To Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia
This research study is investigating a new medication called Pegozafermin for individuals in the UK who have severe hypertriglyceridemia, which means they have very high levels of triglycerides – a type of fat in their blood. The main aim is to find out if Pegozafermin can safely and effectively reduce these triglyceride levels over a period of 26 weeks. Some participants will receive Pegozafermin, while others will receive a placebo (a dummy drug with no active ingredients) to allow for a fair comparison. This is a Phase 3 trial, meaning the drug has already undergone earlier testing and is now being studied in a larger group of people to confirm its effectiveness and monitor for any side effects.
At a glance
What is this study about?
This study is focused on a condition called severe hypertriglyceridemia. Triglycerides are a type of fat found in your blood, and having very high levels can increase your risk of certain health problems. We're looking at a new medication, Pegozafermin, to see if it can help bring these levels down effectively and safely.
The main goal is to compare how well Pegozafermin works against a 'placebo', which is an inactive substance that looks just like the study drug. This is a common and important way in medical research to ensure any observed effects are genuinely due to the new medication and not other factors. Participants will be monitored over 26 weeks to see the impact on their triglyceride levels.
By taking part, you would be contributing valuable information that could help doctors understand if Pegozafermin could be a new treatment option for people with this condition in the future. The study is designed to be as safe as possible for participants, with close medical supervision throughout.
Key takeaways
- New study for people with very high blood triglyceride levels.
- Investigating a new drug called Pegozafermin.
- Compares Pegozafermin to a 'dummy' drug (placebo).
- Study lasts 26 weeks to check safety and effectiveness.
- Regular health checks and blood tests are part of participation.
- Your contribution could help develop new treatments.
Who may be eligible?
To join this study, you need to be at least 22 years old. You should also be willing to keep your current medications, diet, and exercise routine consistent throughout the study period. If you're taking medication to help manage cholesterol or other fats in your blood, it needs to have been stable for at least 4 weeks before you join.
There are certain reasons why you might not be able to participate. For example, if you have certain infections like hepatitis B or C, or HIV. People with uncontrolled type 2 diabetes or a recent diagnosis (within the last 3 months) would also not be able to join, and your long-term blood sugar levels (HbA1c) need to be below a certain point. If you have type 1 diabetes, you also wouldn't be eligible.
Additionally, if you have a history of certain gallbladder issues, recent acute pancreatitis, or a specific genetic condition called familial chylomicronemia syndrome, you wouldn't be able to take part. The study team will discuss all the specific criteria with you to determine if you are a good fit.
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 22 years old or older?
- Can you keep your current medications, diet, and exercise stable for the study duration?
- Do you have severe high triglycerides (blood fat levels)?
- Have you had stable lipid-lowering medication for at least 4 weeks?
- Do you have Type 1 diabetes, or uncontrolled/newly diagnosed Type 2 diabetes?
- Have you recently had acute pancreatitis or specific gallbladder issues?
What does participation involve?
If you decide to participate, you will receive either the study drug, Pegozafermin, or a placebo (a dummy drug). You'll have regular visits to the clinic over 26 weeks where doctors will monitor your health, take blood samples to check your triglyceride levels and other markers, and discuss how you're feeling. These visits help us understand how the drug is working and check for any side effects. You'll be asked to maintain your medication, eating, and exercise habits as consistently as possible throughout the study. The total duration of active treatment and follow-up will be outlined by the study team.
Potential risks and benefits
Locations (177)
- 89bio Clinical Study SiteVerified postcodeChandler, United States
- 89bio Clinical Study SiteVerified postcodePeoria, United States
- 89Bio Clinical Study SiteVerified postcodeTucson, United States
- 89bio Clinical Study SiteVerified postcodeConway, United States
- 89bio Clinical Study SiteVerified postcodeJonesboro, United States
- 89bio Clinical Study SiteVerified postcodeLittle Rock, United States
- 89bio Clinical Trial SiteVerified postcodeHuntington Park, United States
- 89Bio Clinical Study SiteVerified postcodeLong Beach, United States
- 89bio Clinical Study SiteVerified postcodeLos Angeles, United States
- 89bio Clinical Trial SiteVerified postcodeNorthridge, United States
- 89bio Clinical Trial SiteVerified postcodePanorama City, United States
- 89bio Clinical Study SiteVerified postcodeSanta Ana, United States
Common questions
What are triglycerides?
Triglycerides are a type of fat found in your blood. High levels can sometimes increase the risk of certain health problems.
What is a Phase 3 trial?
A Phase 3 trial means the drug has already been tested in smaller groups and is now being studied in a larger group of people to confirm its effectiveness and safety.
Will I know if I'm getting the active drug or the placebo?
No, during the study, neither you nor your doctor will know whether you are receiving Pegozafermin or the placebo. This helps ensure fair and accurate results.
How long will I be in the study?
The treatment period for checking triglyceride levels is 26 weeks, with additional follow-up visits as determined by the study team.
Can I stop participating at any time?
Yes, you have the right to withdraw from the study at any point, for any reason, without affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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