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

NCT05771675 | Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: STUDY00002293CDMRP-PR221971
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 5

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).

Conditions

Recurrent Acute Pancreatitis; Chronic Pancreatitis

Outcome Measures

Primary Outcomes (1)

• Examine the feasibility and acceptability of testing the effect of simvastatin on health-related quality of life outcomes in patients with recurrent acute and chronic pancreatitis.

  A priori thresholds to evaluate feasibility are: 50% enrollment, \<15% attrition, \>75% adherence with doses, \<20% side effects. A score of \>75% acceptability ratings per an "Acceptability Form" that will be provided during the last visit will be used to gauge the general acceptability of the intervention (Simvastatin or Placebo) and study procedures to each participating subject.

  End of study (12 Months)

Secondary Outcomes (1)

• Determine the effect of simvastatin treatment on health-related quality of life (QoL) outcomes in patients with recurrent acute and chronic pancreatitis.

  End of study (12 Months)

Study Arms (2)

Simvastatin

EXPERIMENTAL

Participants receive Simvastatin 40mg capsule once daily for 6 months.

Drug: Simvastatin

Placebo

PLACEBO COMPARATOR

Participants receive Placebo capsule matching Simvastatin once daily for 6 months.

Drug: Placebo

Interventions

Simvastatin DRUG

40Mg Oral Tablet

Simvastatin

Placebo DRUG

Matching Simvastatin Placebo tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• United States Department of Defense: collaborator

Study Sites (5)

University of Southern California

Los Angeles, California, 90033, United States

RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Stanford University

Stanford, California, 94305, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Pancreatitis; Pancreatitis, Chronic

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Stephen Pandol, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arax Shanlian

CONTACT

3109671110; arax.shanlian@cshs.org

Arax Shanlian

CONTACT

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Basic and Translational Pancreas Research Medicine

Model Details: Drug: Simvastatin Drug: Placebo

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: March 16, 2023
• Study Start: October 24, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)