100 Participants Needed

Inclisiran for Hypercholesterolemia

(SOLVE-LDL-C Trial)

PT
AS
Overseen ByAntoinette S Birs, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of California, San Diego
Must be taking: Statins
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

Drug-drug interactions often limit statin optimization in a population of patients prescribed cytochrome P3A4 inhibitors, which include immunosuppressive agents, protease inhibitors, and antifungals. These patients frequently have autoimmune conditions or rheumatologic disorders that require complex drug regimens and are often on low-dose statin therapy or no statin at all, resulting in suboptimal LDL levels despite increased cardiovascular (CV) risk.There is an unmet clinical need to improve LDL levels in this vulnerable patient population, which faces increased CV risk due to underlying conditions that also contribute to polypharmacy and multiple drug-drug interactions. This study is a randomized, open-label trial evaluating subcutaneous inclisiran plus standard of care for LDL-C lowering in high-risk primary prevention patients with multiple comorbidities (e.g., Type II diabetes, liver disease, chronic kidney disease, autoimmune disease, solid-organ transplant) who are taking five or more medications in which drug-drug interactions prevent optimization of statin therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, it mentions that participants should be on five or more prescription drugs and on maximally tolerated statin therapy, which can be no statin if you have intolerance. It's best to discuss your specific medications with the trial team.

Is Inclisiran safe for humans?

Inclisiran has been tested in several clinical trials, and no severe adverse effects or safety concerns directly related to the drug have been reported. It is considered safe and well-tolerated for lowering cholesterol levels.12345

How is the drug Inclisiran different from other treatments for hypercholesterolemia?

Inclisiran is unique because it is a small interfering RNA drug that lowers bad cholesterol (LDL-C) by blocking the production of a protein called PCSK9, and it only needs to be administered twice a year. This infrequent dosing helps with medication adherence, making it different from other treatments like statins, which require daily intake.46789

What data supports the effectiveness of the drug Inclisiran for treating hypercholesterolemia?

Inclisiran has been shown to significantly lower LDL cholesterol (the 'bad' cholesterol) by about 50% in patients with high cholesterol, even when they are already on other cholesterol-lowering medications. It also helps reduce the risk of major heart-related events, making it an effective treatment for managing cholesterol levels and improving heart health.4571011

Who Is on the Research Team?

MW

Michael Wilkinson, MD

Principal Investigator

University of California, San Diego

ED

Eric D Adler, MD

Principal Investigator

University of California, San Diego

PT

Pam Taub, MD

Principal Investigator

University of California, San Diego

AB

Antoinette Birs, MD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 with metabolic syndrome or hypercholesterolemia, taking five or more prescription drugs. It's aimed at those who can't fully use statins due to drug interactions, like people with Type II diabetes, liver disease, chronic kidney disease, autoimmune diseases, or organ transplants. Participants should have an elevated risk of heart disease and be willing to receive injections.

Inclusion Criteria

I have signed the consent form.
My LDL is over 90 mg/dL or my non-HDL is over 120 mg/dL.
My heart disease risk score for the next 10 years is 7.5% or higher.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Baseline

Baseline assessments and first dose of inclisiran for the intervention group

1 day
1 visit (in-person)

Treatment

Participants receive inclisiran injections at baseline, 3 months, and 9 months; standard of care continues for all

12 months
3 visits (in-person) for inclisiran group, 5 visits (in-person) for all

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Inclisiran
Trial Overview The study tests Inclisiran sodium as a subcutaneous injection for lowering bad cholesterol (LDL-C) in patients where other medications interfere with statin use. The trial is open-label and randomized; participants will also continue their standard care while receiving the new treatment.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Standard of Care, no interventionActive Control1 Intervention
Group II: Inclisiran ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials
1,215
Recruited
1,593,000+

Novartis

Industry Sponsor

Trials
1,646
Recruited
2,778,000+
Vasant Narasimhan profile image

Vasant Narasimhan

Novartis

Chief Executive Officer since 2018

MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government

Shreeram Aradhye profile image

Shreeram Aradhye

Novartis

Chief Medical Officer since 2022

MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania

Published Research Related to This Trial

Inclisiran, a novel treatment for lowering LDL cholesterol, was evaluated in two phase 3 trials involving a significant number of patients, demonstrating its efficacy in reducing LDL levels over time.
The results indicated that inclisiran effectively lowered LDL cholesterol levels compared to placebo, suggesting it could be a valuable option for patients struggling with high cholesterol.
In patients with ASCVD and elevated LDL-C with maximal statin therapy, inclisiran reduced LDL-C levels at 18 months.Clark, J., Montori, V.[2020]
Inclisiran is an effective treatment for dyslipidemia, significantly lowering LDL cholesterol (LDL-C) levels through a novel mechanism that silences the PCSK9 gene, as demonstrated in clinical trials from the ORION program.
The safety profile of inclisiran is favorable, with adverse events similar to placebo, although injection-site reactions were more common; this suggests it is a well-tolerated option for patients compared to other PCSK9 therapies.
Inclisiran: a small interfering RNA strategy targeting PCSK9 to treat hypercholesterolemia.Banerjee, Y., Pantea Stoian, A., Cicero, AFG., et al.[2022]
Inclisiran significantly reduces low-density lipoprotein cholesterol (LDL-C) by approximately 50%, with this reduction sustained for up to 4 years, making it an effective long-term treatment option for managing cholesterol levels.
The treatment is well tolerated, with injection-site reactions being the most common side effect, and it has shown potential for reducing cardiovascular events compared to placebo, suggesting it may be a cost-effective alternative to other therapies like PCSK-9 inhibitors.
Inclisiran for the Treatment of Hyperlipidemia and for Atherosclerotic Cardiovascular Disease Risk Reduction: A Narrative Review.Cowart, K., Singleton, J., Carris, NW.[2023]

Citations

In patients with ASCVD and elevated LDL-C with maximal statin therapy, inclisiran reduced LDL-C levels at 18 months. [2020]
Inclisiran: a small interfering RNA strategy targeting PCSK9 to treat hypercholesterolemia. [2022]
Inclisiran for the Treatment of Hyperlipidemia and for Atherosclerotic Cardiovascular Disease Risk Reduction: A Narrative Review. [2023]
Clinical implications and outcomes of the ORION Phase III trials. [2022]
Estimation of the major cardiovascular events prevention with Inclisiran. [2022]
Can Clinicians Start Prescribing Inclisiran for Hypercholesterolemia Today? A Review of Clinical Studies for Internal Medicine Physicians and Endocrinologists. [2021]
Serious adverse events of Inclisiran in patients with hypercholesterolemia, a meta analysis of ORION trials. [2023]
Inclisiran: A First-in-Class siRNA Therapy for Lowering Low-Density Lipoprotein Cholesterol. [2023]
Rationale and design of two trials assessing the efficacy, safety, and tolerability of inclisiran in adolescents with homozygous and heterozygous familial hypercholesterolaemia. [2022]
Cost Effectiveness of Inclisiran in Atherosclerotic Cardiovascular Patients with Elevated Low-Density Lipoprotein Cholesterol Despite Statin Use: A Threshold Analysis. [2023]
Inclisiran for the Treatment of Cardiovascular Disease: A Short Review on the Emerging Data and Therapeutic Potential. [2020]
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