AzTrials
AzTrials

Heterozygous Familial Hypercholesterolemia (HeFH)Phase 2/3NCT07058077

A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)

A Phase 2/3 study testing Enlicitide Decanoate in people with Heterozygous Familial Hypercholesterolemia (HeFH), run by Merck Sharp & Dohme LLC at 47 sites in 19 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

Search all trials

Trial summary

This study is designed to learn if enlicitide decanoate is safe and effective to treat children and adolescents with heterozygous familial hypercholesterolemia (HeFH) and high amounts of low-density lipoprotein cholesterol (LDL-C) in the blood. Read more about this study

Who is it for?
Ages 6 to 17 years
What is being tested?
Enlicitide Decanoate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
153 participants
Where
47 sitesin 19 countries
Study dates
21 Aug 2025to 23 Jan 2037
Phase
Phase 2/3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

47 sites in 19 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

47 sites in 19 countries

United States8 sites, 8 recruiting

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

    Atlanta, Georgia, 30329

    Study Coordinator, 404-256-2593

    Recruiting

  • Excel Medical Clinical Trials ( Site 0008)

    Boca Raton, Florida, 33434

    Study Coordinator, 561-529-4356

    Recruiting

  • Boston Children's Hospital ( Site 0018)

    Boston, Massachusetts, 02115

    Study Coordinator, 616-354-3372

    Recruiting

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

    Cincinnati, Ohio, 45229

    Study Coordinator, 513-636-3200

    Recruiting

  • West Virginia University ( Site 0013)

    Morgantown, West Virginia, 26506

    Study Coordinator, 304-598-4000

    Recruiting

  • St. Louis Children's Hospital ( Site 0014)

    St Louis, Missouri, 63110

    Study Coordinator, 314-454-6000

    Recruiting

  • Children's National Medical Center ( Site 0015)

    Washington D.C., District of Columbia, 20010

    Study Coordinator, 202-476-5000

    Recruiting

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

    Wilmington, Delaware, 19803

    Study Coordinator, 302-651-6600

    Recruiting

Other trials in United States

China6 sites, 6 recruiting

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

    Beijing, Beijing Municipality, 100020

    Study Coordinator, 010-85695555

    Recruiting

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

    Beijing, Beijing Municipality, 100029

    Study Coordinator, 010-64412431

    Recruiting

  • Guangdong Provincial People's Hospital ( Site 1915)

    Guangzhou, Guangdong, 510080

    Study Coordinator, 02083882222

    Recruiting

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

    Hangzhou, Zhejiang, 310057

    Study Coordinator, 0571-86036545

    Recruiting

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

    Shanghai, Shanghai Municipality, 200032

    Study Coordinator, 021-96999176

    Recruiting

  • Shanghai Children's Medical Center ( Site 1918)

    Shanghai, Shanghai Municipality, 200120

    Study Coordinator, 021-38626161

    Recruiting

Other trials in China

Colombia4 sites, 4 recruiting

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

    Barranquilla, Atlántico, 080020

    Study Coordinator, +57 3133894240

    Recruiting

  • Fundacion Valle del Lili ( Site 0403)

    Cali, Valle del Cauca Department, 760032

    Study Coordinator, +573166237452

    Recruiting

  • Oncomédica S.A.S ( Site 0401)

    Montería, Departamento de Córdoba, 230002

    Study Coordinator, +57 3135342052

    Recruiting

  • Fundación Cardiovascular de Colombia ( Site 0402)

    Piedecuesta, Santander Department, 681017

    Study Coordinator, +573203400438

    Recruiting

Other trials in Colombia

Brazil3 sites, 3 recruiting

  • Universidade Federal Do Ceara ( Site 0201)

    Fortaleza, Ceará, 60430270

    Study Coordinator, +558533668590

    Recruiting

  • Instituto Dante Pazzanese de Cardiology ( Site 0206)

    São Paulo, 04012-909

    Study Coordinator, +551150856419

    Recruiting

  • Incor - Instituto do Coracao ( Site 0200)

    São Paulo, 05403900

    Study Coordinator, +551126615450

    Recruiting

Other trials in Brazil

Chile3 sites, 3 recruiting

  • Biocenter ( Site 0305)

    Concepción, Biobio, 4070196

    Study Coordinator, +56412858421

    Recruiting

  • Explora Salud ( Site 0304)

    Santiago, Region M. de Santiago, 7500504

    Study Coordinator, +56944213579

    Recruiting

  • Pontificia Universidad Catolica de Chile ( Site 0300)

    Santiago, Region M. de Santiago, 8330032

    Study Coordinator, 56934331806

    Recruiting

Other trials in Chile

Czechia3 sites, 3 recruiting

  • Detska nemocnice FN Brno ( Site 0701)

    Brno, Brno-mesto, 613 00

    Study Coordinator, +420532231111

    Recruiting

  • Vseobecna fakultni nemocnice v Praze ( Site 0702)

    Prague, Praha 2, 128 00

    Study Coordinator, +420224967708

    Recruiting

  • Fakultni nemocnice v Motole ( Site 0700)

    Prague, 150 00

    Study Coordinator, +420224435332

    Recruiting

Other trials in Czechia

Mexico3 sites, 3 recruiting

  • INVECORDIS S.C. ( Site 0503)

    Huixquilucan, 52763

    Study Coordinator, +525552469710

    Recruiting

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

    Monterrey, Nuevo León, 64460

    Study Coordinator, +52 8183338623

    Recruiting

  • Centro de Investigacion Clinica de Oaxaca ( Site 0505)

    Oaxaca City, Oaxaca, 68020

    Study Coordinator, +52 9516035559

    Recruiting

Other trials in Mexico

Spain3 sites, 3 recruiting

  • Hospital Universitario Central de Asturias ( Site 1303)

    Oviedo, Asturias, Principado de, 33011

    Study Coordinator, +34985108000

    Recruiting

  • COMPLEJO HOSPITALARIO DE NAVARRA ( Site 1302)

    Pamplona, Navarre, 31009

    Study Coordinator, +34660021505

    Recruiting

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

    Santiago de Compostela, La Coruna, 15706

    Study Coordinator, +34981951108

    Recruiting

Other trials in Spain

United Kingdom3 sites, 3 recruiting

  • Birmingham Childrens Hospital ( Site 1501)

    Birmingham, B4 6NH

    Study Coordinator, +441213338504

    Recruiting

  • Sheffield Childrens Hospital ( Site 1503)

    Sheffield, S10 2TH

    Study Coordinator, +441142717000

    Recruiting

  • Southampton General Hospital ( Site 1502)

    Southampton, SO16 6YD

    Study Coordinator, +442381204989

    Recruiting

Other trials in United Kingdom

Australia2 sites, 2 recruiting

  • Monash Children s Hospital ( Site 1603)

    Clayton, Victoria, 3168

    Study Coordinator, +61385723000

    Recruiting

  • Perth Children s Hospital ( Site 1601)

    Nedlands, Western Australia, 6909

    Study Coordinator, +61864565671

    Recruiting

Other trials in Australia

Belgium1 site, 1 recruiting

  • UZ Antwerpen ( Site 0601)

    Edegem, Antwerpen, 2650

    Study Coordinator, +323 821 32 51

    Recruiting

Other trials in Belgium

Finland1 site, 1 recruiting

  • New Childrens Hospital ( Site 0800)

    Helsinki, Uusimaa, 00029

    Study Coordinator, +358 9 4711

    Recruiting

Other trials in Finland

France1 site, 1 recruiting

  • Hopital Femme Mere Enfant ( Site 2101)

    Bron, Rhone, 69500

    Study Coordinator, +33472357050

    Recruiting

Other trials in France

Germany1 site, 1 recruiting

  • Universitaetsklinikum Freiburg ( Site 2203)

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

    Study Coordinator, +49 761 270 - 43000

    Recruiting

Other trials in Germany

Netherlands1 site, 1 recruiting

  • Amsterdam UMC, locatie AMC ( Site 1000)

    Amsterdam, North Holland, 1105 AZ

    Study Coordinator, +31205666360

    Recruiting

Other trials in Netherlands

New Zealand1 site, 1 recruiting

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

    Christchurch, Canterbury, 8011

    Study Coordinator, NZCR +6433729477

    Recruiting

Other trials in New Zealand

Norway1 site, 1 recruiting

  • Oslo Universitetssykehus Aker-Lipidklinikken ( Site 1100)

    Oslo, 0586

    Study Coordinator, 4722894808

    Recruiting

Other trials in Norway

Poland1 site, 1 recruiting

  • Instytut Centrum Zdrowia Matki Polki ( Site 1201)

    Lodz, Łódź Voivodeship, 93-338

    Study Coordinator, +48422711266

    Recruiting

Other trials in Poland

Singapore1 site, 1 recruiting

  • National University Hospital-Paediatrics ( Site 1800)

    Singapore, Central Singapore, 117599

    Study Coordinator, +6567795555

    Recruiting

Other trials in Singapore

About this study

Official title: An Operationally Seamless Phase 2/3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Enlicitide Decanoate in Pediatric Participants With Heterozygous Familial Hypercholesterolemia

This study is designed to learn if enlicitide decanoate is safe and effective to treat children and adolescents with heterozygous familial hypercholesterolemia (HeFH) and high amounts of low-density lipoprotein cholesterol (LDL-C) in the blood.

The goals of this study are to learn about the safety of enlicitide and if children tolerate it, what happens to enlicitide in a child's body over time, and if enlicitide works to lower cholesterol levels in children more than a placebo.

Being tested
Enlicitide Decanoate, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enlicitide DecanoateDrug

    Also called MK-0616, Enlicitide

    Enlicitide decanoate taken by mouth

  • PlaceboDrug

    Placebo tablet matched to enlicitide decanoate taken by mouth

Study groups in NCT07058077
Study groupRoleWhat they receive
Part A: Enlicitide DecanoateExperimentalParticipants receive enlicitide decanoate orally once daily (QD) at a dosage determined by age for up to 2 weeks.
Receives: Drug: Enlicitide Decanoate
Part B: Enlicitide DecanoateExperimentalParticipants receive enlicitide decanoate QD at a dosage determined by age for up to 24 weeks.
Receives: Drug: Enlicitide Decanoate
Part B: PlaceboPlacebo comparatorParticipants receive placebo orally QD for up to 24 weeks.
Receives: Drug: Placebo
Open-Label Extension: Enlicitide DecanoateExperimentalParticipants who complete either Part A or Part B may enroll in this open-label extension arm. Participants in the extension arm receive enlicitide decanoate QD at a dosage determined by age for up to 3 years.
Receives: Drug: Enlicitide Decanoate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Maximum Plasma Concentration (Cmax) of Enlicitide

    Blood samples will be collected to determine the Cmax of enlicitide.

    Measured: At designated timepoints (up to 24 hours postdose on day 14)

  2. Part A: Area Under the Concentration-Time Curve from 0 to 24 Hours (AUC0-24) of Enlicitide

    Blood samples will be collected to determine the AUC0-24 of enlicitide.

    Measured: At designated timepoints (up to 24 hours postdose on day 14)

  3. Part B: Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)

    Blood samples will be collected to determine the percent change from baseline in LDL-C.

    Measured: Baseline and Week 24

  4. Number of Participants Who Experience an Adverse Event (AE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    Measured: Up to approximately 188 weeks

  5. Number of Participants Who Discontinue Study Treatment Due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    Measured: Up to approximately 180 weeks

Secondary outcomes (7)

  1. Part B: Percent Change from Baseline in Apolipoprotein B (ApoB)

    Blood samples will be collected to determine the percent change from baseline in apolipoprotein B.

    Measured: Baseline and week 24

  2. Part B: Percent Change from Baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C)

    Blood samples will be collected to determine the percent change from baseline in non-HDL-C.

    Measured: Baseline and week 24

  3. Part B: Percent Change from Baseline in Lipoprotein (a) (Lp(a))

    Blood samples will be collected to determine the percent change from baseline in Lp(a).

    Measured: Baseline and week 24

  4. Part B: Percentage of Participants With LDL-C <130 mg/dL at Week 24

    The percentage of participants with LDL-C <130 mg/dL at week 24 will be reported.

    Measured: Week 24

  5. Part B: Percentage of Participants With ≥50% LDL-C Reduction from Baseline at Week 24

    The percentage of participants with ≥50% LDL-C reduction from baseline at week 24 will be reported.

    Measured: Baseline and week 24

  6. Part B: Percentage of Participants With LDL-C <100 mg/dL at Week 24

    The percentage of participants with LDL-C <100 mg/dL at week 24 will be reported.

    Measured: Week 24

  7. Change in Carotid Intima-media Thickness (cIMT)

    Ultrasound measurements will be performed to determine the change from baseline in cIMT.

    Measured: Baseline and week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2025
  2. Study start21 Aug 2025
  3. Primary completion4 Dec 2033 (estimated)
  4. Study completion23 Jan 2037 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
There are two parts of the study. Part A is a non randomized single treatment group. Part B is randomized parallel treatment groups. Participants who complete either part are then eligible to enroll in an open label extension (single group).
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
153 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07058077
Sponsor's protocol ID
0616-029
Other IDs
U1111-1314-5796, 2024-519068-42-00, jRCT2040260089
Status last verified
Oct 2026
First submitted
1 Jul 2025
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in