Study to Explore the Efficacy and Safety of BIO89-100 (Pegozafermin) in Participants With Severe Hypertriglyceridemia

Completed · Phase 2 · Has a placebo group

Conditions studied: Severe Hypertriglyceridemia

In brief

This study is designed to assess the efficacy, safety, and tolerability of different doses and dose regimens (once weekly \[QW\] or every 2 weeks \[Q2W\]), subcutaneous (SC) dosing of BIO89-100 (pegozafermin) compared to placebo in participants with severe hypertriglyceridemia (SHTG).

Key facts

Study ID

NCT04541186

Run by

89bio, Inc.

People needed

86

Starts

2020-09-01

Expected to finish

2022-05-31

Last updated by the study team

2024-07-25

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female age ≥21 to ≤75 years.
• Screening fasting triglyceride ≥500 milligrams (mg)/deciliters (dL) and ≤2000 mg/dL.
• Willing to maintain current eating and exercise habits from time of signing the informed consent and for the duration of the study.
• Participants could be taking statins and/or prescription fish oil as background therapy or not be taking any background therapy.
• Magnetic resonance imaging - whole liver proton density fat fraction (MRI-PDFF) of ≥6% for participants screened for the Fibrate Expansion cohort.

You may not qualify if…

• Uncontrolled or newly diagnosed hypertension.
• Body mass index >45 kilograms (kg)/meters squared (m\^2).
• Receiving niacin, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, or supplements that could lower lipid levels.
• Type 1 diabetes mellitus.
• Diagnosis of Type 2 diabetes mellitus <6 months prior to screening.
• History of malignancy within 5 years prior to screening.
• Participants 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 first screening visit or weight change ≥5% during screening or planning to try to lose weight during conduct of study.

Where it is running

• 89Bio Clinical Study Site — La Mesa, California, United States
• 89Bio Clinical Study Site — San Francisco, California, United States
• 89Bio Clinical Study Site — Clearwater, Florida, United States
• 89Bio Clinical Study Site — Greenacres City, Florida, United States
• 89Bio Clinical Study Site — Jacksonville, Florida, United States
• 89Bio Clinical Study Site — Miami, Florida, United States
• 89Bio Clinical Study Site — Miami, Florida, United States
• 89Bio Clinical Study Site — Miami Lakes, Florida, United States
• 89Bio Clinical Study Site — Miami Lakes, Florida, United States
• 89Bio Clinical Study Site — North Miami Beach, Florida, United States
• 89Bio Clinical Study Site — Orlando, Florida, United States
• 89Bio Clinical Study Site — Tampa, Florida, United States
• 89Bio Clinical Study Site — Lawrenceville, Georgia, United States
• 89Bio Clinical Study Site — Quincy, Illinois, United States
• 89Bio Clinical Study Site — Wauconda, Illinois, United States
• 89Bio Clinical Study Site — West Des Moines, Iowa, United States
• 89Bio Clinical Study Site — Louisville, Kentucky, United States
• 89Bio Clinical Study Site — Olive Branch, Mississippi, United States
• 89Bio Clinical Study Site — Albany, New York, United States
• 89Bio Clinical Study Site — Greensboro, North Carolina, United States
• 89Bio Clinical Study Site — Morganton, North Carolina, United States
• 89Bio Clinical Study Site — Marion, Ohio, United States
• 89Bio Clinical Study Site — Summerville, South Carolina, United States
• 89Bio Clinical Study Site — Chattanooga, Tennessee, United States
• 89Bio Clinical Study Site — Kingsport, Tennessee, United States

Full record on ClinicalTrials.gov

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