Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia
This research is looking at the long-term safety and effectiveness of a new medication called Plozasiran. It's an injection for adults who have dangerously high levels of fat in their blood, known as hypertriglyceridemia. Participants in this study have previously taken part in other related studies testing Plozasiran. Those eligible will receive a Plozasiran injection under the skin about every three months for two years. Throughout the study, people will be encouraged to stick to a low-fat diet, which is standard advice for this condition. The study aims to gather more information about how well Plozasiran works and if it's safe over a longer period.
At a glance
What is this study about?
This study is investigating a new medicine called Plozasiran. It's designed for adults who have very high levels of a type of fat in their blood, called triglycerides. When triglyceride levels are too high, it can increase the risk of serious health problems like pancreatitis (a painful inflammation of the pancreas) or heart disease. The aim of this research is to understand if Plozasiran can effectively lower these triglyceride levels and if it is safe for people to use over a longer period, specifically two years.
Participants in this study have already taken part in previous related trials looking at Plozasiran. This 'follow-on' study will provide valuable information about the medicine's effects over time. It's important to understand how new treatments work in the long run, not just for a few weeks or months. This helps doctors make informed decisions about prescribing new medicines in the future.
Throughout the study, participants will receive the Plozasiran injection regularly and will also be advised to follow a low-fat diet. This combination approach helps researchers understand the full impact of the new medicine when used alongside established lifestyle recommendations. By gathering this comprehensive data, the study hopes to contribute to better ways of managing high triglyceride levels.
Key takeaways
- This study is for adults with very high triglycerides who took part in a previous Plozasiran trial.
- It aims to check the long-term safety and effectiveness of Plozasiran.
- The medication is given as an injection every three months for two years.
- Participants will also be advised to follow a low-fat diet.
- Your health will be closely monitored throughout the study period.
Who may be eligible?
This study is specifically for adults who have already taken part in one of several previous related studies on the medication Plozasiran and completed all the required visits in those studies. You would also need to meet other health criteria to be included.
Key health requirements include having your blood sugar (HbA1c) at or below 10% within a month before starting this study. If you were in a specific previous study (AROAOC3-2003), you also needed to have completed another study before that and met certain very high triglyceride levels at the start of the first study, particularly if you had a history of pancreatitis.
Beyond these specific previous study requirements, for all participants, women must not be pregnant or breastfeeding and must use highly effective contraception if they could become pregnant. Men must also use contraception. Everyone must be on their usual medications for managing cholesterol and triglycerides, unless their doctor says they cannot take them. If you have heart disease or a high risk of it, you must be on appropriate cholesterol-lowering treatment as well. If you have diabetes, it must be well-managed according to your doctor's advice.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you an adult aged 18 or older?
- Have you already completed all visits in a previous Plozasiran study (e.g., AROAPOC3-2003, AROAPOC3-3001, AROAPOC3-3003, AROAPOC3-3004, or AROAPOC3-3009)?
- Is your blood sugar level (HbA1c) at or below 10%?
- If you are a woman, are you not pregnant or breastfeeding, and are you willing to use effective contraception if you could become pregnant?
- Are you currently taking your usual medications for high cholesterol and triglycerides, if applicable, or is there a documented reason why you cannot?
- If you have diabetes, is it well-managed as advised by your local healthcare team?
What does participation involve?
If you join this study, you will receive Plozasiran as an injection under the skin approximately every three months for a total of two years. You will have regular appointments where study staff will check your health, take blood samples, and monitor how you are responding to the treatment. You will also be strongly advised to continue following a low-fat diet throughout the two-year study period. The exact schedule of visits and assessments will be provided by the study team, but typically involves regular check-ups to monitor your safety and the effectiveness of the treatment.
Potential risks and benefits
Locations (275)
- Research Site 21Verified postcodeBakersfield, United States· Recruiting
- Research Site 9Verified postcodeBeverly Hills, United States· Recruiting
- Research Site 11Verified postcodeCanoga Park, United States· Recruiting
- Research Site 40Verified postcodeGarden Grove, United States· Recruiting
- Research Site 235Verified postcodeHuntington Beach, United States· Recruiting
- Research Site 236Verified postcodeLake Forest, United States· Recruiting
- Research Site 39Verified postcodeLincoln, United States· Recruiting
- Research Site 34Verified postcodeOxnard, United States· Recruiting
- Research Site 229Verified postcodePalm Springs, United States· Recruiting
- Research Site 275Verified postcodeRedding, United States· Recruiting
- Research Site 155Verified postcodeFort Lauderdale, United States· Recruiting
- Research Site 14Verified postcodeHialeah, United States· Recruiting
Common questions
What is Plozasiran?
Plozasiran is a new investigational medication being studied to lower very high levels of fat in the blood called triglycerides.
Who can take part in this study?
This study is for adults who have already participated in certain previous Plozasiran studies and meet specific health criteria, including having well-controlled blood sugar.
How will the medication be given?
Plozasiran will be given as an injection under the skin, approximately every three months.
How long does the study last?
Your participation in this part of the study will last for two years.
Do I need to follow a special diet during the study?
Yes, you will be advised to continue following a low-fat diet throughout the study, as recommended by your healthcare team.
How to find out more
Medical Monitor
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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