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Anti-sense Oligonucleotide

Plozasiran Injection for Hypertriglyceridemia (SHASTA-3 Trial)

Phase 3

Recruiting

Research Sponsored by Arrowhead Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Established diagnosis of severe hypertriglyceridemia (SHTG) with prior documented evidence of fasting TG levels of ≥ 500 mg/dL (≥5.65mmol/L)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 10, month 12

Awards & highlights

SHASTA-3 Trial Summary

This trial will test the safety and effectiveness of plozasiran injection in adults with severe high levels of triglycerides. Participants will receive either plozasiran or a placebo every 3 months

Who is the study for?

Adults with severe hypertriglyceridemia (very high triglycerides) can join this study. They must have a history of fasting triglyceride levels over 500 mg/dL, low LDL cholesterol at screening, stable blood sugar control (HbA1C ≤8.5%), and be willing to follow a low-fat diet while on standard lipid-lowering meds unless intolerant.Check my eligibility

What is being tested?

The trial is testing Plozasiran injections against a placebo in adults with severe hypertriglyceridemia. Participants will receive four doses every three months and will be monitored for safety and effectiveness. After one year, they may continue in an extension study.See study design

What are the potential side effects?

Potential side effects are not detailed here but could include reactions at the injection site, changes in liver function tests, fatigue or other symptoms related to lowering of triglycerides or immune responses.

SHASTA-3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with very high blood fat levels.

SHASTA-3 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 10, month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 10, month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 10, month 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent Change in Fasting Serum Triglyceride (TG) Levels from Baseline to Month 12 Compared to Placebo

Secondary outcome measures

Adjudicated Abdominal Clinical Event Rate (Including Emergency Room Visits or Hospitalizations for Abdominal Pain Attributed to Hypertriglyceridemia and Events of Documented Pancreatitis) During the Treatment Period Compared to Placebo at Month 12

Adjudicated Major Adverse Cardiovascular Events (MACE) Rates During the Treatment Period Compared to Placebo

Change from Baseline in C-peptide During the Treatment Period Compared to Placebo

+14 more

SHASTA-3 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Plozasiran InjectionExperimental Treatment1 Intervention

4 doses of plozasiran (ARO-APOC3) by subcutaneous (sc) injection

Group II: PlaceboPlacebo Group1 Intervention

calculated volume to match active treatment by sc injection

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Arrowhead PharmaceuticalsLead Sponsor

39 Previous Clinical Trials

4,556 Total Patients Enrolled

5 Trials studying Hypertriglyceridemia

2,062 Patients Enrolled for Hypertriglyceridemia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the potential risks associated with the administration of Plozasiran Injection to individuals?

"The safety assessment for Plozasiran Injection has been rated as 3 by our team at Power, aligning with the Phase 3 trial status. This indicates a combination of efficacy data and robust safety evidence."

Answered by AI

What is the upper limit of participants enrolled in this clinical investigation?

"Affirmative, information on clinicaltrials.gov confirms that this investigation is presently enrolling participants. Originally shared on May 1st, 2024, the latest update was made on April 27th, 2024. The aim is to recruit a total of 405 individuals from one designated site."

Answered by AI

Are there any ongoing efforts to enroll patients in this current medical study?

"Indeed, as per the details on clinicaltrials.gov, this research initiative is actively seeking eligible individuals. The trial's initial posting date was 5/1/2024 with the most recent update made on 4/27/2024. Recruitment aims to enlist 405 participants from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Plozasiran (ARO-APOC3) in Adults With Severe Hypertriglyceridemia

2024. "Study of Plozasiran (ARO-APOC3) in Adults With Severe Hypertriglyceridemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06347003.

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