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Tests treatment safety and results for Hypertriglyceridemia
Official title Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia
ClinicalTrials.gov ID: NCT06822790
What this study is testing
What is Plozasiran Injection?
Plozasiran Injection is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for hypertriglyceridemia.
Also referred to as ARO-APOC3.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open-label study to be conducted in adults with hypertriglyceridemia (HTG) and severe hypertriglyceridemia (SHTG). Each participant must have completed all required visits per protocol in the parent study AROAPOC3-2003 (USA and Canada participants only; NCT# 05413135), AROAPOC3-3001(Canada and Japan participants only; NCT05089084), AROAPOC3-3003 (NCT06347003), AROAPOC3-3004 (NCT06347016) or AROAPOC3-3009 (Argentina, Italy, South Africa, and Spain; NCT06347133).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult males, or nonpregnant (who do not plan to become pregnant), nonlactating adult females, who are able and willing to provide written informed...
- Completed all required study visits per protocol in the parent study
- Female people of childbearing potential must agree to use a highly effective method of contraception during the study and for at least 90 days after...
- people must be on standard of care lipid and TG-lowering medications per local guidelines (unless documented as intolerant as determined by the...
- If the subject has a medical history of clinical atherosclerotic cardiovascular disease (ASCVD) or elevated 10-year ASCVD risk (eg, ≥7.5% per...
You likely can't join if
- Subject was permanently discontinued from receiving plozasiran in the parent study due to elevated aspartate aminotransferase (AST) or alanine...
- Subject withdrew consent for continued study treatment in the parent study
- Known hypersensitivity to the active substance or to any of the excipients of plozasiran
- Known hypersensitivity to the active substance or to any of the excipients of plozasiran
- Any new condition or worsening of existing condition or any other situation that in the Investigator's judgment, would make the subject unsuitable...
- Unwilling to limit alcohol consumption to within moderate limits for the duration of the study.
See the full eligibility criteria
- Adult males, or nonpregnant (who do not plan to become pregnant), nonlactating adult females, who are able and willing to provide written informed consent prior to the performance of any study-specific procedures
- Completed all required study visits per protocol in the parent study
- Female people of childbearing potential must agree to use a highly effective method of contraception during the study and for at least 90 days after the End of Study (EOS) or the last dose of plozasiran, whichever is...
- people must be on standard of care lipid and TG-lowering medications per local guidelines (unless documented as intolerant as determined by the Investigator, including an inability to safely administer or re-administer...
- If the subject has a medical history of clinical atherosclerotic cardiovascular disease (ASCVD) or elevated 10-year ASCVD risk (eg, ≥7.5% per American Heart Association/American College of Cardiology [AHA/ACC] risk...
- Subject must be on optimized antidiabetic regimen as defined by the local standards, Investigator, and institutional practices
- Subject must have no events of diabetic ketoacidosis, diabetic decompensation/ hyperosmolar hyperglycemic nonketotic coma, diabetes complications, recurrent infections, or hospitalization related to poor glycemic...
- HbA1c ≤10% within 30 days prior to Day 1
- Completed AROAPOC3-2001 prior to entry into AROAPOC3-2003 AND either (c) or (d) below:
- Baseline fasting TG level of ≥500 mg/dL and prior history of acute pancreatitis at the time of enrollment into AROAPOC3-2001
- Baseline fasting TG level of ≥1000 mg/dL at the time of enrollment into AROAPOC3-2001
- people who previously met all eligibility requirements for AROAPOC3-3003, or AROAPOC3-3004 and were not permitted to proceed to randomization per Sponsor's direction in order to prevent excessive over-enrollment may...
- Subject was permanently discontinued from receiving plozasiran in the parent study due to elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or due to HbA1c elevation that did not respond to...
- Subject withdrew consent for continued study treatment in the parent study
- Known hypersensitivity to the active substance or to any of the excipients of plozasiran
- Known hypersensitivity to the active substance or to any of the excipients of plozasiran
- Any new condition or worsening of existing condition or any other situation that in the Investigator's judgment, would make the subject unsuitable for enrollment, could interfere with the subject participating in or...
- Unwilling to limit alcohol consumption to within moderate limits for the duration of the study.
- Poorly controlled glycemia (ie, HbA1c \>10%) based upon the most recent HbA1c level reported in the parent trial prior to Day 1
- Acute pancreatitis within 4 weeks prior to Day 1
- Use of any hepatocyte-targeted siRNA that targets lipids and/or triglycerides within 365 days before Day 1 (except plozasiran or inclisiran, which are permitted). Administration of inclisiran must be separated from...
- 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 PK, whichever is longer.
- Use of an investigational agent (other than plozasiran) or device within 30 days or within 5 half-lives, based on plasma PK, whichever is longer, prior to Day 1 (V1) or current participation in an treatment...
- Recent unstable or symptomatic cardiac arrhythmia (including any associated medication changes) within 90 days prior to Day 1. Individuals with stable well-controlled atrial arrhythmias will be allowed to participate in...
- Uncontrolled hypertension (ie, seated systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg) at Day 1; subject may be re-evaluated when hypertension is controlled. Note: Other inclusion/exclusion...
The study team makes the final eligibility decision.
Where it's taking place
- Bakersfield, California, United States
- Beverly Hills, California, United States
- Canoga Park, California, United States
- Garden Grove, California, United States
- Huntington Beach, California, United States
- Lake Forest, California, United States
- Lincoln, California, United States
- Oxnard, California, United States
- Palm Springs, California, United States
- Redding, California, United States
- Fort Lauderdale, Florida, United States
- Hialeah, Florida, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Mt. Dora, Florida, United States
- North Miami, Florida, United States
- Orlando, Florida, United States
- Tamarac, Florida, United States
- Tampa, Florida, United States
- Lawrenceville, Georgia, United States
+ 185 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bakersfield, California, United States; Beverly Hills, California, United States; Canoga Park, California, United States; Garden Grove, California, United States; Huntington Beach, California, United States; Lake Forest, California, United States and 199 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.