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NCT06597019RECRUITINGIRB Ready

Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia

(ORION-20)

Sponsored by Novartis Pharmaceuticals

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
๐Ÿ“Š
1 of 51 participants interested
2% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 6 to \<12 years) with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol (LDLC).

Who Can Participate

Inclusion Criteria

Male or female participants, 6 to \<12 years of age at screening
HeFH diagnosed either by genetic testing or on phenotypic criteria
Fasting LDL-C \>130 mg/dL (3.4 mmol/L) at screening
For participants 8 to \<12 years, on an optimal dose of statin (investigator's discretion) unless statin intolerant, with or without other lipid-lowering therapy (e.g. ezetimibe). For participants \<8 years, the use of background lipid-lowering treatment is based on investigator's discretion.
Participants on lipid-lowering therapies (such as statin and/or e.g. ezetimibe) must be on a stable dose for โ‰ฅ30 days before screening with no planned medication or dose changes during study participation.

Exclusion Criteria

Previous treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9
Secondary hypercholesterolemia, e.g. hypothyroidism or nephrotic syndrome
Homozygous familial hypercholesterolemia (HoFH)
Body weight \<16 kg at the screeni

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

51 participants

๐ŸŽ‚

Age Range

6 Years - 11 Years

โšง

Gender

ALL

๐Ÿข

Sponsor

Novartis Pharmaceuticals

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

San Francisco

California

Location available
View San Francisco location page
RECRUITING

San Francisco

California

Location available
View San Francisco location page
NOT_YET_RECRUITING

Washington D.C.

District of Columbia

Location available
View Washington D.C. location page
RECRUITING

Washington D.C.

District of Columbia

Location available
View Washington D.C. location page
RECRUITING

Boca Raton

Florida

Location available
View Boca Raton location page
RECRUITING

New York

New York

Location available
View New York location page
NOT_YET_RECRUITING

Salt Lake City

Utah

Location available
View Salt Lake City location page
RECRUITING

Salt Lake City

Utah

Location available
View Salt Lake City location page
RECRUITING

Richmond

Virginia

Location available
View Richmond location page

๐Ÿ“ And 2 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for High Cholesterol Treatment in San Francisco?

Join others in California exploring innovative treatment options through clinical research

High Cholesterol Treatment Options in San Francisco, California

If you're searching for High Cholesterol treatment in San Francisco, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in San Francisco, Washington D.C., Washington D.C. and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with High Cholesterol. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 51 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for High Cholesterol?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for High Cholesterol

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This High Cholesterol Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06597019. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.