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NCT04365400 · ClinicalTrials.gov registry record · Phase 2
Assess Efficacy and Safety of Epeleuton in Patients With Hypertriglyceridemia and Type 2 Diabetes
A Phase 2 study, sponsored by Afimmune.
- Terminated
- Registry status
- Phase 2
- Development phase
- 233
- Enrollment target
NCT04365400: Clinical Trial Phase 2 study, sponsored by Afimmune.
NCT04365400 is a Phase 2 study that was terminated before completion, run by Afimmune. The registered enrollment target is 233 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04365400, a Phase 2 study, was terminated before completion, sponsored by Afimmune.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 233 participants
- Enrollment target
Study Summary
To assess the efficacy and safety of orally administered Epeleuton capsules versus placebo, in the treatment of adult patients with hypertriglyceridemia and type 2 diabetes
Primary Outcome
Analysis of changes and percentage changes of triglycerides was performed using a Wilcoxon rank sum test with the Hodges Lehmann median and 95% confidence intervals estimates. For analysis of triglycerides, baseline was defined as the mean of the Baseline (Visit 3) and Screening 2/Week -1 (Visit 2) measurements.
Interventions
- DRUG Placebo
- DRUG DS102
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 233 participants |
| Start Date | 2020-10-13 |
| Est. Completion | 2022-05-03 |
| Phase | Phase 2 |
Why NCT04365400 stopped before completion
NCT04365400 is an interventional study that assigns participants to a tested intervention. The registered 233 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04365400 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04365400 about?
NCT04365400 is a clinical study titled "Assess Efficacy and Safety of Epeleuton in Patients With Hypertriglyceridemia and Type 2 Diabetes". To assess the efficacy and safety of orally administered Epeleuton capsules versus placebo, in the treatment of adult patients with hypertriglyceridemia and type 2 diabetes
What is the current status of trial NCT04365400?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 233 participants. The study started on 2020-10-13. Estimated completion is 2022-05-03.
What interventions are being tested in trial NCT04365400?
The interventions under investigation include: Placebo (DRUG), DS102 (DRUG).
Who is sponsoring clinical trial NCT04365400?
This trial is sponsored by Afimmune, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04365400's enrollment target sits among peer trials
233 256th of 2000 higher than 1,745 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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