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

November 16, 2023 updated by: Region Stockholm
Eight healthy male volunteers will be studied in consecutive sessions regarding the acute effect of evolocumab and atorvastatin on cholesterol and bile metabolism.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

8

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cholesterol metabolism effect
Time Frame: 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.
32 hours
Bile acid metabolism effect
Time Frame: 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.
32 hours
Bile acid metabolism effect
Time Frame: 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.
32 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Stockholm

Collaborators

Amgen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

May 10, 2023

First Submitted That Met QC Criteria

November 16, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

November 18, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSM1A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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