Phase
Condition
Hypercholesterolemia
Familial Hypercholesterolemia
Treatment
Enlicitide Decanoate
Placebo
Clinical Study ID
Ages 6-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Inclusion criteria include, but are not limited to:
Has possible or definite diagnosis of HeFH based on a locally accepted diagnosticalgorithm or diagnosis by genetic testing results
Has a fasted LDL-C value (evaluated by the central laboratory) that is ≥130 mg/dL
Is receiving either an optimized daily dose of statin (± nonstatin LLT); or anonstatin LLT with documented intolerance to at least 2 different statins or refusalof statin therapy by the participant or legally acceptable representative
Is on a stable dose of all background LLTs for at least 30 days prior to screening,with no medication or dose changes planned during participation in Part A or Part B
Exclusion
Exclusion Criteria:
Exclusion criteria include, but are not limited to:
Has a history of homozygous FH based on genetic or clinical criteria, or history ofknown compound heterozygous FH, or double heterozygous FH
Has a history of nephrotic syndrome
Has any clinically significant malabsorption condition based on principalinvestigator assessment
Was previously treated/is being treated with certain other cholesterol loweringmedications, including proprotein convertase subtilisin/kexin type 9 (PCSK9)inhibitors without adequate washout
Study Design
Connect with a study center
Monash Children s Hospital ( Site 1603)
Clayton, Victoria 3168
AustraliaActive - Recruiting
Monash Children s Hospital ( Site 1603)
Clayton 2171400, Victoria 2145234 3168
AustraliaSite Not Available
UZ Antwerpen ( Site 0601)
Edegem, Antwerpen 2650
BelgiumActive - Recruiting
Universidade Federal Do Ceara ( Site 0201)
Fortaleza, Ceará 60430270
BrazilActive - Recruiting
Universidade Federal Do Ceara ( Site 0201)
Fortaleza 3399415, Ceará 3402362 60430270
BrazilSite Not Available
Incor - Instituto do Coracao ( Site 0200)
São Paulo, 05403900
BrazilActive - Recruiting
Incor - Instituto do Coracao ( Site 0200)
São Paulo 3448439, 05403900
BrazilSite Not Available
Beijing Anzhen Hospital. Capital Medical University ( Site 1917)
Beijing, Beijing Municipality 100029
ChinaActive - Recruiting
Beijing Anzhen Hospital. Capital Medical University ( Site 1917)
Beijing 1816670, Beijing Municipality 2038349 100029
ChinaSite Not Available
The Children's Hospital of Zhejiang University School of Medicine ( Site 1905)
Hangzhou, Zhejiang 310057
ChinaActive - Recruiting
The Children's Hospital of Zhejiang University School of Medicine ( Site 1905)
Hangzhou 1808926, Zhejiang 1784764 310057
ChinaSite Not Available
Clinica de la Costa S.A.S. ( Site 0400)
Barranquilla, Atlántico 080020
ColombiaActive - Recruiting
Clinica de la Costa S.A.S. ( Site 0400)
Barranquilla 3689147, Atlántico 3689436 080020
ColombiaSite Not Available
Oncomédica S.A.S ( Site 0401)
Montería, Departamento de Córdoba 230002
ColombiaActive - Recruiting
Oncomédica S.A.S ( Site 0401)
Montería 3674453, Departamento de Córdoba 3685889 230002
ColombiaSite Not Available
Fundación Cardiovascular de Colombia ( Site 0402)
Piedecuesta, Santander Department 681017
ColombiaActive - Recruiting
Fundación Cardiovascular de Colombia ( Site 0402)
Piedecuesta 3672328, Santander Department 3668578 681017
ColombiaSite Not Available
Fundacion Valle del Lili ( Site 0403)
Cali, Valle del Cauca Department 760032
ColombiaActive - Recruiting
Fundacion Valle del Lili ( Site 0403)
Cali 3687925, Valle del Cauca Department 3666313 760032
ColombiaSite Not Available
New Childrens Hospital ( Site 0800)
Helsinki, Uusimaa 00029
FinlandActive - Recruiting
New Childrens Hospital ( Site 0800)
Helsinki 658225, Uusimaa 830709 00029
FinlandSite Not Available
Amsterdam UMC, locatie AMC ( Site 1000)
Amsterdam, North Holland 1105 AZ
NetherlandsActive - Recruiting
Amsterdam UMC, locatie AMC ( Site 1000)
Amsterdam 2759794, North Holland 2749879 1105 AZ
NetherlandsSite Not Available
New Zealand Clinical Research (Christchurch) ( Site 1700)
Christchurch, Canterbury 8011
New ZealandActive - Recruiting
New Zealand Clinical Research (Christchurch) ( Site 1700)
Christchurch 2192362, Canterbury 2192628 8011
New ZealandSite Not Available
National University Hospital-Paediatrics ( Site 1800)
Singapore, Central Singapore 117599
SingaporeActive - Recruiting
COMPLEJO HOSPITALARIO DE NAVARRA ( Site 1302)
Pamplona, Navarre 31009
SpainActive - Recruiting
Nemours/Alfred I. duPont Hospital for Children ( Site 0001)
Wilmington, Delaware 19803
United StatesActive - Recruiting
Nemours/Alfred I. duPont Hospital for Children ( Site 0001)
Wilmington 4145381, Delaware 4142224 19803
United StatesSite Not Available
Nemours/Alfred I. duPont Hospital for Children (0001)
Wilmington 4145381, Delaware 4142224 19803
United StatesActive - Recruiting
Children's National Medical Center ( Site 0015)
Washington D.C., District of Columbia 20010
United StatesActive - Recruiting
Children's National Medical Center ( Site 0015)
Washington D.C. 4140963, District of Columbia 4138106 20010
United StatesSite Not Available
Excel Medical Clinical Trials ( Site 0008)
Boca Raton, Florida 33434
United StatesActive - Recruiting
Excel Medical Clinical Trials ( Site 0008)
Boca Raton 4148411, Florida 4155751 33434
United StatesSite Not Available
Excel Medical Clinical Trials (0008)
Boca Raton 4148411, Florida 4155751 33434
United StatesActive - Recruiting
Children's Healthcare of Atlanta Cardiology ( Site 0026)
Atlanta, Georgia 30329
United StatesActive - Recruiting
Children's Healthcare of Atlanta Cardiology ( Site 0026)
Atlanta 4180439, Georgia 4197000 30329
United StatesSite Not Available

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