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

NCT06140095 | Unknown Early Phase 1 FDA Drug

• 1 other identifier: PSM1A
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Metabolic Effects of Evolocumab and Atorvastatin

Outcome Measures

Primary Outcomes (3)

• Cholesterol metabolism effect

  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

  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

  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

Study Arms (1)

Full group

EXPERIMENTAL

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

Interventions

Evolocumab DRUG

See arm description

Also known as: Atorvastatin

Full group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male
• \>18 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Stockholm: lead
• Amgen: collaborator

MeSH Terms

Interventions

evolocumab; Atorvastatin

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Central Study Contacts

Erik Hoffmann, MD

CONTACT

+46 8-517 700 00; erik.hoffmann@ki.se

Mats Eriksson, MD PhD

CONTACT

mats.eriksson@ki.se

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: November 18, 2023
• Study Start: February 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-05