Cholesterol CholelithiasisPhase 4NCT07005752
A Study to Evaluate the Efficacy and Safety of CnU Capsule 750 mg in Patients With Cholesterol Gallstones(GB Stones).
A Phase 4 study of Cholesterol Cholelithiasis, run by Myungmoon Pharma. Co. Ltd. at 13 sites in South Korea.
Trial 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) Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cholesterol Cholelithiasis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 484 participants
- Where
- 13 sitesSouth Korea
- Study dates
- 28 Jul 2025to 13 Jun 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 1. 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).
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- 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.
- 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.
- Individuals with drug or alcohol addiction.
- 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:
- BMI ≥ 35 kg/m².
- ALT or AST > 2.0 x ULN.
- Total bilirubin > 2.0 x ULN.
- eGFR < 60 mL/min/1.73 m² (CKD-EPI formula).
- 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:
- 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).
- Medications containing cholestyramine, colestipol, activated charcoal, magnesium, or aluminum hydroxide antacids within 2 weeks prior to screening.
- Oral bile acid dissolution agents within 4 weeks prior to screening (e.g., chenodeoxycholic acid (CDCA), ursodeoxycholic acid (UDCA), HMG-CoA reductase inhibitors, Terpene).
- Oral anti-diabetic medications (e.g., tolbutamide).
- 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:
- Use of intrauterine devices (IUD) or intrauterine systems (IUS) with proven failure rates of pregnancy.
- Use of dual barrier contraception (male condom and cervical cap: contraceptive vaginal diaphragm or cervical cap) combined with spermicides.
- Sterilization procedures (vasectomy, tubal ligation or cauterization, hysterectomy).
- 6. Other individuals deemed inappropriate for participation in the clinical trial by the investigator.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
South Korea13 sites, 13 recruiting
- Recruiting
Korea University Ansan Hospital
Ansan, Gyeonggi-do, 15355
JONG JIN HYUN, M.D., 82-31-412-4856, sean4h@korea.ac.kr
- Recruiting
Soonchunhyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, 14584
IL SANG SHIN, M.D., 82-32-621-5094, ilsang.shin@schmc.ac.kr
- Recruiting
Pusan National University Hospital
Busan
SUNG YONG HAN, M.D., +82-10-6278-7420, mirsaint@hanmail.net
- Recruiting
Kyungpook National University Hospital
Daegu, 41944
MIN KYU JUNG, M.D., 82-53-200-5514, minky1973@knu.ac.kr
- Recruiting
CHA Bundang Medical Center
Gyeonggi-do
GWANG HYEON GO, M.D., +82-10-5345-9273, bluehipp@cha.ac.kr
- Recruiting
Hallym University Dongtan Sacred Heart Hospital
Gyeonggi-do
DONG HEE KOH, M.D., +82-10-4607-2886, dhkoh@hallym.or.kr
- Recruiting
Soonchunhyang University Cheonan Hospital
Gyeonggi-do
TAE HOON LEE, M.D., +82-10-4020-9370, taewoolee9@gmail.com
- Recruiting
Inha University Hospital
Incheon
SEOK JEONG, M.D., +82-10-4309-7417, inos@inha.ac.kr
- Recruiting
Inje University Sanggye Paik Hospital
Seoul, 01757
TAE JOO JEON, M.D., 82-2-950-1340, drjtj@paik.ac.kr
- Recruiting
Kangbuk Samsung Hospital
Seoul, 03181
HONG JOO KIM, M.D., 82-2-2001-8330, ringer2003@gmail.com
- Recruiting
Eunpyeong St. Mary's Hospital, The Catholic University of Korea
Seoul, 03312
SEUNG BAE YOON, M.D., 82-10-8625-5979, sbyoon@catholic.ac.kr
- Recruiting
Gangnam Severance Hospital
Seoul
SEONG IL JANG, M.D., +82-10-9831-7721, aerojsi88@gmail.com
- Recruiting
Ajou University Hospital
Suwon, Gyeonggi-do, 16499
MIN JAE YANG, M.D., 82-31-219-7821, creator1999@hanmail.net
About this study
Official title: 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
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
- Being tested
- CnU cap. 250mg & Ursa placebo tab. 200mg, Ursa tab. 200mg & CnU placebo cap. 250mg
- Keywords
- Cholesterol gallstone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CnU cap. 250mg & Ursa placebo tab. 200mgDrug
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.
Ursa tab. 200mg & CnU placebo cap. 250mgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| CnU capsule 250 mg(1 capsule) and Ursa placebo tablet 200 mg(1 tablet) | Experimental | Not described Receives: Drug: CnU cap. 250mg & Ursa placebo tab. 200mg |
| Ursa tablet 200 mg(1 tablet) and CnU placebo capsule 250 mg(1 capsule) | Active comparator | Not described Receives: Drug: Ursa tab. 200mg & CnU placebo cap. 250mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
- GB stones complete dissolution rate: The complete GB stones dissolution rate is defined as the proportion of subjects with no detectable gallbladder stones on ultrasonography.
- GB stones partial dissolution rate: The partial GB stones dissolution rate is defined as the proportion of subjects who show a reduction of more than 50% in GB stones volume.
- GB stones dissolution rate: The GB stones dissolution rates are defined as the rate of reduction in GB stones volume and the area of gallbladder sludge as measured by ultrasonography.
Measured: From baseline to the end of treatment at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start28 Jul 2025
- Primary completion10 Nov 2027 (estimated)
- Study completion13 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholesterol CholelithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 484 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Myungmoon Pharma. Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005752
- Sponsor's protocol ID
- MMP-401
- Status last verified
- Jul 2026
- First submitted
- 14 May 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07005752
- Acronym / sponsor ID
- MMP-401
- Conditions
- Cholesterol Cholelithiasis
- Keywords
- Cholesterol gallstone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 484 participants (estimated)
- Lead sponsor
- Myungmoon Pharma. Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 10 Nov 2027 (estimated)
- Study completion
- 13 Jun 2028 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (39 listed)
- 1. 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CnU cap. 250mg & Ursa placebo tab. 200mgCnU 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. | Drug | CnU capsule 250 mg(1 capsule) and Ursa placebo tablet 200 mg(1 tablet) |
| Ursa tab. 200mg & CnU placebo cap. 250mgUrsa 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. | Drug | Ursa tablet 200 mg(1 tablet) and CnU placebo capsule 250 mg(1 capsule) |
Primary outcome
Response to dissolution therapy
Time frame: From baseline to the end of treatment at 24 weeks
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.
1 secondary outcome
1) GB stones complete dissolution rate 2) GB stones partial dissolution rate 3) GB stones dissolution rate
Time frame: From baseline to the end of treatment at 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Soonchunhyang University Bucheon Hospital
Bucheon-si, South Korea
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Cholesterol Cholelithiasis, run by Myungmoon Pharma. Co. Ltd. at 13 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to dissolution therapy (time frame: From baseline to the end of treatment at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.