Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Cholesterol. (V-Mono China)

Novartis

Status and phase: Completed; Phase 3

Conditions: Primary Hypercholesterolemia or Mixed Dyslipidemia

Treatments: Drug: Matching Placebo for Inclisiran; Drug: Inclisiran

Study type: Interventional

Funder types: Industry

Identifiers

NCT05888103

CKJX839D12305

Details and patient eligibility

About

The purpose of this study was to evaluate the efficacy and safety of inclisiran as a monotherapy in Chinese adults with low or moderate atherosclerotic cardiovascular disease (ASCVD) risk and elevated low-density lipoprotein cholesterol (LDL-C) who were not on any lipid lowering therapy.

Full description

This study was designed as a randomized, double-blind, multi-center Phase III trial, with a placebo-controlled treatment period and an open label treatment period, to evaluate the efficacy and safety of inclisiran sodium 300 mg s.c. in participants aged 18 to 75 years with a low or moderate ASCVD risk and fasting LDL-C value of ≥ 130 mg/dL but < 190 mg/dL who were not on any lipid lowering therapy.

The study consisted of 3 parts:

• Screening: the screening period was up to 14 days to allow adequate time for the eligibility evaluations.
• Core Part: a double-blind, placebo-controlled treatment period of 180 days in which eligible participants were randomized 1:1 to receive either inclisiran sodium 300 mg s.c.

(inclisiran group) or matching placebo s.c. (control group) on Day 1 and Day 90. The end of core part (EOC) visit was conducted on Day 180. The database lock for the core part was planned to occur after all randomized participants have completed the EOC visit (or have discontinued from the study before EOC). The primary analysis was conducted after the database lock for the core part.

• Extension Part: an extended treatment period of 180 days. In the extension part, participants originally randomized to inclisiran in the core part were to continue the inclisiran treatment while participants initially randomized to placebo were to transit to the inclisiran. The extension part was to start from the Day 180 treatment dose (placebo in the inclisiran group and inclisiran for participants originally randomized to the control group).

Enrollment: 207 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent must be obtained before any assessment is performed.
• Fasting LDL-C of ≥ 130 mg/dL but < 190 mg/dL
• Triglycerides ≤ 400 mg/dL
• Categorized as low or moderate ASCVD risk by the 2016 Chinese Guideline

Exclusion criteria

• Use of any LLT within 90 days prior to screening visit
• History of ASCVD
• Diabetes mellitus or fasting plasma glucose of ≥ 7.0 mmol/L or HbA1c ≥ 6.5%
• Secondary hypercholesterolemia, e.g. hypothyroidism or nephrotic syndrome

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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207 participants in 2 patient groups, including a placebo group

Inclisiran - Inclisiran

Experimental group

Description:

Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Day 1, Day 90, and Day 270, and placebo on Day 180

Treatment:

Drug: Inclisiran

Drug: Matching Placebo for Inclisiran

Placebo- Inclisiran

Placebo Comparator group

Description:

Placebo on Day 1 and Day 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c on Day 180 and 270

Treatment:

Drug: Inclisiran

Drug: Matching Placebo for Inclisiran