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New daily pill could help kids with inherited high cholesterol

NCT ID NCT07058077

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 15, 2026 · Updated 9 times

Summary

This study tests a daily pill called enlicitide decanoate in 153 children and teens with heterozygous familial hypercholesterolemia (HeFH), a genetic condition causing very high cholesterol. The goal is to see if the drug safely lowers LDL cholesterol more than a placebo. Researchers will also check how the drug moves through the body and any side effects.

What this could mean

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

Active substance
enlicitide decanoate (a daily pill to lower cholesterol)
What this could lead to
If it works, this could give children with inherited high cholesterol a new daily pill option to lower their cholesterol and reduce heart risks.
What could go wrong
This is an early-to-mid stage study with only 153 children, so results may not confirm long-term safety or effectiveness. Side effects are possible, and the drug may not work for 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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 153 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Jan 2037

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

6 to 17 years

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: Inclusion criteria include, but are not limited to: * Has possible or definite diagnosis of HeFH based on a locally accepted diagnostic algorithm or diagnosis by genetic testing results * Has a fasted LDL-C value (evaluated by the central laboratory) that is ≥130 mg/dL * Is receiving either: * An optimized daily dose of statin (± nonstatin LLT) * A nonstatin LLT with documented intolerance to at least 2 different statins, or documented intolerance to 1 statin plus refusal of statin therapy by the participant or legally acceptable representative * Is on a stable dose of all background LLTs for at least 30 days prior to screening, with no medication or dose changes planned during participation in Part A or Part B Exclusion Criteria: Exclusion criteria include, but are not limited to: * Has a history of homozygous FH based on genetic or clinical criteria, or history of known compound heterozygous FH, or double heterozygous FH * Has a history of nephrotic syndrome * Has any clinically significant malabsorption condition based on investigator assessment * Was previously treated/is being treated with certain other cholesterol lowering medications, including proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout

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Conditions

The condition(s) this trial relates to.

familial hypercholesterolemia

As listed by the trial registrant

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

Heterozygous familial hypercholesterolemia (HEFH)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    43 sites in 18 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Amsterdam UMC, locatie AMC ( Site 1000)

    RECRUITING

    Amsterdam, North Holland, 1105 AZ, Netherlands

  • Beijing Anzhen Hospital. Capital Medical University ( Site 1917)

    RECRUITING

    Beijing, Beijing Municipality, 100029, China

  • Birmingham Childrens Hospital ( Site 1501)

    RECRUITING

    Birmingham, B4 6NH, United Kingdom

  • Boston Children's Hospital ( Site 0018)

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • COMPLEJO HOSPITALARIO DE NAVARRA ( Site 1302)

    RECRUITING

    Pamplona, Navarre, 31009, Spain

  • Centro de Investigacion Clinica de Oaxaca ( Site 0505)

    RECRUITING

    Oaxaca City, Oaxaca, 68020, Mexico

  • Children's Healthcare of Atlanta Cardiology ( Site 0026)

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Children's Hospital Capital Institute of Pediatrics ( Site 1908)

    RECRUITING

    Beijing, Beijing Municipality, 100020, China

  • Children's Hospital of Fudan University ( Site 1906)

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

  • Children's National Medical Center ( Site 0015)

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Cincinnati Children's Hospital Medical Center ( Site 0016)

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Clinica de la Costa S.A.S. ( Site 0400)

    RECRUITING

    Barranquilla, Atlántico, 080020, Colombia

  • Detska nemocnice FN Brno ( Site 0701)

    RECRUITING

    Brno, Brno-mesto, 613 00, Czechia

  • Excel Medical Clinical Trials ( Site 0008)

    RECRUITING

    Boca Raton, Florida, 33434, United States

  • Explora Salud ( Site 0304)

    RECRUITING

    Santiago, Region M. de Santiago, 7500504, Chile

  • Fakultni nemocnice v Motole ( Site 0700)

    RECRUITING

    Prague, 150 00, Czechia

  • Fundacion Valle del Lili ( Site 0403)

    RECRUITING

    Cali, Valle del Cauca Department, 760032, Colombia

  • Fundación Cardiovascular de Colombia ( Site 0402)

    RECRUITING

    Piedecuesta, Santander Department, 681017, Colombia

  • Guangdong Provincial People's Hospital ( Site 1915)

    RECRUITING

    Guangzhou, Guangdong, 510080, China

  • Hopital Femme Mere Enfant ( Site 2101)

    RECRUITING

    Bron, Rhone, 69500, France

  • Hospital Clinico Universitario de Santiago de Compostela ( Site 1300)

    RECRUITING

    Santiago de Compostela, La Coruna, 15706, Spain

  • Hospital Universitario Central de Asturias ( Site 1303)

    RECRUITING

    Oviedo, Asturias, Principado de, 33011, Spain

  • INVECORDIS S.C. ( Site 0503)

    RECRUITING

    Huixquilucan, 52763, Mexico

  • Incor - Instituto do Coracao ( Site 0200)

    RECRUITING

    São Paulo, 05403900, Brazil

  • Instituto Dante Pazzanese de Cardiology ( Site 0206)

    RECRUITING

    São Paulo, 04012-909, Brazil

  • Instytut Centrum Zdrowia Matki Polki ( Site 1201)

    RECRUITING

    Lodz, Łódź Voivodeship, 93-338, Poland

  • Laboratorio de Patología Clínica del Hospital Universitario "Dr. José Eleuterio González" ( Site 0501)

    RECRUITING

    Monterrey, Nuevo León, 64460, Mexico

  • Monash Children s Hospital ( Site 1603)

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • National University Hospital-Paediatrics ( Site 1800)

    RECRUITING

    Singapore, Central Singapore, 117599, Singapore

  • Nemours/Alfred I. duPont Hospital for Children ( Site 0001)

    RECRUITING

    Wilmington, Delaware, 19803, United States

  • New Childrens Hospital ( Site 0800)

    RECRUITING

    Helsinki, Uusimaa, 00029, Finland

  • New Zealand Clinical Research (Christchurch) ( Site 1700)

    RECRUITING

    Christchurch, Canterbury, 8011, New Zealand

  • Oncomédica S.A.S ( Site 0401)

    RECRUITING

    Montería, Departamento de Córdoba, 230002, Colombia

  • Perth Children s Hospital ( Site 1601)

    RECRUITING

    Nedlands, Western Australia, 6909, Australia

  • Pontificia Universidad Catolica de Chile ( Site 0300)

    RECRUITING

    Santiago, Region M. de Santiago, 8330032, Chile

  • Shanghai Children's Medical Center ( Site 1918)

    RECRUITING

    Shanghai, Shanghai Municipality, 200120, China

  • Sheffield Childrens Hospital ( Site 1503)

    RECRUITING

    Sheffield, S10 2TH, United Kingdom

  • Southampton General Hospital ( Site 1502)

    RECRUITING

    Southampton, SO16 6YD, United Kingdom

  • The Children's Hospital of Zhejiang University School of Medicine ( Site 1905)

    RECRUITING

    Hangzhou, Zhejiang, 310057, China

  • UZ Antwerpen ( Site 0601)

    RECRUITING

    Edegem, Antwerpen, 2650, Belgium

  • Universidade Federal Do Ceara ( Site 0201)

    RECRUITING

    Fortaleza, Ceará, 60430270, Brazil

  • Universitaetsklinikum Freiburg ( Site 2203)

    RECRUITING

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • West Virginia University ( Site 0013)

    RECRUITING

    Morgantown, West Virginia, 26506, United States

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Other studies related to the condition(s) this trial covers.