CompletedPhase 1

Study of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inclisiran in Chinese Participants With Elevated Serum LDL-C

China40 participantsStarted 2021-02-26

Plain-language summary

Study to evaluate the pharmacokinetics and pharmacodynamics of inclisiran treatment given as single subcutaneous injection in Chinese participants with elevated low-density lipoprotein cholesterol (LDL-C) despite treatment with LDL-C lowering therapies

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Written informed consent must be obtained before any assessment is performed.
. Male or female participants ≥ 18 years of age at screening
. Participants should meet fasting serum LDL-C ≥ 100 mg/dL (≥ 2.6 mmol/L) at screening
. Participants should meet fasting triglyceride \< 400 mg/dL (\< 4.52 mmol/L) at screening
. Participants should be receiving a maximally tolerated dose of statin#.
. For all participants, all the lipid-lowering therapy/ies (such as but not limited to statins and/or ezetimibe) should have remained stable (stable dose and no medication change) for ≥ 30 days before screening with no planned medication or dose change during study participation. #Maximum tolerated dose was defined as the maximum dose of statin that could be taken on a regular basis without intolerable AEs.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

PK parameters (Cmax) maximum peak observed plasma inclisiran concentration in treated participants

Timeframe: 0-48 hours post-dose

PK parameters (Tmax) time to reach maximum peak plasma inclisiran concentration in treated participants

Timeframe: 0-48 hours post-dose

PK parameters (T1/2) the elimination half-life associated with the terminal slope of a semi-logarithmic concentration-time curve in inclisiran treated participants

Timeframe: 0-48 hours post-dose

PK parameters (AUC) area under the plasma concentration-time curve in inclisiran treated participants

Timeframe: 0-48 hours post-dose

Percentage change in Proprotein convertase subtilisin kexin 9 (PCSK9) from baseline overtime

Timeframe: Baseline to Days 5, 8, 15, 30, 60 and 90

Percentage change in Low density lipoprotein cholesterol (LDL-C) from baseline overtime

Timeframe: Baseline to Days 5, 8, 15, 30, 60 and 90

Trial details

NCT IDNCT04774003

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-10-18

View on ClinicalTrials.gov More Hyperlipidemia trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Written informed consent must be obtained before any assessment is performed.
. Male or female participants ≥ 18 years of age at screening
. Participants should meet fasting serum LDL-C ≥ 100 mg/dL (≥ 2.6 mmol/L) at screening
. Participants should meet fasting triglyceride \< 400 mg/dL (\< 4.52 mmol/L) at screening
. Participants should be receiving a maximally tolerated dose of statin#.
. For all participants, all the lipid-lowering therapy/ies (such as but not limited to statins and/or ezetimibe) should have remained stable (stable dose and no medication change) for ≥ 30 days before screening with no planned medication or dose change during study participation. #Maximum tolerated dose was defined as the maximum dose of statin that could be taken on a regular basis without intolerable AEs.

What they're measuring

PK parameters (Cmax) maximum peak observed plasma inclisiran concentration in treated participants

Timeframe: 0-48 hours post-dose

PK parameters (Tmax) time to reach maximum peak plasma inclisiran concentration in treated participants

Timeframe: 0-48 hours post-dose

PK parameters (T1/2) the elimination half-life associated with the terminal slope of a semi-logarithmic concentration-time curve in inclisiran treated participants

Timeframe: 0-48 hours post-dose

PK parameters (AUC) area under the plasma concentration-time curve in inclisiran treated participants

Timeframe: 0-48 hours post-dose

Percentage change in Proprotein convertase subtilisin kexin 9 (PCSK9) from baseline overtime

Timeframe: Baseline to Days 5, 8, 15, 30, 60 and 90

Percentage change in Low density lipoprotein cholesterol (LDL-C) from baseline overtime

Timeframe: Baseline to Days 5, 8, 15, 30, 60 and 90

Study of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inclisiran in Chinese Participants With Elevated Serum LDL-C

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Study of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inclisiran in Chinese Participants With Elevated Serum LDL-C

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria