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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1314-5796 | Registry Identifier | UTN | |
| 2024-519068-42-00 | Registry Identifier | EU CT |
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This study is designed to learn if enlicitide decanoate is safe and effective to treat children and adolescents with heterozygous familial hypercholesterolemia (HeFH) and high amounts of low-density lipoprotein cholesterol (LDL-C) in the blood.
The goals of this study are to learn about the safety of enlicitide and if children tolerate it, what happens to enlicitide in a child's body over time, and if enlicitide works to lower cholesterol levels in children more than a placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Enlicitide Decanoate | Experimental | Participants receive enlicitide decanoate orally once daily (QD) at a dosage determined by age for up to 2 weeks. |
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| Part B: Enlicitide Decanoate | Experimental | Participants receive enlicitide decanoate QD at a dosage determined by age for up to 24 weeks. |
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| Part B: Placebo | Placebo Comparator | Participants receive placebo orally QD for up to 24 weeks. |
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| Open-Label Extension: Enlicitide Decanoate | Experimental | Participants who complete either Part A or Part B may enroll in this open-label extension arm. Participants in the extension arm receive enlicitide decanoate QD at a dosage determined by age for up to 3 years. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enlicitide Decanoate | Drug | Enlicitide decanoate taken by mouth |
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| Measure | Description | Time Frame |
|---|---|---|
| Part A: Maximum Plasma Concentration (Cmax) of Enlicitide | Blood samples will be collected to determine the Cmax of enlicitide. | At designated timepoints (up to 24 hours postdose on day 14) |
| Part A: Area Under the Concentration-Time Curve from 0 to 24 Hours (AUC0-24) of Enlicitide | Blood samples will be collected to determine the AUC0-24 of enlicitide. | At designated timepoints (up to 24 hours postdose on day 14) |
| Part B: Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) | Blood samples will be collected to determine the percent change from baseline in LDL-C. | Baseline and Week 24 |
| Number of Participants Who Experience an Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to approximately 188 weeks |
| Number of Participants Who Discontinue Study Treatment Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to approximately 180 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Part B: Percent Change from Baseline in Apolipoprotein B (ApoB) | Blood samples will be collected to determine the percent change from baseline in apolipoprotein B. | Baseline and week 24 |
| Part B: Percent Change from Baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C) |
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Inclusion Criteria:
Inclusion criteria include, but are not limited to:
Has possible or definite diagnosis of HeFH based on a locally accepted diagnostic algorithm 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:
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 Criteria:
Exclusion criteria include, but are not limited to:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemours/Alfred I. duPont Hospital for Children ( Site 0001) | Recruiting | Wilmington | Delaware | 19803 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
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There are two parts of the study. Part A is a non randomized single treatment group. Part B is randomized parallel treatment groups. Participants who complete either part are then eligible to enroll in an open label extension (single group).
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Part A and the extension period are open-label. Part B is double-blinded.
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| Placebo | Drug | Placebo tablet matched to enlicitide decanoate taken by mouth |
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Blood samples will be collected to determine the percent change from baseline in non-HDL-C. |
| Baseline and week 24 |
| Part B: Percent Change from Baseline in Lipoprotein (a) (Lp(a)) | Blood samples will be collected to determine the percent change from baseline in Lp(a). | Baseline and week 24 |
| Part B: Percentage of Participants With LDL-C <130 mg/dL at Week 24 | The percentage of participants with LDL-C <130 mg/dL at week 24 will be reported. | Week 24 |
| Part B: Percentage of Participants With ≥50% LDL-C Reduction from Baseline at Week 24 | The percentage of participants with ≥50% LDL-C reduction from baseline at week 24 will be reported. | Baseline and week 24 |
| Part B: Percentage of Participants With LDL-C <100 mg/dL at Week 24 | The percentage of participants with LDL-C <100 mg/dL at week 24 will be reported. | Week 24 |
| Change in Carotid Intima-media Thickness (cIMT) | Ultrasound measurements will be performed to determine the change from baseline in cIMT. | Baseline and week 24 |
| Children's National Medical Center ( Site 0015) | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
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| Excel Medical Clinical Trials ( Site 0008) | Recruiting | Boca Raton | Florida | 33434 | United States |
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| Children's Healthcare of Atlanta Cardiology ( Site 0026) | Recruiting | Atlanta | Georgia | 30329 | United States |
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| Cincinnati Children's Hospital Medical Center ( Site 0016) | Recruiting | Cincinnati | Ohio | 45229 | United States |
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| West Virginia University ( Site 0013) | Recruiting | Morgantown | West Virginia | 26506 | United States |
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| Monash Children s Hospital ( Site 1603) | Recruiting | Clayton | Victoria | 3168 | Australia |
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| UZ Antwerpen ( Site 0601) | Recruiting | Edegem | Antwerpen | 2650 | Belgium |
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| Universidade Federal Do Ceara ( Site 0201) | Recruiting | Fortaleza | Ceará | 60430270 | Brazil |
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| Incor - Instituto do Coracao ( Site 0200) | Recruiting | São Paulo | 05403900 | Brazil |
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| Explora Salud ( Site 0304) | Recruiting | Santiago | Region M. de Santiago | 7500504 | Chile |
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| Pontificia Universidad Catolica de Chile ( Site 0300) | Recruiting | Santiago | Region M. de Santiago | 8320165 | Chile |
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| Beijing Anzhen Hospital. Capital Medical University ( Site 1917) | Recruiting | Beijing | Beijing Municipality | 100029 | China |
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| Shanghai Children's Medical Center ( Site 1918) | Recruiting | Shanghai | Shanghai Municipality | 200120 | China |
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| The Children's Hospital of Zhejiang University School of Medicine ( Site 1905) | Recruiting | Hangzhou | Zhejiang | 310057 | China |
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| Clinica de la Costa S.A.S. ( Site 0400) | Recruiting | Barranquilla | Atlántico | 080020 | Colombia |
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| Oncomédica S.A.S ( Site 0401) | Recruiting | Montería | Departamento de Córdoba | 230002 | Colombia |
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| Fundación Cardiovascular de Colombia ( Site 0402) | Recruiting | Piedecuesta | Santander Department | 681017 | Colombia |
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| Fundacion Valle del Lili ( Site 0403) | Recruiting | Cali | Valle del Cauca Department | 760032 | Colombia |
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| New Childrens Hospital ( Site 0800) | Recruiting | Helsinki | Uusimaa | 00029 | Finland |
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| Universitaetsklinikum Freiburg ( Site 2203) | Recruiting | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
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| Laboratorio de Patología Clínica del Hospital Universitario "Dr. José Eleuterio González" ( Site 0501) | Recruiting | Monterrey | Nuevo León | 64460 | Mexico |
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| Centro de Investigacion Clinica de Oaxaca ( Site 0505) | Recruiting | Oaxaca City | Oaxaca | 68020 | Mexico |
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| INVECORDIS S.C. ( Site 0503) | Recruiting | Huixquilucan | 52763 | Mexico |
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| Amsterdam UMC, locatie AMC ( Site 1000) | Recruiting | Amsterdam | North Holland | 1105 AZ | Netherlands |
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| New Zealand Clinical Research (Christchurch) ( Site 1700) | Recruiting | Christchurch | Canterbury | 8011 | New Zealand |
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| National University Hospital-Paediatrics ( Site 1800) | Recruiting | Singapore | Central Singapore | 117599 | Singapore |
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| Hospital Universitario Central de Asturias ( Site 1303) | Recruiting | Oviedo | Asturias, Principado de | 33011 | Spain |
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| Hospital Clinico Universitario de Santiago de Compostela ( Site 1300) | Recruiting | Santiago de Compostela | La Coruna | 15706 | Spain |
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| COMPLEJO HOSPITALARIO DE NAVARRA ( Site 1302) | Recruiting | Pamplona | Navarre | 31009 | Spain |
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| Birmingham Childrens Hospital ( Site 1501) | Recruiting | Birmingham | B4 6NH | United Kingdom |
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| Sheffield Childrens Hospital ( Site 1503) | Recruiting | Sheffield | S10 2TH | United Kingdom |
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| Southampton General Hospital ( Site 1502) | Recruiting | Southampton | SO16 6YD | United Kingdom |
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| ID | Term |
|---|---|
| C000728674 | MK-0616 |
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