Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy. (V-Mono)

Novartis

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05763875

CKJX839D12304

Details and patient eligibility

About

CKJX839D12304 is a research study to determine if the study treatment, called inclisiran, in comparison to placebo or ezetimibe can effectively reduce LDL-C as measured by percentage change from baseline to Day 150. This study is being conducted in eligible participants with primary hypercholesterolemia not receiving any lipid-lowering therapy (LLT), with a 10-year Atherosclerotic Cardiovascular Disease (ASCVD) risk of less than 7.5%.

Full description

This study is a randomized, double-blind, placebo- and active comparator-controlled, multicenter study in 300 adult participants with primary hypercholesterolemia not receiving any LLT with a 10-year ASCVD risk score of less than 7.5%. This study will evaluate the efficacy and safety of inclisiran sodium 300 mg, administered as a monotherapy in comparison to ezetimibe and placebo.

The study consists of:

• a screening period of up to 14 days;
• a double-blind treatment period of 150+/- 5 days during which participants will be randomly assigned to either the inclisiran arm, the ezetimibe arm or the placebo arm in a 2:1:1 ratio; and
• a safety follow-up / End of Study visit conducted 30+5 days after the Day 150 visit.

The overall study duration is approximately 190 days.

Enrollment: 350 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria to be met at screening:

• informed consent must be signed prior to participation in study
• fasting LDL-C of >= 100mg/dL but < 190mg/dL
• fasting triglycerides <= 400 mg/dL
• 10-year ASCVD risk score < 7.5%
• not on any lipid-lowering therapy within 90 days

Key Exclusion Criteria:

• history of ASCVD
• diabetes mellitus or fasting plasma glucose of >= 7.0 mmol/L or HbA1c >= 6.5%
• secondary hypercholesterolemia, e.g. hypothyroidism (TSH above upper limit of normal)

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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350 participants in 3 patient groups, including a placebo group

Inclisiran

Experimental group

Description:

Inclisiran s.c and Placebo p.o

Treatment:

Drug: Matching Placebo for Ezetimibe

Drug: Inclisiran

Ezetimibe

Active Comparator group

Description:

Placebo s.c. and Ezetimibe p.o.

Treatment:

Drug: Matching Placebo for Inclisiran

Drug: Ezetimibe

Placebo

Placebo Comparator group

Description:

Placebo s.c. and Placebo p.o.

Treatment:

Drug: Matching Placebo for Ezetimibe

Drug: Matching Placebo for Inclisiran