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

  • End date
    May 5, 2022
  • participants needed
  • sponsor
    89bio, Inc.
Updated on 5 June 2021


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).

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


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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