A Study to Evaluate the Efficacy and Safety of CnU Capsule 750 mg in Patients With Cholesterol Gallstones(GB Stones).

NCT07005752 | Recruiting Phase 4

• 1 other identifier: MMP-401
• Study Type: interventional
• Target: 484
• Locations: 1 country
• Sites: 6

Brief Summary

The objective of this clinical trial is to evaluate the efficacy and safety of CnU capsule 750 mg administration in patients with Cholesterol gallstone (radiolucent gallstones)

Conditions

Cholesterol Cholelithiasis

Keywords

Cholesterol gallstone

Outcome Measures

Primary Outcomes (1)

• Response to dissolution therapy

  Response to dissolution therapy at 24 weeks compared to baseline in patients with Cholesterol gallstones. The dissolution response rate is defined as the sum of the GB stones complete and partial dissolution rates.

  From baseline to the end of treatment at 24 weeks

Secondary Outcomes (1)

• 1) GB stones complete dissolution rate 2) GB stones partial dissolution rate 3) GB stones dissolution rate

  From baseline to the end of treatment at 24 weeks

Study Arms (2)

CnU capsule 250 mg(1 capsule) and Ursa placebo tablet 200 mg(1 tablet)

EXPERIMENTAL

Drug: CnU cap. 250mg & Ursa placebo tab. 200mg

Ursa tablet 200 mg(1 tablet) and CnU placebo capsule 250 mg(1 capsule)

ACTIVE COMPARATOR

Drug: Ursa tab. 200mg & CnU placebo cap. 250mg

Interventions

CnU cap. 250mg & Ursa placebo tab. 200mg DRUG

CnU capsule(Magnesium Salt Trihydrate of Chenodeoxycholic Acid and Ursodeoxycholic Acid) and Ursa placebo tablet will be orally administered three times a day after meals at regular intervals for a total of 24 weeks.

CnU capsule 250 mg(1 capsule) and Ursa placebo tablet 200 mg(1 tablet)

Ursa tab. 200mg & CnU placebo cap. 250mg DRUG

Ursa tablet(Ursodeoxycholic Acid) and CnU placebo capsule will be orally administered three times a day after meals at regular intervals for a total of 24 weeks.

Ursa tablet 200 mg(1 tablet) and CnU placebo capsule 250 mg(1 capsule)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who have voluntarily agreed to participate in this clinical trial
• Adults aged 19 years and older
• 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

You may not qualify if:

• \. Medical History
• 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).
• Patients with obstructive jaundice.
• Patients with liver disease.
• Patients with severe kidney disease.
• Patients with severe biliary obstruction (due to choleretic effects, symptoms may worsen).
• Patients with underlying diseases that could worsen biliary obstruction (such as biliary cancer, cholangitis, or biliary cysts).
• Patients with acute cholecystitis.
• Patients with peptic ulcers (due to mucosal irritation, symptoms may worsen).
• Patients with inflammatory bowel diseases, such as Crohn's disease.
• Patients with cholestasis.
• Patients with abnormal gallbladder contraction.
• Individuals with a history of malignant tumors within 5 years prior to the screening stage.
• Individuals with a history of gastrointestinal surgery.
• Individuals known to have hypersensitivity to the ingredients or additives of the clinical trial drug.

Sponsors & Collaborators

• Myungmoon Pharma. Co. Ltd.: lead

Study Sites (6)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: June 5, 2025
• Study Start: July 28, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

KR (6)