Study of ARO-ANG3 in Adults With Mixed Dyslipidemia (ARCHES-2)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04832971 |
|
Recruitment Status :
Active, not recruiting
First Posted : April 6, 2021
Results First Posted : January 16, 2024
Last Update Posted : April 18, 2024
|
Sponsor:
Arrowhead Pharmaceuticals
Information provided by (Responsible Party):
Arrowhead Pharmaceuticals
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief Summary:
The purpose of AROANG3-2001 is to evaluate the efficacy and safety of ARO-ANG3 in participants with mixed dyslipidemia. Participants will initially receive 2 subcutaneous injections of ARO-ANG3 or placebo. Participants who complete the double-blind treatment period may opt to continue in an open-label extension during which they will receive up to 8 doses of ARO-ANG3.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Mixed Dyslipidemia | Drug: ARO-ANG3 Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 204 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Double-blind, Placebo-controlled Phase 2b Study to Evaluate the Efficacy and Safety of ARO-ANG3 in Adults With Mixed Dyslipidemia |
| Actual Study Start Date : | June 28, 2021 |
| Actual Primary Completion Date : | August 30, 2022 |
| Estimated Study Completion Date : | December 2024 |
| Arm | Intervention/treatment |
|---|---|
|
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.
|
Drug: ARO-ANG3
ARO-ANG3 Injection |
|
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.
|
Drug: ARO-ANG3
ARO-ANG3 Injection |
|
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.
|
Drug: ARO-ANG3
ARO-ANG3 Injection |
|
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.
|
Drug: ARO-ANG3
ARO-ANG3 Injection Drug: Placebo Sterile Normal Saline (0.9% NaCl) |
Primary Outcome Measures :
- Percent Change From Baseline in Fasting TG at Week 24 [ Time Frame: Baseline, Week 24 ]
Secondary Outcome Measures :
- Percent Change From Baseline in Fasting TG Over Time [ Time Frame: Baseline, up to Week 36 (double-blind treatment period), up to Month 24 (open-label extension) ]
- Percent Change From Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 24 [ Time Frame: Baseline, Week 24 ]
- Percent Change From Baseline in Fasting Non-HDL-C Over Time [ Time Frame: Baseline, up to Week 36 (double-blind treatment period), up to Month 24 (open-label extension) ]
- Percent Change From Baseline in Fasting Total Apolipoprotein B (ApoB) at Week 24 [ Time Frame: Baseline, Week 24 ]
- Percent Change From Baseline in Fasting Total ApoB Over Time [ Time Frame: Baseline, up to Week 36 (double-blind treatment period), up to Month 24 (open-label extension) ]
- Percent Change From Baseline in Fasting Low-density Lipoprotein-Cholesterol (LDL-C) Using Ultracentrifugation at Week 24 [ Time Frame: Baseline, Week 24 ]
- Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time [ Time Frame: Baseline, up to Week 36 (double-blind treatment period), up to Month 24 (open-label extension) ]
- Percent Change From Baseline in Angiopoietin-like Protein 3 (ANGPTL3) at Week 24 [ Time Frame: Baseline, Week 24 ]
- Percent Change From Baseline in ANGPTL3 Over Time [ Time Frame: Baseline, up to Week 36 (double-blind treatment period), up to Month 24 (open-label extension) ]
- Percent Change From Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) at Week 24 [ Time Frame: Baseline, Week 24 ]
- Percent Change From Baseline in Fasting HDL-C Over Time [ Time Frame: Baseline, up to Week 36 (double-blind treatment period), up to Month 24 (open-label extension) ]
- Plasma Concentrations of ARO-ANG3 Over Time [ Time Frame: Baseline, up to Week 12 (double-blind treatment period), up to Month 24 (open-label extension) ]
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and/or Serious TEAEs up to Week 24 [ Time Frame: From first dose of IP up to Week 24 ]TEAEs are adverse events (AEs) that occur following IP administration or a pre-existing condition exacerbated following IP administration. An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is an AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction.
- Number of Participants With AEs and/or SAEs Over Time in the Double-Blind Treatment Period [ Time Frame: up to Week 36 (double-blind treatment period) ]
- Number of Participants With AEs and/or SAEs Over Time in the Open-Label Extension [ Time Frame: up to Month 24 (open-label extension) ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04832971
Locations
Show 24 study locations
Sponsors and Collaborators
Arrowhead Pharmaceuticals
Study Documents (Full-Text)
Documents provided by Arrowhead Pharmaceuticals:
Documents provided by Arrowhead Pharmaceuticals:
Study Protocol [PDF] November 22, 2022
Statistical Analysis Plan [PDF] October 5, 2022
| Responsible Party: | Arrowhead Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT04832971 |
| Other Study ID Numbers: |
AROANG3-2001 |
| First Posted: | April 6, 2021 Key Record Dates |
| Results First Posted: | January 16, 2024 |
| Last Update Posted: | April 18, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
|
Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |