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New oral drug shows promise for genetic high cholesterol

NCT ID NCT05952869

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tested an oral drug called enlicitide decanoate (MK-0616) in 303 adults with heterozygous familial hypercholesterolemia, an inherited condition causing very high cholesterol. Participants took either the drug or a placebo daily for up to 52 weeks. The main goal was to see if the drug lowers LDL (bad) cholesterol more than placebo at 24 weeks, while also checking safety. This study is complete, and results will show if this pill could become a new treatment option.

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 (MK-0616), an oral tablet
What this could lead to
If successful, this could provide a new daily pill to help people with inherited high cholesterol lower their LDL levels, potentially reducing heart disease risk.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The drug may not prove significantly better than placebo, and side effects are still being evaluated.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

303 people

The number who actually took part.

Started

Aug 2023

Finished

Apr 2025

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

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: * Has possible or definite diagnosis of heterozygous familial hypercholesterolemia (HeFH) based on a locally accepted diagnostic algorithm * Has an LDL-C ≥55 mg/dL or ≥70 mg/dL depending on medical history * Is treated with a moderate- or high-intensity statin medication * Is on a stable dose of all background lipid-lowering therapies (LLTs) with no planned medication change Exclusion Criteria: * Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous FH, or double heterozygous FH * Has a history of heart failure or heart failure hospitalization within 3 months before first study visit * Is undergoing or previously underwent an LDL-C apheresis program within 3 months before first study visit or plans to initiate an LDL-C apheresis program * Was previously treated/is being treated with certain other cholesterol lowering medications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors

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Conditions

The condition(s) this trial relates to.

familial hypercholesterolemia Hypercholesterolemia hyperlipidemia Hyperlipoproteinemia Type II

As listed by the trial registrant

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

Familial hypercholesterolemia Hypercholesterolemia

Contacts and locations

Locations

  • Advanced Pharma Research ( Site 0007)

    Cutler Bay, Florida, 33189, United States

  • Alliance for Multispecialty Research, LLC ( Site 0023)

    Daphne, Alabama, 36526, United States

  • Amsterdam UMC, locatie AMC-Vascular Medicine Clin Trial Unit ( Site 1954)

    Amsterdam, North Holland, 1105 AZ, Netherlands

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0001)

    Troy, Michigan, 48098, United States

  • CDIEM ( Site 0814)

    Providencia, Region M. de Santiago, 7500859, Chile

  • Changi General Hospital ( Site 3211)

    Singapore, Central Singapore, 529889, Singapore

  • Ciensalud Ips S A S ( Site 0903)

    Barranquilla, Atlántico, 08001, Colombia

  • Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 1700)

    Sakhnin, 308100, Israel

  • Clinica de la Costa S.A.S. ( Site 0902)

    Barranquilla, Atlántico, 080020, Colombia

  • Clinical Research Chile SpA ( Site 0804)

    Valdivia, Los Ríos Region, 5110683, Chile

  • Clinical Site Partners LLC, dba CSP Orlando ( Site 0028)

    Winter Park, Florida, 32789, United States

  • Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Anyagcsere Tanszék) ( Site 1601)

    Debrecen, 4032, Hungary

  • Diex Recherche Trois-Rivieres ( Site 0513)

    Trois-Rivières, Quebec, G9A 4P3, Canada

  • Ecogene-21 ( Site 0510)

    Chicoutimi, Quebec, G7H 7K9, Canada

  • Enroll SpA ( Site 0803)

    Santiago, Region M. de Santiago, 7500587, Chile

  • Excel Medical Clinical Trials ( Site 0008)

    Boca Raton, Florida, 33434, United States

  • Fakultni Nemocnice u sv. Anny v Brne ( Site 3604)

    Brno, South Moravian, 60200, Czechia

  • Fakultní nemocnice Brno Bohunice-Interni kardiologicka klinika ( Site 3602)

    Brno, Brno-mesto, 625 00, Czechia

  • Franciscan Physician Network - Indiana Heart Physicians ( Site 0040)

    Indianapolis, Indiana, 46237, United States

  • Fundación Centro de Investigación Clínica CIC ( Site 0906)

    Medellín, Antioquia, 050021, Colombia

  • HOSPITAL CLINICO DE VALENCIA ( Site 2321)

    Valencia, Valenciana, Comunitat, 46010, Spain

  • Hadassah Medical Center ( Site 1709)

    Jerusalem, 9112001, Israel

  • Health Research of Hampton Roads, Inc. ( Site 0020)

    Newport News, Virginia, 23606, United States

  • Hospital de Sant Joan Despí Moisès Broggi ( Site 2335)

    Sant Joan Despí, Catalonia, 08970, Spain

  • Incor - Instituto do Coracao ( Site 0703)

    São Paulo, 05403-000, Brazil

  • Institut Klinicke a Experimentalni Mediciny ( Site 3601)

    Prague, Praha 4, 140 21, Czechia

  • Institut de Cardiologie de Montreal ( Site 0506)

    Montreal, Quebec, H1T 1C8, Canada

  • Instituto Dante Pazzanese de Cardiology-Fundação Adib Jatene ( Site 0701)

    São Paulo, São Paulo, 04012-909, Brazil

  • Jubilee Clinical Research ( Site 0030)

    Las Vegas, Nevada, 89106, United States

  • Mackay Memorial Hospital -Tamshui Branch ( Site 3109)

    New Taipei City, New Taipei, 251, Taiwan

  • Meilahden tornisairaala - Meilahti Tower Hospital ( Site 1300)

    Helsinki, Uusimaa, 00290, Finland

  • National Cheng Kung University Hospital-Internal Medicine ( Site 3107)

    Tainan, 704, Taiwan

  • National Taiwan University Hospital ( Site 3100)

    Taipei, 10002, Taiwan

  • National University Hospital-Department of Medicine ( Site 3212)

    Singapore, Central Singapore, 119074, Singapore

  • New Zealand Clinical Research (Christchurch) ( Site 2901)

    Christchurch, Canterbury, 8011, New Zealand

  • Nordlandssykehuset ( Site 2001)

    Bodø, Nordland, 8005, Norway

  • Oslo Universitetssykehus Aker-Lipidklinikken ( Site 2000)

    Oslo, 0316, Norway

  • Pacific Clinical Research Network - Rotorua ( Site 2902)

    Rotorua, Bay of Plenty, 3010, New Zealand

  • Pontificia Universidad Catolica de Chile-CICUC ( Site 0812)

    Santiago, Region M. de Santiago, 8330034, Chile

  • Prince of Wales Hospital ( Site 3304)

    Shatin, NT, Hong Kong

  • Progressive Medical Research ( Site 0021)

    Port Orange, Florida, 32127, United States

  • Queen Mary Hospital-Medical ( Site 3300)

    Pok Fu Lam, Hong Kong

  • Rabin Medical Center ( Site 1717)

    Petah Tikva, 4941492, Israel

  • Radboudumc-internal medicine ( Site 1952)

    Nijmegen, Gelderland, 6525 GA, Netherlands

  • Royal Prince Alfred Hospital-6West CV Ambulatory Care ( Site 2808)

    Camperdown, New South Wales, 2050, Australia

  • SALUT SANT JOAN DE REUS-BAIX CAMP (EDP)-Vascular and Metabolism Unit ( Site 2329)

    Reus, Tarragona, 43204, Spain

  • Salud SURA Calle 100 ( Site 0918)

    Bogotá, Cundinamarca, 110231, Colombia

  • Semmelweis Egyetem-Városmajori Szív- és Érgyógyászati Klinika ( Site 1600)

    Budapest, 1122, Hungary

  • Shaare Zedek Medical Center ( Site 1710)

    Jerusalem, 9103102, Israel

  • Shin Kong Wu Ho-Su Memorial Hospital ( Site 3106)

    Taipei City, Taipei, 111, Taiwan

  • Synexus Clinical Research US - Evansville ( Site 0031)

    Evansville, Indiana, 47714, United States

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Belgyógyászati Klinika ( Site 1603)

    Szeged, Csongrád megye, 6725, Hungary

  • Universidade Federal Do Ceara ( Site 0702)

    Fortaleza, Ceará, 60430-270, Brazil

  • Universitair Medisch Centrum Utrecht-Vascular Medicine Research ( Site 1955)

    Utrecht, 3584 CX, Netherlands

  • Vasculair Onderzoek Centrum Hoorn ( Site 1953)

    Hoorn, North Holland, 1625 HV, Netherlands

  • Velocity Clinical Research at The Pioneer Heart Institute, Lincoln ( Site 0026)

    Lincoln, Nebraska, 68506, United States

  • Velocity Clinical Research, Salt Lake City ( Site 0004)

    West Jordan, Utah, 84088, United States

  • Victorian Heart Hospital-Monash Cardiovascular Research Centre (MCRC) ( Site 2803)

    Clayton, Victoria, 3168, Australia

  • Wake Forest Baptist Health-Cardiovascular Medicine ( Site 0041)

    Winston-Salem, North Carolina, 27157, United States

More trials for these conditions

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