About the Study Medication

What is the study medication?

The investigational study medication, Pegozafermin, is a man-made form of a natural hormone in the body called FGF21 that is made to last longer in the body than the natural form. This hormone is involved in the body's processing and storing of energy in the form of fats and sugars.

People with SHTG often have low levels of FGF21, and researchers think having higher FGF21 levels may help their bodies process fats and sugars better and lead to lower TG levels. Pegozafermin is designed to stay in the body longer than natural FGF21, giving it more time to possibly help lower extremely high triglycerides.

Pegozafermin is an investigational medication, which means it has not been approved by any health or regulatory agency as an option for managing severe hypertriglyceridemia.

Will I receive the study medication?

Not everyone in the study receives Pegozafermin. About 1 in 4 participants receive a placebo, which looks like Pegozafermin and is also given by injection, but it has no active ingredients. Neither you nor the study doctor or staff will know whether you are receiving Pegozafermin or placebo. The study doctor can find out in an emergency, if necessary.

What is an “investigational medicine?”

Investigational means the study medication is not approved by regulatory authorities like the US Food and Drug Administration (FDA), and it can only be used in clinical research studies like ENTRUST.