Summary

Eligibility
for people ages 21-75 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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).

Official Title

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

Keywords

Severe Hypertriglyceridemia Hypertriglyceridemia Dyslipidemia Lipid disorder FGF21 BIO89-100 Fibrate Expansion Study

Eligibility

You can join if…

Open to people ages 21-75

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

You CAN'T join if...

  1. Uncontrolled or newly diagnosed hypertension.
  2. Body mass index (BMI) >45 kg/m2.
  3. Receiving niacin, PCSK9 inhibitors, or supplements that could lower lipid levels.
  4. Type 1 diabetes mellitus (T1DM).
  5. Diagnosis of Type 2 diabetes mellitus (T2DM) <6 months prior to screening.
  6. History of malignancy within 5 years prior to screening.
  7. Subjects with known lipoprotein lipase impairment or deficiency (Fredrickson Type 1), apolipoprotein C-II deficiency, or familial dysbetalipoproteinemia (Fredrickson Type 3).
  8. Clinically or otherwise documented cardiovascular or cerebrovascular disease.
  9. 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.

Locations

  • University of California San Francisco accepting new patients
    San Francisco California 94158 United States
  • Family Medicine Clinic Science accepting new patients
    Lampasas Texas 76550 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
89bio, Inc.
ID
NCT04541186
Phase
Phase 2
Study Type
Interventional
Last Updated