NCT05952869CompletedPhase 3
A clinical study of MK-0616 for people with high amounts of low-density lipoprotein cholesterol
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Heterozygous Familial Hypercholesterolemia
Source: EU CTIS (euclinicaltrials.eu) · Last updated 20 Feb 2025
Brief summary (registry, in English)
1. To evaluate the efficacy of MK-0616 compared with placebo on mean percent change from baseline in LDL-C at Week 24. 2. To evaluate the safety and tolerability of MK-0616.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 123 (actual)
- First submitted
- 5 Jun 2023
- Start date
- 28 Sept 2023
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT05952869
- EU CT number
- 2022-502782-14-00
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 123
- 15 sites in 6 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
- Has a history of heart failure or heart failure hospitalization within 3 months before first study visit
- Is undergoing or previously underwent an LDL-C apheresis program within 3 months before first study visit or plans to initiate an LDL-C apheresis program
- Was previously treated/is being treated with certain other cholesterol lowering medications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors
Other illness
- Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous FH, or double heterozygous FH
Who the study is looking for
- Has possible or definite diagnosis of heterozygous familial hypercholesterolemia (HeFH) based on a locally accepted diagnostic algorithm
- Has an LDL-C ≥55 mg/dL or ≥70 mg/dL depending on medical history
- Is treated with a moderate- or high-intensity statin medication
- Is on a stable dose of all background lipid-lowering therapies (LLTs) with no planned medication change
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Completed |
| Fakultni Nemocnice U Sv Anny V Brne Coordinator of this site? Confirm its status | Brno-Stred | Czechia | Completed |
| Institute For Clinical And Experimental Medicine Coordinator of this site? Confirm its status | Prague 4 | Czechia | Completed |
| Salut Sant Joan de Reus Coordinator of this site? Confirm its status | Reus | Spain | Completed |
| HUS Helsinki University Hospital Coordinator of this site? Confirm its status | Helsinki | Finland | Completed |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest XII | Hungary | Completed |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Completed |
| University of Szeged Coordinator of this site? Confirm its status | Szeged | Hungary | Completed |
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Completed |
| Dijklander Ziekenhuis Coordinator of this site? Confirm its status | Hoorn Nh | Netherlands | Completed |
| Stichting Radboud University Medical Center Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Completed |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Completed |
| University Medical Center Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Completed |
| Nordlandssykehuset HF Coordinator of this site? Confirm its status | Bodo | Norway | Completed |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Completed |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.