JRCT ID: jRCT2031210399
Registered date:29/10/2021
A Research Study Looking at How NNC0385-0434 Tablets Work to Lower Blood Cholesterol in People With Heart Disease or a High Risk of Heart Disease
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | Atherosclerotic Cardiovascular Disease |
Date of first enrollment | 22/10/2021 |
Target sample size | 255 |
Countries of recruitment | Belgium,Japan,Germany,Japan,Greece,Japan,Netherlands,Japan,Poland,Japan,United States,Japan |
Study type | Interventional |
Intervention(s) | Drug: NNC0385-0434 A 15 mg Other: Placebo I A (for NNC0385-0434 A 15 mg) Drug: NNC0385-0434 A 40 mg Other: Placebo I A (for NNC0385-0434 A 40 mg) Drug: NNC0385-0434 A 100 mg Other: Placebo II A (for NNC0385-0434 A 100 mg) The drug/placebo administered as one oral tablet once daily in the morning in a fasting state. The tablet should be taken at least 30 min before the first food, beverage or other oral medications of the day. The tablet can be taken with up to half a glass of water (approximately 120 mL/ 4 fluid ounces). placebo tablets are sized match to the active arm within dose level Drug: Evolocumab 140 mg/mL, Repatha Every 2 weeks subcutaneous (s.c.) injection of 140 mg into areas of the abdomen, thigh, or upper arm that are not tender, bruised, red, or indurated. Administered using a pre-filled SureClick autoinjector (single-use). Dose volume: 1 mL |
Outcome(s)
Primary Outcome | Change in low-density lipoprotein (LDL)-cholesterol [ Time Frame: From baseline (week 0) to visit 9 (week 12) ] |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 40age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | Males or females of non-childbearing potential. Established atherosclerotic cardiovascular disease (ASCVD) (criteria a) or ASCVD risk (criteria b): a) Age 40 years or older at the time of signing informed consent and history of ASCVD b) Age above 50 years at the time of signing informed consent and with ASCVD risk Serum LDL-C above or equal to 1.8 mmol/L (above or equal to 70 mg/dL) as measured by the central laboratory at screening. Japanese participants: Serum LDL-C above or equal to 2.6 mmol/L (above or equal to 100 mg/dL) for participants of 40 years of age or older and with a history of coronary heart disease, and serum LDL-C above or equal to 3.1 mmol/L (above or equal to 120 mg/dL) for all other Japanese participants Participants must be on maximally tolerated dose of statins. Participants not receiving statin must have documented evidence of intolerance to all doses of at least two different statins. |
Exclude criteria | Treatment with PCSK9i therapy (alirocumab or evolocumab within 90 days prior to screening) or PCSK9 siRNA therapy (inclisiran within 12 months prior to screening). Fasting triglyceride above 4.52 mmol/L (above 400 mg/dL) as measured by the central laboratory at screening. Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening. Renal impairment with eGFR less than 30 ml/min/1.73 m2 as measured by the central laboratory at screening |
Related Information
Primary Sponsor | Hirata Takashi |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT04992065,2020-002630-32,U1111-1252-3392 |
Contact
Public contact | |
Name | Takashi Hirata |
Address | 2-1-1, Marunouchi, Chiyodaku Tokyo Japan 100-0005 |
Telephone | +81-362661000 |
JPHC_clinical_trials@novonordisk.com | |
Affiliation | Novo Nordisk Pharma Ltd. |
Scientific contact | |
Name | Takashi Hirata |
Address | 2-1-1, Marunouchi, Chiyodaku, Tokyo Tokyo Japan 100-0005 |
Telephone | +81-362661000 |
JPHC_clinical_trials@novonordisk.com | |
Affiliation | Novo Nordisk Pharma Ltd. |