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An Operationally Seamless Phase 2/3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Enlicitide Decanoate in Pediatric Participants with Heterozygous Familial Hypercholesterolemia

Status
Not yet recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519068-42-00
Acronym
MK-0616-029
Enrollment
10
Registered
2026-01-26
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

​Heterozygous Familial Hypercholesterolemia​ in pediatric patients

Brief summary

Maximum Plasma Concentration (Cmax) of Enlicitide for Part A (Age Cohort 1), Maximum Plasma Concentration (Cmax) of Enlicitide for Part A (Age Cohort 2), Area Under the Concentration-time Curve From 0 to 24 (AUC0-24) Hours of Enlicitide for Part A (Age Cohort 1), Area Under the Concentration-time Curve From 0 to 24 (AUC0-24) Hours of Enlicitide for Part A (Age Cohort 2), Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24 in Part B Participants, Percent Change From Baseline in LDL-C at Week 24 in Part B Age Cohort 1 Participants, Number of Participants With One or More Adverse Events (AEs), Number of Participants Who Discontinue Study Treatment Due to an AE

Detailed description

Percentage Change From Baseline in Apolipoprotein B (ApoB) at Week 24 in Part B Participants, Percentage Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 in Part B Participants, Percentage Change From Baseline in Lipoprotein (a) [Lp (a)] at Week 24 in Part B Participants, Proportion of Participants With LDL-C <130 mg/dL (3.37 mmol/L) at Week 24 in Part B Participants, Proportion of Participants LDL-C ≥50% Reduction From Baseline at Week 24 in Part B Participants, Proportion of Participants With LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 in Part B Participants, Change in Ultrasound Determined Mean cIMT at Week 24 in Part B Participants

Interventions

DRUGPlacebo to MK-0616

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Maximum Plasma Concentration (Cmax) of Enlicitide for Part A (Age Cohort 1), Maximum Plasma Concentration (Cmax) of Enlicitide for Part A (Age Cohort 2), Area Under the Concentration-time Curve From 0 to 24 (AUC0-24) Hours of Enlicitide for Part A (Age Cohort 1), Area Under the Concentration-time Curve From 0 to 24 (AUC0-24) Hours of Enlicitide for Part A (Age Cohort 2), Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24 in Part B Participants, Percent Change From Baseline in LDL-C at Week 24 in Part B Age Cohort 1 Participants, Number of Participants With One or More Adverse Events (AEs), Number of Participants Who Discontinue Study Treatment Due to an AE

Secondary

MeasureTime frame
Percentage Change From Baseline in Apolipoprotein B (ApoB) at Week 24 in Part B Participants, Percentage Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 in Part B Participants, Percentage Change From Baseline in Lipoprotein (a) [Lp (a)] at Week 24 in Part B Participants, Proportion of Participants With LDL-C <130 mg/dL (3.37 mmol/L) at Week 24 in Part B Participants, Proportion of Participants LDL-C ≥50% Reduction From Baseline at Week 24 in Part B Participants, Proportion of Participants With LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 in Part B Participants, Change in Ultrasound Determined Mean cIMT at Week 24 in Part B Participants

Countries

Finland, Germany, Italy, Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026