CnU 750 mg capsule treatment for cholesterol gallstones

Multi-center, Randomized, Double-blind, Active Controlled, Parallel Clinical Trial for the Evaluation of the Efficacy and Safety of CnU Cap. 750 mg in Patients With Cholesterol Gallstone

This trial tests whether taking CnU 750 mg capsules can dissolve or shrink radiolucent cholesterol gallstones in adults.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 484 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Myungmoon Pharma. Co. Ltd. (industry)
• Locations: 6 sites (Busan and 5 other locations)
• Trial ID: NCT07005752 on ClinicalTrials.gov

What this trial studies

This phase 4 interventional trial compares oral CnU 750 mg with standard ursodeoxycholic acid in adults who have radiolucent cholesterol gallstones up to 15 mm in diameter. Participants receive either CnU plus matching placebo or ursodeoxycholic acid plus matching placebo and are followed with imaging and safety monitoring to document stone dissolution and adverse events. Key eligibility requires confirmation of radiolucent gallstones by ultrasound and plain abdominal X‑ray, and excludes patients with obstructive jaundice, significant liver or kidney disease, severe biliary obstruction, or active biliary infection. The primary outcomes are gallstone disappearance or size reduction on imaging and the occurrence of treatment-related side effects over the treatment period.

Who should consider this trial

Good fit: Adults aged 19 years or older with radiolucent cholesterol gallstones ≤15 mm on ultrasound and plain X‑ray who can attend the study visits and give informed consent.

Not a fit: Patients with obstructive jaundice, significant liver or kidney disease, severe biliary obstruction, recurrent biliary infections, or other conditions needing surgical management are unlikely to benefit from the treatment tested here.

Why it matters

Potential benefit: If successful, CnU could provide an effective oral option to dissolve small cholesterol gallstones and help some patients avoid surgery.

How similar studies have performed: Ursodeoxycholic acid (UDCA) has previously been shown to dissolve small cholesterol gallstones in selected patients, while CnU is a newer agent being compared directly to UDCA in this trial.

Eligibility criteria

Inclusion Criteria:

1. Individuals who have voluntarily agreed to participate in this clinical trial
2. Adults aged 19 years and older
3. Individuals diagnosed with gall bladder stone(GB stone) with a maximum diameter size of 15 mm or less, as determined by abdominal ultrasonography at the screening stage, and who have radiolucent GB stones on plain abdominal X-ray

Exclusion Criteria:

1\. Medical History

1. Patients with frequent biliary colic or biliary infections (severe pancreatic changes, such as ileal resection, resection surgery, or partial ileitis, may alter the composition of bile acids circulating in the intestines).
2. Patients with obstructive jaundice.
3. Patients with liver disease.
4. Patients with severe kidney disease.
5. Patients with severe biliary obstruction (due to choleretic effects, symptoms may worsen).
6. Patients with underlying diseases that could worsen biliary obstruction (such as biliary cancer, cholangitis, or biliary cysts).
7. Patients with acute cholecystitis.
8. Patients with peptic ulcers (due to mucosal irritation, symptoms may worsen).
9. Patients with inflammatory bowel diseases, such as Crohn's disease.
10. Patients with cholestasis.
11. Patients with abnormal gallbladder contraction.
12. Individuals with a history of malignant tumors within 5 years prior to the screening stage.
13. Individuals with a history of gastrointestinal surgery.
14. Individuals known to have hypersensitivity to the ingredients or additives of the clinical trial drug.
15. Individuals showing clinically significant disorders in the cardiovascular, gastrointestinal, respiratory, endocrine, or central nervous systems, or individuals who have had or currently have a mental disorder that could significantly affect this clinical trial.
16. Individuals with drug or alcohol addiction.
17. Individuals with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.

2\. Individuals showing abnormal test results at the screening stage:

1. BMI ≥ 35 kg/m².
2. ALT or AST \> 2.0 x ULN.
3. Total bilirubin \> 2.0 x ULN.
4. eGFR \< 60 mL/min/1.73 m² (CKD-EPI formula).
5. Positive results in serum tests (HBsAg, HCV Ab, HIV Ab, Syphilis reagin test).

3\. Contraindicated drugs and therapies

The following drugs may be used after a washout period and registration:

1. Medications that increase bile secretion within 1 week prior to screening (e.g., estrogen, hormonal contraceptives, some lipid-lowering agents), or medications that reduce blood cholesterol (e.g., clofibrate).
2. Medications containing cholestyramine, colestipol, activated charcoal, magnesium, or aluminum hydroxide antacids within 2 weeks prior to screening.
3. Oral bile acid dissolution agents within 4 weeks prior to screening (e.g., chenodeoxycholic acid (CDCA), ursodeoxycholic acid (UDCA), HMG-CoA reductase inhibitors, Terpene).
4. Oral anti-diabetic medications (e.g., tolbutamide).
5. Individuals who have received bile acid treatment within 4 weeks prior to screening.

The following drugs cannot be used regardless of the washout period: Alpha-methyldopa.

4\. Pregnant and breastfeeding women

5\. Contraception

Participants and their spouses (or partners) who do not use medically acceptable contraceptive methods throughout the clinical trial period:

1. Use of intrauterine devices (IUD) or intrauterine systems (IUS) with proven failure rates of pregnancy.
2. Use of dual barrier contraception (male condom and cervical cap: contraceptive vaginal diaphragm or cervical cap) combined with spermicides.
3. Sterilization procedures (vasectomy, tubal ligation or cauterization, hysterectomy).

6\. Other individuals deemed inappropriate for participation in the clinical trial by the investigator.

Where this trial is running

Busan and 5 other locations

• Pusan National University Hospital — Busan, South Korea (RECRUITING)
• CHA Bundang Medical Center — Gyeonggi-do, South Korea (RECRUITING)
• Hallym University Dongtan Sacred Heart Hospital — Gyeonggi-do, South Korea (RECRUITING)
• Soonchunhyang University Cheonan Hospital — Gyeonggi-do, South Korea (RECRUITING)
• Inha University Hospital — Incheon, South Korea (RECRUITING)
• Gangnam Severance Hospital — Seoul, South Korea (RECRUITING)

Conditions: Cholesterol Cholelithiasis, Cholesterol gallstone