New pill could dissolve gallstones without surgery
NCT ID NCT07005752
First seen Jun 27, 2026 · Last updated Jul 30, 2026 · Updated 2 times
Summary
This study tests a capsule called CnU (750 mg) to see if it can dissolve cholesterol gallstones. About 484 adults with small, non-calcified gallstones will take the capsule for 24 weeks. The goal is to check if the stones shrink or disappear, and to ensure the treatment is safe.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 484 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
13 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Ajou University Hospital
RECRUITINGSuwon, Gyeonggi-do, 16499, South Korea
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CHA Bundang Medical Center
RECRUITINGGyeonggi-do, South Korea
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Eunpyeong St. Mary's Hospital, The Catholic University of Korea
RECRUITINGSeoul, 03312, South Korea
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Gangnam Severance Hospital
RECRUITINGSeoul, South Korea
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Hallym University Dongtan Sacred Heart Hospital
RECRUITINGGyeonggi-do, South Korea
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Inha University Hospital
RECRUITINGIncheon, South Korea
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Inje University Sanggye Paik Hospital
RECRUITINGSeoul, 01757, South Korea
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Kangbuk Samsung Hospital
RECRUITINGSeoul, 03181, South Korea
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Korea University Ansan Hospital
RECRUITINGAnsan, Gyeonggi-do, 15355, South Korea
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Kyungpook National University Hospital
RECRUITINGDaegu, 41944, South Korea
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Pusan National University Hospital
RECRUITINGBusan, South Korea
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Soonchunhyang University Bucheon Hospital
RECRUITINGBucheon-si, Gyeonggi-do, 14584, South Korea
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Soonchunhyang University Cheonan Hospital
RECRUITINGGyeonggi-do, South Korea