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New pill could dissolve gallstones without surgery

NCT ID NCT07005752

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 484 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

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

19 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    13 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Ajou University Hospital

    RECRUITING

    Suwon, Gyeonggi-do, 16499, South Korea

  • CHA Bundang Medical Center

    RECRUITING

    Gyeonggi-do, South Korea

  • Eunpyeong St. Mary's Hospital, The Catholic University of Korea

    RECRUITING

    Seoul, 03312, South Korea

  • Gangnam Severance Hospital

    RECRUITING

    Seoul, South Korea

  • Hallym University Dongtan Sacred Heart Hospital

    RECRUITING

    Gyeonggi-do, South Korea

  • Inha University Hospital

    RECRUITING

    Incheon, South Korea

  • Inje University Sanggye Paik Hospital

    RECRUITING

    Seoul, 01757, South Korea

  • Kangbuk Samsung Hospital

    RECRUITING

    Seoul, 03181, South Korea

  • Korea University Ansan Hospital

    RECRUITING

    Ansan, Gyeonggi-do, 15355, South Korea

  • Kyungpook National University Hospital

    RECRUITING

    Daegu, 41944, South Korea

  • Pusan National University Hospital

    RECRUITING

    Busan, South Korea

  • Soonchunhyang University Bucheon Hospital

    RECRUITING

    Bucheon-si, Gyeonggi-do, 14584, South Korea

  • Soonchunhyang University Cheonan Hospital

    RECRUITING

    Gyeonggi-do, South Korea