Study to Explore the Efficacy and Safety of BIO89-100 (Pegozafermin) in Participants With Severe … (NCT04541186) | Clinical Trial Compass
CompletedPhase 2
Study to Explore the Efficacy and Safety of BIO89-100 (Pegozafermin) in Participants With Severe Hypertriglyceridemia
United States86 participantsStarted 2020-09-01
Plain-language summary
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).
Who can participate
Age range21 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. 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.
Exclusion criteria
✕. 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).
What they're measuring
1
Percent Change From Baseline to Week 8 in Serum Triglyceride (TG)