Overview
Sponsor-declared trial summary
Healthy volunteers
To learn more about the effects of the drugs statin (atorvastatin) and PCSK9 inhibitors (evolocumab) on the metabolism of cholesterol and bile acids in the human body.
Key facts
- Sponsor
- Karolinska University Hospital
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Phenomena and Processes [G] - Metabolism [G03]
- Decision date (initial)
- 2024-04-12
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Region Stockholm/ALF · Hjärt-Lungfonden · Amgen AB
External identifiers
- EU CT number
- 2023-505726-34-02
- ClinicalTrials.gov
- NCT06140095
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic
To learn more about the effects of the drugs statin (atorvastatin) and PCSK9 inhibitors (evolocumab) on the metabolism of cholesterol and bile acids in the human body.
Conditions and MedDRA coding
Healthy volunteers
Regulatory references
- Plan to share IPD
- No
- IPD plan description
- Individual participant data will not be shared. Results will be published by the investigators in academic journals.
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-505726-34-01 | Studies to gain insight how the drugs PCSK9-inhibitors and statins affect cholesterol and bile acid metabolism | Karolinska University Hospital |
| 2023-505726-34-00 | Studies to gain insight how the drugs PCSK9-inhibitors and statins affect cholesterol and bile acid metabolism | Karolinska University Hospital |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- 18-64 year old
- Male
Exclusion criteria 14
- 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 CKD criteria)
- Active inflammatory bowel syndrome
- Cancer
- Pregnancy
- Smoker
- Any chronic medication use
- Steroid treatment for the last six months or HRT
- Coagulopathy
- Musculoskeletal or neurologic disease
- Inclusion in any other concurrent medical research study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Changes in the measured parameters of cholesterol and bile acid metabolism
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB128552 · Substance
- Active substance
- Evolocumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 1 U unit(s)
- Max total dose
- 2 U unit(s)
- Max treatment duration
- 2 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05600MIG · Substance
- Active substance
- Atorvastatin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 2 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Karolinska University Hospital
- Sponsor organisation
- Karolinska University Hospital
- Address
- Halsovagen, Flemingsberg Flemingsberg
- City
- Huddinge
- Postcode
- 141 86
- Country
- Sweden
Scientific contact point
- Organisation
- Karolinska University Hospital
- Contact name
- Mats Eriksson
Public contact point
- Organisation
- Karolinska University Hospital
- Contact name
- Mats Eriksson
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Authorised, recruitment pending | 8 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Project plan PCSK9 inhib EPM 241119 | 1 |
| Protocol (for publication) | Provningsprotokoll FINAL 241119 no mark | 1 |
| Protocol (for publication) | Provningsprotokoll FINAL 241119 signerad | 1 |
| Recruitment arrangements (for publication) | recruitment | 1 |
| Subject information and informed consent form (for publication) | 2 Samtyckesblankett EPM mall 221021 | 1 |
| Subject information and informed consent form (for publication) | FPI 241112 | 1 |
| Subject information and informed consent form (for publication) | FPI 241112 markup | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | 5 - Bipacksedel Atorvastatin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | 5 - Bipacksedel Evolocumab | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-31 | Sweden | Acceptable 2024-04-11
|
2024-04-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-12-03 | Sweden | Acceptable 2025-01-14
|
2025-03-10 |