ARO-APOC3 for Dyslipidemias

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Dyslipidemias+1 More
ARO-APOC3 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug to see if it is safe and effective. Participants will be randomly assigned to take the drug or a placebo, and will be monitored for 48 weeks. Those taking the placebo will be given the option to take the drug during an extension study.

Eligible Conditions
  • Dyslipidemias

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 17 Secondary · Reporting Duration: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 36, Week 48

Baseline, Week 24
Percent Change from Baseline in Apolipoprotein (APO) C-III at Week 24
Percent Change from Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 24
Percent Change from Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24
Percent Change from Baseline in Fasting Total Apolipoprotein B (ApoB) at Week 24
Percent Change from Baseline in Fasting Total Low Density Lipoprotein Cholesterol (LDL-C) Using Ultracentrifugation at Week 24
Percent Change from Baseline in Fasting Triglycerides (TG) at Week 24
Week 48
Percent Change from Baseline in Fasting TG
Week 48
Percent Change form Baseline in Non-HDL-C Over Time
Percent Change from Baseline in APOC-III Over Time
Percent Change from Baseline in ApoB Over Time
Percent Change from Baseline in Fasting Total LDL-C Using Ultracentrifugation Over Time
Percent Change from Baseline in HDL-C Over Time
Week 24
Number of Participants with Treatment-Emergent Adverse Events (AEs) and/or Serious Adverse Events (SAEs) at Week 24
up to Week 24
Change from Baseline in Plasma Concentrations of ARO-APOC3 Over Time
PK of ARO-APOC3: Area Under the Plasma Concentration Versus Time Curve From Zero to Time of Last Measurable Concentration (AUClast)
PK of ARO-APOC3: Time to Maximum Plasma Concentration (Tmax)
Pharmacokinetics (PK) of ARO-APOC3: Maximum Observed Plasma Concentration (Cmax)
up to Week 48
Number of Participants with Treatment- Emergent AEs and/or SAEs Through Week 48

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

ARO-APOC3
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

353 Total Participants · 2 Treatment Groups

Primary Treatment: ARO-APOC3 · Has Placebo Group · Phase 2

ARO-APOC3
Drug
Experimental Group · 1 Intervention: ARO-APOC3 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ARO-APOC3
2019
Completed Phase 1
~120

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 36, week 48

Who is running the clinical trial?

Arrowhead PharmaceuticalsLead Sponsor
31 Previous Clinical Trials
2,382 Total Patients Enrolled
3 Trials studying Dyslipidemias
833 Patients Enrolled for Dyslipidemias

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are willing to follow a diet plan as per Investigator judgment based on local standard of care.
You have TG levels that are ≥ 150 mg/dL but ≤ 499 mg/dL on more than one occasion.
You are willing to provide written informed consent and to comply with study requirements.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 20th, 2021

Last Reviewed: November 1st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Texas100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Research Site100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%