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

Region Stockholm

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Acute Metabolic Effects of Evolocumab and Atorvastatin

Treatments: Drug: Evolocumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06140095

PSM1A

Details and patient eligibility

About

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

Enrollment: 8 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Full group

Experimental group

Description:

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

Treatment:

Drug: Evolocumab