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NOT YET RECRUITING
NCT07712042

Tafolecimab in Hyperlipidemia: A Study of Different Dosing Intervals

Sponsor: Mei Gao

View on ClinicalTrials.gov

Summary

This is a prospective, observational cohort study. Patients will be assigned to either the Q2W or Q3W group based on the treating physician's clinical decision, not by randomization. The aim is to evaluate the real-world effectiveness and safety of the two dosing regimens.This study aims to systematically evaluate the lipid-lowering efficacy and safety of two dosing regimens of Tafolecimab 150 mg-administered every two weeks (Q2W) versus every three weeks (Q3W)-over a 12-week period in patients with hyperlipidemia whose LDL-C remains above the target after 4 weeks of treatment with moderate-intensity statins with or without cholesterol absorption inhibitors. The primary efficacy endpoint is the percent change in LDL-C from baseline at week 12 of the initial treatment.

Official title: Efficacy and Safety of Tafolecimab With Different Dosing Intervals in Patients With Hyperlipidemia

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2026-08

Completion Date

2028-12

Last Updated

2026-07-17

Healthy Volunteers

No

Conditions

Interventions

DRUG

Tafolecimab

150 mgSubcutaneous injection

Locations (1)

Qianfoshan Hospital

Ji'nan, China