Metabolic Dysfunction-Associated Steatoic Liver DiseasePhase 2NCT07878091
A Phase 2a Study of Kylo-0603 Capsule in Participants With Metabolic Dysfunction Associated Steatotic Liver Disease (MASLD)
A Phase 2 study testing Kylo 0603 Capsule 8mg, Kylo 0603 Capsule 12mg and Kylo 0603 Capsule 16mg in people with Metabolic Dysfunction-Associated Steatoic Liver Disease, run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. at 1 site in China.
Trial summary
Metabolic dysfunction-associated steatotic liver disease (MASLD) is a metabolic stress-related liver injury closely associated with insulin resistance, with a global prevalence of approximately 25%. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatoic Liver Disease
- What is being tested?
- Kylo 0603 Capsule 8mg, Kylo 0603 Capsule 12mg and Kylo 0603 Capsule 16mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2026to 15 Aug 2027
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following inclusion criteria to be eligible for this study:
- Age between 18 and 70 years, inclusive.
- Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) ≥ 10% at screening.
- Body weight stable within 6 weeks before screening (absolute change in body weight ≤ 5%).
- Liver stiffness measurement (LSM) by FibroScan at screening: 8 kPa ≤ LSM < 15 kPa.
- Body mass index (BMI) between 25.0 and 40.0 kg/m², inclusive, at screening.
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- Participants must have no childbearing plans during the study and for 6 months after the last dose, and must voluntarily use effective contraceptive measures.
- No alcohol consumption or no history of excessive alcohol consumption. A history of excessive alcohol consumption is defined as: in the past 12 months, weekly ethanol (alcohol) intake ≥ 210 g for men and ≥ 140 g for women. Ethanol intake (g) = alcohol consumption volume (mL) × alcohol by volume (%) × 0.8.
- Participants must voluntarily participate in the clinical trial, be able to sign the informed consent form (ICF), and be able to understand and comply with the trial procedures.
Who cannot join
- Chronic liver disease of other etiologies, including viral hepatitis (hepatitis B virus [HBV], hepatitis C virus [HCV]), human immunodeficiency virus (HIV), syphilis, primary sclerosing cholangitis, primary biliary cholangitis, autoimmune hepatitis, drug-induced liver disease, alcoholic liver disease, Wilson disease, or other etiologies judged by the investigator.
- History of liver transplantation or planned liver transplantation.
- Confirmed or suspected cirrhosis, or current or previous hepatic decompensation, including portal hypertension (e.g., esophageal varices, ascites) or hepatic encephalopathy.
- History of thyroid disease, current use of drugs affecting thyroid function, positive thyroid-related antibodies, or abnormal thyroid function tests at screening. Thyroid-related antibodies include anti-thyroid peroxidase antibody (TPOAb), thyroid-stimulating hormone receptor antibody (TRAb), and anti-thyroglobulin antibody (TGAb). Thyroid function tests include thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), free thyroxine (FT4), total triiodothyronine (TT3), and total thyroxine (TT4).
- Diabetes other than type 2 diabetes mellitus; poor glycemic control (hemoglobin A1c [HbA1c] >= 9% or fasting plasma glucose >= 13.9 mmol/L); need for additional glucose-lowering therapy during the study; or history of severe hypoglycemia.
- History of bariatric surgery within 5 years before screening.
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- Use of medications that may cause hepatic steatosis, steatohepatitis, or hepatotoxicity within 12 months before screening, including but not limited to valproic acid, tamoxifen, methotrexate, amiodarone, oral glucocorticoids > 5 mg/day prednisone or equivalent, or estrogens at doses greater than those used for contraception or hormone replacement.
- Receipt of insulin, glucagon-like peptide-1 (GLP-1) receptor agonists, glucose-dependent insulinotropic polypeptide (GIP) receptor agonists, or glucagon receptor (GCGR) agonists within 6 months before screening.
- Use of weight-loss medications within 6 months before screening or planned use during the study.
- Current or recent use of approved metabolic dysfunction-associated steatohepatitis (MASH) therapies, or participation in another MASH clinical trial within 6 months or 5 half-lives before screening, whichever is longer.
- Use of hepatoprotective drugs within 4 weeks before screening or planned use during the study.
- Unstable doses of vitamin E, osteoporosis therapies, sodium-glucose cotransporter-2 (SGLT2) inhibitors, thiazolidinediones, statins, fibrates, or other glucose-lowering, weight-affecting, or lipid-modifying drugs within the specified period before screening.
- Poorly controlled hypertension, defined as systolic blood pressure (SBP) >= 160 mmHg or diastolic blood pressure (DBP) >= 100 mmHg based on the mean of 3 measurements at screening.
- History of malignancy within 5 years before screening, or active or suspected malignancy under evaluation at screening. Adequately treated basal cell carcinoma, squamous cell skin cancer, and carcinoma in situ of the cervix are excluded.
- Major surgery within 3 months before signing the informed consent form (ICF), or planned major surgery during the study.
- History of drug abuse within 1 year before screening.
- Participation in another clinical trial of an approved or unapproved investigational drug or device within 3 months or 5 half-lives before screening, whichever is longer.
- Known or suspected intolerance or allergy to the investigational drug, its excipients, or drugs with the same target.
- Abnormal laboratory values at screening: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 x upper limit of normal (ULN); alkaline phosphatase (ALP) >= 2 x ULN; estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2; international normalized ratio (INR) >= 1.3; total bilirubin > 1.5 x ULN; or platelet count < lower limit of normal (LLN).
- Blood transfusion within 2 months before screening, blood donation within 1 month before screening, breastfeeding, or positive pregnancy test in female participants.
- Significant systemic or major diseases other than liver disease, including recent (within 6 months before screening) congestive heart failure (New York Heart Association [NYHA] functional class III-IV), unstable coronary artery disease, arterial revascularization, respiratory disease, renal failure, stroke, transient ischemic attack, organ transplantation, psychiatric disorders, or any clinically significant disease-related event requiring hospitalization.
- Contraindications to magnetic resonance imaging (MRI); clinically significant electrocardiogram (ECG) abnormalities, including Fridericia's formula-corrected QT interval (QTcF) >= 450 msec in men or >= 470 msec in women at screening; or any condition that, in the investigator's opinion, may increase safety risk or interfere with study participation or compliance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Tsinghua Changgung Hospital, Affiliated to Tsinghua University
Beijing, Beijing Municipality
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Characteristics of Kylo-0603 Capsule in Study Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic dysfunction-associated steatotic liver disease (MASLD) is a metabolic stress-related liver injury closely associated with insulin resistance, with a global prevalence of approximately 25%. It may progress to metabolic dysfunction-associated steatohepatitis (MASH), which can lead to cirrhosis, end-stage liver disease, and increased cardiovascular risk, representing a major unmet medical need. Thyroid hormone receptor beta (THRβ) is predominantly expressed in the liver; selective agonism regulates hepatic lipid metabolism, reduces fat accumulation, suppresses hepatic inflammation and fibrosis, and may delay MASH progression. Kylo-0603 is a liver-targeted, highly selective THRβ agonist modified with GalNAc to enrich hepatic exposure and reduce peripheral effects. This multicenter, randomized, double-blind, placebo-controlled Phase 2a study will evaluate the efficacy, safety, and pharmacokinetics of once-daily oral Kylo-0603 capsules in approximately 120 participants with MASLD and overweight or obesity. Participants will be randomized 1:1:1:1 to Kylo-0603 8 mg, 12 mg, 16 mg, or placebo for 12 weeks. The primary endpoint is the percentage change from baseline in liver fat content assessed by MRI-PDFF at Week 12.
- Being tested
- Kylo 0603 Capsule 8mg, Kylo 0603 Capsule 12mg, Kylo 0603 Capsule 16mg, Kylo 0603 Capsule Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kylo 0603 Capsule 8mgDrug
THR β agonist
Kylo 0603 Capsule 12mgDrug
THR β agonist
Kylo 0603 Capsule 16mgDrug
THR β agonist
Kylo 0603 Capsule PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Test group: Kylo-0603 Capsules 8mg | Experimental | Kylo 0603 capsule 8 mg，administered for 12 weeks Receives: Drug: Kylo 0603 Capsule 8mg |
| Test group: Kylo-0603 Capsules 12mg | Experimental | Kylo 0603 capsule 12 mg, administered for 12 weeks Receives: Drug: Kylo 0603 Capsule 12mg |
| Test group: Kylo-0603 Capsules 16mg | Experimental | Kylo 0603 capsule 16 mg, administered for 12 weeks Receives: Drug: Kylo 0603 Capsule 16mg |
| Control Group: Kylo 0603 Capsule Placebo | Placebo comparator | Kylo 0603 Capsules placebo, administered for 12 weeks Receives: Drug: Kylo 0603 Capsule Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage change from baseline in liver fat content
The percentage change from baseline in liver fat content assessed by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) after 12 weeks of treatment.
Measured: After 12 weeks of treatment.
Secondary outcomes (21)
Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFFZ)
Change from baseline in MRI-PDFF
Measured: After 12 weeks of treatment
Proportion of participants with a decrease in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF)
Proportion of Study Participants with ≥30% and 50% reduction in MRI-PDFF from baseline
Measured: After 12 weeks of treatment.
Change from baseline in liver stiffness measurement (LSM)
Measured: After 12 weeks of treatment.
Change in low-density lipoprotein cholesterol (LDL-c)
Measured: After 12 weeks of treatment.
Change from baseline in alanine aminotransferase (ALT)
Measured: After 12 weeks of treatment.
High-sensitivity C-reactive protein (hsCRP)
Measured: After 12 weeks of treatment.
Change from baseline in cytokeratin-18 (CK-18)
Measured: After 12 weeks of treatment.
Change in body mass index [BMI]
Measured: After 12 weeks of treatment.
Change in the level of insulin resistance
Change from baseline in the level of insulin resistance: assessed by the Homeostasis Model Assessment (HOMA-IR)
Measured: After 12 weeks of treatment.
Percentage change from baseline in sex hormone-binding globulin (SHBG)
Measured: After 12 weeks of treatment.
Incidence of adverse events
Measured: From enrollment to the end of 12 weeks
maximum plasma concentration (Cmax) of Kylo-0603
Measured: From administration to the end of 12 weeks
Percentage change from baseline in controlled attenuation parameter (CAP) assessed by FibroScan
Measured: After 12 weeks of treatment.
Change from baseline in aspartate aminotransferase (AST)
Measured: After 12 weeks of treatment.
Change from baseline in high-density lipoprotein cholesterol (HDL-c)
Measured: After 12 weeks of treatment.
Change from baseline in non-high-density lipoprotein cholesterol (non-HDL-c)
Measured: After 12 weeks of treatment.
Change from baseline in total cholesterol (TC)
Measured: After 12 weeks of treatment.
Change from baseline in triglyceride
Measured: After 12 weeks of treatment.
Change from baseline in the liver fibrosis marker FIB-4 score
Measured: After 12 weeks of treatment.
Change from baseline in the Enhanced Liver Fibrosis (ELF) test
Measured: After 12 weeks of treatment.
Change from baseline in the AST to Platelet Ratio Index (APRI) score
Measured: After 12 weeks of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start15 Nov 2026 (estimated)
- Primary completion15 Aug 2027 (estimated)
- Study completion15 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated Steatoic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.The sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878091
- Sponsor's protocol ID
- Kylo-0603-IIa-01
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Characteristics of Kylo-0603 Capsule in Study Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
- ClinicalTrials.gov ID
- NCT07878091
- Acronym / sponsor ID
- Kylo-0603-IIa-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 15 Aug 2027 (estimated)
- Study completion
- 15 Aug 2027 (estimated)
- First posted
- 16 Oct 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.
Metabolic dysfunction-associated steatotic liver disease (MASLD) is a metabolic stress-related liver injury closely associated with insulin resistance, with a global prevalence of approximately 25%. It may progress to metabolic dysfunction-associated steatohepatitis (MASH), which can lead to cirrhosis, end-stage liver disease, and increased cardiovascular risk, representing a major unmet medical need. Thyroid hormone receptor beta (THRβ) is predominantly expressed in the liver; selective agonism regulates hepatic lipid metabolism, reduces fat accumulation, suppresses hepatic inflammation and fibrosis, and may delay MASH progression. Kylo-0603 is a liver-targeted, highly selective THRβ agonist modified with GalNAc to enrich hepatic exposure and reduce peripheral effects. This multicenter, randomized, double-blind, placebo-controlled Phase 2a study will evaluate the efficacy, safety, and pharmacokinetics of once-daily oral Kylo-0603 capsules in approximately 120 participants with MASLD and overweight or obesity. Participants will be randomized 1:1:1:1 to Kylo-0603 8 mg, 12 mg, 16 mg, or placebo for 12 weeks. The primary endpoint is the percentage change from baseline in liver fat content assessed by MRI-PDFF at Week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test group: Kylo-0603 Capsules 8mg | Experimental | Drug: Kylo 0603 Capsule 8mgKylo 0603 capsule 8 mg，administered for 12 weeks |
| Test group: Kylo-0603 Capsules 12mg | Experimental | Drug: Kylo 0603 Capsule 12mgKylo 0603 capsule 12 mg, administered for 12 weeks |
| Test group: Kylo-0603 Capsules 16mg | Experimental | Drug: Kylo 0603 Capsule 16mgKylo 0603 capsule 16 mg, administered for 12 weeks |
| Control Group: Kylo 0603 Capsule Placebo | Placebo comparator | Drug: Kylo 0603 Capsule PlaceboKylo 0603 Capsules placebo, administered for 12 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants must meet all of the following inclusion criteria to be eligible for this study:
- Age between 18 and 70 years, inclusive.
- Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) ≥ 10% at screening.
- Body weight stable within 6 weeks before screening (absolute change in body weight ≤ 5%).
- Liver stiffness measurement (LSM) by FibroScan at screening: 8 kPa ≤ LSM < 15 kPa.
Key exclusion criteria (22 listed)
- Chronic liver disease of other etiologies, including viral hepatitis (hepatitis B virus [HBV], hepatitis C virus [HCV]), human immunodeficiency virus (HIV), syphilis, primary sclerosing cholangitis, primary biliary cholangitis, autoimmune hepatitis, drug-induced liver disease, alcoholic liver disease, Wilson disease, or other etiologies judged by the investigator.
- History of liver transplantation or planned liver transplantation.
- Confirmed or suspected cirrhosis, or current or previous hepatic decompensation, including portal hypertension (e.g., esophageal varices, ascites) or hepatic encephalopathy.
- History of thyroid disease, current use of drugs affecting thyroid function, positive thyroid-related antibodies, or abnormal thyroid function tests at screening. Thyroid-related antibodies include anti-thyroid peroxidase antibody (TPOAb), thyroid-stimulating hormone receptor antibody (TRAb), and anti-thyroglobulin antibody (TGAb). Thyroid function tests include thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), free thyroxine (FT4), total triiodothyronine (TT3), and total thyroxine (TT4).
- Diabetes other than type 2 diabetes mellitus; poor glycemic control (hemoglobin A1c [HbA1c] >= 9% or fasting plasma glucose >= 13.9 mmol/L); need for additional glucose-lowering therapy during the study; or history of severe hypoglycemia.
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 |
|---|---|---|
| Kylo 0603 Capsule 8mgTHR β agonist | Drug | Test group: Kylo-0603 Capsules 8mg |
| Kylo 0603 Capsule 12mgTHR β agonist | Drug | Test group: Kylo-0603 Capsules 12mg |
| Kylo 0603 Capsule 16mgTHR β agonist | Drug | Test group: Kylo-0603 Capsules 16mg |
| Kylo 0603 Capsule PlaceboPlacebo | Drug | Control Group: Kylo 0603 Capsule Placebo |
Primary outcome
The percentage change from baseline in liver fat content
Time frame: After 12 weeks of treatment.
The percentage change from baseline in liver fat content assessed by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) after 12 weeks of treatment.
21 secondary outcomes
Change in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFFZ)
Time frame: After 12 weeks of treatment
Proportion of participants with a decrease in Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF)
Time frame: After 12 weeks of treatment.
Change from baseline in liver stiffness measurement (LSM)
Time frame: After 12 weeks of treatment.
Change in low-density lipoprotein cholesterol (LDL-c)
Time frame: After 12 weeks of treatment.
Change from baseline in alanine aminotransferase (ALT)
Time frame: After 12 weeks of treatment.
High-sensitivity C-reactive protein (hsCRP)
Time frame: After 12 weeks of treatment.
Change from baseline in cytokeratin-18 (CK-18)
Time frame: After 12 weeks of treatment.
Change in body mass index [BMI]
Time frame: After 12 weeks of treatment.
Change in the level of insulin resistance
Time frame: After 12 weeks of treatment.
Percentage change from baseline in sex hormone-binding globulin (SHBG)
Time frame: After 12 weeks of treatment.
Incidence of adverse events
Time frame: From enrollment to the end of 12 weeks
maximum plasma concentration (Cmax) of Kylo-0603
Time frame: From administration to the end of 12 weeks
Percentage change from baseline in controlled attenuation parameter (CAP) assessed by FibroScan
Time frame: After 12 weeks of treatment.
Change from baseline in aspartate aminotransferase (AST)
Time frame: After 12 weeks of treatment.
Change from baseline in high-density lipoprotein cholesterol (HDL-c)
Time frame: After 12 weeks of treatment.
Change from baseline in non-high-density lipoprotein cholesterol (non-HDL-c)
Time frame: After 12 weeks of treatment.
Change from baseline in total cholesterol (TC)
Time frame: After 12 weeks of treatment.
Change from baseline in triglyceride
Time frame: After 12 weeks of treatment.
Change from baseline in the liver fibrosis marker FIB-4 score
Time frame: After 12 weeks of treatment.
Change from baseline in the Enhanced Liver Fibrosis (ELF) test
Time frame: After 12 weeks of treatment.
Change from baseline in the AST to Platelet Ratio Index (APRI) score
Time frame: After 12 weeks of treatment.
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 16 Oct 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Kylo 0603 Capsule 8mg, Kylo 0603 Capsule 12mg and Kylo 0603 Capsule 16mg in people with Metabolic Dysfunction-Associated Steatoic Liver Disease, run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development 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 9 inclusion and 22 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 16 Oct 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Lai Wei, Doctor (13601281862, weilai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage change from baseline in liver fat content (time frame: After 12 weeks of treatment.). 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 16 Oct 2026.