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RNA-based Therapeutic

Inclisiran for High Cholesterol (V-Mono Trial)

Phase 3
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Fasting LDL-C of >= 100mg/dL but < 190mg/dL
Be older than 18 years old
Must not have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 150
Awards & highlights
Pivotal Trial

Summary

This trial is examining if a new treatment can reduce cholesterol levels in those with high cholesterol who are not already taking medication.

Who is the study for?
This trial is for adults with high cholesterol who haven't used any cholesterol-lowering treatments recently. They should have a low risk of heart disease in the next 10 years and LDL-C levels that are high but not extremely so. People with conditions causing high cholesterol, like thyroid issues, or those with diabetes or past heart problems can't join.
What is being tested?
The study tests if inclisiran can lower 'bad' cholesterol (LDL-C) more effectively than a placebo or ezetimibe by day 150. Participants will be randomly assigned to receive either inclisiran, ezetimibe, or placebos for these drugs without knowing which one they're getting.
What are the potential side effects?
Inclisiran may cause side effects such as injection site reactions, allergic responses, common cold symptoms, and potential liver enzyme increases. Ezetimibe could lead to muscle pain, diarrhea, and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My fasting LDL cholesterol is between 100 and 190 mg/dL.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have diabetes or my blood sugar/HbA1c levels are high.
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My high cholesterol is due to an underactive thyroid.
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I have a history of heart or blood vessel disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 150
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 150 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage change in LDL-C from Baseline to Day 150 compared with ezetimibe
Percentage change in Low-density Lipoprotein Cholesterol (LDL-C) from Baseline to Day 150 compared with placebo
Secondary study objectives
Absolute change in LDL-C from Baseline to Day 150
Percentage change in Apo B/Apo A-1 ratio from Baseline to Day 150
Percentage change in Apolipoprotein B (Apo B) from Baseline to Day 150
+4 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: InclisiranExperimental Treatment2 Interventions
Inclisiran s.c and Placebo p.o
Group II: EzetimibeActive Control2 Interventions
Placebo s.c. and Ezetimibe p.o.
Group III: PlaceboPlacebo Group2 Interventions
Placebo s.c. and Placebo p.o.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inclisiran
2021
Completed Phase 3
~2820
Matching Placebo for Ezetimibe
2023
Completed Phase 3
~350

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,905 Previous Clinical Trials
4,207,765 Total Patients Enrolled
24 Trials studying Hypercholesterolemia
29,115 Patients Enrolled for Hypercholesterolemia

Media Library

Inclisiran (RNA-based Therapeutic) Clinical Trial Eligibility Overview. Trial Name: NCT05763875 — Phase 3
Hypercholesterolemia Research Study Groups: Inclisiran, Ezetimibe, Placebo
Hypercholesterolemia Clinical Trial 2023: Inclisiran Highlights & Side Effects. Trial Name: NCT05763875 — Phase 3
Inclisiran (RNA-based Therapeutic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05763875 — Phase 3
~135 spots leftby Nov 2025
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