Last Update: Apr 10, 2024
A Double-blind, Randomized, Placebo- and Active-Comparator Controlled Study to Evaluate the Efficacy of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-Lowering Therapy (VictORION-Mono)
ClinicalTrials.gov Identifier:
NCT05763875
Novartis Reference Number:CKJX839D12304
See if you Pre-qualify
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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%.

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.

Hypercholesterolemia
Phase 3
Recruiting
300
Mar 15, 2023
Jun 21, 2024
All
18 Years - 75 Years (Adult, Older Adult)

Interventions

Drug

Ezetimibe

10 mg over-encapsulated tablet taken once a day from Day 1 through Day 149
Drug

Inclisiran

284 mg (equivalent to 300 mg inclisiran sodium) subcutaneous injection given on Day 1 and Day 90
Drug

Matching Placebo for Ezetimibe

0mg over-encapsulated placebo tablet taken once a day from Day 1 through Day 149
Drug

Matching Placebo for Inclisiran

0mg placebo injection solution for subcutaneous injection on Day 1 and Day 90

Eligibility 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.

Study Location

Inpatient Research Clinical LLC

Recruiting

Miami Lakes,Sergio Ramirez (786-502-4303) email: [email protected] -- Alexis Gutierrez,33014 - Florida,United States

Worldwide Contacts

If the location of your choosing does not feature any contact detail, please reach out using the information below.

Novartis Pharmaceuticals

+41613241111

Novartis Pharmaceuticals

1-888-669-6682