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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05413135




Registration number
NCT05413135
Ethics application status
Date submitted
7/06/2022
Date registered
9/06/2022
Date last updated
25/10/2023

Titles & IDs
Public title
Study of ARO-APOC3 in Adults With Dyslipidemia
Scientific title
A Phase 2 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of ARO-APOC3 in Adults With Dyslipidemia
Secondary ID [1] 0 0
AROAPOC3-2003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dyslipidemias 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ARO-APOC3

Experimental: ARO-APOC3 - 1 dose of ARO-APOC3 by subcutaneous (sc) injection every 3 or 6 months


Treatment: Drugs: ARO-APOC3
ARO-APOC3 Injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Through 24 months
Secondary outcome [1] 0 0
Change from Baseline in Fasting Triglycerides (TG) Over Time
Timepoint [1] 0 0
Through 24 months
Secondary outcome [2] 0 0
Percent Change from Baseline in Fasting TG Over Time
Timepoint [2] 0 0
Through 24 months
Secondary outcome [3] 0 0
Change from Baseline in Apolipoprotein (Apo) C-III Over Time
Timepoint [3] 0 0
Through 24 months
Secondary outcome [4] 0 0
Percent Change from Baseline in ApoC-III Over Time
Timepoint [4] 0 0
Through 24 months
Secondary outcome [5] 0 0
Change from Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) Over Time
Timepoint [5] 0 0
Through 24 months
Secondary outcome [6] 0 0
Percent Change from Baseline in Fasting Non-HDL-C Over Time
Timepoint [6] 0 0
Through 24 months
Secondary outcome [7] 0 0
Change from Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) Over Time
Timepoint [7] 0 0
Through 24 months
Secondary outcome [8] 0 0
Percent Change from Baseline in Fasting HDL-C Over Time
Timepoint [8] 0 0
Through 24 months
Secondary outcome [9] 0 0
Change from Baseline in Fasting Total Apolipoprotein B (ApoB) Over Time
Timepoint [9] 0 0
Through 24 months
Secondary outcome [10] 0 0
Percent Change from Baseline in Fasting Total ApoB Over Time
Timepoint [10] 0 0
Through 24 months
Secondary outcome [11] 0 0
Change from Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) Over Time Using Ultracentrifugation
Timepoint [11] 0 0
Through 24 months
Secondary outcome [12] 0 0
Percent Change from Baseline in Fasting LDL-C Over Time Using Ultracentrifugation
Timepoint [12] 0 0
Through 24 months

Eligibility
Key inclusion criteria
* Adults who are nonpregnant, nonlactating and do not plan to become pregnant during the study
* Able and willing to provide written informed consent
* Completed the 48-week study treatment period in the parent study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subject was permanently discontinued from ARO-APOC3 in the parent study due to elevated glycated hemoglobin (HbA1c), aspartate aminotransferase (AST) or alanine aminotransferase (ALT)
* Any new condition or worsening of existing condition or any other situation that would make the subject unsuitable for enrollment, could interfere with the subject participating in or completing the study, would make it difficult to comply with protocol requirements or put the subject at additional safety risk
* Unwilling to limit alcohol consumption to within moderate limits for the duration of the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2025
Actual
Sample size
Target
Accrual to date
Final
418
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Core Research Group Pty Ltd - Milton
Recruitment hospital [3] 0 0
USC Clinical Trials - Sippy Downs - Sippy Downs
Recruitment hospital [4] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 0 0
Monash Health - Clayton
Recruitment hospital [6] 0 0
Genesis Care changing to Advara heartcare - Joondalup
Recruitment hospital [7] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4068 - Milton
Recruitment postcode(s) [3] 0 0
4556 - Sippy Downs
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment postcode(s) [6] 0 0
6027 - Joondalup
Recruitment postcode(s) [7] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
Mississippi
Country [6] 0 0
United States of America
State/province [6] 0 0
Nebraska
Country [7] 0 0
United States of America
State/province [7] 0 0
Nevada
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
North Dakota
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oklahoma
Country [13] 0 0
United States of America
State/province [13] 0 0
South Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
Country [19] 0 0
Hungary
State/province [19] 0 0
Baja
Country [20] 0 0
Hungary
State/province [20] 0 0
Balatonfüred
Country [21] 0 0
Hungary
State/province [21] 0 0
Békéscsaba
Country [22] 0 0
Hungary
State/province [22] 0 0
Debrecen
Country [23] 0 0
Hungary
State/province [23] 0 0
Gyöngyös
Country [24] 0 0
Hungary
State/province [24] 0 0
Komárom
Country [25] 0 0
Hungary
State/province [25] 0 0
Nyíregyháza
Country [26] 0 0
Netherlands
State/province [26] 0 0
Amsterdam
Country [27] 0 0
Netherlands
State/province [27] 0 0
Sneek
Country [28] 0 0
Netherlands
State/province [28] 0 0
Zwijndrecht
Country [29] 0 0
New Zealand
State/province [29] 0 0
Aukland
Country [30] 0 0
New Zealand
State/province [30] 0 0
Christchurch
Country [31] 0 0
Poland
State/province [31] 0 0
Bydgoszcz
Country [32] 0 0
Poland
State/province [32] 0 0
Oswiecim
Country [33] 0 0
Poland
State/province [33] 0 0
Poznan
Country [34] 0 0
Poland
State/province [34] 0 0
Rzeszów
Country [35] 0 0
Poland
State/province [35] 0 0
Lódz

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Arrowhead Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is an open-label extension of the parent studies AROAPOC3-2001 and AROAPOC3-2002. Adult participants with dyslipidemia who completed the blinded 12-month period from either parent study and continue to meet eligibility criteria have the option to be enrolled into this study. Eligible enrolled participants will initially receive open-label ARO-APOC3 at the assigned dose level until a final dose is selected, at which point all participants will be transitioned to the selected dosing regimen.
Trial website
https://clinicaltrials.gov/study/NCT05413135
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05413135