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

Early Phase 1

Not yet recruiting

• Conditions: Acute Metabolic Effects of Evolocumab and Atorvastatin
• Interventions: Drug: Evolocumab

• Registration Number: NCT06140095
• Lead Sponsor: Region Stockholm

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-10
• Study First Submitted QC: 2023-11-16
• Last Update Submitted: 2023-11-16
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18
• Study Start: 2024-02
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

• Male
• >18 years of age

Exclusion Criteria

• Cardiovascular disease
• Cerebrovascular disease (e.g. stroke, prior aneurysm)
• Pulmonary disease (e.g. pulmonary hypertension, COPD)
• Metabolic disease (incl. but not limited to Cushing disease, Diabetes)
• Renal disease (by Chronic kidney disease criteria)
• Active inflammatory bowel syndrome
• Cancer
• Pregnancy
• Smoker
• Any chronic medication use
• Steroid treatment for the last six months or hormone replacement therapy
• Coagulopathy
• Musculoskeletal or neurologic disease
• Know allergy against any of the studied substances
• Inclusion in any other concurrent medical research study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Full group	Evolocumab	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 Measures

Name	Time	Method
Bile acid metabolism effect	32 hours	Effect of these treatments on markers for cholesterol and bile acid metabolism, namely bile acids; measured as change from baseline concentration (mikromol/ml) per unit time.
Cholesterol metabolism effect	32 hours	Effect of these treatments on markers for cholesterol metabolism, namely lathosterol and campesterol, measured as change from baseline concentration (mg/mmol) per unit time.