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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0616-008 | Other Identifier | MSD | |
| jRCT2031210701 | Registry Identifier | jRCT | |
| 2021-005221-24 | EudraCT Number |
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The purpose of this study is to evaluate the efficacy and safety of enclitide chloride, an oral PCSK9 inhibitor, in lowering low-density lipoprotein cholesterol (LDL-C) in participants with hypercholesterolemia. The primary hypothesis is that at least one of the four doses of enclitide chloride tested in this study is superior to placebo on percent change from baseline in LDL-C at Week 8.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enclitide Chloride 6 mg | Experimental | Participants will receive 6 mg of enlicitide chloride orally QD for 8 weeks |
|
| Enclitide Chloride 12 mg | Experimental | Participants will receive 12 mg of enlicitide chloride orally QD for 8 weeks |
|
| Enclitide Chloride 18 mg | Experimental | Participants will receive 18 mg of enlicitide chloride orally QD for 8 weeks |
|
| Enclitide Chloride 30 mg | Experimental | Participants will receive 30 mg of enlicitide chloride orally QD for 8 weeks |
|
| Placebo | Placebo Comparator | Participants will receive enlicitide chloride-matching placebo orally QD for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enclitide Chloride | Drug | Enclitide Chloride administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 8 | Blood samples were collected at baseline and after 8 weeks of treatment to assess mean percent change in LDL-C. Based on a constrained longitudinal analysis (cLDA) model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time. The percent change from baseline in LDL-C at week 8 was reported. | Baseline and up to Week 8 |
| Percentage of Participants Who Experienced One or More Adverse Events (AEs) | An AE was 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. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced at least one AE was reported. | Up to approximately 17 Weeks |
| Percentage of Participants Who Discontinued Study Intervention Due to AEs | An AE was 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. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinued study intervention due to AEs was reported. | Up to approximately 9 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 8 | Blood samples were collected at baseline and after 8 weeks of treatment to assess mean percent change in ApoB. The least square mean and 95% CI were obtained from fitting a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time. The percent change from baseline in ApoB at week 8 was reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Westside Medical Associates of Los Angeles ( Site 0026) | Beverly Hills | California | 90211 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36889610 | Result | Ballantyne CM, Banka P, Mendez G, Garcia R, Rosenstock J, Rodgers A, Mendizabal G, Mitchel Y, Catapano AL. Phase 2b Randomized Trial of the Oral PCSK9 Inhibitor MK-0616. J Am Coll Cardiol. 2023 Apr 25;81(16):1553-1564. doi: 10.1016/j.jacc.2023.02.018. Epub 2023 Mar 6. |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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Of 668 participants screened for inclusion, 381 were randomized 1:1:1:1:1 to receive MK-0616 6 mg, 12 mg, 18 mg, 30 mg, or placebo. Of the 381 randomized participants, one participant did not receive at least one dose of study intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | MK-0616 6 mg | Participants received 6 mg of MK-0616 orally once daily (QD) for 8 weeks |
| FG001 | MK-0616 12 mg | Participants received 12 mg of MK-0616 orally QD for 8 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 24, 2022 |
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|
| Placebo | Drug | Placebo matching enclitide chloride administered orally |
|
| Baseline and up to Week 8 |
| Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 8 | Blood samples were collected at baseline and after 8 weeks of treatment to assess mean percent change in non-HDL-C. The least square mean and 95% CI were obtained from fitting a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time. The percent change from baseline in non-HDL-C at week 8 was reported. | Baseline and up to Week 8 |
| Percentage of Participants With LDL-C Value at Goal at Week 8 | LDL-C goal was defined as: LDL-C <70 mg/dL (<1.81 mmol/L) in participants with clinical atherosclerotic cardiovascular disease (ASCVD), LDL-C <100 mg/dL (<2.59 mmol/L) in participants with an ASCVD risk-equivalent and/or a 10-year risk of having an ASCVD event that is ≥7.5%, OR LDL-C <130 mg/dL (<3.37mmol/L) in participants with a 10-year risk of having an ASCVD event that is ≥5.0% and <7.5%. The percentage of participants with LDL-C value at goal at week 8 were reported. | Week 8 |
| Clinical Trials Research ( Site 0007) |
| Sacramento |
| California |
| 95821 |
| United States |
| National Research Institute (NRI) - Santa Ana ( Site 0024) | Santa Ana | California | 92704 | United States |
| Excel Medical Clinical Trials ( Site 0042) | Boca Raton | Florida | 33434 | United States |
| Alliance for Multispecialty Research, LLC ( Site 0050) | Coral Gables | Florida | 33134 | United States |
| ForCare Clinical Research ( Site 0017) | Tampa | Florida | 33613 | United States |
| Healthcare Research Network - Chicago ( Site 0037) | Flossmoor | Illinois | 60422 | United States |
| Midwest Institute For Clinical Research ( Site 0036) | Indianapolis | Indiana | 46260 | United States |
| Cotton O'Neil Mulvane ( Site 0022) | Topeka | Kansas | 66606 | United States |
| L-MARC Research Center ( Site 0003) | Louisville | Kentucky | 40213 | United States |
| The University of Mississippi Medical Center-Clinical Research and Trials Unit ( Site 0028) | Jackson | Mississippi | 39216 | United States |
| Jubilee Clinical Research ( Site 0047) | Las Vegas | Nevada | 89106 | United States |
| New Mexico Clinical Research & Osteoporosis Center ( Site 0032) | Albuquerque | New Mexico | 87106 | United States |
| Mid Hudson Medical Research ( Site 0004) | New Windsor | New York | 12553 | United States |
| altoona center for clinical research ( Site 0045) | Duncansville | Pennsylvania | 16635 | United States |
| Piedmont Research Partners ( Site 0005) | Fort Mill | South Carolina | 29707 | United States |
| Dallas Diabetes Research Center ( Site 0012) | Dallas | Texas | 75230 | United States |
| Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0051) | Houston | Texas | 77030 | United States |
| Northeast Clinical Research of San Antonio ( Site 0014) | San Antonio | Texas | 78233 | United States |
| National Clinical Research, Inc-research office ( Site 0019) | Richmond | Virginia | 23294 | United States |
| Klinikum der Ludwig-Maximilians-Universitaet Muenchen ( Site 0504) | München | Bavaria | 80336 | Germany |
| Kardiologische Gemeinschaftspraxis ( Site 0502) | Nuremberg | Bavaria | 90402 | Germany |
| Ambulantes Herzzentrum Kassel ( Site 0501) | Kassel | Hesse | 34121 | Germany |
| Universitätsklinikum Leipzig ( Site 0500) | Leipzig | Saxony | 04103 | Germany |
| Charité Campus Virchow-Klinikum ( Site 0505) | Berlin | 13353 | Germany |
| Chubu Rosal Hospital ( Site 1612) | Nagoya | Aichi-ken | 455-8530 | Japan |
| Kyoto Okamoto Memorial Hospital ( Site 1611) | Kuse-gun Kumiyama-cho | Kyoto | 613-0034 | Japan |
| Kitada Clinic ( Site 1604) | Osaka | Osaka | 538-0044 | Japan |
| Medical Corporation Heishinkai OCROM Clinic ( Site 1600) | Suita-shi | Osaka | 565-0853 | Japan |
| Seiwa Clinic ( Site 1605) | Adachi-ku | Tokyo | 123-0845 | Japan |
| meiwa hospital ( Site 1602) | Chiyoda-ku | Tokyo | 101-0041 | Japan |
| Heishinkai Medical Group ToCROM Clinic ( Site 1601) | Shinjuku-ku | Tokyo | 160-0008 | Japan |
| Sekino Hospital ( Site 1603) | Toshimaku | Tokyo | 171-0014 | Japan |
| Instituto Jalisciense de Investigacion en Diabetes y Obesidad-Endocrinology ( Site 0205) | Guadalajara | Jalisco | 04460 | Mexico |
| Unidad de Investigaci�n Cl�nica Cardiometabolica de Occident-Unidad de Investigación ClÃnica Cardio | Guadalajara | Jalisco | 44150 | Mexico |
| Bio Investigación AMARC, S.C. ( Site 0204) | Mexico City | Mexico City | 11410 | Mexico |
| Hospital Angeles Mocel ( Site 0209) | Mexico City | Mexico City | 11850 | Mexico |
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0212) | Mexico City | Mexico City | 14080 | Mexico |
| Unidad biomedica avanzada monterrey-Clinical Trials ( Site 0200) | Monterrey | Nuevo León | 64460 | Mexico |
| Centro de Estudios de Investigacion Metabolicos y Cardiovasculares-Subinvestigation ( Site 0201) | Ciudad Madero | Tamaulipas | 89440 | Mexico |
| Hospital Angeles Xalapa-Internal Medicine-Cardiology ( Site 0202) | Xalapa | Veracruz | 91193 | Mexico |
| Medical Care and Research SA de CV ( Site 0211) | Mérida | Yucatán | 97070 | Mexico |
| Centro de Atención e Investigación ClÃnica ( Site 0214) | Aguascalientes | 20129 | Mexico |
| Akershus Universitetssykehus-Hjertemedisinsk Avdeling ( Site 0705) | Lørenskog | Akershus | 1478 | Norway |
| Nordlandssykehuset ( Site 0709) | Bodø | Nordland | 8005 | Norway |
| Stavanger Universitetssykehus ( Site 0706) | Stavanger | Rogaland | 4011 | Norway |
| Sykehuset i Vestfold-Hjerteseksjonen ( Site 0703) | Tønsberg | Vestfold | 3103 | Norway |
| Oslo Universitetssykehus Aker-Preventiv kardiologi Aker ( Site 0704) | Oslo | 0316 | Norway |
| Oslo Universitetssykehus Rikshospitalet-Kardiologisk avdeling ( Site 0702) | Oslo | 0372 | Norway |
| Oslo Universitetssykehus Ullevål-Hjertemedisinsk avdeling, Ullevål ( Site 0701) | Oslo | 0450 | Norway |
| Oslo Universitetssykehus Aker-Lipidklinikken ( Site 0700) | Oslo | 0586 | Norway |
| Keimyung University Dongsan Hospital ( Site 1703) | Daegu | Taegu-Kwangyokshi | 42601 | South Korea |
| Seoul National University Hospital ( Site 1702) | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System ( Site 1701) | Seoul | 03722 | South Korea |
| Samsung Medical Center ( Site 1700) | Seoul | 06351 | South Korea |
| Ege University Medicine of Faculty-Cardilogy Department ( Site 1003) | Bornova | İzmir | 35100 | Turkey (Türkiye) |
| Hacettepe Universitesi ( Site 1002) | Ankara | 06230 | Turkey (Türkiye) |
| Eskisehir Osmangazi University-Cardiology ( Site 1000) | Eskişehir | 26480 | Turkey (Türkiye) |
| Royal Free Hospital ( Site 1311) | London | England | NW32QG | United Kingdom |
| Queen Elizabeth University Hospital-Glasgow Clinical Research Facility ( Site 1310) | Glasgow | Glasgow City | G51 4TF | United Kingdom |
| Layton Medical Centre ( Site 1303) | Blackpool | Lancashire | FY3 7EN | United Kingdom |
| William Harvey Heart Centre ( Site 1308) | London | London, City of | EC1M 5PZ | United Kingdom |
| Walsall Manor Hospital ( Site 1309) | West Midlands | Walsall | WS2 9PS | United Kingdom |
| FG002 | MK-0616 18 mg | Participants received 18 mg of MK-0616 orally QD for 8 weeks |
| FG003 | MK-0616 30 mg | Participants received 30 mg of MK-0616 orally QD for 8 weeks |
| FG004 | Placebo | Participants received MK-0616-matching placebo orally QD for 8 weeks |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MK-0616 6 mg | Participants received 6 mg of MK-0616 orally QD for 8 weeks |
| BG001 | MK-0616 12 mg | Participants received 12 mg of MK-0616 orally QD for 8 weeks |
| BG002 | MK-0616 18 mg | Participants received 18 mg of MK-0616 orally QD for 8 weeks |
| BG003 | MK-0616 30 mg | Participants received 30 mg of MK-0616 orally QD for 8 weeks |
| BG004 | Placebo | Participants received MK-0616-matching placebo orally QD for 8 weeks |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Randomization Strata: Background Statin Dose | Participants were stratified by the following background statin dose: no statin therapy, low-intensity to moderate-intensity statin therapy, or high-intensity statin therapy. | Count of Participants | Participants |
| |||||||||||||||
| Randomization Strata: Renal Function | Estimated glomerular filtration rate (eGFR) was calculated using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine. Participants were stratified by the following renal function at baseline: eGFR ≥60 vs <60 ml/min/1.73 m^2. | Count of Participants | Participants |
| |||||||||||||||
| Baseline Low-density Lipoprotein Cholesterol (LDL-C) | Blood samples were taken at baseline to determine baseline LDL-C levels. | Mean | Standard Deviation | mg/dL |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 8 | Blood samples were collected at baseline and after 8 weeks of treatment to assess mean percent change in LDL-C. Based on a constrained longitudinal analysis (cLDA) model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time. The percent change from baseline in LDL-C at week 8 was reported. | All randomized participants who received at least one dose of study intervention, had at least one observation for the analysis endpoint, and had baseline data were analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and up to Week 8 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Experienced One or More Adverse Events (AEs) | An AE was 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. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced at least one AE was reported. | All randomized participants who received at least one dose of study intervention were analyzed. | Posted | Number | Percentage of Participants | Up to approximately 17 Weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Discontinued Study Intervention Due to AEs | An AE was 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. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinued study intervention due to AEs was reported. | All randomized participants who received at least one dose of study intervention were analyzed. | Posted | Number | Percentage of Participants | Up to approximately 9 Weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 8 | Blood samples were collected at baseline and after 8 weeks of treatment to assess mean percent change in ApoB. The least square mean and 95% CI were obtained from fitting a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time. The percent change from baseline in ApoB at week 8 was reported. | All randomized participants who received at least one dose of study intervention, had at least one observation for the analysis endpoint, and had baseline data were analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and up to Week 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 8 | Blood samples were collected at baseline and after 8 weeks of treatment to assess mean percent change in non-HDL-C. The least square mean and 95% CI were obtained from fitting a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time. The percent change from baseline in non-HDL-C at week 8 was reported. | All randomized participants who received at least one dose of study intervention, had at least one observation for the analysis endpoint, and had baseline data were analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and up to Week 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With LDL-C Value at Goal at Week 8 | LDL-C goal was defined as: LDL-C <70 mg/dL (<1.81 mmol/L) in participants with clinical atherosclerotic cardiovascular disease (ASCVD), LDL-C <100 mg/dL (<2.59 mmol/L) in participants with an ASCVD risk-equivalent and/or a 10-year risk of having an ASCVD event that is ≥7.5%, OR LDL-C <130 mg/dL (<3.37mmol/L) in participants with a 10-year risk of having an ASCVD event that is ≥5.0% and <7.5%. The percentage of participants with LDL-C value at goal at week 8 were reported. | All randomized participants who received at least one dose of study intervention and had at least one observation for the analysis endpoint were analyzed. | Posted | Number | Percentage of Participants | Week 8 |
|
Up to approximately 17 weeks
The population analyzed for the All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least one dose of study treatment, corresponding to the study treatment they actually received.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MK-0616 6 mg | Participants received 6 mg of MK-0616 orally QD for 8 weeks | 0 | 77 | 1 | 77 | 11 | 77 |
| EG001 | MK-0616 12 mg | Participants received 12 mg of MK-0616 orally QD for 8 weeks | 0 | 76 | 3 | 76 | 13 | 76 |
| EG002 | MK-0616 18 mg | Participants received 18 mg of MK-0616 orally QD for 8 weeks | 1 | 76 | 2 | 76 | 15 | 76 |
| EG003 | MK-0616 30 mg | Participants received 30 mg of MK-0616 orally QD for 8 weeks | 0 | 76 | 2 | 76 | 8 | 76 |
| EG004 | Placebo | Participants received MK-0616-matching placebo orally QD for 8 weeks | 0 | 76 | 0 | 75 | 15 | 75 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute left ventricular failure | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Post-traumatic stress disorder | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
The Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Nov 15, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D006938 | Hyperlipoproteinemia Type II |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006951 | Hyperlipoproteinemias |
Not provided
Not provided
| ID | Term |
|---|---|
| C000728674 | MK-0616 |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Low- to Moderate-intensity Statin Therapy |
|
| High-intensity Statin Therapy |
|
| eGFR <60 ml/min/1.73 m^2 |
|
| cLDA |
| <0.001 |
| Difference in Least Squares Means |
| -55.7 |
| 2-Sided |
| 95 |
| -62.3 |
| -49.1 |
MK-0616 12 mg minus Placebo |
| Superiority |
One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time. |
| cLDA | <0.001 | Difference in Least Squares Means | -59.1 | 2-Sided | 95 | -65.7 | -52.5 | MK-0616 18 mg minus Placebo | Superiority | One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time. |
| cLDA | <0.001 | Difference in Least Squares Means | -60.9 | 2-Sided | 95 | -67.6 | -54.3 | MK-0616 30 mg minus Placebo | Superiority | One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time. |
Participants received 30 mg of MK-0616 orally QD for 8 weeks |
| OG004 | Placebo | Participants received MK-0616-matching placebo orally QD for 8 weeks |
|
|
|
Participants received 30 mg of MK-0616 orally QD for 8 weeks |
| OG004 | Placebo | Participants received MK-0616-matching placebo orally QD for 8 weeks |
|
|
Participants received 30 mg of MK-0616 orally QD for 8 weeks |
| OG004 | Placebo | Participants received MK-0616-matching placebo orally QD for 8 weeks |
|
|
|
Participants received 30 mg of MK-0616 orally QD for 8 weeks |
| OG004 | Placebo | Participants received MK-0616-matching placebo orally QD for 8 weeks |
|
|
|
Participants received 30 mg of MK-0616 orally QD for 8 weeks |
| OG004 | Placebo | Participants received MK-0616-matching placebo orally QD for 8 weeks |
|
|
|