Simvastatin Treatment to Improve Patient-reported Outcomes in Patients With Chronic Pancreatitis

Recruiting now · Early Phase 1 · Has a placebo group

Conditions studied: Recurrent Acute Pancreatitis, Chronic Pancreatitis

In brief

The purpose of this pilot study to examine the feasibility and acceptability of simvastatin in adults with Recurrent Acute Pancreatitis (RAP) and Chronic Pancreatitis (CP).

Key facts

Study ID: NCT05771675
Run by: Cedars-Sinai Medical Center
People needed: 90
Starts: 2024-10-24
Expected to finish: 2028-06-01
Last updated by the study team: 2026-08-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, aged 18-75 at time of enrollment
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.
Ability to take oral medication and be willing to adhere to the dosing regimen.
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.
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.
No prior pancreatic surgery
No current statin use for 6 months.

You may not qualify if…

Pregnancy or lactation
History of autoimmune, medication caused or traumatic pancreatitis.
Primary pancreatic tumors - pancreatic ductal adenocarcinoma, suspected cystic neoplasm (>1 cm. in size or main duct involvement), neuroendocrine tumors, and other uncommon tumors.
Pancreatic metastasis from other malignancies.
History of solid organ transplant, HIV/AIDS.
Known isolated pancreatic exocrine insufficiency (i.e.., in the absence of any eligible inclusion criteria).
Subjects required to take itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, gemfibrozil, cyclosporine, danazol, amiodarone, or verapamil for other clinical indications.
Current simvastatin use within the past 6 months.
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.
Patients with active liver disease.
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.
Currently incarcerated.
Inability to comply with study activities.

Where it is running

University of Southern California — Los Angeles, California, United States (enrolling)
Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
Stanford University — Stanford, California, United States (enrolling)
Ohio State University — Columbus, Ohio, United States (enrolling)
University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.