Bile Acid DiarrheaPhase 4BASTANCT07042165
Treatment of Bile Acid Diarrhoea With Atorvastatin
A Phase 4 study testing Atorvastatin in people with Bile Acid Diarrhea and Bile Acid Malabsorption, run by Asger Lund, MD at 1 site in Denmark.
Trial summary
Bile acid diarrhoea (BAD) is a socially debilitating disease with stomach pain, high stool frequency, urgency, and faecal incontinence as the main symptoms. Studies estimate that 1-2% of the population suffers from the disease. There is an unmet need for more treatment options in patients suffering from BAD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bile Acid Diarrhea, Bile Acid Malabsorption
- What is being tested?
- Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Oct 2025to 27 Oct 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 years or above
- Self-identification as White
- Confirmed moderate-severe bile acid diarrhoea with a SeHCAT test result of ≤ 10 %
- Reported number of average daily stools ≥ 3 stools per day
- Reported number of average daily watery (6 or 7 on the Bristol Stool Chart) stools ≥ 1 stools per day(30)
- Informed and written consent
Who cannot join
- Unwillingness to pause any of the following medications during the trial: bile acid sequestrants, morphine medication, liraglutide or anti-constipation medication (e.g., lactulose, laxoberal, magnesia)
- Unwillingness to pause any anti-diarrhoea medication (e.g., imodium) from 3 days before initiation of each stool diary until after the respective visit
- If regularly administering psyllium or metformin, unwillingness to agree to a stable dose of psyllium or metformin throughout the trial
- Concomitant use of any drug in the GLP-1 receptor agonist drug class with the exception of paused liraglutide, see above
- Concomitant use of any kind of insulin medication
- Planned major changes in food consumption throughout the trial, including planned weight loss attempts
Show all 27Show fewer
- Prior use of any statin within the recent 6 months
- Intake of larger quantities of grapefruit juice during trial participation, at the discretion of the investigator
- 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
- Crohn's disease, ulcerative colitis, celiac disease or lactose intolerance
- Previous intestinal resection or major intra-abdominal surgery incl. stoma (cholecystectomy and appendectomy not included)
- Nephropathy with estimated glomerular filtration rate < 45 ml/min/1,73 m2
- Plasma level of creatine kinase ≥ 5 times the upper limit of normal
- A recent stroke or transient ischemic attack (within 6 months)
- Any treatment or condition requiring acute or subacute medical or surgical intervention
- Hypothyroidism or hyperthyroidism, if not well regulated, at the discretion of the investigator
- Active or recent (within 6 months) clinically significant malignant disease (non-melanoma skin cancer not included), at the discretion of the investigator
- Alcohol consumption exceeding 12 units/week for women or 18 units/week for men, respectively. These thresholds are based on the limits of the European Association for the Study of the Liver
- Drug abuse, at the discretion of the investigator
- Fertile women not using any of the following contraceptive methods for the duration of the trial until at least 5 days after end of trial: Hormonal (tablet/pill, depot injection of progesterone, subdermal gestagen implantation, hormone intrauterine devices (IUD), hormonal vaginal ring or transdermal hormonal patch) associated with inhibition of ovulation, chemical (copper IUD), sterilisation, vasectomised partner with a confirmatory test, or sexual abstinence per the investigator's discretion
- Pregnant or nursing women
- Known or suspected hypersensitivity to atorvastatin or any of the additives in the tablet
- Receipt of any investigational drug within 30 days prior to visit 0
- Concomitant treatment with any of the following (topical administration not included): ciclosporin, telithromycin, clarithromycin, delavirdin, stiripentol, ketoconazol, voriconazol, itraconazol, posaconazol, letermovir, ritonavir, lopinavir, atazanavir, indinavir, darunavir, bocepravir, telaprevir, elbasvir/grazoprevir, ledipasvir/sofosbuvir, erythromycin, niacin, ezetimibe, fusidic acid, gemfibrozil, colchicine, digoxin, warfarin
- Unable to speak or understand Danish or mental incapacity that preclude adequate understanding or cooperation or unwillingness to comply with trial requirements
- Active participation in any other clinical intervention trial (observational studies not included)
- Other concomitant disease or treatment that according to the investigator's assessment makes the person unsuitable for study participation
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Clinical Metabolic Research, Gentofte Hospital
Hellerup, 2900
About this study
Official title: Treatment of Bile Acid Diarrhoea With Atorvastatin (BASTA): A Randomised, Double-Blind, Placebo-Controlled, Crossover, Investigator-Initiated Trial
Bile acid diarrhoea (BAD) is a socially debilitating disease with stomach pain, high stool frequency, urgency, and faecal incontinence as the main symptoms. Studies estimate that 1-2% of the population suffers from the disease.
There is an unmet need for more treatment options in patients suffering from BAD.
The investigators hypothesise that atorvastatin treatment lowers bile acid synthesis in patients with bile acid diarrhoea. The investigators will investigate this hypothesis in the current study, BASTA, which is a Randomised, Double-Blind, Placebo-Controlled, Crossover, Proof of Concept, Investigator-Initiated, Trial.
Read the detailed description
Bile acid diarrhoea (BAD) is a socially debilitating disease with stomach pain, high stool frequency, urgency, and faecal incontinence as the main symptoms. Studies estimate that 1-2% of the population suffers from the disease.
Bile acids are synthesised from cholesterol in hepatocytes through a tightly regulated enzymatic process and then excreted to the gut lumen in response to food ingestion. In a healthy individual 95 % of the bile acids are recycled in the enterohepatic circulation in a tightly regulated process. BAD symptoms arise due to a pathological spill-over of bile acids to the colon.
Currently, individuals with BAD are typically treated with bile acids sequestrants. However, only about 2/3 patients experience an improvement in their symptoms on this treatment. Thus, the possibility of yet another tool in the toolbox is compelling.
Statins are used by millions of patients world-wide to reduce their risk of cardiovascular morbidity and mortality and are considered safe with overall mild and benign adverse effects. Statins lower the intracellular levels of cholesterol in hepatocytes. As such, atorvastatin could potentially reduce the bile acid production in individuals with BAD leading to a reduction or normalisation of the amount of bile acids secreted to the intestinal lumen and entering the colon. Unpublished results from the investigators' group show a 43 % reduction of serum C4, a biomarker of bile acid synthesis which can also be used to diagnose BAD, in healthy, young men, who were treated with atorvastatin for 14 days (7 days of 40 mg atorvastatin once daily followed by 7 days of 80 mg atorvastatin once daily) compared to placebo treatment.
The investigators hypothesise that atorvastatin treatment lowers bile acid synthesis in patients with 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 severe bile acid diarrhoea. The investigators expect the reduction of bile acid synthesis to lead to a reduction in bile acid diarrhoea symptoms since the pathophysiology of the disease is a spill-over of bile acids to the colon. Specifically, the primary endpoint is the reduction in percentage of C4 at the end of the 80 mg treatment period compared to placebo. Additionally, the investigators will investigate the effect of atorvastatin treatment in patients with severe bile acid diarrhoea on symptoms, hepatobiliary markers, metabolic markers, glycaemic control markers, stool samples and safety.
- Conditions
- Bile Acid Diarrhea, Bile Acid Malabsorption
- Being tested
- Atorvastatin, Placebo
- Keywords
- Bile Acid Diarrhea, Bile Acid Malabsorption, Atorvastatin, Randomised, Placebo, 7-alpha-C4, Crossover, Double-blind, Investigator-initiated, Proof of concept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Participants will be orally administering one tablet daily of 40 mg Atorvastatin for two weeks followed by two tablets daily for two weeks (totalling 80 mg daily).
PlaceboDrug
Placebo tablets are manufactored by the Central Pharmacy of the Capital Region of Denmark and are identical to the IMP except with the active ingredient (atorvastatin) omitted. Participants will be orally administering one tablet daily for two weeks followed by two tablets daily for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo tablets are manufactored by the Central Pharmacy of the Capital Region of Denmark and are identical to the IMP except with the active ingredient (atorvastatin) omitted. Participants will be administering one tablet for two weeks followed by two tablets for two weeks. Then four weeks of washout before entering the atorvastatin arm (crossover). Receives: Drug: Placebo |
| Atorvastatin | Experimental | 40 mg Atorvastatin tablets are manufactored by the Central Pharmacy of the Capital Region of Denmark and are identical to the placebo tablets except containing the active ingredient (atorvastatin). Participants will be administering one tablet for two weeks followed by two tablets for two weeks (80 mg atorvastatin). Then four weeks of washout before entering the placebo arm (crossover). Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in bile acid synthesis measured via 7alpha-Hydroxy-4-cholesten-3-on (C4)
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.
Measured: The end of week 4 and the end of week 12.
Secondary outcomes (11)
Reduction in bile acid synthesis measured via C4
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.
Measured: The end of week 4 and the end of week 12.
Reduction in BAD symptoms measured via a stool diary.
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
Measured: Week 4 and week 12.
A reduction in BAD symptoms measured via a 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
Measured: Week 4 and week 12.
Symptom severity measured via IBS-SSS
Difference in symptom severity measured via a danish translation of the validated questionnaire Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS).
The answers are on a scale of 0-500, where a higher score indicates worse symptoms.
Measured: The end of week 4 and the end of week 12.
Reduction in bile acid synthesis measured via C4.
Proportion of patients with a reduction of 7alpha-Hydroxy-4-cholesten-3-on (C4) below 31 μg/L (%)
Measured: The end of week 4 and the end of week 12.
Reduction in bile acid synthesis measured via C4
Proportion of patients with a reduction of 7alpha-Hydroxy-4-cholesten-3-on (C4) below 46 μg/L (%)
Measured: The end of week 4 and the end of week 12.
Bile acid metabolism measured via FGF-19
Fibroblast growth factor 19 (FGF-19) (pg/mL)
Measured: The end of week 4 and the end of week 12.
Bile acid metabolism measured via blood levels of total bile acids
Blood levels of total bile acids (μmol/L)
Measured: The end of week 4 and the end of week 12.
Cholesterol metabolism
Total cholesterol (mmol/L)
Measured: The end of week 4 and the end of week 12.
Cholesterol metabolism
Low-density lipoprotein (LDL) cholesterol (mmol/L)
Measured: The end of week 4 and the end of week 12.
Bile acid levels measured in stool samples
Stool sample levels of total bile acids (μmol/g)
Measured: The end of week 4 and the end of week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start15 Oct 2025
- Primary completion27 Oct 2026
- Study completion27 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bile Acid DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asger Lund, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Fonden til Lægevidenskabens Fremme, Prosektor Axel Søeborg Ohlsens Mindelegat, Læge Sofus Carl Emil Friis og Hustru Olga Doris Friis' Legat, Aase and Ejnar Danielsens Foundation
- Responsible party
- Sponsor-investigator, Asger Lund, MD, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042165
- Sponsor's protocol ID
- EU trial no. 2025-521856-47-00
- Acronym
- BASTA
- Status last verified
- Oct 2026
- First submitted
- 5 Jun 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Lynggaard MB, Olsen SS, Forman JL, Karhus ML, Gluud LL, Lund AB, Ellegaard AM. BASTA trial: protocol for a randomised, double-blind, placebo-controlled, crossover trial investigating the effects of atorvastatin on bile acid diarrhoea. BMJ Open. 2026 Jul 28;16(7):e119827. doi: 10.1136/bmjopen-2026-119827.
PubMed 42521312
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Bile Acid Diarrhoea With Atorvastatin (BASTA): A Randomised, Double-Blind, Placebo-Controlled, Crossover, Investigator-Initiated Trial
- ClinicalTrials.gov ID
- NCT07042165
- Acronym / sponsor ID
- BASTA / EU trial no. 2025-521856-47-00
- Conditions
- Bile Acid Diarrhea, Bile Acid Malabsorption
- Keywords
- Bile Acid Diarrhea, Bile Acid Malabsorption, Atorvastatin, Randomised, Placebo, 7-alpha-C4, Crossover, Double-blind
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Asger Lund, MDUniversity, hospital or other
- Collaborators
- Fonden til Lægevidenskabens Fremme, Prosektor Axel Søeborg Ohlsens Mindelegat, Læge Sofus Carl Emil Friis og Hustru Olga Doris Friis' Legat, Aase and Ejnar Danielsens Foundation
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 27 Oct 2026 (actual)
- Study completion
- 27 Oct 2026 (actual)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bile acid diarrhoea (BAD) is a socially debilitating disease with stomach pain, high stool frequency, urgency, and faecal incontinence as the main symptoms. Studies estimate that 1-2% of the population suffers from the disease.
There is an unmet need for more treatment options in patients suffering from BAD.
The investigators hypothesise that atorvastatin treatment lowers bile acid synthesis in patients with bile acid diarrhoea. The investigators will investigate this hypothesis in the current study, BASTA, which is a Randomised, Double-Blind, Placebo-Controlled, Crossover, Proof of Concept, Investigator-Initiated, Trial.
Detailed description
Bile acid diarrhoea (BAD) is a socially debilitating disease with stomach pain, high stool frequency, urgency, and faecal incontinence as the main symptoms. Studies estimate that 1-2% of the population suffers from the disease.
Bile acids are synthesised from cholesterol in hepatocytes through a tightly regulated enzymatic process and then excreted to the gut lumen in response to food ingestion. In a healthy individual 95 % of the bile acids are recycled in the enterohepatic circulation in a tightly regulated process. BAD symptoms arise due to a pathological spill-over of bile acids to the colon.
Currently, individuals with BAD are typically treated with bile acids sequestrants. However, only about 2/3 patients experience an improvement in their symptoms on this treatment. Thus, the possibility of yet another tool in the toolbox is compelling.
Statins are used by millions of patients world-wide to reduce their risk of cardiovascular morbidity and mortality and are considered safe with overall mild and benign adverse effects. Statins lower the intracellular levels of cholesterol in hepatocytes. As such, atorvastatin could potentially reduce the bile acid production in individuals with BAD leading to a reduction or normalisation of the amount of bile acids secreted to the intestinal lumen and entering the colon. Unpublished results from the investigators' group show a 43 % reduction of serum C4, a biomarker of bile acid synthesis which can also be used to diagnose BAD, in healthy, young men, who were treated with atorvastatin for 14 days (7 days of 40 mg atorvastatin once daily followed by 7 days of 80 mg atorvastatin once daily) compared to placebo treatment.
The investigators hypothesise that atorvastatin treatment lowers bile acid synthesis in patients with 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 severe bile acid diarrhoea. The investigators expect the reduction of bile acid synthesis to lead to a reduction in bile acid diarrhoea symptoms since the pathophysiology of the disease is a spill-over of bile acids to the colon. Specifically, the primary endpoint is the reduction in percentage of C4 at the end of the 80 mg treatment period compared to placebo. Additionally, the investigators will investigate the effect of atorvastatin treatment in patients with severe bile acid diarrhoea on symptoms, hepatobiliary markers, metabolic markers, glycaemic control markers, stool samples and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablets are manufactored by the Central Pharmacy of the Capital Region of Denmark and are identical to the IMP except with the active ingredient (atorvastatin) omitted. Participants will be administering one tablet for two weeks followed by two tablets for two weeks. Then four weeks of washout before entering the atorvastatin arm (crossover). |
| Atorvastatin | Experimental | Drug: Atorvastatin40 mg Atorvastatin tablets are manufactored by the Central Pharmacy of the Capital Region of Denmark and are identical to the placebo tablets except containing the active ingredient (atorvastatin). Participants will be administering one tablet for two weeks followed by two tablets for two weeks (80 mg atorvastatin). Then four weeks of washout before entering the placebo arm (crossover). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age 18 years or above
- Self-identification as White
- Confirmed moderate-severe bile acid diarrhoea with a SeHCAT test result of ≤ 10 %
- Reported number of average daily stools ≥ 3 stools per day
- Reported number of average daily watery (6 or 7 on the Bristol Stool Chart) stools ≥ 1 stools per day(30)
Key exclusion criteria (27 listed)
- Unwillingness to pause any of the following medications during the trial: bile acid sequestrants, morphine medication, liraglutide or anti-constipation medication (e.g., lactulose, laxoberal, magnesia)
- Unwillingness to pause any anti-diarrhoea medication (e.g., imodium) from 3 days before initiation of each stool diary until after the respective visit
- If regularly administering psyllium or metformin, unwillingness to agree to a stable dose of psyllium or metformin throughout the trial
- Concomitant use of any drug in the GLP-1 receptor agonist drug class with the exception of paused liraglutide, see above
- Concomitant use of any kind of insulin medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinParticipants will be orally administering one tablet daily of 40 mg Atorvastatin for two weeks followed by two tablets daily for two weeks (totalling 80 mg daily). | Drug | Atorvastatin |
| PlaceboPlacebo tablets are manufactored by the Central Pharmacy of the Capital Region of Denmark and are identical to the IMP except with the active ingredient (atorvastatin) omitted. Participants will be orally administering one tablet daily for two weeks followed by two tablets daily for two weeks. | Drug | Placebo |
Primary outcome
Reduction in bile acid synthesis measured via 7alpha-Hydroxy-4-cholesten-3-on (C4)
Time frame: The end of week 4 and the end of week 12.
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.
11 secondary outcomes
Reduction in bile acid synthesis measured via C4
Time frame: The end of week 4 and the end of week 12.
Reduction in BAD symptoms measured via a stool diary.
Time frame: Week 4 and week 12.
A reduction in BAD symptoms measured via a stool diary.
Time frame: Week 4 and week 12.
Symptom severity measured via IBS-SSS
Time frame: The end of week 4 and the end of week 12.
Reduction in bile acid synthesis measured via C4.
Time frame: The end of week 4 and the end of week 12.
Reduction in bile acid synthesis measured via C4
Time frame: The end of week 4 and the end of week 12.
Bile acid metabolism measured via FGF-19
Time frame: The end of week 4 and the end of week 12.
Bile acid metabolism measured via blood levels of total bile acids
Time frame: The end of week 4 and the end of week 12.
Cholesterol metabolism
Time frame: The end of week 4 and the end of week 12.
Cholesterol metabolism
Time frame: The end of week 4 and the end of week 12.
Bile acid levels measured in stool samples
Time frame: The end of week 4 and the end of week 12.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Derived from this study: PubMed 42521312Lynggaard MB, Olsen SS, Forman JL, Karhus ML, Gluud LL, Lund AB, Ellegaard AM. BASTA trial: protocol for a randomised, double-blind, placebo-controlled, crossover trial investigating the effects of atorvastatin on bile acid diarrhoea. BMJ Open. 2026 Jul 28;16(7):e119827. doi: 10.1136/bmjopen-2026-119827.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atorvastatin in people with Bile Acid Diarrhea and Bile Acid Malabsorption, run by Asger Lund, MD at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in bile acid synthesis measured via 7alpha-Hydroxy-4-cholesten-3-on (C4) (time frame: The end of week 4 and the end of week 12.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07042165, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.