Mathematical modeling of the impact of 'PCSK9 inhibitior'-drugs on the fat metabolism in patients with an impaired fat metabolism

Modeling of the impact of a PCSK9 inhibition on lipoproteins in patients with dyslipidemia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003551-30-DE

Enrollment

Registered

2017-02-27

Start date

2017-03-02

Completion date

Unknown

Last updated

2019-04-30

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

Conditions

dyslipidemia MedDRA version: 19.1 Level: HLGT Classification code 10013317 Term: Lipid metabolism disorders System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: Praluent Product Name: Praluent Product Code: EMA/504805/2015 Pharmaceutical Form: Injection Trade Name: Repatha

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age >=18 • written consent • Criteria for a therapy with PSCK9 inhibitors are given Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: 1. severe Liver-disease g (Child-Pugh C) 2. severe renal insufficiency 3. TSH not im reference range 4. uncontrolled aterial hypertension: Diastolic RR >=105 mmHg and/or systolic RR >=160 mmHg. 5. alcohol abuse or other drug abuse (except smoking) 6. blood donation within the last 6 weeks before the screening 7. Patients with a severe acute disease 8. HbA1c > 8.0% 9. Other important severe internistic diseases, which may alter the lipidmetabolism 10. hypersensitivity against the substance 11. pregnancy oder planned pregnancy and lactation period

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective is to study the impact of PCSK9 inhibitors in patients with dyslipidemia using a mathematical model describing the lipoproteins of low density (LDL)based on clinical data ;Secondary Objective: Secondary objectives are to characterize the impact of PCSK9 inhibitors on lipid metabolism and its enzyme activities using a mathematical model;Primary end point(s): Difference (before and after the lipidlowering therapy with PCSK9-inhibitors) between lipid and apolipoprotein composition of LDL-particles, as well as their exchange rates.; Timepoint(s) of evaluation of this end point: each visit	—

Measure

Time frame

Main Objective: The objective is to study the impact of PCSK9 inhibitors in patients with dyslipidemia using a mathematical model describing the lipoproteins of low density (LDL)based on clinical data ;Secondary Objective: Secondary objectives are to characterize the impact of PCSK9 inhibitors on lipid metabolism and its enzyme activities using a mathematical model;Primary end point(s): Difference (before and after the lipidlowering therapy with PCSK9-inhibitors) between lipid and apolipoprotein composition of LDL-particles, as well as their exchange rates.; Timepoint(s) of evaluation of this end point: each visit

—

Secondary

Measure	Time frame
Secondary end point(s): Difference (before and after the lipidlowering therapy with PCSK9-inhibitors) between lipid and apolipoprotein composition of non-LDL particles, as well as their exchange rates.;Timepoint(s) of evaluation of this end point: each visit	—

Countries

Germany

Contacts

Public ContactKarl Winkler

Universitätsklinikum Freiburg Institut für klinische Chemie und Laboratoriumsmedizin

karl.winkler@uniklinik-freiburg.de4976127033160

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026