NCT05771675 Simvastatin Treatment to Improve Patient-reported Outcomes in Patients With Chronic Pancreatitis
| NCT ID | NCT05771675 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Cedars-Sinai Medical Center |
| Condition | Recurrent Acute Pancreatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-10-24 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 90 participants in total. It began in 2024-10-24 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
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.
Contact & Investigator
Stephen Pandol, MD
PRINCIPAL INVESTIGATOR
Cedars-Sinai Medical Center
Frequently Asked Questions
Who can join the NCT05771675 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Recurrent Acute Pancreatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05771675 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05771675 currently recruiting?
Yes, NCT05771675 is actively recruiting participants. Contact the research team at arax.shanlian@cshs.org for enrollment information.
Where is the NCT05771675 trial being conducted?
This trial is being conducted at Los Angeles, United States, Los Angeles, United States, Stanford, United States, Columbus, United States and 1 additional location.
Who is sponsoring the NCT05771675 clinical trial?
NCT05771675 is sponsored by Cedars-Sinai Medical Center. The principal investigator is Stephen Pandol, MD at Cedars-Sinai Medical Center. The trial plans to enroll 90 participants.