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New Twice-Yearly shot aims to close cholesterol care gaps in heart disease

NCT ID NCT06249165

Disease control Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jul 30, 2026 · Updated 3 times

Summary

This study tests inclisiran, a twice-yearly injection, to help people with heart disease or at high risk for it reach their LDL cholesterol goals. It focuses on groups often understudied, like women, Black, Hispanic, and rural patients. The trial enrolls 130 adults and measures whether they hit target LDL levels after one year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Inclisiran (a twice-yearly injection to lower LDL cholesterol)
What this could lead to
If successful, inclisiran could offer a convenient, long-acting option to help more people with heart disease reach their cholesterol goals, especially those who are often left out of studies.
What could go wrong
This is a small, early-stage Phase 4 trial with only 130 participants. It may not prove that inclisiran works better than current treatments, and results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

130 people

The number who actually took part.

Started

Dec 2024

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Must meet all criteria below. 1. Males and females \>= 18 years of age 2. Have clinical ASCVD or ASCVD risk equivalent diagnosis captured in EHR 3. Serum LDL-C ≥ 70 mg/dL for participants with ASCVD, or LDL-C ≥ 100 mg/dL for ASCVD risk equivalent participants, based on last recorded LDL-C value within the preceding eighteen (18) months without a subsequent change in lipid lowering therapy. 4. Willing and able to give informed consent before initiation of any study related procedures and willing to comply with all required study procedures. 5. On statin therapy, or have documented statin intolerance, as determined by the treating clinician. Participants for whom statin therapy has been recently initiated must be on stable therapy for at least 4 weeks and subsequent LDL-C must be above the threshold. 6. From historically underrepresented populations in cardiovascular clinical research, including at least one of the following: female sex; Hispanic/Latino ethnicity; Black/African-American, Asian, or Native American race; rural dwelling based on the HRSA definition for determining rural grant eligibility using the Federal Office of Rural Health Policy (FORHP) 2010 County and Census Tract file. Exclusion Criteria: Cannot meet any criteria below. 1. Planned use of other investigational products or devices during the course of the study. 2. Treatment with monoclonal antibodies directed towards PCSK9 within 90 days or with inclisiran within 180 days of pre-screening. 3. History of hypersensitivity to the study treatment or its excipients or to other siRNA drugs. 4. Pregnant or nursing (lactating) women. 5. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of contraception during dosing of study treatment. 6. New York Heart Association (NYHA) class III or IV heart failure or last known left ventricular ejection fraction \<25%. 7. Significant cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication or other methods (i.e. via ablation etc.) at the time of pre-screening. Controlled arrhythmia is not an exclusion. 8. Uncontrolled hypertension: systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg prior to randomization despite antihypertensive therapy. 9. Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or alanine aminotransferase (ALT) elevation \>3x ULN, aspartate aminotransferase (AST) elevation \>3x ULN, or total bilirubin elevation \>2x ULN (except participants with Gilbert's syndrome) at pre-screening confirmed by a repeat measurement at least one week apart. Lack of repeat measurement is not considered an exclusion. 10. End-stage renal disease (ESRD), defined as being on dialysis of any kind.

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Conditions

The condition(s) this trial relates to.

atherosclerosis atherosclerotic cardiovascular disease Hypercholesterolemia hyperlipidemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atherosclerotic cardiovascular disease

Contacts and locations

Locations

  • Baylor Scott & White - Waco

    Waco, Texas, 76708, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Emory University

    Atlanta, Georgia, 30324, United States

  • Essentia Health

    Duluth, Minnesota, 55805, United States

  • Heart House of NJ

    Haddon Heights, New Jersey, 08035, United States

  • Houston Methodist

    Houston, Texas, 77030, United States

  • JHU - Suburban Hospital

    Bethesda, Maryland, 20814, United States

  • Johns Hopkins

    Columbia, Maryland, 21044, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Medical Univ. of South Carolina

    Charleston, South Carolina, 29403, United States

  • Rush University

    Chicago, Illinois, 60612, United States

  • San Francisco General Hospital

    San Francisco, California, 94110, United States

  • Temple University

    Philadelphia, Pennsylvania, 19140, United States

  • Univ. of Alabama - Birmingham

    Birmingham, Alabama, 35205, United States

  • Univ. of California - Irvine

    Orange, California, 92868, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Missouri

    Columbia, Missouri, 65212, United States

  • University of Nebraska

    Omaha, Nebraska, 68198, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27514, United States

  • University of Utah

    Salt Lake City, Utah, 84132, United States

  • Wake Forest University

    Winston-Salem, North Carolina, 27157, United States

  • Washington University

    St Louis, Missouri, 63110, United States

  • Wellstar Paulding

    Hiram, Georgia, 30141, United States

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