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

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: 89bio, Inc.

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.