Enlicitide Decanoate Evidence: Trial Results and Peer-Reviewed Publications

Hipa.ai Research · Source: PubMed & ClinicalTrials.gov / AACT · Last updated:

The clinical evidence base for Enlicitide Decanoate comprises 3 peer-reviewed publications across 3 journals, 4 pivotal-trial primary-outcome rows reported to ClinicalTrials.gov, spanning indications including Hypercholesterolemia. Most recent publication: Efficacy and Safety of Oral PCSK9 Inhibitor Enlicitide in Adults With Heterozygous Familial Hypercholesterolemia: A Randomized Clinical Trial., JAMA, 2026.

Top peer-reviewed publications

Curated set of pivotal-trial result papers and recent publications in high-tier journals.

  1. Efficacy and Safety of Oral PCSK9 Inhibitor Enlicitide in Adults With Heterozygous Familial Hypercholesterolemia: A Randomized Clinical Trial.
    Ballantyne CM, Gellis L, Tardif JC, et al. · JAMA · 2026
    PubMed: PMID 41206969 · NCT05952869 · Hypercholesterolemia
  2. A Placebo-Controlled Trial of the Oral PCSK9 Inhibitor Enlicitide.
    Navar AM, Mikhailova E, Catapano AL, et al. · N Engl J Med · 2026
    PubMed: PMID 41879224 · NCT05952856 · Hypercholesterolemia
  3. Oral PCSK9 Inhibitor Enlicitide Versus Oral Nonstatin Therapies: A Phase 3 Randomized Clinical Trial.
    Catapano AL, Mikhailova E, Navar AM, et al. · J Am Coll Cardiol · 2026
    PubMed: PMID 42017875 · NCT06450366 · Hypercholesterolemia

Primary-outcome results across pivotal trials

Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.

TrialIndicationPrimary endpointArmValue
NCT05952869HypercholesterolemiaMean Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24
Baseline and Week 24
Enlicitide Decanoate-58.2 Percent Change (±28.0 Standard Deviation)
Placebo2.6 Percent Change (±23.6 Standard Deviation)
NCT05952869HypercholesterolemiaNumber of Participants Who Discontinued Study Drug Due to an AE
Up to 56 weeks
Enlicitide Decanoate4 Participants
Placebo3 Participants
NCT05952869HypercholesterolemiaNumber of Participants With Adverse Events (AEs)
Up to 64 weeks (8 weeks postdose)
Enlicitide Decanoate157 Participants
Placebo77 Participants
NCT06450366HypercholesterolemiaMean Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 56
Baseline and Day 56
Bempedoic Acid-6.3 Percent Change
Enlicitide-64.6 Percent Change
Ezetimibe-27.8 Percent Change
Ezetimibe + Bempedoic Acid-36.5 Percent Change

Publications by year

2026–2026: 3 publications.

2026
3

Publications by indication

Hypercholesterolemia (3)

  • Efficacy and Safety of Oral PCSK9 Inhibitor Enlicitide in Adults With Heterozygous Familial Hypercholesterolemia: A Randomized Clinical Trial.
    JAMA · 2026 · PMID 41206969 · NCT05952869
  • A Placebo-Controlled Trial of the Oral PCSK9 Inhibitor Enlicitide.
    N Engl J Med · 2026 · PMID 41879224 · NCT05952856
  • Oral PCSK9 Inhibitor Enlicitide Versus Oral Nonstatin Therapies: A Phase 3 Randomized Clinical Trial.
    J Am Coll Cardiol · 2026 · PMID 42017875 · NCT06450366

Publications by journal

Trial-results highlights

For the indication of hypercholesterolemia, a key pivotal trial, NCT05952869, reported on the mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at week 24. In the Enlicitide Decanoate arm, participants experienced a mean change of -58.2 percent from baseline. In the same trial, the placebo arm showed a mean change of 2.6 percent from baseline. Another study, NCT06450366, also evaluated the mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at day 56 across multiple treatment groups. The reported changes were:

  • For the Bempedoic Acid arm, a -6.3 percent change.
  • For the Enlicitide arm, a -64.6 percent change.
  • For the Ezetimibe arm, a -27.8 percent change.
  • For the Ezetimibe + Bempedoic Acid arm, a -36.5 percent change.

Regarding safety outcomes in the NCT05952869 trial for hypercholesterolemia, data were collected on adverse events (AEs). Up to 56 weeks, the number of participants who discontinued the study drug due to an AE was 4 participants in the Enlicitide Decanoate arm, compared to 3 participants in the placebo arm. Furthermore, the total number of participants who experienced any adverse event up to 64 weeks (which included 8 weeks postdose) was 157 participants in the Enlicitide Decanoate arm, while 77 participants were reported in the placebo arm.

All values presented are sourced from primary registry reporting; individual published papers should be consulted for clinical decisions.

All Enlicitide Decanoate publications (3)

2026 (3 papers)

  1. Efficacy and Safety of Oral PCSK9 Inhibitor Enlicitide in Adults With Heterozygous Familial Hypercholesterolemia: A Randomized Clinical Trial.
    Ballantyne CM, Gellis L, Tardif JC, et al. · JAMA · 2026 · Trial result
    PubMed: PMID 41206969 · NCT05952869 · Hypercholesterolemia
  2. A Placebo-Controlled Trial of the Oral PCSK9 Inhibitor Enlicitide.
    Navar AM, Mikhailova E, Catapano AL, et al. · N Engl J Med · 2026 · Derived
    PubMed: PMID 41879224 · NCT05952856 · Hypercholesterolemia
  3. Oral PCSK9 Inhibitor Enlicitide Versus Oral Nonstatin Therapies: A Phase 3 Randomized Clinical Trial.
    Catapano AL, Mikhailova E, Navar AM, et al. · J Am Coll Cardiol · 2026 · Derived
    PubMed: PMID 42017875 · NCT06450366 · Hypercholesterolemia

Sources and methodology

This page summarizes published evidence for general reference and does not constitute medical advice. For clinical decisions, consult the linked primary publications and your healthcare provider. Data sourced from PubMed and the ClinicalTrials.gov / AACT database maintained by the Clinical Trials Transformation Initiative (CTTI).