Overview
Sponsor-declared trial summary
Bile acid diarrhoea
The current study aims to investigate whether atorvastatin treatment lowers the synthesis of bile acids, measured via the well-known bile acid synthesis marker C4, in a dose-response manner in patients with moderate-severe bile acid diarrhoea.
Key facts
- Sponsor
- Gentofte Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 29 Sep 2025 → ongoing
- Decision date (initial)
- 2025-06-04
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Prosektor Axel Søeborg Ohlsens Mindelegat, Læge Sofus Carl Emil Friis og Hustru Olga Doris Friis...
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The current study aims to investigate whether atorvastatin treatment lowers the synthesis of bile acids, measured via the well-known bile acid synthesis marker C4, in a dose-response manner in patients with moderate-severe bile acid diarrhoea.
Secondary objectives 1
- Additionally, we will investigate the effect of atorvastatin treatment in patients with moderate-severe BAD on symptoms, hepatobiliary markers, metabolic markers, glycaemic control markers, stool samples and safety.
Conditions and MedDRA coding
Bile acid diarrhoea
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Confirmed moderate-severe bile acid diarrhoea with a SeHCAT test result of ≤ 10 %
Exclusion criteria 1
- History of/present hepatobiliary disorder (except for simple metabolic dysfunction-associated fatty liver disease) and/or alanine aminotransferase and/or serum aspartate aminotransferase ≥ 3 times upper limit of normal
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Ratio of geometric mean concentration of 7alpha-Hydroxy-4-cholesten-3-on (C4) at the end of the 80 mg atorvastatin treatment period compared to the end of the placebo treatment period.
Secondary endpoints 3
- Difference in mean concentration of 7alpha-Hydroxy-4-cholesten-3-on (C4) in µg/L at the end of the 80 mg atorvastatin treatment period compared to the end of the placebo treatment period.
- Difference in mean daily stools during the last week of the 80 mg atorvastatin treatment period compared to the last week of the placebo treatment period as assessed by a 7-day stool diary.
- Difference in mean daily watery stools during the last week of the 80 mg atorvastatin treatment period compared to the last week of the placebo treatment period as assessed by the total watery (6 or 7 on the Bristol Stool Chart) stools in a 7-day stool diary
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Atorvastatin Viatris 40 mg Filmtabletten
PRD10001937 · Product
- Active substance
- Atorvastatin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 4200 mg milligram(s)
- Max treatment duration
- 10 Week(s)
- Authorisation status
- Authorised
- ATC code
- C10AA05 — ATORVASTATIN
- Marketing authorisation
- 38635.02.00
- MA holder
- VIATRIS PHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
SUB21402 · Substance
- Active substance
- Placebo
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 0
- Max total dose
- 0
- Max treatment duration
- 4 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
Gentofte Hospital
- Sponsor organisation
- Gentofte Hospital
- Address
- Kildegaardsvej 28
- City
- Hellerup
- Postcode
- 2900
- Country
- Denmark
Scientific contact point
- Organisation
- Gentofte Hospital
- Contact name
- Center for Clinical Metabolic Research
Public contact point
- Organisation
- Gentofte Hospital
- Contact name
- Center for Clinical Metabolic Research
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2025-09-29 | 2025-10-15 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 12 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol BASTA | 3 |
| Recruitment arrangements (for publication) | Information about rights as a study participant BASTA | 1 |
| Recruitment arrangements (for publication) | Recruitment and Informed Consent Procedure BASTA | 2 |
| Recruitment arrangements (for publication) | Recruitment and Informed Consent Procedure BASTA Track Changes | 2 |
| Recruitment arrangements (for publication) | Recruitment material BASTA | 1 |
| Subject information and informed consent form (for publication) | Informed consent BASTA | 1 |
| Subject information and informed consent form (for publication) | Written Participant Information BASTA | 2 |
| Subject information and informed consent form (for publication) | Written Participant Information BASTA Track Changes | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Atorvastatin BASTA | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Atorvastatin BASTA Track Changes | 2 |
| Synopsis of the protocol (for publication) | Protocol synopsis BASTA | 2 |
| Synopsis of the protocol (for publication) | Protocol synopsis BASTA Track Changes | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-04 | Denmark | Acceptable 2025-06-04
|
2025-06-04 |