Using simvastatin to improve outcomes in patients with chronic pancreatitis

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

This study is testing if simvastatin can help improve the quality of life and slow down disease progression for adults with chronic pancreatitis and recurrent acute pancreatitis.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Cedars-Sinai Medical Center (Academic / other)
• Locations: 5 sites (Los Angeles, California and 4 other locations)
• Trial ID: NCT05771675 on ClinicalTrials.gov

What this trial studies

This pilot study aims to evaluate the feasibility and acceptability of simvastatin in adults suffering from Recurrent Acute Pancreatitis (RAP) and Chronic Pancreatitis (CP). The study will investigate whether simvastatin can enhance quality of life and delay disease progression by addressing underlying cellular disorders in the pancreas. It will be a double-blind, placebo-controlled trial involving 90 patients, with a treatment duration of 6 months and a recruitment period of 24 months. The study will also measure changes in blood biomarkers to assess the treatment's effectiveness.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with a diagnosis of recurrent acute or chronic pancreatitis not related to gallstones or other specific causes.

Not a fit: Patients with pancreatitis attributable to gallstones, medications, trauma, or autoimmune conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce pain and improve the quality of life for patients with chronic pancreatitis.

How similar studies have performed: While this approach is novel in the context of pancreatitis, similar studies using statins for other inflammatory conditions have shown promising results.

Eligibility criteria

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.

Where this trial is running

Los Angeles, California and 4 other locations

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

Study contacts

• Principal investigator: Stephen Pandol, MD — Cedars-Sinai Medical Center
• Study coordinator: Arax Shanlian

Conditions Recurrent Acute Pancreatitis; Chronic Pancreatitis