Studies to Gain Insight How the Drugs PCSK9-inhibitors and Statins Affect Cholesterol and Bile Acid Metabolism
Launched by REGION STOCKHOLM · Nov 16, 2023
Trial Information
Current as of August 21, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking to understand how two different medications, evolocumab and atorvastatin, affect cholesterol levels and bile acid metabolism in the body. Both drugs are used to help manage cholesterol, but this study will focus on how they work in healthy men between the ages of 65 and 74. By studying their effects closely, researchers hope to gain important insights into how these treatments can benefit patients in the future.
To participate in the trial, volunteers must be healthy men over 18 years old and should not have any serious health conditions like heart disease, diabetes, or cancer. Participants will take part in several sessions where they will receive either of the medications, and researchers will monitor their cholesterol and bile acid levels. The study is not currently recruiting participants, but it is an important step in exploring how these medications can help manage cholesterol more effectively.
Gender
MALE
Eligibility criteria
- 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
About Region Stockholm
Region Stockholm is a leading healthcare authority committed to advancing medical research and improving patient care through innovative clinical trials. As a sponsor, Region Stockholm collaborates with hospitals, research institutions, and industry partners to facilitate the development of new therapies and treatment protocols. With a focus on quality, safety, and ethical standards, the organization aims to enhance health outcomes for the diverse population of Stockholm and beyond, leveraging cutting-edge research to translate scientific discoveries into effective healthcare solutions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported