Phase 3 N=350 Randomized Triple-blind Treatment

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

Hypercholesterolemia

Bottom Line

View on ClinicalTrials.gov: NCT05763875 ↗

Enrolled (actual)

350

Serious AEs

0.3%

Results posted

Aug 2025

Primary outcome: Primary: Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 150 — -46.54; -11.17; 1.37; -49.37 Percentage change from baseline — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Inclisiran (Drug); Ezetimibe (Drug); Matching Placebo for Inclisiran (Drug); Matching Placebo for Ezetimibe (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Jun 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 150	-46.54; -11.17; 1.37; -49.37; -11.92; -1.53	<0.0001 sig
SECONDARY Absolute Change in LDL-C From Baseline to Day 150	-64.86; -17.55; -1.29; -68.57; -18.52; -1.07	<0.0001 sig
SECONDARY Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Day 150	-67.12; 6.04; 7.82; -71.31; 5.56; 8.16	<0.0001 sig
SECONDARY Percentage Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Day 150	-40.45; -9.97; 1.88; -42.82; -10.84; 2.04	<0.0001 sig
SECONDARY Percentage Change in Total Cholesterol (TC)/HDL-C Ratio From Baseline to Day 150	-31.54; -6.70; 2.31; -33.56; -6.98; 2.51	<0.0001 sig
SECONDARY Percentage Change in Apolipoprotein B (Apo B) From Baseline to Day 150	-37.39; -8.41; -0.73; -39.36; -9.20; -0.58	<0.0001 sig
SECONDARY Percentage Change in Apo B/Apo A-1 Ratio From Baseline to Day 150	-37.79; -7.55; -2.65; -40.03; -7.69; -2.65	<0.0001 sig
SECONDARY Change in Lipoprotein (a) [Lp(a)] From Baseline to Day 150	0.690; 0.911; 0.923; 0.687; 0.912; 0.922	0.0002 sig
SECONDARY Incidence of Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)	54; 27; 25; 11; 4; 0	—

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%.

Eligibility Criteria

Inclusion Criteria at screening:

informed consent signed prior to participation in study
fasting LDL-C of >= 100 mg/dL but = 7.0 mmol/L or HbA1c >= 6.5%
secondary hypercholesterolemia, e.g. hypothyroidism (TSH above upper limit of normal)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05763875). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.