This clinical trial is focused on studying a condition known as Severe Hypertriglyceridemia, which is characterized by very high levels of triglycerides in the blood. The study will evaluate a treatment called Pegozafermin, which is a solution for injection. Pegozafermin is also known by its code name BIO89-100. The purpose of the study is to determine how Pegozafermin affects triglyceride levels in people with Severe Hypertriglyceridemia after 26 weeks of treatment. Participants in the study will receive either Pegozafermin or a placebo, which is a substance with no active medication.

In addition to Pegozafermin, the study involves the use of Simvastatin, a medication commonly used to lower cholesterol levels. Simvastatin will be provided in the form of film-coated tablets. Participants will continue their usual lipid-modifying therapy, which helps manage cholesterol levels, throughout the study. The study will last for a total of 52 weeks, with the main focus on changes in triglyceride levels at the 26-week mark.

Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment. The study will also look at changes in other cholesterol levels, such as non-high-density lipoprotein cholesterol (non-HDL-C) and high-density lipoprotein cholesterol (HDL-C), as well as liver fat content using MRI scans. The goal is to gather information on the safety and effectiveness of Pegozafermin in managing Severe Hypertriglyceridemia.