New pill XTYW007 enters human testing for fatty liver
NCT ID NCT07407634
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial is testing a new drug called XTYW007 in healthy volunteers and people with high LDL cholesterol. The main goal is to check the drug's safety and how the body processes it, not yet to see if it treats non-alcoholic fatty liver disease (NAFLD). The study will involve 94 participants and includes both single and multiple doses, as well as looking at the effect of food on the drug.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- XTYW007 capsules
- What this could lead to
- If this early trial shows XTYW007 is safe and well-tolerated, it could pave the way for larger studies to see if it helps control non-alcoholic fatty liver disease.
- What could go wrong
- This is a very early (Phase I/IIa) trial with only 94 participants, focused on safety and dosing, not on whether the drug actually works. Many drugs fail at this stage.
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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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 94 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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. Subjects voluntarily sign the informed consent before the trial, and fully understand the content, process and possible adverse effects of the trial; 2. They are able to complete the study according to the requirements of the trial protocol; 3. Subjects (including partners) are willing to have no pregnancy plan and voluntarily use effective contraceptive measures within 6 months from screening to the last dose of study drug; 4. Male and female subjects between the ages of 18 and 65 (including borderline values); 5. Male subjects weighing not less than 50 kg and female subjects weighing not less than 45 kg. Body mass index (BMI) = weight (kg)/ height 2 (m2), BMI within the range of 18-28 kg/m2 (including the threshold value); 6. During screening, for single-dose studies, fasting low-density lipoprotein cholesterol (LDL-C): 80 mg/dL \< LDL-C \< 120 mg/dL (2.06 mmol/L \~ 3.1 mmol/L); for multiple-dose studies, fasting low-density lipoprotein cholesterol (LDL-C) \> 110 mg/dL (2.85 mmol/L); 7. Physical examination and vital signs are normal or abnormal without clinical significance. Exclusion Criteria: 1. Individuals with allergic constitution (allergic to multiple drugs and foods) or intolerance to β-blockers; 2. History of thyroid-related diseases and/or thyroid function abnormalities during the screening phase that are clinically significant; 3. Individuals who smoked more than 5 cigarettes per day in the 3 months prior to the trial; 4. History of drug abuse and/or alcoholism (consuming 14 units of alcohol per week: 1 unit = 285 mL beer, 25 mL spirits, or 100 mL wine); 5. Blood donation or significant blood loss (\>450 mL) within 3 months prior to taking the study drug; 6. Use of any prescription drugs, over-the-counter drugs, vitamins, herbal products, or alcohol within 14 days before taking the study drug; 7. Consumption of special foods (such as grapefruit, mango, dragon fruit, grape juice, orange juice, etc., rich in flavonoids or coumarins) within 2 weeks before taking the study drug, or engaging in intense exercise, or other factors affecting drug absorption, distribution, metabolism, or excretion; 8. Significant changes in diet or exercise habits recently; 9. Use of the study drug or participation in a drug clinical trial within 3 months before taking the study drug; 10. Difficulty swallowing or any gastrointestinal diseases affecting drug absorption within 6 months prior to the study; 11. Any disease that increases bleeding risk, such as hemorrhoids, acute gastritis, or gastroduodenal ulcer; 12. Clinically significant ECG abnormalities; QTcF \> 470 ms (QTcF = QT/(RR)\^0.33); 13. Female subjects who are breastfeeding during the screening or trial phase, planning pregnancy in the near future, or have positive serum pregnancy results; 14. Abnormal clinical laboratory test results with clinical significance, or other clinical findings within 12 months prior to screening that are clinically significant, including but not limited to diseases of the gastrointestinal tract, kidney, liver, nervous system, hematopoietic system, endocrine system, tumors, lungs, immune system, mental health, or cardiovascular and cerebrovascular systems; 15. Any positive result for hepatitis B surface antigen, hepatitis C antibody/core antigen, HIV antigen/antibody, or syphilis treponema antibody during screening; 16. Occurrence of acute illness or concomitant medication use from the screening phase to the start of study medication; 17. Consumption of chocolate, any caffeine-containing or xanthine-containing foods or beverages within 24 hours before taking the study drug; 18. Serum creatinine clearance ≤ 70 mL/min \[calculation formula: Ccr: (140 - age) × weight (kg) / (0.818 × Scr) (μmol/L), ×0.85 for females\]; 19. Subjects with special dietary requirements who cannot consume the complete study meal or who do not agree to adhere to water intake regimen and position restrictions during the trial; 20. Subjects whom the investigator considers to have other factors that make them unsuitable for participation in this trial.
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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
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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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The First Hospital of Jilin University
Jilin City, Changchun, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Ketogenic diet vs mediterranean diet: which better reshapes metabolism?
- Can a simple scan reveal hidden liver damage in diabetes patients?