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

Phase 1

• Conditions: Established atherosclerotic cardiovascular disease (ASCVD) or ASCVD riskElevated cholesterol; MedDRA version: 21.1Level: LLTClassification code 10051615Term: Atherosclerotic cardiovascular diseaseSystem Organ Class: 100000004866; MedDRA version: 20.1Level: PTClassification code 10005425Term: Blood cholesterol increasedSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-002630-32-DE
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-11
• Last Update Posted: 13 December 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 255

Inclusion Criteria

- Male patient or female patient of non-childbearing potential.
- Established atherosclerotic cardiovascular disease (ASCVD) (criteria a) or ASCVD risk (criteria b):
a)Age greater than or equal to 40 years at the time of signing informed consent and history of ASCVD
b)Age greater than 50 years at the time of signing informed consent and with ASCVD risk
- Serum LDL-C greater than or equal to1.8 mmol/L (greater than or equal to 70 mg/dL) as measured by the central laboratory at screening. Japanese patients: Serum LDL-C greater than or equal to 2.6 mmol/L (greater than or equal to 100 mg/dL) for patients of greater than or equal to 40 years of age and with a history of coronary heart disease, and serum LDL-C greater than or equal to 3.1 mmol/L (greater than or equal to 120 mg/dL) for all other Japanese patients
- Patients must be on maximally tolerated dose of statins.
- Patients not receiving statin must have documented evidence of intolerance to all doses of at least two different statins.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 153
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 102

Exclusion 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 greater than 4.52 mmol/L (greater than 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 below 30 ml/min/1.73 m^2 as measured by the central laboratory at screening.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified