At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 86 enrolled
Drug / intervention
Pegozafermin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Explore the Efficacy and Safety of BIO89-100 in Subjects With Severe Hypertriglyceridemia
In Brief
A Phase 2 clinical trial evaluating Pegozafermin and Placebo for Severe Hypertriglyceridemia. Completed, enrolled 86 participants across 48 sites in 4 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Hypertriglyceridemia
CountriesCzechia, Hungary, Poland, United States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
Enrollment StartSep 2020
First PostedSep 2020
Primary CompletionMay 2022
Study CompletionMay 2022
TodayJul 2026
First PostedSep 9, 2020
Enrollment StartSep 1, 2020
Primary CompletionMay 19, 2022
Study CompletionMay 31, 2022
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 5.8 years ago
Interventions
Pegozafermindrug
Subcutaneous injection
Placebodrug
Matching placebo