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Eplontersen for Cardiomyopathy

Phase 3
Waitlist Available
Research Sponsored by Ionis Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
New York Heart Association (NYHA) class I-III
Be older than 18 years old
Must not have
Prior liver or heart transplant, and/or Left Ventricular Assist Device (LVAD) or anticipated liver transplant or LVAD within 1 year after randomization
Cardiomyopathy not primarily caused by ATTR-CM, for example, cardiomyopathy due to hypertension, valvular heart disease, or ischemic heart disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 121
Awards & highlights
Pivotal Trial

Summary

This trial is testing a new drug compared to placebo (a "sugar pill" with no medicine) to see if it can help people with a certain heart condition.

Who is the study for?
This trial is for adults with ATTR-CM, a type of heart disease caused by amyloid deposits. Participants must have certain heart measurements and confirmed amyloid deposits but can't be on specific heart medications, have had recent major cardiovascular events or procedures, or expect to need a heart transplant or assist device within a year.
What is being tested?
The study tests Eplontersen's effectiveness against a placebo in patients with ATTR-CM who are also receiving standard care. The goal is to see if Eplontersen improves the condition more than an inactive substance.
What are the potential side effects?
While not specified here, side effects may include reactions at the injection site, potential liver issues (as it's common with similar drugs), fatigue, nausea, and possible blood-related problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My heart condition allows me to perform daily activities with minimal to moderate difficulty.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had or am expected to have a liver or heart transplant, or need an LVAD within a year.
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My heart condition is not mainly due to ATTR-CM.
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I haven't had any major heart issues or surgeries in the last 3 months.
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I have been treated with Tegsedi, Onpattro, or similar RNA-based therapies.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 121
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 121 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change From Baseline in the 6-minute Walk Test (6MWT) Distance at Week 121
Change From Baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores at Week 121

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: EplontersenExperimental Treatment1 Intervention
Eplontersen by subcutaneous injection once every 4 weeks
Group II: PlaceboPlacebo Group1 Intervention
Eplontersen-matching placebo by subcutaneous injection once every 4 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eplontersen
2020
Completed Phase 3
~200

Find a Location

Who is running the clinical trial?

Ionis Pharmaceuticals, Inc.Lead Sponsor
149 Previous Clinical Trials
14,101 Total Patients Enrolled
1 Trials studying Transthyretin Amyloid Cardiomyopathy
80 Patients Enrolled for Transthyretin Amyloid Cardiomyopathy

Media Library

AKCEA-TTR-LRx Clinical Trial Eligibility Overview. Trial Name: NCT04136171 — Phase 3
Transthyretin Amyloid Cardiomyopathy Research Study Groups: Eplontersen, Placebo
Transthyretin Amyloid Cardiomyopathy Clinical Trial 2023: AKCEA-TTR-LRx Highlights & Side Effects. Trial Name: NCT04136171 — Phase 3
AKCEA-TTR-LRx 2023 Treatment Timeline for Medical Study. Trial Name: NCT04136171 — Phase 3
~139 spots leftby Jun 2025
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