Study to Explore the Efficacy and Safety of BIO89-100 in Subjects With Severe Hypertriglyceridemia

  • STATUS
    Recruiting
  • End date
    May 5, 2022
  • participants needed
    126
  • sponsor
    89bio, Inc.
Updated on 5 June 2021
Investigator
Jerome Pinkett
Primary Contact
Family Medicine Specialists, Inc. (0.6 mi away) Contact
+39 other location

Summary

This study is designed to assess the efficacy, safety, and tolerability of different doses and dose regimens (QW or every 2 weeks [Q2W]), subcutaneous (SC) dosing of BIO89-100 compared to placebo in subjects with Severe Hypertriglyceridemia (SHTG).

Details
Condition Severe Hypertriglyceridemia
Treatment Placebo, BIO89-100
Clinical Study IdentifierNCT04541186
Sponsor89bio, Inc.
Last Modified on5 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female age 21 to 75 years
Screening fasting triglyceride 500 mg/dL and 2000 mg/dL
Willing to follow a lifestyle for optimal control of TGs and disease management during the study
Patients could be taking statins and/or prescription fish oil as background therapy OR not be taking any background therapy
MRI-PDFF of 6% for subjects screened for the fibrate expansion cohort

Exclusion Criteria

Uncontrolled or newly diagnosed hypertension
Body mass index (BMI) >45 kg/m2
Receiving niacin, PCSK9 inhibitors, or supplements that could lower lipid levels
Type 1 diabetes mellitus (T1DM)
Diagnosis of Type 2 diabetes mellitus (T2DM) <6 months prior to screening
History of malignancy within 5 years prior to screening
Subjects with 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 5% in 3 months prior to screening visit 1 or weight change 5% during screening or planning to try to lose weight during conduct of study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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