Cholesterol lowering with atorvastatine for the prevention of gallstones following bariatric surgery: an investigator- blinded randomised controlled trial (CHOLSTONE)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Spaarne Gasthuis Stichting

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18], Diseases [C] - Digestive System Diseases [C06]

Decision date (initial)

2026-03-17

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

To evaluate the efficacy of atorvastatin 40 mg once daily, initiated two weeks before and continued for six months after bariatric surgery, in preventing the formation of gallstones compared with standard care.

Secondary objectives 3

1. To evaluate the reduction in LDL cholesterol levels six months after bariatric surgery.
2. To assess the impact of atorvastatin on bile acid composition in stool and plasma.
3. To assess the safety profile and side effects of atorvastatin in the post-bariatric population.

Conditions and MedDRA coding

Gallstones (chole(cysto)lithiasis) following bariatric surgery

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Scheduled to undergo laparoscopic Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG).
2. Presence of an intact gallbladder without gallstones, confirmed by preoperative ultrasound.
3. Preoperative LDL cholesterol level equal to or exceeding 2.0 mmol/L.

Exclusion criteria 9

1. Previous bariatric surgery.
2. Current use of PCSK9 inhibitors, statins, ezetimibe, or fibrates.
3. Known intolerance to statins.
4. Presence of symptomatic or asymptomatic gallstones prior to bariatric surgery.
5. Familial hypercholesterolemia.
6. Severe liver disease (Child-Pugh score 10–15).
7. Severe renal impairment (eGFR < 30 mL/min/1.73 m²).
8. Use of CYP3A4 inhibitors due to potential interactions with atorvastatin and increased risk of myopathy.
9. Use of CYP3A4 inducers, as these may reduce plasma concentrations of atorvastatin and potentially influence the pharmacological effect of the study treatment.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence of gallstone formation six months after bariatric surgery, confirmed by ultrasound examination.

Secondary endpoints 3

1. Change in plasma LDL-cholesterol levels between baseline and six months after bariatric surgery.
2. Change in fecal and plasma bile acid profiles between baseline and six months after bariatric surgery.
3. Incidence and severity of adverse events related to atorvastatin in the post- bariatric population

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Spaarne Gasthuis Stichting

Sponsor organisation

Spaarne Gasthuis Stichting

Address

Spaarnepoort 1

City

Hoofddorp

Postcode

2134 TM

Country

Netherlands

Scientific contact point

Organisation

Spaarne Gasthuis Stichting

Contact name

Victor Gerdes (PI)

Public contact point

Organisation

Spaarne Gasthuis Stichting

Contact name

Victor Gerdes (PI)

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications