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 2

• Conditions: Atherosclerotic Cardiovascular Disease

• Registration Number: JPRN-jRCT2031210399
• Lead Sponsor: Hirata Takashi

Brief Summary

Efficacy - Superiority of oral NNC0385-0434 (all doses) vs placebo in LDL-C lowering was confirmed after 12 weeks of treatment - Oral NNC0385-0434 (15, 40 and 100 mg) demonstrated dose-dependent LDL-C lowering - LDLLDL-C lowering was similar for oral NNC0385-0434 100 mg and evolocumab 140 mg - Oral NNC0385-0434 improved lipid parameters compared to placebo Safety -Multiple doses of oral NNC0385-0434 were well-tolerated and no safety concerns were identified

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-29
• Study Completion: 2022-06-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 267

Inclusion 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.

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 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified