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

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).

Timeline

Start

2020-09-01

Primary completion

2022-05-19

Completion

2022-05-31

Outcome

Met primary endpoint

registry analysis (superiority test); Pegozafermin vs Placebo; p <0.001; Median Percent Change Difference -43.73 (95% CI -57.08 to -30.31) NCT04541186 ↗

paper meeting the primary endpoint of the trial. PMID 37355760 ↗

release “The Phase 2 trial, ENTRIGUE, met its primary endpoint of statistically significant reductions in median TGs from baseline in patients across all dose groups” 89bio.com ↗

release “ENTRIGUE met its primary endpoint of demonstrating statistically significant reductions in median triglycerides (TGs) from baseline” 89bio.com ↗

Publications

• Results Bhatt DL, Bays HE, Miller M, Cain JE 3rd, Wasilewska K, Andrawis NS, Parli T, Feng S, Sterling L, Tseng L, Hartsfield CL, Agollah GD, Mansbach H, Kastelein JJP; ENTRIGUE Principal Investigators. The FGF21 analog pegozafermin in severe hypertriglyceridemia: a randomized phase 2 trial. Nat Med. 2023 Jul;29(7):1782-1792. doi: 10.1038/s41591-023-02427-z. Epub 2023 Jun 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pegozafermin	Protein / enzyme biologic	9 mg	Subcutaneous
Subject	Pegozafermin	Protein / enzyme biologic	18 mg	Subcutaneous
Subject	Pegozafermin	Protein / enzyme biologic	27 mg	Subcutaneous
Subject	Pegozafermin	Protein / enzyme biologic	36 mg	Subcutaneous

Indications

No indication recorded.