The ENTRUST clinical research study is for people who have severe hypertriglyceridemia. The study will test a new investigational medication for hypertriglyceridemia to learn if it can safely and effectively lower triglyceride levels in people that have elevated triglycerides.
Study participants may be able to join the study if they meet the following requirements:
- 22 years of age or older
- Diagnosed with severe hypertriglyceridemia (blood triglyceride levels of 500 mg/dL to 2000 mg/dL (5.7-22.6 mmol/L)
- Willing to adhere to medication requirements and maintain lifestyle habits for the duration of the study
Other study requirements will apply
Participation in the ENTRUST study lasts about 1 year and 4 months. Study participants can expect the following:
- 1. Review & sign the Informed Consent Form
- 2. Screening period (up to 6 weeks): Visit the study clinic 3-4 times for study health checks to find out if you qualify.
- Obtain information on a diet and physical activity for those with very high triglycerides.
- 3. Study treatment period (about 1 year): Recieve Pegozafermin or a placebo (no active medication) administered through injections into the skin of your belly once a week. These injections are sometimes given by a nurse and sometimes may be given by yourself or a caregiver at home.
- Patients are expected to visit the study clinic up to 24 times.
- 4. Follow-up period (about 3 and a half months): Visit the study clinic 3 more times for study health checks.
Participation in a clinical study in voluntary. You can ask any questions you have and may leave the study at any time, for any reason.