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

Sponsor
Region Stockholm (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06140095
Collaborator
Amgen (Industry)
8
Enrollment
1
Arm
22
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Studies to Gain Insight How the Drugs PCSK9-inhibitors and Statins Affect Cholesterol and Bile Acid Metabolism
Anticipated Study Start Date :
Feb 1, 2024
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
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.

Drug: Evolocumab
See arm description
Other Names:
  • Atorvastatin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. Bile acid metabolism effect [32 hours]

      Effect of these treatments on markers for bile acid metabolism, namely C4; measured as change from baseline concentration (mg/mmol) per unit time.

    3. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Region Stockholm
    • Amgen

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Region Stockholm
    ClinicalTrials.gov Identifier:
    NCT06140095
    Other Study ID Numbers:
    • PSM1A
    First Posted:
    Nov 18, 2023
    Last Update Posted:
    Nov 18, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Atorvastatin
    Evolocumab

    Study Results

    No Results Posted as of Nov 18, 2023