Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 2 / Phase 3interventionalRules rewrite

Phase 2 / Phase 3: testing Enlicitide Decanoate for Heterozygous Familial Hypercholesterolemia (HeFH)

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 dummy treatment (placebo).

Official registry: https://clinicaltrials.gov/study/NCT07058077 · Merck Sharp & Dohme LLC · enrollment listed as 153

What this phase means

Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Enlicitide Decanoate, or Placebo. The registry lists allocation as randomized. 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.

They plan to enroll about 153 people at 48 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: Enlicitide Decanoate, Placebo

Primary outcome (registry wording): Part A: Maximum Plasma Concentration (Cmax) of Enlicitide

Who it is for (from inclusion criteria)

  • Ages 6 Years to 17 Years
  • who can join 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

Public study contact (from the registry)

Toll Free Number

1-888-577-8839

Trialsites@msd.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

48 listed

+ 40 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07058077 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07058077?

Phase 2 / Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07058077?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary