Study to Evaluate ARO-APOC3 in Adults With Severe Hypertriglyceridemia (SHASTA-2)
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ClinicalTrials.gov Identifier: NCT04720534 |
Recruitment Status :
Completed
First Posted : January 22, 2021
Last Update Posted : April 18, 2024
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Severe Hypertriglyceridemia | Drug: ARO-APOC3 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 229 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-APOC3 in Adults With Severe Hypertriglyceridemia |
Actual Study Start Date : | May 31, 2021 |
Actual Primary Completion Date : | March 9, 2023 |
Actual Study Completion Date : | August 31, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: ARO-APOC3 10 mg, Day 1 and Week 12
2 doses of ARO-APOC3 by subcutaneous (sc) injection
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Drug: ARO-APOC3
2 doses of ARO-APOC3 by subcutaneous (sc) injection |
Experimental: ARO-APOC3 25 mg, Day 1 and Week 12
2 doses of ARO-APOC3 by sc injection
|
Drug: ARO-APOC3
2 doses of ARO-APOC3 by subcutaneous (sc) injection |
Experimental: ARO-APOC3 50 mg, Day 1 and Week 12
2 doses of ARO-APOC3 by sc injection
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Drug: ARO-APOC3
2 doses of ARO-APOC3 by subcutaneous (sc) injection |
Placebo Comparator: Placebo, Day 1 and Week 12
calculated volume to match active treatment by sc injection
|
Drug: Placebo
calculated volume to match active treatment by sc injection |
- Percent Change from Baseline in Fasting Triglycerides (TG) at Week 24 [ Time Frame: Baseline, Week 24 ]
- Percent Change from Baseline in Fasting TG Over Time Through Week 48 [ Time Frame: Baseline, up to Week 48 ]
- Percent Change from Baseline in Apolipoprotein (Apo)C-III at Week 24 [ Time Frame: Baseline, Week 24 ]
- Percent Change from Baseline in ApoC-III Over Time Through Week 48 [ Time Frame: Baseline, up to Week 48 ]
- 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 Through Week 48 [ Time Frame: Baseline, up to Week 48 ]
- 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 Through Week 48 [ Time Frame: Baseline, up to Week 48 ]
- 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 Through Week 48 [ Time Frame: Baseline, up to Week 48 ]
- Percent Change from Baseline in Fasting Low-density Lipoprotein-Cholesterol (LDL-C) Using Ultracentrifugation [ Time Frame: Baseline, Week 24 ]
- Percent Change from Baseline in Fasting LDL-C Using Ultracentrifugation Over Time Through Week 48 [ Time Frame: Baseline, up to Week 48 ]
- Change from Baseline in Plasma Concentration of ARO-APOC3 Over Time Through Week 48 [ Time Frame: Baseline, up to Week 48 ]
- Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs) Possibly or Probably Related to Treatment [ Time Frame: up to Week 48 ]
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 |
Inclusion Criteria:
- Based on medical history, evidence of TG ≥ 500 mg/dL and ≤ 4000 mg/dL at Screening
- Fasting TG ≥ 500 mg/dL at Screening
- Willing to follow diet counseling per Investigator judgment based on local standard of care
- Women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception
- Willing to provide written informed consent and to comply with study requirements
Exclusion Criteria:
- Active pancreatitis within 12 weeks prior to first dose
- 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 first dose
- Major surgery within 12 weeks of first dose
- Planned coronary intervention (e.g., stent placement or heart bypass) or any non-cardiac major surgical procedure throughout 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 first dose
- 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
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): NCT04720534
Responsible Party: | Arrowhead Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT04720534 |
Other Study ID Numbers: |
AROAPOC3-2001 |
First Posted: | January 22, 2021 Key Record Dates |
Last Update Posted: | April 18, 2024 |
Last Verified: | April 2024 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Hypertriglyceridemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |