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

NCT05763875 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2025-10-16

Study results available
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Summary

CKJX839D12304 was a research study to determine if the study treatment, called inclisiran, in comparison to placebo and ezetimibe effectively reduces Low-Density Lipoprotein Cholesterol (LDL-C) as measured by percentage change from baseline to Day 150. This study was 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%.

Conditions

Interventions

DRUG

Inclisiran

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

DRUG

Ezetimibe

10 mg over-encapsulated 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

DRUG

Matching Placebo for Ezetimibe

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

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-15
Primary Completion
2024-06-20
Completion
2024-06-20
FDA Drug
Yes

Countries

  • United States
  • Colombia
  • Germany
  • Hungary
  • Mexico

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05763875 on ClinicalTrials.gov