Heterozygous Familial Hypercholesterolemia study: Enlicitide Decanoate
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?
This is an investigational medicine being studied to see if it can lower cholesterol in children with a specific genetic condition.
Also referred to as MK-0616.
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
- The study aims to find out if the medicine is safe for children and if it lowers bad cholesterol levels better than a sugar pill.
- Who it's for
- Children and teenagers who have a genetic condition called heterozygous familial hypercholesterolemia and high levels of bad cholesterol.
- What's involved
- Participants will take a daily pill and visit the clinic for blood tests to check cholesterol levels and monitor safety.
- Time commitment
- The study involves regular visits over a set period to track how the body handles the medicine and its effects on cholesterol.
- 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
- 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
- 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...
- 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...
You likely can't join if
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Wilmington, Delaware, United States
- Washington D.C., District of Columbia, United States
- Boca Raton, Florida, United States
- Atlanta, Georgia, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Cincinnati, Ohio, United States
- Morgantown, West Virginia, United States
- Clayton, Victoria, Australia
- Nedlands, Western Australia, Australia
- Edegem, Antwerpen, Belgium
- Fortaleza, Ceará, Brazil
- São Paulo, Brazil
- Temuco, Araucania, Chile
- Concepción, Biobio, Chile
- Santiago, Region M. de Santiago, Chile
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Shanghai, Shanghai Municipality, China
- Hangzhou, Zhejiang, China
+ 26 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, but 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?
This study is enrolling now at Wilmington, Delaware, United States; Washington D.C., District of Columbia, United States; Boca Raton, Florida, United States; Atlanta, Georgia, United States; Boston, Massachusetts, United States; St Louis, Missouri, United States and 40 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.