A clinical study of enlicitide in children with high cholesterol (MK-0616-029)
EU CTIS ID: 2024-519068-42-00
What this study is testing
1. Part A (Age Cohort 1 and Age Cohort 2 separately): To evaluate the pharmacokinetics of enlicitide. 2. Part B (Age Cohort 1 and Age Cohort 2 combined): To evaluate the efficacy of enlicitide compared with placebo on percent change from baseline in LDL-C at Week 24. 3. Part B Age Cohort 1: To evaluate the efficacy of enlicitide compared with placebo on percent change from baseline in LDL-C at Week 24. 4. Part A, Part B, and OLE: To evaluate the safety and tolerability of enlicitide.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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
- Is receiving either: a. An optimized daily dose of statin (± nonstatin LLT) b. 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
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 (PCSK9) inhibitors without adequate washout
The study team makes the final eligibility decision.
Where it's taking place
- Germany
- Spain
- Belgium
- Czechia
- Norway
- France
- Poland
- Netherlands
- Finland
- United States
- Mexico
- Canada
- Chile
- Turkey
- New Zealand
- United Kingdom
- Singapore
- Japan
- Colombia
- Brazil
+ 2 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, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Germany; Spain; Belgium; Czechia; Norway; France and 16 more locations. Enter your location above to see the nearest 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 EU CTIS. The study team decides eligibility, and your own doctor gives medical advice.