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Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C

NCT ID: NCT04666298

Last Updated: 2024-06-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-29

Study Completion Date

2022-10-19

Brief Summary

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This was a placebo-controlled, double-blind, randomized trial in Japanese participants with history of coronary artery disease (CAD) or participants categorized in 'high risk' by JAS 2017 guideline, or Japanese participants with heterozygous familial hypercholesterolemia (HeFH) and elevated Low-density lipoprotein cholesterol (LDL-C) despite maximum tolerated dose of statin(s) to evaluate the efficacy, safety, tolerability, and PK of subcutaneous inclisiran injection(s).

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Detailed Description

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The expected duration of the participants' involvement in the study was approximately 374 days which included screening (up to 14 days), Day 1 study drug administration, two additional injections on Day 90 and Day 270, and the follow-up period to Day 360.

The primary analysis was conducted after all participants had finished Day 180 visit assessments or discontinued before Day 180 visit.

After the primary analysis, double-blind treatment period were maintained to Day 360, although specific sponsor members (except for blinded monitors) were unblinded for the regulatory submission in Japan.

Conditions

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Hypercholesterolemia Heterozygous Familial Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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300 mg inclisiran sodium

Subcutaneous injection

Group Type EXPERIMENTAL

Inclisiran sodium

Intervention Type DRUG

Subcutaneously injected on Day 1, 90 and 270.

200 mg inclisiran sodium

Subcutaneous injection

Group Type EXPERIMENTAL

Inclisiran sodium

Intervention Type DRUG

Subcutaneously injected on Day 1, 90 and 270.

100 mg inclisiran sodium

Subcutaneous injection

Group Type EXPERIMENTAL

Inclisiran sodium

Intervention Type DRUG

Subcutaneously injected on Day 1, 90 and 270.

Placebo

Subcutaneous injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subcutaneously injected on Day 1, 90, and 270.

Interventions

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Inclisiran sodium

Subcutaneously injected on Day 1, 90 and 270.

Intervention Type DRUG

Placebo

Subcutaneously injected on Day 1, 90, and 270.

Intervention Type DRUG

Other Intervention Names

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KJX839 KJX839 placebo

Eligibility Criteria

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Inclusion Criteria

* Participants with history of CAD or participants categorized in 'high risk' by Japan Atherosclerosis Society (JAS) 2017 guidelines or participants with heterozygous familial hypercholesterolemia (HeFH)
* As per the JAS 2017 guideline, participants not meeting the LDL-C management targets.
* Participants on statins should be receiving a maximally tolerated dose.
* Participants not receiving statins must have documented evidence of intolerance to at least one statin.
* The lipid-lowering therapy should have remained stable for ≥ 30 days before screening with no planned medication/ dose change until Day 180

Exclusion Criteria

* Participants diagnosed with homozygous familial hypercholesterolemia (HoFH).
* Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9.
* New York Heart Association (NYHA) class IV heart failure or last known left ventricular ejection fraction \<25%.
* Cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication or via ablation.
* Uncontrolled hypertension: systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg prior to randomization despite antihypertensive therapy.
* Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or unexplained elevations in alanine aminotransferase (ALT), aspartate aminotransferase (AST), \>3x the upper limit of normal (ULN), or total bilirubin \>2x ULN at screening.
* Severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 2 years.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Site Status

Novartis Investigative Site

Matsudo, Chiba, Japan

Site Status

Novartis Investigative Site

Itoshima, Fukuoka, Japan

Site Status

Novartis Investigative Site

Kitakyushu, Fukuoka, Japan

Site Status

Novartis Investigative Site

Kitakyushu, Fukuoka, Japan

Site Status

Novartis Investigative Site

Kitakyushu, Fukuoka, Japan

Site Status

Novartis Investigative Site

Kitakyushu, Fukuoka, Japan

Site Status

Novartis Investigative Site

Nakagawa, Fukuoka, Japan

Site Status

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Site Status

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Site Status

Novartis Investigative Site

Sashima-gun, Ibaraki, Japan

Site Status

Novartis Investigative Site

Tsuchiura, Ibaraki, Japan

Site Status

Novartis Investigative Site

Kahoku-gun, Ishikawa-ken, Japan

Site Status

Novartis Investigative Site

Kanazawa, Ishikawa-ken, Japan

Site Status

Novartis Investigative Site

Kanazawa, Ishikawa-ken, Japan

Site Status

Novartis Investigative Site

Komatsu, Ishikawa-ken, Japan

Site Status

Novartis Investigative Site

Takamatsu, Kagawa-ken, Japan

Site Status

Novartis Investigative Site

Fujisawa, Kanagawa, Japan

Site Status

Novartis Investigative Site

Kawasaki, Kanagawa, Japan

Site Status

Novartis Investigative Site

Kuse, Kyoto, Japan

Site Status

Novartis Investigative Site

Sendai, Miyagi, Japan

Site Status

Novartis Investigative Site

Ōmura, Nagasaki, Japan

Site Status

Novartis Investigative Site

Izumisano, Osaka, Japan

Site Status

Novartis Investigative Site

Matsubara, Osaka, Japan

Site Status

Novartis Investigative Site

Osaka, Osaka, Japan

Site Status

Novartis Investigative Site

Osaka, Osaka, Japan

Site Status

Novartis Investigative Site

Osaka, Osaka, Japan

Site Status

Novartis Investigative Site

Suita, Osaka, Japan

Site Status

Novartis Investigative Site

Suita, Osaka, Japan

Site Status

Novartis Investigative Site

Iruma-gun, Saitama, Japan

Site Status

Novartis Investigative Site

Sayama, Saitama, Japan

Site Status

Novartis Investigative Site

Chiyoda City, Tokyo, Japan

Site Status

Novartis Investigative Site

Chuo-ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Chuo-ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Nerima-ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Shinagawa-ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Shinjuku Ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Chuoh-ku, , Japan

Site Status

Novartis Investigative Site

Gifu, , Japan

Site Status

Novartis Investigative Site

Kyoto, , Japan

Site Status

Novartis Investigative Site

Ōita, , Japan

Site Status

Novartis Investigative Site

Saga, , Japan

Site Status

Countries

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Japan

References

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Warden BA, Duell PB. Inclisiran: A Novel Agent for Lowering Apolipoprotein B-containing Lipoproteins. J Cardiovasc Pharmacol. 2021 Aug 1;78(2):e157-e174. doi: 10.1097/FJC.0000000000001053.

Reference Type DERIVED
PMID: 33990512 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=1656

Patient Lay Trial Summary

Other Identifiers

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CKJX839A11201

Identifier Type: -

Identifier Source: org_study_id

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