Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
PK/PD of Lerodalcibep Process 1 vs Process 2
NCT05234775Phase 3
Key facts
- Status
- Completed
- Start
- Jan 2022
- Primary completion
- Jun 2022
- Countries
- 1
- Sponsor
- LIB Therapeutics
- Modality
- Fc-Fusion Proteins
- Drugs
- lerodalcibep
- Conditions
- hypercholesterolemia
01
Overview
Phase 3, randomised trial of lerodalcibep in hypercholesterolemia (2 arms), sponsored by LIB Therapeutics. Primary endpoints: Free Proprotein Convertase Subtilisin/Kexin Type 9 Pharmacodynamics at 4 weeks, Low-Density Lipoprotein Cholesterol Pharmacodynamics at 4 weeks and 3 more. Started Jan 2022; status: completed.
02
Design
2 arms- Study design
- Randomized
Sequence 1
Process 1 then Process 2
Sequence 2
Process 2 then Process 1
03
Who it enrols
Adults with LDL-C >= 70 mg/dL on stable diet or statin therapy, excluding severe renal impairment, uncontrolled diabetes, and severe heart failure.
04
Endpoints
Primary
Free Proprotein Convertase Subtilisin/Kexin Type 9 Pharmacodynamics
Low-Density Lipoprotein Cholesterol Pharmacodynamics
Maximum Observed Serum Concentration
Area Under the Concentration-Time Curve from Time Zero to Last Quantifiable Concentration
Terminal Half-Life
Secondary
Comparison of Low-Density Lipoprotein Cholesterol
Beyond the preview
Go deeper on NCT05234775.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT05234775.