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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1319-9502 | Registry Identifier | UTN | |
| 2025-521495-54-00 | Registry Identifier | EU CT | |
| MK-0616-037 | Other Identifier | MSD |
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Researchers designed a study medicine called enlicitide to lower low-density lipoprotein cholesterol (LDL-C). In this study, researchers want to learn about giving enlicitide with another medicine called rosuvastatin. Rosuvastatin is a standard (usual) treatment to lower LDL-C.
The goal of this study is to learn if enlicitide given with rosuvastatin works better than placebo on lowering LDL-C in a person's blood. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of a study medicine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enlicitide | Experimental | Participants will receive enlicitide and a rosuvastatin-matching placebo. Both will be delivered orally once daily (QD) for up to 12 weeks. |
|
| Enlicitide + Rosuvastatin | Experimental | Participants will receive enlicitide and rosuvastatin. Both will be delivered orally QD for up to 12 weeks. |
|
| Rosuvastatin | Active Comparator | Participants will receive rosuvastatin and an enlicitide-matching placebo. Both will be delivered orally QD for up to 12 weeks. |
|
| Placebo | Placebo Comparator | Participants will receive an enlicitide-matching placebo and a rosuvastatin-matching placebo. Placebos will be delivered orally QD for up to 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enlicitide | Drug | Oral Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change from Baseline in LDL-C at Week 8 (Enlicitide + Rosuvastatin Versus Placebo) | Blood samples will be collected at baseline and at Week 8 to assess mean percent change in LDL-C between participants treated with enlicitide and rosuvastatin versus placebo. | Baseline and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change from Baseline in LDL-C at Week 8 | Blood samples will be collected at baseline and at Week 8 to assess mean percent change in LDL-C. | Baseline and Week 8 |
| Mean Percent Change from Baseline in Apolipoprotein B (ApoB) at Week 8 |
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Inclusion Criteria:
-Has either not received lipid-lowering therapy (LLT) or has not received certain LLTs within a specified time period prior to the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Research Associates ( Site 0009) | Birmingham | Alabama | 35205 | United States | ||
| G&L Research ( Site 0024) |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
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| Rosuvastatin | Drug | Oral Capsule |
|
| Placebo for Enlicitide | Drug | Oral Tablet |
|
| Placebo for Rosuvastatin | Drug | Oral Capsule |
|
Blood samples will be collected at baseline and at Week 8 to assess mean percent change in ApoB.
| Baseline and Week 8 |
| 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 approximately 20 weeks |
| Number of Participants who Discontinue Study Drug Due to One or More 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 approximately 12 weeks |
| Mean Percent Change from Baseline in LDL-C at Week 12 | Blood samples will be collected at baseline and at Week 12 to assess mean percent change in LDL-C. | Baseline and Week 12 |
| Mean Percent Change from Baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C) at Week 8 | Blood samples will be collected at baseline and at Week 8 to assess mean percent change in non-HDL-C. | Baseline and Week 8 |
| Percent Change from Baseline in Lipoprotein (a) (Lp[a]) at Week 8 | Blood samples will be collected at baseline and at Week 8 to assess percent change in Lp(a). | Baseline and Week 8 |
| Percentage of Participants with LDL-C <70 mg/dL and ≥50% Reduction from Baseline at Week 8 | Blood samples will be collected at baseline and at Week 8 to assess the percentage of participants who have LDL-C <70 mg/dL and ≥50% reduction from baseline. | Baseline and Week 8 |
| Percentage of Participants with LDL-C <55 mg/dL and ≥50% Reduction from Baseline at Week 8 | Blood samples will be collected at baseline and at Week 8 to assess the percentage of participants who have LDL-C <55 mg/dL and ≥50% reduction from baseline. | Baseline and Week 8 |
| Foley |
| Alabama |
| 36535 |
| United States |
| Synexus Clinical Research US, Inc. - Phoenix Central ( Site 0030) | Phoenix | Arizona | 85020 | United States |
| Alliance for Multispecialty Research LLC ( Site 0049) | Tempe | Arizona | 85281 | United States |
| Chemidox Clinical Trials ( Site 0008) | Lancaster | California | 93534 | United States |
| Clinical Trials Research ( Site 0036) | Sacramento | California | 95821 | United States |
| Legacy Clinical Trials ( Site 0044) | Colorado Springs | Colorado | 80909 | United States |
| Alliance for Multispecialty Research, LLC ( Site 0040) | Fort Myers | Florida | 33912 | United States |
| Soffer Health Institute ( Site 0046) | Hollywood | Florida | 33020 | United States |
| East Coast Institute for Research ( Site 0041) | Lake City | Florida | 32055 | United States |
| Inpatient Research Clinic ( Site 0017) | Miami Lakes | Florida | 33014 | United States |
| Clinical Research Trials of Florida ( Site 0001) | Tampa | Florida | 33607 | United States |
| Clinical Site Partners LLC, dba CSP Orlando ( Site 0014) | Winter Park | Florida | 32789 | United States |
| Trialmed ( Site 0026) | Chicago | Illinois | 60602 | United States |
| Great Lakes Clinical Trials - Ravenswood ( Site 0018) | Chicago | Illinois | 60640 | United States |
| Midwest Institute For Clinical Research ( Site 0033) | Indianapolis | Indiana | 46260-5310 | United States |
| Alliance for Multispecialty Research, LLC ( Site 0048) | Newton | Kansas | 67114 | United States |
| Cotton O'Neil Clinical Research Center ( Site 0006) | Topeka | Kansas | 66606 | United States |
| Monroe Biomedical Research ( Site 0004) | Louisville | Kentucky | 40213 | United States |
| Jubilee Clinical Research ( Site 0031) | Las Vegas | Nevada | 89106 | United States |
| Cardiovascular Associates of the Delaware Valley ( Site 0035) | Elmer | New Jersey | 08318 | United States |
| New Mexico Clinical Research & Osteoporosis Center, Inc. ( Site 0027) | Albuquerque | New Mexico | 87106-4725 | United States |
| Alliance for Multispecialty Research, LLC - Norman ( Site 0043) | Norman | Oklahoma | 73069 | United States |
| Cardiology Consultants of Philadelphia Yardley ( Site 0016) | Yardley | Pennsylvania | 19067 | United States |
| Provecta Research Network LLC ( Site 0022) | Houston | Texas | 77027 | United States |
| Permian Research Foundation ( Site 0005) | Odessa | Texas | 79761 | United States |
| LinQ Research ( Site 0025) | Pearland | Texas | 77584 | United States |
| Clinical Trials of Texas, Inc. ( Site 0010) | San Antonio | Texas | 78229 | United States |
| Stone Oak, LLC dba Discovery Clinical Trials (DCT) ( Site 0021) | San Antonio | Texas | 78258 | United States |
| LinQ Research - Tomball ( Site 0047) | Tomball | Texas | 77375 | United States |
| Manassas Clinical Research Center ( Site 0002) | Manassas | Virginia | 20110 | United States |
| Health Research of Hampton Roads, Inc. ( Site 0013) | Newport News | Virginia | 23606 | United States |
| National Clinical Research, Inc ( Site 0028) | Richmond | Virginia | 23294 | United States |
| Conquest Research ( Site 0045) | Vienna | Virginia | 22182 | United States |
| Rainier Clinical Research ( Site 0023) | Renton | Washington | 98057 | United States |
| CEMEDIC ( Site 0201) | CABA | Buenos Aires | C1407GTL | Argentina |
| Instituto de Investigaciones Clínicas Mar del Plata ( Site 0202) | Mar del Plata | Buenos Aires | B7600FZO | Argentina |
| CIPREC-CIPREC Sede Arenales ( Site 0200) | Buenos Aires | Buenos Aires F.D. | C1061AAS | Argentina |
| Fundacion Estudios Clinicos ( Site 0203) | Rosario | Santa Fe Province | S2000CVD | Argentina |
| Instituto de Investigaciones Clinicas Rosario ( Site 0204) | Rosario | Santa Fe Province | S2000CVD | Argentina |
| Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0206) | CABA | C1425AGC | Argentina |
| Instituto de Cardiología "Juana F. Cabral"-Cardiología ( Site 0205) | Corrientes | W3400AMZ | Argentina |
| Australian Clinical Research Network ( Site 0900) | Maroubra | New South Wales | 2035 | Australia |
| Momentum Darlinghurst ( Site 0906) | Sydney | New South Wales | 2010 | Australia |
| Momentum Clinical Research Taringa ( Site 0907) | Taringa | Queensland | 4068 | Australia |
| Fusion Clinical Research ( Site 0901) | Norwood | South Australia | 5067 | Australia |
| Emeritus Research ( Site 0904) | Camberwell | Victoria | 3124 | Australia |
| Baker - HeartWest ( Site 0902) | Hoppers Crossing | Victoria | 3029 | Australia |
| Centro de Pesquisas em Diabetes e Doenças Endócrino-Metabólicas ( Site 0306) | Fortaleza | Ceará | 60430-350 | Brazil |
| Centro de Pesquisa Clinica do Coracao ( Site 0303) | Aracaju | Sergipe | 49055-530 | Brazil |
| Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0305) | Bragança Paulista | São Paulo | 12916-542 | Brazil |
| Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0309) | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| IBPClin - Instituto Brasil de Pesquisa Clínica ( Site 0302) | Rio de Janeiro | 20241-180 | Brazil |
| G A Research Associates ( Site 0102) | Moncton | New Brunswick | E1G 1A7 | Canada |
| Milestone Research Inc. ( Site 0111) | London | Ontario | N5W 6A2 | Canada |
| North York Diagnostic and Cardiac Centre ( Site 0110) | North York | Ontario | M6B 3H7 | Canada |
| Care Access - Thunder Bay ( Site 0130) | Thunder Bay | Ontario | P7B 7C7 | Canada |
| Centricity Research Mirabel Multispecialty ( Site 0107) | Mirabel | Quebec | J7J 2K8 | Canada |
| Institut de Cardiologie de Montreal ( Site 0109) | Montreal | Quebec | H1T 1C8 | Canada |
| Recherche Clinique Sigma Inc ( Site 0108) | Québec | Quebec | G1G 5X1 | Canada |
| Lausmed Egészségügyi Szolgáltató ( Site 1105) | Baja | Bács-Kiskun county | 6500 | Hungary |
| Borbánya Praxis ( Site 1103) | Nyíregyháza | Szabolcs-Szatmár-Bereg | 4405 | Hungary |
| DRC Gyógyszervizsgáló Központ ( Site 1109) | Balatonfüred | Veszprém megye | 8230 | Hungary |
| Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Anyagcsere Tanszék) ( Site 1102) | Debrecen | 4032 | Hungary |
| Barzilai Medical Center ( Site 0504) | Ashkelon | 7830604 | Israel |
| Linn Medical Center ( Site 0503) | Haifa | 3100000 | Israel |
| Rambam Health Care Campus ( Site 0500) | Haifa | 3109601 | Israel |
| Meir Medical Center. ( Site 0501) | Kfar Saba | 4428164 | Israel |
| Clalit Health Services - Sakhnin Community Clinic ( Site 0502) | Sakhnin | 3081000 | Israel |
| Pacific Clinical Research Network - Rotorua ( Site 1001) | Rotorua | Bay of Plenty | 3010 | New Zealand |
| Pacific Clinical Research Network - Forte ( Site 1004) | Christchurch | Canterbury | 8013 | New Zealand |
| Pacific Clinical Research Network - Tasman ( Site 1003) | Nelson | Tasman District | 7011 | New Zealand |
| Lakeland Clinical Trials Waikato ( Site 1000) | Nawton | Waikato Region | 3200 | New Zealand |
| Lakeland Clinical Trials Wellington ( Site 1002) | Upper Hutt | Wellington Region | 5018 | New Zealand |
| Centro de Salud Concepcion Arenal ( Site 0603) | Santiago de Compostela | Galicia | 15701 | Spain |
| EAP Sardenya ( Site 0601) | Barcelona | 08025 | Spain |
| EBA Centelles ( Site 0600) | Barcelona | 08540 | Spain |
| Hacettepe Universite Hastaneleri ( Site 0700) | Sıhhiye | Ankara | 06230 | Turkey (Türkiye) |
| Ufuk University Dr.Ridvan Ege Hospital ( Site 0709) | Ankara | 06520 | Turkey (Türkiye) |
| Eskisehir Osmangazi University ( Site 0705) | Eskişehir | 26480 | Turkey (Türkiye) |
| Istanbul Universitesi - Cerrahpasa Kardiyoloji Enstitusu ( Site 0703) | Istanbul | 34080 | Turkey (Türkiye) |
| Ege Universitesi Hastanesi ( Site 0708) | Izmir | 35080 | Turkey (Türkiye) |
| Erciyes Universitesi Tıp Fakultesi Hastaneleri ( Site 0701) | Kayseri | 38030 | Turkey (Türkiye) |
| İnönü Üniversitesi Turgut Özal Tıp Merkezi ( Site 0702) | Malatya | 44280 | Turkey (Türkiye) |
| Velocity Clinical Research, Bristol ( Site 0803) | Bristol | Bristol, City of | BS8 2RA | United Kingdom |
| West Walk Surgery ( Site 0801) | Yate | Gloucestershire | BS37 4AX | United Kingdom |
| Velocity Clinical Research Havering ( Site 0804) | London | Havering | RM1 3PJ | United Kingdom |
| William Harvey Heart Centre ( Site 0800) | London | London, City of | EC1M 6BQ | United Kingdom |
| Lakeside Surgery ( Site 0802) | Corby | Northamptonshire | NN17 2UR | United Kingdom |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000728674 | MK-0616 |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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