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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04832971




Registration number
NCT04832971
Ethics application status
Date submitted
2/04/2021
Date registered
6/04/2021

Titles & IDs
Public title
Study of ARO-ANG3 in Adults With Mixed Dyslipidemia
Scientific title
A Double-blind, Placebo-controlled Phase 2b Study to Evaluate the Efficacy and Safety of ARO-ANG3 in Adults With Mixed Dyslipidemia
Secondary ID [1] 0 0
AROANG3-2001
Universal Trial Number (UTN)
Trial acronym
ARCHES-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mixed Dyslipidemia 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-ANG3
Treatment: Drugs - Placebo

Experimental: ARO-ANG3 50 mg - Two doses of ARO-ANG3 by subcutaneous (sc) injection at Day 1 and Week 12 during double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.

Experimental: ARO-ANG3 100 mg - Two doses of ARO-ANG3 bysc injection at Day 1 and Week 12 during double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.

Experimental: ARO-ANG3 200 mg - Two doses of ARO-ANG3 by sc injection at Day 1 and Week 12 during double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.

Placebo comparator: Placebo - Calculated volume to match active treatment by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.


Treatment: Drugs: ARO-ANG3
ARO-ANG3 Injection

Treatment: Drugs: Placebo
Sterile Normal Saline (0.9% NaCl)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Change From Baseline in Fasting TG at Week 24
Timepoint [1] 0 0
Baseline, Week 24
Secondary outcome [1] 0 0
Percent Change From Baseline in Fasting TG Over Time
Timepoint [1] 0 0
Baseline, up to Week 36 (double-blind treatment period), up to Month 24 (open-label extension)
Secondary outcome [2] 0 0
Percent Change From Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 24
Timepoint [2] 0 0
Baseline, Week 24
Secondary outcome [3] 0 0
Percent Change From Baseline in Fasting Non-HDL-C Over Time
Timepoint [3] 0 0
Baseline, up to Week 36 (double-blind treatment period), up to Month 24 (open-label extension)
Secondary outcome [4] 0 0
Percent Change From Baseline in Fasting Total Apolipoprotein B (ApoB) at Week 24
Timepoint [4] 0 0
Baseline, Week 24
Secondary outcome [5] 0 0
Percent Change From Baseline in Fasting Total ApoB Over Time
Timepoint [5] 0 0
Baseline, up to Week 36 (double-blind treatment period), up to Month 24 (open-label extension)
Secondary outcome [6] 0 0
Percent Change From Baseline in Fasting Low-density Lipoprotein-Cholesterol (LDL-C) Using Ultracentrifugation at Week 24
Timepoint [6] 0 0
Baseline, Week 24
Secondary outcome [7] 0 0
Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time
Timepoint [7] 0 0
Baseline, up to Week 36 (double-blind treatment period), up to Month 24 (open-label extension)
Secondary outcome [8] 0 0
Percent Change From Baseline in Angiopoietin-like Protein 3 (ANGPTL3) at Week 24
Timepoint [8] 0 0
Baseline, Week 24
Secondary outcome [9] 0 0
Percent Change From Baseline in ANGPTL3 Over Time
Timepoint [9] 0 0
Baseline, up to Week 36 (double-blind treatment period), up to Month 24 (open-label extension)
Secondary outcome [10] 0 0
Percent Change From Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) at Week 24
Timepoint [10] 0 0
Baseline, Week 24
Secondary outcome [11] 0 0
Percent Change From Baseline in Fasting HDL-C Over Time
Timepoint [11] 0 0
Baseline, up to Week 36 (double-blind treatment period), up to Month 24 (open-label extension)
Secondary outcome [12] 0 0
Plasma Concentrations of ARO-ANG3 Over Time
Timepoint [12] 0 0
Baseline, up to Week 12 (double-blind treatment period), up to Month 24 (open-label extension)
Secondary outcome [13] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and/or Serious TEAEs up to Week 24
Timepoint [13] 0 0
From first dose of IP up to Week 24
Secondary outcome [14] 0 0
Number of Participants With AEs and/or SAEs Over Time in the Double-Blind Treatment Period
Timepoint [14] 0 0
up to Week 36 (double-blind treatment period)
Secondary outcome [15] 0 0
Number of Participants With AEs and/or SAEs Over Time in the Open-Label Extension
Timepoint [15] 0 0
up to Month 24 (open-label extension)

Eligibility
Key inclusion criteria
* Based on medical history, evidence of TG = 150 mg/dL but = 499 mg/dL
* Fasting levels at Screening of LDL-C = 70 mg/dL OR non-HDL-C = 100 mg/dL after at least 4 weeks of stable diet and stable optimal statin therapy
* Mean fasting TG = 150 mg/dL and = 499 mg/dL during Screening collected at two separate and consecutive visits and at least 7 days apart and not more than 17 days apart
* Willing to follow diet counseling and maintain a stable diet per Investigator judgment based on local standard of care
* Participants of childbearing potential must agree to use highly-effective contraception during the study and for at least 24 weeks from last dose of study medication
* Women of childbearing potential must have a negative pregnancy test and cannot be breastfeeding
* Women of childbearing potential on hormonal contraceptives must be stable on the medication for = 2 menstrual cycles prior to Day 1
* Men must not donate sperm during the study and for at least 24 weeks following the last dose of study medication
* Able and willing to provide written informed consent and to comply with study requirements
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Current use or use within 365 days from Day 1 of any hepatocyte targeted siRNA or antisense oligonucleotide molecule
* Active pancreatitis within 12 weeks prior to Day 1
* Any planned bariatric surgery or similar procedures to induce weight loss from consent to end of study
* Acute coronary syndrome event within 24 weeks of Day 1
* Major surgery within 12 weeks of Day 1 or planned surgery during the study
* Planned coronary intervention (e.g., stent placement or heart bypass) during the study
* Uncontrolled hypertension
* Human immunodeficiency virus (HIV) infection, seropositive for Hepatitis B (HBV), seropositive for Hepatitis C (HCV)
* Uncontrolled hypothyroidism or hyperthyroidism
* Hemorrhagic stroke within 24 weeks of Day 1
* History of bleeding diathesis or coagulopathy
* Current diagnosis of nephrotic syndrome
* Systemic use of corticosteroids or anabolic steroids within 4 weeks prior to Day 1 or planned use during the study
* Malignancy within the last 2 years prior to date of consent requiring systemic treatment (some exceptions apply)

Note: additional inclusion/exclusion criteria may apply per protocol

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/09/2024
Sample size
Target
Accrual to date
Final
204
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Paratus Clinical Research - Blacktown
Recruitment hospital [2] 0 0
University of the Sunshine Coast Clinical Trials Centre - Sippy Downs
Recruitment hospital [3] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
4556 - Sippy Downs
Recruitment postcode(s) [3] 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
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
Nebraska
Country [5] 0 0
United States of America
State/province [5] 0 0
Nevada
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Canada
State/province [11] 0 0
Ontario
Country [12] 0 0
Canada
State/province [12] 0 0
Quebec
Country [13] 0 0
Canada
State/province [13] 0 0
Québec
Country [14] 0 0
New Zealand
State/province [14] 0 0
Birkenhead
Country [15] 0 0
New Zealand
State/province [15] 0 0
Christchurch
Country [16] 0 0
New Zealand
State/province [16] 0 0
Hamilton
Country [17] 0 0
New Zealand
State/province [17] 0 0
Rotorua

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04832971