ARO-ANG3 for Dyslipidemias

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Dyslipidemias+1 More
ARO-ANG3 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug, ARO-ANG3, to see if it is effective and safe in treating mixed dyslipidemia. Participants will receive injections of either the drug or a placebo, and then may continue receiving the drug in an extension of the trial.

Eligible Conditions
  • Dyslipidemias

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 18 Secondary · Reporting Duration: Baseline, up to Week 36 (double-blind treatment period), up to Month 24 (open-label extension)

Baseline, Week 24
Percent Change from Baseline in Angiopoietin-like Protein 3 (ANGPTL3) at Week 24
Percent Change from Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) at Week 24
Percent Change from Baseline in Fasting Low-density Lipoprotein-Cholesterol (LDL-C) Using Ultracentrifugation 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 Triglycerides (TG) at Week 24
Week 12
Change from Baseline in Plasma Concentrations of ARO-ANG3 Over Time
Month 24
Plasma Concentrations of ARO-ANG3 Over Time
Week 36
Percent Change from Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) Over Time
Month 24
Percent Change from Baseline in ANGPTL3 Over Time
Percent Change from Baseline in Fasting HDL-C Over Time
Percent Change from Baseline in Fasting LDL-C Using Ultracentrifugation Over Time
Percent Change from Baseline in Fasting Non-HDL-C Over Time
Percent Change from Baseline in Fasting TG Over Time
Percent Change from Baseline in Fasting Total ApoB Over Time
Week 24
Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs) at Week 24
Month 24
Number of Participants with AEs and/or SAEs Over Time in the Open-Label Extension
up to Week 36
Number of Participants with AEs and/or SAEs Through Week 36
Week 36
Number of Participants with AEs and/or SAEs Over Time in the Double-Blind Treatment Period

Trial Safety

Safety Progress

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

Trial Design

2 Treatment Groups

ARO-ANG3
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

204 Total Participants · 2 Treatment Groups

Primary Treatment: ARO-ANG3 · Has Placebo Group · Phase 2

ARO-ANG3
Drug
Experimental Group · 1 Intervention: ARO-ANG3 · Intervention Types: Drug
PlaceboPlaceboComparator Group · 2 Interventions: Placebo, ARO-ANG3 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ARO-ANG3
2019
Completed Phase 1
~100

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, up to week 36 (double-blind treatment period), up to month 24 (open-label extension)

Who is running the clinical trial?

Arrowhead PharmaceuticalsLead Sponsor
31 Previous Clinical Trials
2,531 Total Patients Enrolled
3 Trials studying Dyslipidemias
982 Patients Enrolled for Dyslipidemias

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are willing to follow a diet and maintain a stable diet.
You have a medical history of hypertriglyceridemia.
You are able and 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 7th, 2021

Last Reviewed: November 23rd, 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?
Florida50.0%
North Carolina50.0%
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%