The trial is taking place at:
S

SEC Clinical Research | Dothan, AL

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

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Novartis

Status and phase

Active, not recruiting
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

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

Trial contacts and locations

42

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Central trial contact

Novartis Pharmaceuticals; Novartis Pharmaceuticals

Data sourced from clinicaltrials.gov

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