A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Severe Hypertriglyceridemia (SHTG)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-503576-25-00

Acronym

BIO89-100-231

Enrollment

169

Registered

2023-08-23

Start date

2023-09-22

Completion date

Unknown

Last updated

2025-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Hypertriglyceridemia

Brief summary

Percent change from baseline in fasting TG at Week 26

Detailed description

1. Percent change from baseline in non-high-density lipoprotein cholesterol (non-HDL-C) at Week 26, 2. Percent change from baseline in high-density lipoprotein cholesterol (HDL-C) at Week 26, 3. Percent change from baseline in very low-density lipoprotein cholesterol (VLDL-C) at Week 26, 4. Percent change from baseline in total cholesterol (TC) at Week 26, 5. Percent change from baseline in fasting TG at Week 52, 6. Change from baseline in liver fat by magnetic resonance imaging - whole liver proton density fat fraction (MRI-PDFF) at Week 26, 7. Percent change from baseline in apolipoprotein B (apo-B) at Week 26, 8. Change in HbA1c at Week 26 for those with baseline ≥7.0%

Interventions

DRUGSIMVASTATINA DOC 10 mg compresse rivestite con film

DRUGPegozafermin

DRUGPlacebo for pegozafermin. combined integral administration device: pre-filled syringe - please refer to the impd pegozafermin section 3.2.p.7 container closure system for detailed description.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percent change from baseline in fasting TG at Week 26	—

Secondary

Measure	Time frame
1. Percent change from baseline in non-high-density lipoprotein cholesterol (non-HDL-C) at Week 26, 2. Percent change from baseline in high-density lipoprotein cholesterol (HDL-C) at Week 26, 3. Percent change from baseline in very low-density lipoprotein cholesterol (VLDL-C) at Week 26, 4. Percent change from baseline in total cholesterol (TC) at Week 26, 5. Percent change from baseline in fasting TG at Week 52, 6. Change from baseline in liver fat by magnetic resonance imaging - whole liver proton density fat fraction (MRI-PDFF) at Week 26, 7. Percent change from baseline in apolipoprotein B (apo-B) at Week 26, 8. Change in HbA1c at Week 26 for those with baseline ≥7.0%	—

Measure

Time frame

—

Countries

Austria, Belgium, Bulgaria, Czechia, France, Germany, Hungary, Italy, Latvia, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026