Clinical Connection

This trial is not actively recruiting.

This trial has completed recruitment on this platform, and is no longer accepting new referrals.

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Explore the Efficacy and Safety of BIO89-100 in Subjects with Severe Hypertriglyceridemia

This study is designed to assess the efficacy, safety and tolerability of different doses and dose regimens (every week or every 2 weeks) of BIO89-100 compared to placebo in subjects with SHTG. The study will separately evaluate the response to BIO89-100 in subjects who are not on fibrate therapy and subjects who remain on their current fibrate therapy.

Trial ID: NCT04541186

Trial Details

The purpose of this clinical study is to evaluate how safe and effective an investigational injectable medication (BIO89-100) is at helping to treat severe hypertriglyceridemia. This is a condition in which there are very high levels of a certain type of fat (triglycerides) in your blood.

You may be asked to attend 3 screening visits to determine if you are eligible to enroll in the study. If enrolled, you will receive either the medication being tested in this study or a placebo as an injection every week for 8 weeks. Your total participation will last approximately 5 months and you will be asked to attend 10 doctor’s visits. During these visits, you will complete various diagnostic and laboratory tests and receive the medication. The doctor’s office conducting the study will be able to provide you with more information about the study requirements.

Estimated Enrollment

126 Participants

Phase

Eligibility Criteria

Participants must:

Be male or female between 21 to 75 years of age
Have screening fasting triglycerides greater than or equal to 500 mg/dL and less than or equal to 2000 mg/dL.
May be taking statins and/or prescription fish oil to treat triglycerides
Consider undergoing an MRI of the liver during screening and at the end of the study
Be willing to use contraception
Be willing to fast at least 12 hours and not drink alcohol for at least 48 hours before to obtaining certain blood tests.

Participants must not:

Uncontrolled or newly diagnosed hypertension (high blood pressure)
Body mass index (BMI) greater than 45 kg/m2
Been taking niacin, PCSK9 inhibitors, or supplements that could lower lipid levels
Type 1 diabetes mellitus (T1DM)
Diagnosis of Type 2 diabetes mellitus (T2DM) less than 6 months prior to screening
History of malignancy within 5 years prior to screening other than treated superficial skin cancers
Known lipoprotein lipase impairment or deficiency (Fredrickson Type 1), apolipoprotein C-II deficiency, or familial dysbetalipoproteinemia (Fredrickson Type 3)
Clinically or otherwise documented cardiovascular or cerebrovascular disease.
Weight change greater than or equal to 5% 3 months prior to screening visit 1, or weight change greater than or equal to 5% during screening , or planning to try to lose weight during conduct of study

What Will Happen in This Study?

You may be asked to attend 3 to 4 screening visits to determine if you are eligible to enroll in the study. If enrolled, you will receive either the medication being tested in this study or a placebo as an injection ever week for 8 weeks. Your total participation will last approximately 5 months and you will be asked to attend 10 doctor’s visits. During these visits, you will complete various diagnostic and medical tests and receive the medication. The doctor’s office conducting the study will be able to provide you with more information about the study requirements.

You will need to travel to one of the study clinics taking part in this clinical trial.

Sites are located in the cities/states identified with the red pin:

Frequently Asked Questions (FAQs)

Will I get paid to be a part of this clinical trial?

Yes, you will be paid for your time. We realize it takes a lot of time to come for study visits, so we want to make sure this is not too much of a burden for you. The study site will review all these details with you. Also, you do not have to pay anything to be in the study. All study related services are provided at no cost.

What is a placebo?

In order to understand if the study vaccine works, medical researchers are comparing the study vaccine to a saltwater placebo. A placebo looks like the study vaccine being tested but does not contain the medication or vaccine.

All study volunteers will receive the same level of quality care regardless of if they are assigned to the study treatment or the placebo.

How can I check to see if I’m eligible for this trial?

You can check if you are potentially eligible for this trial by completing a set of screening questions. You can find these on this web page by clicking the ‘Get Started’ button.

What does a typical research study look like?

Clinical trials help determine the safety and effectiveness of new medications or treatments. A research plan or protocol is created that outlines how trial participants may receive interventions which can include investigational medications or procedures. The trial may compare a new medical approach to a standard treatment option already available, to a placebo with no active investigational medication, or to no intervention at all. The trial team will share more details before you participate.

Can I quit the trial at any time?

Study volunteers have the right to drop out of the study at any time for any reason, or no reason at all. The study doctor or sponsor also has the right to discontinue a study volunteer at any time for the participant’s safety, or if the participant no longer meets the study requirements. If you decide to stop study treatment, we will still ask you to come back to the hospital or clinic to have an end of treatment visit within 7 days of terminating the treatment and an end of study visit 4 weeks later.

What personal information is collected about you for the study?

The study doctor and other study staff will collect your personal information. This may include: - Your name, address, telephone number, health insurance number where applicable. - Your age, sex, ethnic and racial background. - Lifestyle information; health and medical history. - Your study treatments and response to study treatments. - Data resulting from testing your biological samples.

Who has access to your personal information?

All your personal information collected for this study will be securely stored in the study medical records at the study site. Sponsor staff, review boards and ethics committees (that approve and monitor studies), and others who have a need to know such as our data hosting provider, and government regulators may check the study records. This is done to make sure that the study is being run properly. Regulatory agencies, such as the US Food and Drug Administration (FDA), European Medicine Agency (EMA) or others, review and approve new medicines. These agencies will be granted direct access to your information. This is so they can verify clinical trial procedures and/or data. If you share your personal data to contact a site, that data will be used by TrialScope to contact you about clinical trials and related information