A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Severe Hypertriglyceridemia (SHTG)
This important study is looking into a new medicine called Pegozafermin for adults who have very high levels of a type of fat in their blood called triglycerides. High triglycerides can be a concern for your health. The main goal is to find out how well Pegozafermin lowers these triglyceride levels over 26 weeks, compared to a dummy medicine (a placebo). We also want to understand if the medicine is safe and look at its effects on other fats in the blood and on liver health. Your doctor might recommend this study if you have severe hypertriglyceridemia.
At a glance
What is this study about?
This study is called a 'Phase 3' trial. This means the medicine, Pegozafermin, has already been tested in earlier studies and shown some promise. Now, we need to test it in a larger group of people to confirm its benefits and understand its safety more fully. We're especially interested in people who have 'severe hypertriglyceridemia,' which is a medical term for having very high levels of triglycerides in your blood.
Triglycerides are a type of fat that circulates in your blood. While some are needed for energy, very high levels can be linked to health problems. Current treatments sometimes aren't enough for everyone, so researchers are hopeful that Pegozafermin could offer a new option. This trial will help us learn if Pegozafermin can effectively lower these high triglyceride levels and improve other related health markers.
The study is designed to be very careful and fair. Some participants will receive Pegozafermin, and others will receive a placebo – which looks exactly like the study drug but contains no active medicine. Neither you nor your study doctor will know which one you are getting, which helps ensure the results are unbiased. This allows us to clearly see if any changes are due to Pegozafermin itself.
Key takeaways
- This study evaluates a new medicine, Pegozafermin, for very high triglycerides.
- It's a Phase 3 study, meaning the medicine has shown promise in earlier tests.
- You'll either get Pegozafermin or a dummy medicine (placebo).
- Participation involves regular clinic visits, blood tests, and possibly MRI scans.
- The main goal is to see how well Pegozafermin lowers triglycerides and if it's safe.
- You can leave the study at any time without affecting your normal care.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or older. Both men and women can take part.
The most important requirement is that you have a condition called 'severe hypertriglyceridemia.' This means you have very high levels of triglycerides in your blood, which your doctor would have diagnosed.
There might be other health conditions or medicines that would prevent you from joining, but the study team will check all of this carefully with you to make sure it's safe and appropriate for you to participate.
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 18 years old or older?
- Have you been diagnosed by a doctor with severe hypertriglyceridemia (very high triglycerides)?
- Are you willing to attend regular clinic visits and have blood tests?
- Are you able to take a study medicine by injection?
What does participation involve?
If you decide to take part, you'll be assigned to either receive the new medicine, Pegozafermin, or a dummy medicine called a placebo. You'll take this medicine regularly, likely by injection using a pre-filled syringe, for at least 26 weeks, and potentially up to 52 weeks.
You'll have regular visits to the clinic for health check-ups, blood tests to measure your triglyceride levels and other fats, and potentially imaging scans (like an MRI) to check your liver health. These visits will be spread out over the study period. All study-related medication and visits will be provided at no cost, and you'll be closely monitored by the study team throughout your participation.
Potential risks and benefits
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Common questions
What are triglycerides?
Triglycerides are a type of fat found in your blood. Your body uses them for energy. Very high levels can be a concern for your health.
What is 'Pegozafermin'?
Pegozafermin is the name of the new medicine being tested in this study to see if it can help lower very high triglyceride levels.
Will I know if I'm getting the real medicine or the dummy medicine?
No, neither you nor your study doctor will know. This is called 'double-blind' and helps make the study results fair and accurate.
How long will the study last if I join?
The main part of the study where we check the primary results is 26 weeks, but your participation might continue for up to 52 weeks.
What is an MRI-PDFF scan?
It's a special type of MRI scan that helps doctors measure the amount of fat in your liver. It's a non-invasive and safe procedure.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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