guro Hospital
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SeoulSouth KoreaCompleted
KyungHee University Medical Center
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SeoulSouth KoreaNot yet recruiting
Uniwersytecki Szpital Kliniczny w Bialymstoku
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BialystokPolandRecruiting
American Heart of Poland S.A.
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Bielsko-BialaPolandRecruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
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CracowPolandRecruiting
Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
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CracowPolandRecruiting
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
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CracowPolandRecruiting
Institute Of Polish Mother's Health Center
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LodzPolandRecruiting
Uniwersytecki Szpital Kliniczny nr 4 w Lublinie
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LublinPolandRecruiting
1. Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej w Lublinie
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LublinPolandRecruiting
Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
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PrzemyślPolandRecruiting
Pomeranian Medical University
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SzczecinPolandRecruiting
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
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WarsawPolandRecruiting
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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WroclawPolandRecruiting
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclaw
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WrocławPolandRecruiting
Śląskie Centrum Chorób Serca w Zabrzu
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ZabrzePolandRecruiting
Abington Memorial Hospital
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AbingtonUnited StatesCompleted
Amarillo Medical Specialists
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AmarilloUnited StatesRecruiting
Univ of Colorado at Denver
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AuroraUnited StatesNot yet recruiting
Univ of Alabama Birmingham
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BirminghamUnited StatesRecruiting
Capital Area Research, LLC
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Camp HillUnited StatesRecruiting
Valley Clinical Trials
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CovinaUnited StatesRecruiting
University of Texas Southwestern Medical Center
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DallasUnited StatesRecruiting
Texama Medical Center
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DenisonUnited StatesNot yet recruiting
Henry Ford Hospital_Detroit
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DetroitUnited StatesRecruiting
Duke University
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DurhamUnited StatesRecruiting
Inova Heart and Vascular Institute
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Falls ChurchUnited StatesRecruiting
East Texas Cardiology PA
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HoustonUnited StatesRecruiting
UCSD NAFLD Research Center
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La JollaUnited StatesRecruiting
UofL Health Care Outpatient
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LouisvilleUnited StatesNot yet recruiting
Inpatient Research Clinic LLC
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Miami LakesUnited StatesRecruiting
University of Minnesota_Minneapolis_1
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MinneapolisUnited StatesCompleted
Vanderbilt University Medical Center
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NashvilleUnited StatesRecruiting
Icahn Sch of Med-Mt Sinai Hosp
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New YorkUnited StatesNot yet recruiting
Sentara Bayside Hospital
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NorfolkUnited StatesCompleted
Valley Clinical Trials
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NorthridgeUnited StatesRecruiting
AdventHealth Orlando
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OrlandoUnited StatesNot yet recruiting
Providence St. Vincent Heart
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PortlandUnited StatesCompleted
University of California San Francisco
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San FranciscoUnited StatesRecruiting
University of California, San Francisco (UCSF)
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San FranciscoUnited StatesRecruiting
Washington University School of Medicine
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St LouisUnited StatesRecruiting
Harbor-UCLA Medical Center
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TorranceUnited StatesRecruiting
PIMA Heart and Vascular
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TucsonUnited StatesNot yet recruiting
TMC Hlthcr Clin Res Office
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TucsonUnited StatesNot yet recruiting
Guardian Research Org LLC
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Winter ParkUnited StatesNot yet recruiting

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