Hypercholesterolemia Clinical Trial
Official title:
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Heterozygous Familial Hypercholesterolemia
| Verified date | March 2024 |
| Source | Merck Sharp & Dohme LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The goal of this study is to evaluate the efficacy, safety, and tolerability of MK-0616 in adult participants with heterozygous familial hypercholesterolemia. The primary hypothesis is that MK-0616 is superior to placebo on mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24.
| Status | Active, not recruiting |
| Enrollment | 270 |
| Est. completion date | April 28, 2025 |
| Est. primary completion date | April 28, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous FH, or double heterozygous FH - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Royal Prince Alfred Hospital-6West CV Ambulatory Care ( Site 2808) | Camperdown | New South Wales |
| Australia | Victorian Heart Hospital-Monash Cardiovascular Research Centre (MCRC) ( Site 2803) | Clayton | Victoria |
| Brazil | Universidade Federal Do Ceara ( Site 0702) | Fortaleza | Ceara |
| Brazil | Incor - Instituto do Coracao ( Site 0703) | Sao Paulo | |
| Brazil | Instituto Dante Pazzanese de Cardiology-Fundação Adib Jatene ( Site 0701) | São Paulo | Sao Paulo |
| Canada | Ecogene-21 ( Site 0510) | Chicoutimi | Quebec |
| Canada | Institut de Cardiologie de Montreal ( Site 0506) | Montreal | Quebec |
| Canada | Diex Recherche Trois-Rivieres ( Site 0513) | Trois-Rivieres | Quebec |
| Chile | CDIEM ( Site 0814) | Providencia | Region M. De Santiago |
| Chile | Enroll SpA ( Site 0803) | Santiago | Region M. De Santiago |
| Chile | Pontificia Universidad Catolica de Chile-CICUC ( Site 0812) | Santiago | Region M. De Santiago |
| Chile | Clinical Research Chile SpA ( Site 0804) | Valdivia | Los Rios |
| Colombia | Ciensalud Ips S A S ( Site 0903) | Barranquilla | Atlantico |
| Colombia | Clinica de la Costa S.A.S. ( Site 0902) | Barranquilla | Atlantico |
| Colombia | Salud SURA Calle 100 ( Site 0918) | Bogotá | Cundinamarca |
| Colombia | Fundación Centro de Investigación Clínica CIC ( Site 0906) | Medellín | Antioquia |
| Czechia | Fakultní nemocnice Brno Bohunice-Interni kardiologicka klinika ( Site 3602) | Brno | Brno-mesto |
| Czechia | Fakultni Nemocnice u sv. Anny v Brne ( Site 3604) | Brno | Jihomoravsky Kraj |
| Czechia | Institut Klinicke a Experimentalni Mediciny ( Site 3601) | Praha | Praha 4 |
| Finland | Meilahden tornisairaala - Meilahti Tower Hospital ( Site 1300) | Helsinki | Uusimaa |
| Hong Kong | Queen Mary Hospital-Medical ( Site 3300) | Pok Fu Lam | |
| Hong Kong | Prince of Wales Hospital ( Site 3304) | Shatin | |
| Hungary | Semmelweis Egyetem-Városmajori Szív- és Érgyógyászati Klinika ( Site 1600) | Budapest | |
| Hungary | Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Anyagcsere Tanszék) ( Site 1601) | Debrecen | |
| Hungary | Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Belgyógyászati Klinika ( Site 1603) | Szeged | Csongrad |
| Israel | Hadassah Medical Center ( Site 1709) | Jerusalem | |
| Israel | Shaare Zedek Medical Center ( Site 1710) | Jerusalem | |
| Israel | Rabin Medical Center ( Site 1717) | Petah Tikva | |
| Israel | Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 1700) | Sakhnin | |
| Netherlands | Amsterdam UMC, locatie AMC-Vascular Medicine Clin Trial Unit ( Site 1954) | Amsterdam | Noord-Holland |
| Netherlands | Vasculair Onderzoek Centrum Hoorn ( Site 1953) | Hoorn | Noord-Holland |
| Netherlands | Radboudumc-internal medicine ( Site 1952) | Nijmegen | Gelderland |
| Netherlands | Universitair Medisch Centrum Utrecht-Vascular Medicine Research ( Site 1955) | Utrecht | |
| New Zealand | New Zealand Clinical Research (Christchurch) ( Site 2901) | Christchurch | Canterbury |
| New Zealand | Pacific Clinical Research Network - Rotorua ( Site 2902) | Rotorua | Bay Of Plenty |
| Norway | Nordlandssykehuset ( Site 2001) | Bodø | Nordland |
| Norway | Oslo Universitetssykehus Aker-Lipidklinikken ( Site 2000) | Oslo | |
| Singapore | Changi General Hospital ( Site 3211) | Singapore | Central Singapore |
| Singapore | National University Hospital-Department of Medicine ( Site 3212) | Singapore | Central Singapore |
| Spain | SALUT SANT JOAN DE REUS-BAIX CAMP (EDP)-Vascular and Metabolism Unit ( Site 2329) | Reus | Tarragona |
| Spain | Hospital de Sant Joan Despí Moisès Broggi ( Site 2335) | Sant Joan Despí | Cataluna |
| Spain | HOSPITAL CLINICO DE VALENCIA ( Site 2321) | Valencia | Valenciana, Comunitat |
| Taiwan | Mackay Memorial Hospital -Tamshui Branch ( Site 3109) | New Taipei City | New Taipei |
| Taiwan | National Cheng Kung University Hospital-Internal Medicine ( Site 3107) | Tainan | |
| Taiwan | National Taiwan University Hospital ( Site 3100) | Taipei | |
| Taiwan | Shin Kong Wu Ho-Su Memorial Hospital ( Site 3106) | Taipei City | Taipei |
| United States | Excel Medical Clinical Trials ( Site 0008) | Boca Raton | Florida |
| United States | Advanced Pharma Research ( Site 0007) | Cutler Bay | Florida |
| United States | Alliance for Multispecialty Research, LLC ( Site 0023) | Daphne | Alabama |
| United States | Synexus Clinical Research US - Evansville ( Site 0031) | Evansville | Indiana |
| United States | Franciscan Physician Network - Indiana Heart Physicians ( Site 0040) | Indianapolis | Indiana |
| United States | Jubilee Clinical Research ( Site 0030) | Las Vegas | Nevada |
| United States | Velocity Clinical Research at The Pioneer Heart Institute, Lincoln ( Site 0026) | Lincoln | Nebraska |
| United States | Health Research of Hampton Roads, Inc. ( Site 0020) | Newport News | Virginia |
| United States | Progressive Medical Research ( Site 0021) | Port Orange | Florida |
| United States | Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0001) | Troy | Michigan |
| United States | Velocity Clinical Research, Salt Lake City ( Site 0004) | West Jordan | Utah |
| United States | Wake Forest Baptist Health-Cardiovascular Medicine ( Site 0041) | Winston-Salem | North Carolina |
| United States | Clinical Site Partners LLC, dba CSP Orlando ( Site 0028) | Winter Park | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
United States, Australia, Brazil, Canada, Chile, Colombia, Czechia, Finland, Hong Kong, Hungary, Israel, Netherlands, New Zealand, Norway, Singapore, Spain, Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24 | Blood samples will be collected at baseline and at Week 24 to assess mean percent change in LDL-C. | Baseline and Week 24 | |
| Primary | Number of participants with one or more adverse events (AEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to ~60 weeks | |
| Primary | Number of participants who discontinue study drug due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to ~52 weeks | |
| Secondary | Mean percent change from baseline in LDL-C at Week 52 | Blood samples will be collected at baseline and at Week 52 to assess mean percent change in LDL-C. | Baseline and Week 52 | |
| Secondary | Mean percent change from baseline in non-high-density lipoprotein cholesterol (HDL-C) at Week 24 | Blood samples will be collected at baseline and at Week 24 to assess mean percent change in non-HDL-C. | Baseline and Week 24 | |
| Secondary | Mean percent change from baseline in apolipoprotein B (ApoB) at Week 24 | Blood samples will be collected at baseline and at Week 24 to assess mean percent change in ApoB. | Baseline and Week 24 | |
| Secondary | Percent change from baseline in lipoprotein(a) (Lp[a]) at Week 24 | Blood samples will be collected at baseline and at Week 24 to assess percent change in Lp(a). | Baseline and Week 24 | |
| Secondary | Percentage of participants with LDL-C <70 mg/dL and =50% reduction from baseline at Week 24 | Blood samples will be collected at baseline and at Week 24 to assess the percentage of participants who have LDL-C <70 mg/dL and =50% reduction from baseline. | Baseline and Week 24 | |
| Secondary | Percentage of participants with LDL-C <55 mg/dL and =50% reduction from baseline at Week 24 | Blood samples will be collected at baseline and at Week 24 to assess the percentage of participants who have LDL-C <55 mg/dL and =50% reduction from baseline. | Baseline and Week 24 |
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