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New treatment option for Heterozygous Familial Hypercholesterolemia (HeFH)
Official title A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)
ClinicalTrials.gov ID: NCT07058077
What this study is testing
What is Enlicitide Decanoate?
Enlicitide Decanoate is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for heterozygous familial hypercholesterolemia (hefh).
Also referred to as MK-0616, Enlicitide.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 17
You may be able to join if
- 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:
- An optimized daily dose of statin (± nonstatin LLT)
You likely can't join if
- Exclusion criteria include, but are not limited to:
- Has a history of homozygous FH based on genetic or clinical criteria, or history of known compound heterozygous FH, or double heterozygous FH
- Has a history of nephrotic syndrome
- Has any clinically significant malabsorption condition based on investigator assessment
- Was previously treated/is being treated with certain other cholesterol lowering medications, including proprotein convertase subtilisin/kexin type 9...
See the full eligibility 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:
- An optimized daily dose of statin (± nonstatin LLT)
- A nonstatin LLT with documented intolerance to at least 2 different statins, or documented intolerance to 1 statin plus refusal of 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 criteria include, but are not limited to:
- Has a history of homozygous FH based on genetic or clinical criteria, or history of known compound heterozygous FH, or double heterozygous FH
- Has a history of nephrotic syndrome
- Has any clinically significant malabsorption condition based on investigator assessment
- Was previously treated/is being treated with certain other cholesterol lowering medications, including proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout
The study team makes the final eligibility decision.
Where it's taking place
- Wilmington, Delaware, United States
- Washington D.C., District of Columbia, United States
- Boca Raton, Florida, United States
- Atlanta, Georgia, United States
- Cincinnati, Ohio, United States
- Morgantown, West Virginia, United States
- Clayton, Victoria, Australia
- Edegem, Antwerpen, Belgium
- Fortaleza, Ceará, Brazil
- São Paulo, Brazil
- Santiago, Region M. de Santiago, Chile
- Beijing, Beijing Municipality, China
- Shanghai, Shanghai Municipality, China
- Hangzhou, Zhejiang, China
- Barranquilla, Atlántico, Colombia
- Montería, Departamento de Córdoba, Colombia
- Piedecuesta, Santander Department, Colombia
- Cali, Valle del Cauca Department, Colombia
- Helsinki, Uusimaa, Finland
- Freiburg im Breisgau, Baden-Wurttemberg, Germany
+ 12 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wilmington, Delaware, United States; Washington D.C., District of Columbia, United States; Boca Raton, Florida, United States; Atlanta, Georgia, United States; Cincinnati, Ohio, United States; Morgantown, West Virginia, United States and 26 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.