Trial · NCT05079919
A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia
NCT05079919, Phase 3, Completed, Ionis Pharmaceuticals, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia. Trials, record NCT05079919. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05079919
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia
- NCT number
- NCT05079919
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 617 participants, actual
- Lead sponsor
- Ionis Pharmaceuticals, Inc.
- Conditions
- Severe Hypertriglyceridemia
- Interventions
- Olezarsen, Placebo
- First posted
- 2021-10-15
- Last updated
- 2026-02-10
- Other registries' IDs
- eudract:2021-002192-19
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change from Baseline in Fasting TG Compared to Placebo | Baseline and Month 6 | |
| Secondary | Percent Change from Baseline in Fasting TG Compared to Placebo | Baseline and Month 12 | |
| Secondary | Percent Change from Baseline in Fasting Apolipoprotein C-III (ApoC-III), Remnant Cholesterol and Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) Compared to Placebo | Baseline, Month 6 and 12 | |
| Secondary | Proportion of Patients Who Achieve Fasting TG <500 mg/dL (5.65 mmol/L) Compared to Placebo | Month 12 | |
| Secondary | Proportion of Participants Who Achieve Fasting TG < 880 mg/dL (10 mmol/L) Compared to Placebo in the Subgroup of Participants with Baseline TG ≥ 880 mg/dL | Month 12 | |
| Secondary | Adjudicated Acute Pancreatitis Event Rate During the Treatment Period Compared to Placebo | Week 1 through Week 53 | |
| Secondary | Absolute Change in Hepatic Fat Fraction (HFF) Between Olezarsen Treatment Group and Pooled Placebo | Baseline through Month 12 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05079919
GET https://conductscience.org/api/trials/v1/NCT05079919/registered