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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06347133
Other study ID # AROAPOC3-3009
Secondary ID 2023-509302-30
Status Recruiting
Phase Phase 3
First received
Last updated
Start date May 21, 2024
Est. completion date October 2026

Study information

Verified date June 2024
Source Arrowhead Pharmaceuticals
Contact Medical Monitor
Phone 626-304-3400
Email plozasiran@arrowheadpharma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with hypertriglyceridemia (HTG). After providing informed consent eligible participants will be randomized to receive 4 doses (once every 3 months) of plozasiran or placebo and be evaluated for efficacy and safety.


Recruitment information / eligibility

Status Recruiting
Enrollment 1328
Est. completion date October 2026
Est. primary completion date July 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Established diagnosis of hypertriglyceridemia (HTG) and prior documented evidence (medical history) of mean fasting TG level =150 mg/dL (=1.69 mm/L) and =499 mg/dL (=5.64 mmol/L) - Mean fasting TG level =150 mg/dL (=1.69 mmol/L) and =499 mg/dL (=5.64 mmol/L) collected at 2 separate and consecutive visits at least 7 days apart and no more than 17 days apart during the screening period - Fasting low density lipoprotein-cholesterol (LDL-C) = 130 mg/dL (=3.37 mmol/L) at screening - Screening HbA1c =8.5% - Willing to follow diet counseling and maintain a stable low-fat diet - Must be on standard of care lipid-lowering medications per local guidelines (unless documented as intolerant as determined by the Investigator) Exclusion Criteria: - Use of any hepatocyte-targeted small interfering ribonucleic acid (siRNA) that targets lipids and/or triglycerides within 365 days before Day 1 (except inclisiran, which is permitted). Administration of investigational drug and inclisiran must be separated by at least 4 weeks. - Use of any other hepatocyte targeted siRNA or antisense Oligonucleotide molecule within 60 days or within 5-half-lives before Day 1 based on plasma pharmacokinetics (PK), whichever is longer - Acute pancreatitis within 4 weeks prior to screening - Body mass index >45 kg/m^2 Note: Additional Inclusion/Exclusion criteria may apply per protocol

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Plozasiran Injection
ARO-APOC3 Injection
Placebo
sterile normal saline (0.9% NaCl)

Locations

Country Name City State
United States Annapolis Internal Medicine Annapolis Maryland
United States National Heart Institute Beverly Hills California
United States Cope Family Medicine Bountiful Utah
United States CHEAR Center LLC Bronx New York
United States Innovative Research of West Florida, Inc. Clearwater Florida
United States Legacy Clinical Trials Colorado Springs Colorado
United States National Institute of Clinical Research Garden Grove California
United States Tribe Clinical Research, LLC Greenville South Carolina
United States Juno Research LLC Houston Texas
United States Spring Clinical Research Houston Texas
United States Jefferson City Medical Group PC Jefferson City Missouri
United States Santa Rosa Medical Centers of Nevada Las Vegas Nevada
United States Panax Clinical Research Miami Lakes Florida
United States Synergy Groups Medical Missouri City Texas
United States Velocity Clinical Research Norfolk Nebraska
United States Lynn Institute of Norman Norman Oklahoma
United States Lynn Health Sci. Inst. Oklahoma City Oklahoma
United States Lynn Health Science Institute East Oklahoma City Oklahoma
United States Midwest Regional Health Services LLC Omaha Nebraska
United States Florida Institute for Clinical Research Orlando Florida
United States Velocity Clinical Research, Panorama City Panorama City California
United States Cardiovascular Research Center of Knoxville Powell Tennessee
United States Meridian Clinical Research, LLC Savannah Georgia
United States The South Bend Clinic LLC South Bend Indiana
United States Cotton-O'Neil Clinical Research Center, Stormont-Vail West Topeka Kansas
United States Crossroads Clinical Research Victoria Texas

Sponsors (1)

Lead Sponsor Collaborator
Arrowhead Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent Change in Fasting Serum Triglyceride (TG) Levels from Baseline to Month 12 Compared to Placebo Baseline, Month 12
Secondary Percent Change in Fasting Serum TG Levels from Baseline to Month 10 Compared to Placebo Baseline, Month 10
Secondary Proportion of Participants who Achieve Fasting TG Levels of <150 mg/dL (<1.69 mmol/L) at Month 10 and Month 12 Compared to Placebo Month 10, Month 12
Secondary Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Over Time through Month 12 as Compared to Placebo From first dose of study drug through Month 12
Secondary Incidence Rates of New-Onset Diabetes Mellitus (NODM) Throughout the Course of Treatment From first dose of study drug through Month 12
Secondary Incidence Rates of Worsening of Existing Diabetes Throughout the Course of Treatment From first dose of study drug through Month 12
Secondary Change from Baseline in Hemoglobin A1c (HbA1c) During the Treatment Period Compared to Placebo From first dose of study drug through Month 12
Secondary Change from Baseline in Fasting Blood Glucose During the Treatment Period Compared to Placebo From first dose of study drug through Month 12
Secondary Change from Baseline in C-peptide During the Treatment Period Compared to Placebo From first dose of study drug through Month 12
Secondary Change from Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) During the Treatment Period Compared to Placebo From first dose of study drug through Month 12
Secondary Change from Baseline in Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) Associated with Worsening Glycemic Control During the Treatment Period Compared to Placebo From first dose of study drug through Month 12
Secondary Initiation of New Medication for Hyperglycemia Among Study Participants Not Known to Have Pre-existing Diabetes Mellitus During the Treatment Period Compared to Placebo From first dose of study drug through Month 12
Secondary Adjudicated Major Adverse Cardiovascular Events (MACE) Rates During the Treatment Period Compared to Placebo From first dose of study drug through Month 12
Secondary Incidence of Anti-drug Antibodies (ADA) to Plozasiran in Participants Receiving Plozasiran Over Time Through Month 12 From first dose of study drug through Month 12
Secondary Titers of Anti-drug Antibodies (ADA) to Plozasiran in Participants Receiving Plozasiran Over Time Through Month 12 From first dose of study drug through Month 12
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