Are you struggling to control very high triglyceride levels?
ONE: ENTRUST Study
What is the ENTRUST Study?
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.
Who can join the ENTRUST study?
Study participants may be able to join the study if they meet the following requirements:
- 22 years of age or older
- Diagnosed with SHTG (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.
What will happen during the study?
Participation in the ENTRUST study lasts about 1 year and 4 months. Study participants can expect the following:
- Review & sign the Informed Consent Form
- 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.
- Study treatment period (about 1 year): Receive 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.
- 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 is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.
TWO: ENTRUST Study
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 more may help their bodies process fats and sugars better and lead to lower TG levels. Since Pegozafermin is also designed to stay in the body longer than natural FGF21, giving it more time to possibly help lower very 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.
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.
THREE: About Severe Hypertriglyceridemia
What is Severe Hypertriglyceridemia?
Severe hypertriglyceridemia is a condition when an individual has very high triglyceride levels (more than three times the normal level) in the bloodstream. Those who have SHTG are at a higher risk to develop serious and life-threatening conditions such as acute pancreatitis and cardiovascular disease.
What are the symptoms of Severe Hypertriglyceridemia and how is diagnosed?
Sometimes people with severe hypertriglyceridemia show no symptoms. If someone is experiencing symptoms, they tend to be:
- Xanthomas (yellow-colored bumps on the skin, usually around the eyelids)
- Recurrent abdominal pain, nausea, and vomiting
- Acute pancreatitis
Severe hypertriglyceridemia is diagnosed through a physical exam and blood test performed by your healthcare provider.
There is currently no cure for SHTG, but researchers are trying to develop new medications and potential treatment for severe hypertriglyceridemia. Participation in the ENTRUST study may help scientists and doctors learn about the study medication and whether it can help lower very high triglyceride levels and alleviate very high triglyceride symptoms.
Where can I learn more?
Ask your doctor for more information about SHTG. You can also learn more about SHTG at the National Lipid Association website.
National Lipid Association Online
FOUR: Overview of Clinical Trials
Here are some common questions and answers about study participation.
What are clinical research studies (trials)?
Clinical research studies help scientists and doctors explore whether a medication is safe and whether it works. Before a doctor can prescribe a new medication, it must go through several phases of clinical research:
Phase 1: First study of the medication in people (often healthy volunteers) to test safety.
Phase 2: Study of the medication in people with the condition the medication is for to further test safety and efficacy.
Phase 3: Study confirming how well the medication works and provide evidence for approval to be prescribed.
Phase 4: Further research after the medication is approved.
The ENTRUST study is a Phase 3 study.
Clinical research studies rely on volunteers. Remember that taking part in the study is your choice. Sometimes the research may not immediately or directly benefit you, but it may provide evidence of benefit to others in the future with the same condition. Know that the rules and ethics that doctors must follow to practice medicine also apply to clinical research studies.
What is informed consent?
Before enrolling in a clinical trial, you must sign an Informed Consent Form (ICF). The ICF contains information about the study, including study goals, how long the study will last, benefits and risks, and the tests and procedures you will receive.
What does study participation involve?
Study participation usually involves visiting a clinic regularly, taking or receiving an investigational medicine, and having assessments to monitor your health. You can still see your regular doctor, but you should let them know that you are participating in a study.
Participation in clinical research studies is your choice, and you may stop at any time.
Interested?
If you meet the listed eligibility criteria and would like to learn more about the ENTRUST study, please call (318) 525-3233 to speak with the clinical research coordinator.