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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
- For Part A and Part B participants: Has possible or definite diagnosis of heterozygous familial hypercholesterolemia (HeFH) based on a locally accepted diagnostic algorithm or diagnosis by genetic testing results before screening.
- For Part A and Part B participants: Is receiving optimized treatment per local guidelines, standard of care, and investigator judgment with an optimized daily dose of statin [(± non-statin lipid-lowering treatment (LLT)] OR non-statin LLT with either a documented intolerance to at least 2 different statins, or refusal of statin therapy by the participant or legally acceptable representative and with written attestation.
- For Part A and Part B participants: Is on a stable dose of all background LLTs (including statin and non-statin agents) before screening and through allocation/randomization with no medication or dose changes planned.
- For Part A and Part B participants: Are 12 to <18 years of age for Age Cohort 1 and 6 to <12 years of age for Age Cohort 2.
- For Part A and Part B participants: Can take study medication by mouth and can swallow the study intervention.
- For open-label extension (OLE) period participants: Is a Part A participant who received at least 1 dose of study intervention and completed Visit 5 (Day 14) OR is a Part B participant who received at least 1 dose of study intervention and completed Visit 7 (Week 24).
You likely can't join if
- For Part A and Part B participants: Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria or history of known compound heterozygous FH, or double heterozygous FH.
- For Part A and Part B participants: Has a history of nephrotic syndrome.
- For Part A and Part B participants: Has any clinically significant malabsorption condition.
- For Part A and Part B participants: Has uncontrolled hypertension.
- For Part A: Has severe chronic kidney disease defined as estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m2 or end stage renal disease (ESRD) on dialysis.
- For Part B: Has ESRD on dialysis.
See the full eligibility criteria
- For Part A and Part B participants: Has possible or definite diagnosis of heterozygous familial hypercholesterolemia (HeFH) based on a locally accepted diagnostic algorithm or diagnosis by genetic testing results before screening.
- For Part A and Part B participants: Is receiving optimized treatment per local guidelines, standard of care, and investigator judgment with an optimized daily dose of statin [(± non-statin lipid-lowering treatment (LLT)] OR non-statin LLT with either a documented intolerance to at least 2 different statins, or refusal of statin therapy by the participant or legally acceptable representative and with written attestation.
- For Part A and Part B participants: Is on a stable dose of all background LLTs (including statin and non-statin agents) before screening and through allocation/randomization with no medication or dose changes planned.
- For Part A and Part B participants: Are 12 to <18 years of age for Age Cohort 1 and 6 to <12 years of age for Age Cohort 2.
- For Part A and Part B participants: Can take study medication by mouth and can swallow the study intervention.
- For open-label extension (OLE) period participants: Is a Part A participant who received at least 1 dose of study intervention and completed Visit 5 (Day 14) OR is a Part B participant who received at least 1 dose of study intervention and completed Visit 7 (Week 24).
- For Part A and Part B participants: Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria or history of known compound heterozygous FH, or double heterozygous FH.
- For Part A and Part B participants: Has a history of nephrotic syndrome.
- For Part A and Part B participants: Has any clinically significant malabsorption condition.
- For Part A and Part B participants: Has uncontrolled hypertension.
- For Part A: Has severe chronic kidney disease defined as estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m2 or end stage renal disease (ESRD) on dialysis.
- For Part B: Has ESRD on dialysis.
- For Part A, Part B and OLE Period: Is undergoing or previously underwent an LDL-C apheresis program within 3 months before visit 1 or plans to initiate an LDL-C apheresis program.
- For Part A, Part B and OLE Period: Is currently participating in or has previously participated in an interventional clinical study within 3 months before visit 1.
- For Part A, Part B and OLE Period: If participant has enrolled in Part A they cannot enroll in Part B and vice versa.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- Singapore
- Canada
- Brazil
- Colombia
- Chile
- New Zealand
- Turkey
- Australia
- China
- United States
- United Kingdom
- Mexico
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, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; Singapore; Canada; Brazil; Colombia; Chile and 7 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 EU CTIS; the study team decides eligibility.