NCT07058077RecruitingPhase 2/3
A clinical study of enlicitide in children with high cholesterol (MK-0616-029)
An Operationally Seamless Phase 2/3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Enlicitide Decanoate in Pediatric Participants with Heterozygous Familial Hypercholesterolemia
Source: EU CTIS (euclinicaltrials.eu) · Last updated 27 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 18 Sept 2025
- Start date
- 12 Feb 2026
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Familial hypercholesterolaemia
- EU CT number
- 2024-519068-42-00
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 36
- 20 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Was previously treated/is being treated with certain other cholesterol lowering medications, including proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: - to 17 years · Sex: All · Does not accept healthy volunteers
Sites (20)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Ziekenhuis Antwerpen Coordinator of this site? Confirm its status | Edegem | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Recruiting |
| Fakultni Nemocnice Motol a Homolka Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Vseobecna Fakultni Nemocnice V Praze Coordinator of this site? Confirm its status | Prague 2 | Czechia | Recruiting |
| Medical Center- University of Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Recruiting |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Recruiting |
| Universitaetsklinikum Magdeburg AöR Coordinator of this site? Confirm its status | Magdeburg | Germany | Recruiting |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Recruiting |
| Hospital Universitario de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Recruiting |
| HUS-Yhtymae Coordinator of this site? Confirm its status | Helsinki | Finland | Recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Bron | France | Recruiting |
| Hopital Des Enfants Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Recruiting |
| Azienda Unita Sanitaria Locale Di Piacenza Coordinator of this site? Confirm its status | Piacenza | Italy | Not yet recruiting |
| Ospedale Pediatrico Bambino Gesù Coordinator of this site? Confirm its status | Rome | Italy | Not yet recruiting |
| Amsterdam UMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| Institute Of Polish Mother's Health Center Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.