Studies to Gain Insight How the Drugs PCSK9-inhibitors and Statins Affect Cholesterol and Bile Acid Metabolism

Sponsor
Region Stockholm
Study ID
NCT06140095
Phase
EARLY_PHASE1
Status
Unknown

Conditions

  • Acute Metabolic Effects of Evolocumab and Atorvastatin

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

Study Details

Eight healthy male volunteers will be studied in consecutive sessions regarding the acute effect of evolocumab and atorvastatin on cholesterol and bile metabolism.

Key Dates

Start date
Feb 29, 2024
Status verified
May 2023
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
8 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Full group
    Evolocumab 140 mg subcutaneously. Två months later, repetitive doses of atorvastatin 40 mg once daily. After continued atorvastatin, evolocumab 140 mg is added subcutaneously.

Primary Outcome Measure

Cholesterol metabolism effect [ Time Frame: 32 hours ]

Central Contacts