← Back to Search

RNA-based Therapeutic

Inclisiran for High Cholesterol (V-Mono Trial)

Phase 3
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 150
Awards & highlights

V-Mono 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.Check my eligibility
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.See study design
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.

V-Mono Trial Eligibility Criteria

Inclusion Criteria

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

V-Mono Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

V-Mono 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
~2240

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,860 Previous Clinical Trials
4,198,009 Total Patients Enrolled
2 Trials studying High Cholesterol
14,560 Patients Enrolled for High Cholesterol

Media Library

Inclisiran (RNA-based Therapeutic) Clinical Trial Eligibility Overview. Trial Name: NCT05763875 — Phase 3
High Cholesterol Research Study Groups: Inclisiran, Ezetimibe, Placebo
High Cholesterol 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I a viable candidate for participation in this research endeavor?

"Participants that wish to take part in this experiment must have a proven medical history of elevated cholesterol levels and be between 18-75 years old. This trial is scheduled to accept 300 patients in total."

Answered by AI

Are there any hazards associated with the use of Inclisiran?

"We assessed the safety of Inclisiran to be a 3, as there is evidence from prior clinical trials that suggest both its efficacy and security."

Answered by AI

Does the patient enrollment for this study extend to those younger than 75?

"This clinical trial is open to participants between 18 and 75 years old. There are 14 studies for minors, as well as 56 trials specifically designed for seniors over 65."

Answered by AI

Are there any more participants being accepted for this study?

"Affirmative. Clinicaltrials.gov has evidence that the medical study is actively looking for participants, which was first shared on March 15th 2023 and revised on March 30th 2023; they are aiming to recruit 300 patients from 3 different health centres."

Answered by AI

How many individuals will be participating in this clinical investigation?

"Affirmative, according to the details accessible on clinicaltrials.gov this trial is currently recruiting participants. This study was originally published on March 15th 2023 and subsequently updated on March 30th of the same year. Approximately 300 patients are needed from 3 distinct medical sites."

Answered by AI

What desired outcomes is this research endeavor striving to attain?

"Novartis Pharmaceuticals, the clinical trial sponsor, has outlined that Percentage change in LDL-C from Baseline to Day 150 compared with ezetimibe is their primary outcome. Secondary metrics being assessed include Percentage change in Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) and Apo B/Apo A-1 ratio between baseline and day 150 when juxtaposed against both ezetimibe and placebo as well as a measurement of percentage difference in Apolipoprotein B levels over this same window."

Answered by AI

Who else is applying?

What site did they apply to?
Mt Olympus Medical Research
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.
2023. "Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05763875.
All > Fargo > Cholesterol
~20 spots leftby Jun 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top