Olezarsen for Severe Hypertriglyceridemia

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Severe HypertriglyceridemiaOlezarsen - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will compare the effects of olezarsen versus placebo on fasting triglyceride levels.

Eligible Conditions
  • Severe Hypertriglyceridemia

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: Month 6 and Month 12

Baseline and Month 12
Percent Change from Baseline in Fasting TG at 12 Months (Average of Weeks 51 and 53) Compared to Placebo
Baseline and Month 6
Percent Change from Baseline in Fasting TG at 6 Months (Average of Weeks 25 and 27) Compared to Placebo
Month 6
High Density Lipoproteins
Cocaine
Very low density lipoprotein
Month 12
Apolipoprotein C-II
Month 12
Percentage of Participants Achieving Fasting TG < 1000 mg/dL in Participants with Baseline TG ≥ 1000 mg
Proportion of Participants Who Achieve Fasting TG < 880 mg/dL (10 mmol/L) at 6 and 12 Months Compared to Placebo in the Subgroup of Participants with Baseline TG ≥ 880 mg/dL
Proportion of Participants Who Achieve Fasting TG Less Than (<) 500 milligrams per deciliter (mg/dL) (5.7 millimoles per liter [mmol/L]) at 6 and 12 Months Compared to Placebo
Week 53
Adjudicated Acute Pancreatitis Event Rate During the Treatment Period Compared to Placebo
Adjudicated Acute Pancreatitis Event Rate During the Treatment Period Compared to Placebo, in Participants with ≥ 2 Events of Adjudicated Acute Pancreatitis in 5 Years Prior to Enrollment

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Olezarsen
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

390 Total Participants · 2 Treatment Groups

Primary Treatment: Olezarsen · Has Placebo Group · Phase 3

Olezarsen
Drug
Experimental Group · 1 Intervention: Olezarsen · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: month 6 and month 12

Who is running the clinical trial?

Ionis Pharmaceuticals, Inc.Lead Sponsor
140 Previous Clinical Trials
14,420 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are willing to comply with diet and lifestyle recommendations as able.