Could a common cholesterol drug ease pancreatitis pain?
NCT ID NCT05771675
First seen Jun 27, 2026 · Last updated Aug 06, 2026 · Updated 2 times
Summary
This pilot study tests whether simvastatin, a common cholesterol medication, can improve quality of life in adults with recurrent acute or chronic pancreatitis. Researchers will enroll 90 participants to check if the drug is feasible and acceptable. The goal is to see if it helps with symptoms like pain and sleep, not to cure the disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 18-75 at time of enrollment 4. Diagnosis of Recurrent Acute or Chronic Pancreatitis not attributable to gallstones (i.e., suspected or definite biliary etiology), medications, trauma or autoimmune pancreatitis. For CP, imaging studies that can be used for diagnosis classification using Cambridge criteria46,47. 5. Ability to take oral medication and be willing to adhere to the dosing regimen. 6. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional one month after administration of study medication. 7. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional one month after administration of study medication. 8. No prior pancreatic surgery 9. No current statin use for 6 months. Exclusion Criteria: 1. Pregnancy or lactation 2. History of autoimmune, medication caused or traumatic pancreatitis. 3. Primary pancreatic tumors - pancreatic ductal adenocarcinoma, suspected cystic neoplasm (\>1 cm. in size or main duct involvement), neuroendocrine tumors, and other uncommon tumors. 4. Pancreatic metastasis from other malignancies. 5. History of solid organ transplant, HIV/AIDS. 6. Known isolated pancreatic exocrine insufficiency (i.e.., in the absence of any eligible inclusion criteria). 7. Subjects required to take itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, gemfibrozil, cyclosporine, danazol, amiodarone, or verapamil for other clinical indications. 8. Current simvastatin use within the past 6 months. 9. Participants must not have medical or psychiatric illnesses or ongoing substance abuse that in the investigator's opinion would compromise their ability to tolerate study interventions or participate in longitudinal follow up. 10. Patients with active liver disease. 11. Known Pregnancy. All participants of childbearing potential, except if post-menopausal (i.e., no menses for ≥2 years) or had a hysterectomy, bilateral tubal ligation/clip (surgical sterilization) or surgical removal of both the ovaries), must have a negative urine or serum B-HCG pregnancy test documented within 2 days prior to any endoscopic or radiologic procedures done for research purposes. Any standard of care tests will follow institutional policies regarding pregnancy test. 12. Currently incarcerated. 13. Inability to comply with study activities.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cedars-Sinai Medical Center
RECRUITINGLos Angeles, California, 90048, United States
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Ohio State University
RECRUITINGColumbus, Ohio, 43210, United States
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Stanford University
RECRUITINGStanford, California, 94305, United States
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University of Pittsburgh Medical Center
RECRUITINGPittsburgh, Pennsylvania, 15213, United States
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University of Southern California
RECRUITINGLos Angeles, California, 90033, United States
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