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Long-term evaluation of enlicitide decanoate for adults with high cholesterol

A Phase 3, Open-label Extension Study to Evaluate the Safety and Efficacy of MK-0616 in Adults With Hypercholesterolemia

Phase 3 Interventional Merck Sharp & Dohme LLC · NCT06492291

This study is testing the long-term safety and effectiveness of enlicitide decanoate in adults with high cholesterol who have already taken part in earlier studies.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment3000 (estimated)
Ages18 Years and up
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Locations222 sites (Daphne, Alabama and 221 other locations)
Trial IDNCT06492291 on ClinicalTrials.gov

What this trial studies

This study is an open-label extension that aims to assess the long-term safety and efficacy of enlicitide decanoate in adults who have previously participated in related studies. Participants must have completed one of the parent studies and demonstrated compliance with the treatment protocol. The study will monitor the effects of the medication over an extended period to gather more data on its performance in managing hypercholesterolemia.

Who should consider this trial

Good fit: Ideal candidates are adults who have completed a prior enlicitide decanoate study and maintained a high level of compliance.

Not a fit: Patients who have discontinued the study intervention in their parent study or are experiencing serious adverse events related to the treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term management of high cholesterol, potentially leading to improved treatment options for patients.

How similar studies have performed: Other studies involving PCSK9 inhibitors have shown promise, suggesting that this approach may yield beneficial results.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Has completed an enlicitide decanoate (also known as enlictide and MK-0616) parent study \[MK-0616-013 (NCT05952856), MK-0616-017 (NCT05952869), and MK-0616-018 (NCT06450366)\] per protocol (including the final assessments/procedures of their parent study)
* Had an overall study intervention compliance ≥80% while participating in their parent study

Exclusion Criteria:

* Has discontinued study intervention in their parent study
* Has an ongoing serious adverse event considered related to study intervention by the investigator in the parent study
* Is planning to begin treatment with a nonstudy protein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) while enrolled in the study
* Is currently participating in an interventional clinical study other than an enlicitide decanoate parent study

Where this trial is running

Daphne, Alabama and 221 other locations

+172 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hypercholesterolemia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.