NCT04541186

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: 89bio, Inc. · Industry
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Severe Hypertriglyceridemia

Interventions

Type	Name	Description
DRUG	Pegozafermin	Subcutaneous injection
DRUG	Placebo	Matching placebo

Timeline

• Start date: 2020-09-01
• Primary completion: 2022-05-19
• Completion: 2022-05-31
• First posted: 2020-09-09
• Last updated: 2024-07-25
• Results posted: 2024-07-25

Locations

48 sites across 4 countries: United States, Czechia, Hungary, Poland

Regulatory

• FDA-regulated drug study