Non-Alcoholic Fatty Liver DiseaseEarly Phase 1NCT07407634
A Randomized, Double-blind, Single-center Phase I/IIa Study of XTYW007 Tablets in Subjects.
A Early Phase 1 study of Non-Alcoholic Fatty Liver Disease, run by Xi'an Xintong Pharmaceutical Research Co.,Ltd. at 1 site in China.
Trial summary
Aimed at evaluating the safety, tolerability, and pharmacokinetic characteristics of single and multiple doses of XTYW007 in healthy subjects and healthy subjects with elevated LDL-C, as well as studying the effects of food on the pharmacokinetics and metabolic transformation of XTYW007, and preliminarily assessing… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2026to 27 May 2027
- Phase
- Early Phase 1
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects voluntarily sign the informed consent before the trial, and fully understand the content, process and possible adverse effects of the trial;
- They are able to complete the study according to the requirements of the trial protocol;
- 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;
- Male and female subjects between the ages of 18 and 65 (including borderline values);
- 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);
- 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);
- Physical examination and vital signs are normal or abnormal without clinical significance.
Who cannot join
- Individuals with allergic constitution (allergic to multiple drugs and foods) or intolerance to β-blockers;
- History of thyroid-related diseases and/or thyroid function abnormalities during the screening phase that are clinically significant;
- Individuals who smoked more than 5 cigarettes per day in the 3 months prior to the trial;
- 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);
- Blood donation or significant blood loss (>450 mL) within 3 months prior to taking the study drug;
- Use of any prescription drugs, over-the-counter drugs, vitamins, herbal products, or alcohol within 14 days before taking the study drug;
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- 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;
- Significant changes in diet or exercise habits recently;
- Use of the study drug or participation in a drug clinical trial within 3 months before taking the study drug;
- Difficulty swallowing or any gastrointestinal diseases affecting drug absorption within 6 months prior to the study;
- Any disease that increases bleeding risk, such as hemorrhoids, acute gastritis, or gastroduodenal ulcer;
- Clinically significant ECG abnormalities; QTcF > 470 ms (QTcF = QT/(RR)^0.33);
- Female subjects who are breastfeeding during the screening or trial phase, planning pregnancy in the near future, or have positive serum pregnancy results;
- 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;
- Any positive result for hepatitis B surface antigen, hepatitis C antibody/core antigen, HIV antigen/antibody, or syphilis treponema antibody during screening;
- Occurrence of acute illness or concomitant medication use from the screening phase to the start of study medication;
- Consumption of chocolate, any caffeine-containing or xanthine-containing foods or beverages within 24 hours before taking the study drug;
- Serum creatinine clearance ≤ 70 mL/min [calculation formula: Ccr: (140 - age) × weight (kg) / (0.818 × Scr) (μmol/L), ×0.85 for females];
- 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;
- Subjects whom the investigator considers to have other factors that make them unsuitable for participation in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of XTYW007 in Healthy Subjects and Healthy Subjects With Elevated LDL-C:A Randomized, Double-Blind, Single-Center Phase I/IIa Study of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect Following Single and Multiple Doses
Aimed at evaluating the safety, tolerability, and pharmacokinetic characteristics of single and multiple doses of XTYW007 in healthy subjects and healthy subjects with elevated LDL-C, as well as studying the effects of food on the pharmacokinetics and metabolic transformation of XTYW007, and preliminarily assessing the pharmacodynamics of XTYW007.
Read the detailed description
This study is a single-center, randomized, double-blind Phase I/IIa clinical trial assessing the safety, tolerability, and pharmacokinetics of single and multiple doses.Aimed at evaluating the safety, tolerability, and pharmacokinetic characteristics of single and multiple doses of XTYW007 in healthy subjects and healthy subjects with elevated LDL-C, as well as studying the effects of food on the pharmacokinetics and metabolic transformation of XTYW007, and preliminarily assessing the pharmacodynamics of XTYW007.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Test drug XTYW007 capsules and placebo,Single dose group, Test drug XTYW007 capsules and placebo,Food Impact Group, Test drug XTYW007 capsules and placebo,Multiple dosing group
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test drug XTYW007 capsules and placebo,Single dose groupDrug
Each group consists of 8 people, with 6 receiving the trial drug XTYW007 and 2 receiving a placebo. The sentinel method is used for enrollment, meaning that the first 2 subjects (one male and one female, both receiving the trial drug) are enrolled and observed for 96 hours (after the Day 5 tolerance assessment). If there are no intolerable reactions, the remaining 6 subjects are enrolled and randomly assigned to receive the trial drug or placebo in a 2:1 ratio.
Test drug XTYW007 capsules and placebo,Food Impact GroupDrug
A two-period crossover administration was used, with a 14-day washout period. In Group A, 8 subjects received the drug on D1 under fasting conditions in the first period, and on D15 under fed conditions in the second period. In Group B, 6 subjects taking the investigational drug received it on D1 under fed conditions in the first period, and on D15 under fasting conditions in the second period.
Test drug XTYW007 capsules and placebo,Multiple dosing groupDrug
Each group consists of 8 subjects, with 6 receiving the investigational drug XTYW007 and 2 receiving a placebo. A sentinel dosing approach is used, where 2 subjects (one male and one female) are first enrolled and administered the investigational drug. After 96 hours of observation (tolerance evaluation on Day 5), if no intolerable issues occur, the remaining 6 subjects are enrolled and randomized 2:1 to receive the investigational drug or placebo. In the multiple-dose group, the drug is administered once every morning on an empty stomach (QD) for 14 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Single dose group | Experimental | Group 1 (0.2 mg), Group 2 (0.6 mg), Group 3 (1.5 mg), Group 4 (3 mg), Group 5, Group A (6 mg), Group 6 (10 mg), Group 7 (15 mg), optional dose Group 8 (20 mg) Receives: Drug: Test drug XTYW007 capsules and placebo,Single dose group |
| Food Impact Group | Experimental | Group 5, Subgroup A（6mg）, Group 5, Subgroup B（ 6 mg） Receives: Drug: Test drug XTYW007 capsules and placebo,Food Impact Group |
| Multiple dosing group | Experimental | Group 9 (1.5 mg), Group 10 (6 mg), Group 11 (15 mg) Receives: Drug: Test drug XTYW007 capsules and placebo,Multiple dosing group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-related adverse events
Number of participants who experienced treatment-related adverse events as assessed by CTCAE v5.0.
Measured: Days 1-11 of administration
Cmax
Cmax
Measured: Days 1-11 of administration
Tmax
Tmax
Measured: Days 1-11 of administration
t1/2
t1/2
Measured: Days 1-11 of administration
AUC
AUC
Measured: Days 1-11 of administration
CL/F
CL/F
Measured: Days 1-11 of administration
Vz/F
Vz/F
Measured: Days 1-11 of administration
CLr/F
CLr/F
Measured: Days 1-11 of administration
Secondary outcomes (5)
Ae0-72 h
Ae0-72 h
Measured: Days 1-4 of administration
Fe0-72 h
Fe0-72 h
Measured: Days 1-4 of administration
Blood lipids
TC , TG , LDL-C, HDL-C, Apo A1, Apo B, Lp(a)
Measured: Days 1-11 of administration
Thyroid function
TSH, TT4, TT3, FT4, FT3
Measured: Days 1-11 of administration
Sex hormone-binding globulin (SHBG)
SHBG
Measured: Days 1-11 of administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start25 Mar 2026 (estimated)
- Primary completion26 Feb 2027 (estimated)
- Study completion27 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xi'an Xintong Pharmaceutical Research Co.,Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407634
- Sponsor's protocol ID
- XTYW007-2025-01
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of XTYW007 in Healthy Subjects and Healthy Subjects With Elevated LDL-C:A Randomized, Double-Blind, Single-Center Phase I/IIa Study of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect Following Single and Multiple Doses
- ClinicalTrials.gov ID
- NCT07407634
- Acronym / sponsor ID
- XTYW007-2025-01
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Xi'an Xintong Pharmaceutical Research Co.,Ltd.University, hospital or other
- Study start
- 25 Mar 2026 (estimated)
- Primary completion
- 26 Feb 2027 (estimated)
- Study completion
- 27 May 2027 (estimated)
- First posted
- 12 Feb 2026 (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.
Aimed at evaluating the safety, tolerability, and pharmacokinetic characteristics of single and multiple doses of XTYW007 in healthy subjects and healthy subjects with elevated LDL-C, as well as studying the effects of food on the pharmacokinetics and metabolic transformation of XTYW007, and preliminarily assessing the pharmacodynamics of XTYW007.
Detailed description
This study is a single-center, randomized, double-blind Phase I/IIa clinical trial assessing the safety, tolerability, and pharmacokinetics of single and multiple doses.Aimed at evaluating the safety, tolerability, and pharmacokinetic characteristics of single and multiple doses of XTYW007 in healthy subjects and healthy subjects with elevated LDL-C, as well as studying the effects of food on the pharmacokinetics and metabolic transformation of XTYW007, and preliminarily assessing the pharmacodynamics of XTYW007.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single dose group | Experimental | Drug: Test drug XTYW007 capsules and placebo,Single dose groupGroup 1 (0.2 mg), Group 2 (0.6 mg), Group 3 (1.5 mg), Group 4 (3 mg), Group 5, Group A (6 mg), Group 6 (10 mg), Group 7 (15 mg), optional dose Group 8 (20 mg) |
| Food Impact Group | Experimental | Drug: Test drug XTYW007 capsules and placebo,Food Impact GroupGroup 5, Subgroup A（6mg）, Group 5, Subgroup B（ 6 mg） |
| Multiple dosing group | Experimental | Drug: Test drug XTYW007 capsules and placebo,Multiple dosing groupGroup 9 (1.5 mg), Group 10 (6 mg), Group 11 (15 mg) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects voluntarily sign the informed consent before the trial, and fully understand the content, process and possible adverse effects of the trial;
- They are able to complete the study according to the requirements of the trial protocol;
- 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;
- Male and female subjects between the ages of 18 and 65 (including borderline values);
- 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);
Key exclusion criteria (20 listed)
- Individuals with allergic constitution (allergic to multiple drugs and foods) or intolerance to β-blockers;
- History of thyroid-related diseases and/or thyroid function abnormalities during the screening phase that are clinically significant;
- Individuals who smoked more than 5 cigarettes per day in the 3 months prior to the trial;
- 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);
- Blood donation or significant blood loss (>450 mL) within 3 months prior to taking the study drug;
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 |
|---|---|---|
| Test drug XTYW007 capsules and placebo,Single dose groupEach group consists of 8 people, with 6 receiving the trial drug XTYW007 and 2 receiving a placebo. The sentinel method is used for enrollment, meaning that the first 2 subjects (one male and one female, both receiving the trial drug) are enrolled and observed for 96 hours (after the Day 5 tolerance assessment). If there are no intolerable reactions, the remaining 6 subjects are enrolled and randomly assigned to receive the trial drug or placebo in a 2:1 ratio. | Drug | Single dose group |
| Test drug XTYW007 capsules and placebo,Food Impact GroupA two-period crossover administration was used, with a 14-day washout period. In Group A, 8 subjects received the drug on D1 under fasting conditions in the first period, and on D15 under fed conditions in the second period. In Group B, 6 subjects taking the investigational drug received it on D1 under fed conditions in the first period, and on D15 under fasting conditions in the second period. | Drug | Food Impact Group |
| Test drug XTYW007 capsules and placebo,Multiple dosing groupEach group consists of 8 subjects, with 6 receiving the investigational drug XTYW007 and 2 receiving a placebo. A sentinel dosing approach is used, where 2 subjects (one male and one female) are first enrolled and administered the investigational drug. After 96 hours of observation (tolerance evaluation on Day 5), if no intolerable issues occur, the remaining 6 subjects are enrolled and randomized 2:1 to receive the investigational drug or placebo. In the multiple-dose group, the drug is administered once every morning on an empty stomach (QD) for 14 consecutive days. | Drug | Multiple dosing group |
Primary outcome
Treatment-related adverse events
Time frame: Days 1-11 of administration
Number of participants who experienced treatment-related adverse events as assessed by CTCAE v5.0.
Cmax
Time frame: Days 1-11 of administration
Cmax
Tmax
Time frame: Days 1-11 of administration
Tmax
t1/2
Time frame: Days 1-11 of administration
t1/2
AUC
Time frame: Days 1-11 of administration
AUC
CL/F
Time frame: Days 1-11 of administration
CL/F
Vz/F
Time frame: Days 1-11 of administration
Vz/F
CLr/F
Time frame: Days 1-11 of administration
CLr/F
5 secondary outcomes
Ae0-72 h
Time frame: Days 1-4 of administration
Fe0-72 h
Time frame: Days 1-4 of administration
Blood lipids
Time frame: Days 1-11 of administration
Thyroid function
Time frame: Days 1-11 of administration
Sex hormone-binding globulin (SHBG)
Time frame: Days 1-11 of administration
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 12 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study of Non-Alcoholic Fatty Liver Disease, run by Xi'an Xintong Pharmaceutical Research Co.,Ltd. at 1 site in China.
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 7 inclusion and 20 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: opening soon, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-related adverse events (time frame: Days 1-11 of administration). The study lists 8 primary outcomes in all. 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 12 Feb 2026; AzTrials last refreshed its copy on 28 Oct 2026.