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Olezarsen for High Triglycerides

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Amicis Research, Northridge, CAHigh Triglycerides+2 MoreOlezarsen - Drug
Eligibility
18+
All Sexes
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Study Summary

This trial studies the effects of a drug on triglyceride levels for people with high triglycerides and cardiovascular disease.

Eligible Conditions
  • High Triglycerides
  • Cardiovascular Disease
  • Atherosclerosis

Treatment Effectiveness

Effectiveness Progress

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

Similar Trials

1
LY3875383 (Part A)
1
LY3561774
1
ARO-ANG 3 Injection

Study Objectives

1 Primary · 13 Secondary · Reporting Duration: Baseline, Weeks 25 and 53

Baseline to Week 25
Percent Change From Baseline to Week 25 in Fasting Triglycerides (TG) Compared to Placebo
Baseline to Week 53
Percent Change From Baseline to Week 53 in Fasting TG Compared to Placebo
Week 25
Percent Change From Baseline to Weeks 25 and 53 in Fasting Apolipoprotein A-1 (apoA-1) Compared to Placebo
Percent Change From Baseline to Weeks 25 and 53 in Fasting Apolipoprotein B (apoB) Compared to Placebo
Percent Change From Baseline to Weeks 25 and 53 in Fasting Apolipoprotein B-48 (apoB-48) Compared to Placebo
Percent Change From Baseline to Weeks 25 and 53 in Fasting Apolipoprotein C-III (apoC-III) Compared to Placebo
Percent Change From Baseline to Weeks 25 and 53 in Fasting High-Density Lipoprotein-Cholesterol (HDL)-C Compared to Placebo
Percent Change From Baseline to Weeks 25 and 53 in Fasting Low-Density Lipoprotein-Cholesterol (LDL)-C Compared to Placebo
Percent Change From Baseline to Weeks 25 and 53 in Fasting Remnant Cholesterol Compared to Placebo
Percent Change From Baseline to Weeks 25 and 53 in Fasting Total Cholesterol (TC) Compared to Placebo
Percent Change From Baseline to Weeks 25 and 53 in Fasting Very Low-Density Lipoprotein-Cholesterol (VLDL)-C Compared to Placebo
Percent Change From Baseline to Weeks 25 and 53 in Fasting non-High Density Lipoprotein-Cholesterol (HDL)-C Compared to Placebo
Week 25
Fasting
Proportion of Participants who Achieve Fasting TG <500 mg/dL at Weeks 25 and 53 Compared to Placebo in the Subgroup of Participants with Baseline TG ≥500 mg/dL

Trial Safety

Safety Progress

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

Similar Trials

1
LY3875383 (Part A)
2
LY3561774
2
ARO-ANG 3 Injection

Trial Design

2 Treatment Groups

Olezarsen
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

1312 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: baseline, weeks 25 and 53

Who is running the clinical trial?

Ionis Pharmaceuticals, Inc.Lead Sponsor
140 Previous Clinical Trials
13,528 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

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References

Frequently Asked Questions

What is the current scale of participation in this research endeavor?

"Indeed, according to clinicaltrials.gov, this medical trial is actively searching for enrollees and has been since November 21st 2022. As of the most recent update on 11/23/2022, 1312 participants are needed from a single location." - Anonymous Online Contributor

Unverified Answer

To what extent is Olezarsen a risk to human health?

"With a score of 3, our team has affirmed that Olezarsen is safe for human consumption as it has been through multiple rounds of clinical testing and efficacy studies." - Anonymous Online Contributor

Unverified Answer

Is this research endeavor currently accepting volunteers?

"This clinical trial, which was first advertised on November 21st 2022, is actively seeking patients and has recently been updated. Information regarding this study can be found on the website of clinicaltrials.gov." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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