A Safety and Tolerability Trial Evaluating CTX310 in Participants With Refractory Dyslipidemias

To join this study, you need to be between 18 and 75 years old and have high levels of cholesterol or other fats in your blood that haven't improved with typical treatments. This means your doctors have tried various standard medications at the highest possible safe doses for at least three months, but your blood fat levels remain elevated. Specific levels of cholesterol and triglycerides (a type of fat) are checked to confirm this.

Importantly, certain health conditions would prevent you from taking part. For example, if you have severe liver, kidney, heart, or blood problems, or if you've recently had a heart attack, stroke (within the last 6 months), or pancreatitis (within the last 3 months), you wouldn't be able to join. The study also cannot include individuals with specific infections like HIV or hepatitis, or those who have had certain types of cancer recently.

For women, you must be past menopause or have had surgery that prevents you from having children. Men and their female partners must agree to use effective birth control throughout the study. The study cannot include women who could potentially become pregnant.

If you decide to take part, you'll receive the study medicine, CTX310, directly into a vein. This is called an intravenous (IV) infusion. The study will involve several visits to the clinic so the research team can monitor your health closely, check how you're responding to the medication, and make sure you're tolerating it well. They'll regularly check your blood pressure, heart rate, and take blood samples to measure your cholesterol and fat levels, as well as checking your general health like liver and kidney function. You'll also be asked about any side effects you might experience. The total length of your participation will depend on the study's design, but typically, early-stage trials involve regular follow-up over several weeks or months to track the medicine's effects and safety.