Metabolic Dysfunction-associated Steatohepatitis (MASH)Phase 2MASHNCT07145151

A Study of UBT251 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)

A Phase 2 study testing UBT251 in people with Metabolic Dysfunction-associated Steatohepatitis (MASH), run by The United Bio-Technology (Hengqin) Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating the efficacy and safety of UBT251 in MASH subjects. Subjects will be randomly assigned to UBT251 2mg-dose, 4mg-dose，6mg-dose and placebo groups. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Metabolic Dysfunction-associated Steatohepatitis (MASH)
What is being tested?: UBT251
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 156 participants
Where: 1 siteChina
Study dates: 30 Sep 2025to 31 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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18-75 years (inclusive) at screening; sex unrestricted.
Subjects with centrally confirmed MASH (metabolic dysfunction-associated steatohepatitis) based on liver histopathology must meet all the following criteria:
NAS (Appendix 1) ≥ 4 （with at least 1 point each for lobular inflammation and ballooning degeneration）;
CRN fibrosis stage (see Appendix 2) of F2 or F3 (a liver biopsy obtained ≤ 6 months before screening is acceptable if it meets the above criteria).
3.Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) ≥ 8 % at screening (MRI-PDFF results obtained within 2 months prior to screening at the trial site are acceptable).
4.Subjects must have <5% body weight fluctuation during the 6 weeks prior to randomization (based on self-reported data), calculated as: [(Highest weight - Lowest weight) / Highest weight] × 100%. For subjects using historical liver biopsy, documented weight change from biopsy to randomization must also be < 5 %.

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5.At least one cardiometabolic risk factor at screening:
Body mass index (BMI) ≥ 24.0 kg/m², or waist circumference ≥90 cm for males or ≥85 cm for females;
Blood pressure ≥ 130/85 mmHg, or on antihypertensive therapy;
Fasting triglycerides ≥ 1.70 mmol/L and < 5.6 mmol/L, or on lipid-lowering therapy;
Fasting HDL-C ≤ 1.0 mmol/L for males or ≤ 1.3 mmol/L for females; or on lipid-lowering therapy;
Fasting glucose ≥ 6.1 mmol/L or glycated hemoglobin (HbA1c) ≥ 5.7 %, or documented history of type 2 diabetes mellitus (T2DM), or Homeostatic Model Assessment of Insulin Resistance index ≥ 2.5.
6.Subjects with type 2 diabetes mellitus (T2DM) must meet glycated hemoglobin (HbA1c) ≤ 9.0 % at screening (local result obtained ≤ 2 weeks before randomization accepted), and stable glycemic control regimen for at least 3 months prior to screening: subjects must be on diet and exercise control alone, or in combination with stable-dose glucose-lowering medications, with the following requirements::
Diet and exercise alone;
Stable-dose use of metformin, sulfonylureas, sodium-glucose cotransporter-2 (SGLT2) inhibitors, or insulin, stable insulin dose defined as ≤35% variation in total daily insulin dose; 7. Subjects (including partners) must have no pregnancy plans from screening through 6 months post-trial and must practice contraception during the study, with no plans to donate sperm/oocytes for 6 months after trial completion.
8. Subjects must provide informed consent prior to trial participation and voluntarily sign the written informed consent form.
9.Voluntarily comply with all trial follow-up requirements, demonstrate good protocol adherence, and be willing and able to undergo protocol-specified liver biopsies.

Who cannot join

Known hypersensitivity to the investigational product or any of its excipients, or allergy to other GLP-1 receptor agonists, or clinically significant history of multiple/severe drug allergies, or current allergic diseases or hypersensitivity diathesis;
Previous use of any of the following drugs or treatments:
1) Use of GLP-1 receptor agonists (GLP-1R), or GLP-1R/GCGR agonists, or GLP-1R/GIPR/GCGR agonists within 3 months prior to screening; 2) Cumulative use for ≥4 weeks within 3 months prior to screening, use within 1 month prior to screening, or planned use during the trial of vitamin E (dose >400 IU/day), thiazolidinediones, polyunsaturated fatty acids, or ursodeoxycholic acid; 3) Cumulative use for ≥4 weeks within 3 months prior to screening, use within 1 month prior to screening, or planned use during the trial of drugs associated with liver injury, hepatic steatosis, or steatohepatitis: including amiodarone, methotrexate, systemic glucocorticoids (dose >5 mg/day prednisone equivalent), estrogens (dose exceeding hormone replacement therapy or contraceptive use), tetracyclines, tamoxifen, anabolic steroids, valproate, or restricted drugs, or any drug deemed likely to interfere with efficacy or safety evaluations; 4) Unstable doses of statins, fibrates, or PCSK9 inhibitors within 1 month prior to screening; 3.History or evidence of any of the following diseases:
Chronic liver disease other than MASH (e.g., autoimmune liver disease, primary biliary cholangitis, primary sclerosing cholangitis, chronic liver disease-related ascites, esophageal varices, hepatic encephalopathy, etc.).
Diagnosis of type 1 diabetes or other specific types of diabetes, except resolved gestational diabetes;
Acute pancreatitis or chronic pancreatitis within 1 year prior to screening, history of pancreatic surgery; or symptomatic gallbladder disease within 1 year prior to screening (e.g., choledocholithiasis, multiple gallstones, etc., except those who underwent cholecystectomy or stone removal);

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Personal or family history (first-degree relatives-parents, children, or siblings) of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2);
History of severe psychiatric disorders, including but not limited to depression, suicidal tendencies or attempts, schizophrenia, bipolar disorder, etc.;
Clinically significant active cardiovascular/cerebrovascular disease within 6 months prior to screening, defined as: ① Myocardial infarction (MI) or unstable angina; ② Cardiac-related surgery (including coronary artery bypass grafting, percutaneous coronary intervention); ③Congestive heart failure (New York Heart Association [NYHA] Class III-IV) (see Appendix 3); ④ Cerebrovascular accident (except old lacunar infarction), including but not limited to stroke/transient ischemic attack; ⑤ Other cardiovascular or cerebrovascular diseases deemed unsuitable for trial participation by the investigator;
Retinal diseases requiring urgent treatment at screening (including but not limited to retinal vascular disorders, retinal inflammation, retinal detachment, retinal degeneration, etc.), as assessed by the investigator;
History of severe hypoglycemic coma or frequent hypoglycemia (≥1 episode/week) within 2 months prior to enrollment (defined as fingertip or venous blood glucose <3.9 mmol/L for T2DM subjects or <2.8 mmol/L for non-T2DM subjects);
Gastroparesis or other gastrointestinal motility disorders (e.g., pyloric obstruction, intestinal obstruction, etc.), uncontrolled gastroesophageal reflux disease, or gastrointestinal conditions deemed by the investigator to increase drug-related risks (e.g., severe active ulcers, inflammatory bowel disease, acute gastroenteritis, symptomatic chronic gastritis, functional gastrointestinal disorders, intestinal tuberculosis, etc.);
Major surgery, severe trauma, or severe infection within 1 month prior to screening, deemed unsuitable for participation by the investigator;
History of malignancy (except adequately treated cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer post-radical therapy, ductal carcinoma in situ of the breast post-radical therapy, and papillary thyroid carcinoma post-radical therapy);
Concurrent diseases deemed by the investigator to affect subject safety, efficacy evaluation, or compliance, e.g., neurological, endocrine, psychiatric, etc. ; 4.Laboratory abnormalities at screening meeting any of the following criteria:
1) Hepatic or renal impairment, based on each hospital laboratory's reference values, serum ALT and/or AST >5× upper limit of normal (ULN); serum total bilirubin ≥1.5×ULN; estimated glomerular filtration rate (eGFR) <60 mL·min-1·1.73m-2. (calculated using CKD-EPI formula see Appendix 4) ; 2) Alkaline phosphatase (ALP) >2.0×ULN; 3) Platelet count < 100 × 10⁹/L; 4) Serum calcitonin ≥ 50 pg/mL (i.e., 50 ng/L); 5) Serum amylase or lipase > 2.0× ULN; 6) International normalized ratio (INR) >1.2×ULN at screening; 7) Albumin < 3.5 g/dL (35.0 g/L). 8) Uncontrolled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg at screening), subjects may be re-screened after 1 month of initiating or adjusting antihypertensive therapy; 9) Unstable thyroid dysfunction requiring medication adjustment at screening, or clinically significant abnormal thyroid function test results necessitating treatment initiation; 10) Subjects with clinically significant ECG abnormalities at screening, including: a) Second- or third-degree atrioventricular block; b) Long QT syndrome, QTcF >470 ms for females or >450 ms for males (QTcF = QT/(RR^0.33) ); c) Wolff-Parkinson-White syndrome; or d) Other severe arrhythmias requiring treatment; 11) Abnormal physical examination, vital signs, or laboratory results deemed clinically significant by the investigator, potentially posing major risks or interfering with efficacy, safety, or PK evaluations; 5.Contraindications to liver biopsy at screening, as assessed by the investigator:(1) Hepatic hemangioma or hepatic alveolar echinococcosis;(2) Extrahepatic obstructive jaundice;(3) Significant bleeding tendency, severe thrombocytopenia, or coagulation disorders;(4) Coma or uncooperative due to other conditions;(5) Infection at the puncture site; 6.Positive for hepatitis B surface antigen, positive for hepatitis B core antibody (except those with positive anti-HBc but hepatitis B virus deoxyribonucleic acid [HBV-DNA] below the lower limit of the reference range), positive for hepatitis C virus antibody with hepatitis C virus ribonucleic acid (HCV-RNA) above the upper limit of the reference range (subjects with a history of HCV infection may be enrolled if HCV PCR has been negative for more than 3 years), positive for human immunodeficiency virus antibody, or positive for syphilis antibody (except cured syphilis) will be excluded; 7.Blood loss or donation > 400 mL within 3 months prior to screening, receipt of blood/component transfusions; or concurrent hemoglobinopathy, hemolytic anemia, or sickle-cell disease.
8.MRI contraindications, including but not limited to severe claustrophobia, large tattoos, inner ear implants, pacemakers or other implantable rhythm management devices, MRI-incompatible intracranial aneurysm clips, or other non-MRI-compatible metal implants (e.g., insulin pumps, hip replacements); 9.Participation in other clinical trial within 3 months prior to screening or 5 half-lives of the investigational drug (whichever is longer)(except for screening-only or non-interventional studies): 10.Excessive alcohol consumption within 12 months prior to screening, defined as >210 g/week (male) or >140 g/week (female) of ethanol (alcohol) for >3 months. Ethanol intake [g] = volume [mL] × alcohol percentage × 0.8); 11.Lactating or pregnant females; 12.Intolerance to venipuncture or history of needle/phobia; 13.Other conditions deemed unsuitable for trial participation by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Haiyan Zhang contact

+86 189 9816 5570

zhanghy@tul.com.cn

China1 site, 1 recruiting

Beijing Tsinghua ChangGung Hospital
Beijing, Beijing Municipality, 100044
Lai Wei, 13601281862, weelai@163.com
Recruiting

Other trials in China

About this study

Official title: A Phase 2, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of UBT251 Injection in Adult Patients With Metabolic Dysfunction-associated Steatohepatitis (MASH)

Conditions: Metabolic Dysfunction-associated Steatohepatitis (MASH)
Being tested: UBT251, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

UBT251Drug
UBT251 administered subcutaneously (SC) once a week.
PlaceboDrug
Placebo,SC,once a week for 48 weeks

Study groups in NCT07145151
Study group	Role	What they receive
UBT251 Low Dose	Experimental	Dose level 1,SC, once a week for 4 weeks; Dose level 2,SC, once a week for 4 weeks; Dose level 3,SC,once a week for 4 weeks; Dose level 3,SC, once a week for 36 weeks. Receives: Drug: UBT251
Placebo	Placebo comparator	Placebo administered subcutaneously (SC) once a week for 48 weeks. Receives: Drug: Placebo
UBT251 Middle Dose	Experimental	Dose level 2,SC, once a week for 4 weeks; Dose level 3,SC, once a week for 4 weeks; Dose level 4,SC,once a week for 4 weeks; Dose level 4,SC, once a week for 36 weeks. Receives: Drug: UBT251
UBT251 High Dose	Experimental	Dose level 2,SC, once a week for 4 weeks; Dose level 3,SC, once a week for 4 weeks; Dose level 4,SC,once a week for 4 weeks; Dose level 5,SC, once a week for 36 weeks. Receives: Drug: UBT251

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With MASH resolution With no Worsening of Fibrosis on Liver Histology
Measured: Baseline, Week 48

Secondary outcomes (25)

Proportion of Participants with MASH improvement with a ≥1-stage histological improvement in liver fibrosis.
Measured: Baseline, Week 48
Proportion of Participants with MASH resolution with a ≥1-stage histological improvement in liver fibrosis.
Measured: Baseline, Week 48
Percentage of Participants With ≥1 Point Decrease in Fibrosis Stage With No Worsening of MASH on Liver Histology
Measured: Baseline, Week 48
Mean Absolute Change and Percent Change from Baseline in Body Weight [kg]
Measured: Baseline, Week 12, Week 24, Week 48
Changes from baseline in waist circumference[cm]
Measured: Baseline, Week 12, Week 24, Week 48
Changes from baseline in waist-to-hip ratio[%]
Measured: Baseline, Week 12, Week 24, Week 48
Change from baseline in liver stiffness measurement (LSM) and controlled attenuation parameter (CAP).
Measured: Baseline, Week 24, Week 48
Percentage change from baseline in MRI-PDFF.
Measured: Baseline, Week 24, Week 48
Proportion of subjects achieving >30%, >50%, or >70% reduction in MRI-PDFF from baseline.
Measured: Baseline, Week 24, Week 48
Mean Absolute Change and Percentage change From Baseline in triglyceride [mmol/L]
Measured: Baseline, Week 12, Week 24, Week 48
Mean Absolute Change and Percentage change From Baseline in total cholesterol[mmol/L]
Measured: Baseline, Week 12, Week 24, Week 48
Mean Absolute Change and Percentage change From Baseline in low-density lipoprotein cholesterol[mmol/L]
Measured: Baseline, Week 12, Week 24, Week 48
Mean Absolute Change and Percentage change From Baseline in high-density lipoprotein cholesterol[mmol/L]
Measured: Baseline, Week 12, Week 24, Week 48
Changes from baseline in fasting insulin (FINS)
Measured: Baseline, Week 24, Week 48
Change from Baseline in homeostatic model assessment of insulin resistance (HOMA-IR)
Measured: Baseline, Week 24, Week 48
Change from Baseline in Homeostasis Model Assessment of β-cell function (HOMA-β)
Measured: Baseline, Week 24, Week 48
Percentage change from baseline in hepatic enzymes alanine aminotransferase (ALT) [%]
Measured: Baseline, Week 12, Week 24, Week 48
Percentage change from baseline in hepatic enzymes aspartate aminotransferase (AST) [%]
Measured: Baseline, Week 12, Week 24, Week 48
Percentage change from baseline in cytokeratin-18 (CK18) fragments[%]
Measured: Baseline, Week 12, Week 24, Week 48
Percentage change from baseline in type III procollagen N-terminal propeptide (Pro-C3)[%]
Measured: Baseline, Week 12, Week 24, Week 48
Percentage change from baseline in high-sensitivity C-reactive protein (hsCRP)[%]
Measured: Baseline, Week 12, Week 24, Week 48
Change from baseline in scores in Fibrosis-4 Index (FIB-4)
Measured: Baseline, Week 12, Week 24, Week 48
Change from baseline in scores in Enhanced Liver Fibrosis (ELF)
Measured: Baseline, Week 12, Week 24, Week 48
Change from baseline in scores in NAFLD Fibrosis Score (NFS)
Measured: Baseline, Week 12, Week 24, Week 48
Change from baseline in scores in AST-to-Platelet Ratio Index (APRI)
Measured: Baseline, Week 12, Week 24, Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Sep 202531 Aug 2027

First posted28 Aug 2025
Study start30 Sep 2025
Primary completion4 Jun 2027 (estimated)
Study completion31 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 Steatohepatitis (MASH)Studies of the same condition, open and under way.
More trials run by The United Bio-Technology (Hengqin) 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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 156 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07145151
Sponsor's protocol ID: TUL-UBT251（Ⅱ-3）202501
Other IDs: Approved No.:2023LP01795
Acronym: MASH
Status last verified: Nov 2026
First submitted: 13 Aug 2025
Last updated: 3 Nov 2026
Results posted: No
Data monitoring committee: 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 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of UBT251 Injection in Adult Patients With Metabolic Dysfunction-associated Steatohepatitis (MASH)
ClinicalTrials.gov ID: NCT07145151
Acronym / sponsor ID: MASH / TUL-UBT251（Ⅱ-3）202501
Conditions: Metabolic Dysfunction-associated Steatohepatitis (MASH)
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 156 participants (estimated)
Lead sponsor: The United Bio-Technology (Hengqin) Co., Ltd.Industry (pharma, biotech, devices)
Study start: 30 Sep 2025 (actual)
Primary completion: 4 Jun 2027 (estimated)
Study completion: 31 Aug 2027 (estimated)
First posted: 28 Aug 2025 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
UBT251 Low Dose	Experimental	Drug: UBT251Dose level 1,SC, once a week for 4 weeks; Dose level 2,SC, once a week for 4 weeks; Dose level 3,SC,once a week for 4 weeks; Dose level 3,SC, once a week for 36 weeks.
Placebo	Placebo comparator	Drug: PlaceboPlacebo administered subcutaneously (SC) once a week for 48 weeks.
UBT251 Middle Dose	Experimental	Drug: UBT251Dose level 2,SC, once a week for 4 weeks; Dose level 3,SC, once a week for 4 weeks; Dose level 4,SC,once a week for 4 weeks; Dose level 4,SC, once a week for 36 weeks.
UBT251 High Dose	Experimental	Drug: UBT251Dose level 2,SC, once a week for 4 weeks; Dose level 3,SC, once a week for 4 weeks; Dose level 4,SC,once a week for 4 weeks; Dose level 5,SC, once a week for 36 weeks.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

Age 18-75 years (inclusive) at screening; sex unrestricted.
Subjects with centrally confirmed MASH (metabolic dysfunction-associated steatohepatitis) based on liver histopathology must meet all the following criteria:
NAS (Appendix 1) ≥ 4 （with at least 1 point each for lobular inflammation and ballooning degeneration）;
CRN fibrosis stage (see Appendix 2) of F2 or F3 (a liver biopsy obtained ≤ 6 months before screening is acceptable if it meets the above criteria).
3.Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) ≥ 8 % at screening (MRI-PDFF results obtained within 2 months prior to screening at the trial site are acceptable).

Key exclusion criteria (17 listed)

Known hypersensitivity to the investigational product or any of its excipients, or allergy to other GLP-1 receptor agonists, or clinically significant history of multiple/severe drug allergies, or current allergic diseases or hypersensitivity diathesis;
Previous use of any of the following drugs or treatments:
1) Use of GLP-1 receptor agonists (GLP-1R), or GLP-1R/GCGR agonists, or GLP-1R/GIPR/GCGR agonists within 3 months prior to screening; 2) Cumulative use for ≥4 weeks within 3 months prior to screening, use within 1 month prior to screening, or planned use during the trial of vitamin E (dose >400 IU/day), thiazolidinediones, polyunsaturated fatty acids, or ursodeoxycholic acid; 3) Cumulative use for ≥4 weeks within 3 months prior to screening, use within 1 month prior to screening, or planned use during the trial of drugs associated with liver injury, hepatic steatosis, or steatohepatitis: including amiodarone, methotrexate, systemic glucocorticoids (dose >5 mg/day prednisone equivalent), estrogens (dose exceeding hormone replacement therapy or contraceptive use), tetracyclines, tamoxifen, anabolic steroids, valproate, or restricted drugs, or any drug deemed likely to interfere with efficacy or safety evaluations; 4) Unstable doses of statins, fibrates, or PCSK9 inhibitors within 1 month prior to screening; 3.History or evidence of any of the following diseases:
Chronic liver disease other than MASH (e.g., autoimmune liver disease, primary biliary cholangitis, primary sclerosing cholangitis, chronic liver disease-related ascites, esophageal varices, hepatic encephalopathy, etc.).
Diagnosis of type 1 diabetes or other specific types of diabetes, except resolved gestational diabetes;

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
UBT251UBT251 administered subcutaneously (SC) once a week.	Drug	UBT251 High Dose, UBT251 Low Dose, UBT251 Middle Dose
PlaceboPlacebo,SC,once a week for 48 weeks	Drug	Placebo

Primary outcome

Percentage of Participants With MASH resolution With no Worsening of Fibrosis on Liver Histology
Time frame: Baseline, Week 48

25 secondary outcomes

Proportion of Participants with MASH improvement with a ≥1-stage histological improvement in liver fibrosis.
Time frame: Baseline, Week 48
Proportion of Participants with MASH resolution with a ≥1-stage histological improvement in liver fibrosis.
Time frame: Baseline, Week 48
Percentage of Participants With ≥1 Point Decrease in Fibrosis Stage With No Worsening of MASH on Liver Histology
Time frame: Baseline, Week 48
Mean Absolute Change and Percent Change from Baseline in Body Weight [kg]
Time frame: Baseline, Week 12, Week 24, Week 48
Changes from baseline in waist circumference[cm]
Time frame: Baseline, Week 12, Week 24, Week 48
Changes from baseline in waist-to-hip ratio[%]
Time frame: Baseline, Week 12, Week 24, Week 48
Change from baseline in liver stiffness measurement (LSM) and controlled attenuation parameter (CAP).
Time frame: Baseline, Week 24, Week 48
Percentage change from baseline in MRI-PDFF.
Time frame: Baseline, Week 24, Week 48
Proportion of subjects achieving >30%, >50%, or >70% reduction in MRI-PDFF from baseline.
Time frame: Baseline, Week 24, Week 48
Mean Absolute Change and Percentage change From Baseline in triglyceride [mmol/L]
Time frame: Baseline, Week 12, Week 24, Week 48
Mean Absolute Change and Percentage change From Baseline in total cholesterol[mmol/L]
Time frame: Baseline, Week 12, Week 24, Week 48
Mean Absolute Change and Percentage change From Baseline in low-density lipoprotein cholesterol[mmol/L]
Time frame: Baseline, Week 12, Week 24, Week 48
Mean Absolute Change and Percentage change From Baseline in high-density lipoprotein cholesterol[mmol/L]
Time frame: Baseline, Week 12, Week 24, Week 48
Changes from baseline in fasting insulin (FINS)
Time frame: Baseline, Week 24, Week 48
Change from Baseline in homeostatic model assessment of insulin resistance (HOMA-IR)
Time frame: Baseline, Week 24, Week 48
Change from Baseline in Homeostasis Model Assessment of β-cell function (HOMA-β)
Time frame: Baseline, Week 24, Week 48
Percentage change from baseline in hepatic enzymes alanine aminotransferase (ALT) [%]
Time frame: Baseline, Week 12, Week 24, Week 48
Percentage change from baseline in hepatic enzymes aspartate aminotransferase (AST) [%]
Time frame: Baseline, Week 12, Week 24, Week 48
Percentage change from baseline in cytokeratin-18 (CK18) fragments[%]
Time frame: Baseline, Week 12, Week 24, Week 48
Percentage change from baseline in type III procollagen N-terminal propeptide (Pro-C3)[%]
Time frame: Baseline, Week 12, Week 24, Week 48
Percentage change from baseline in high-sensitivity C-reactive protein (hsCRP)[%]
Time frame: Baseline, Week 12, Week 24, Week 48
Change from baseline in scores in Fibrosis-4 Index (FIB-4)
Time frame: Baseline, Week 12, Week 24, Week 48
Change from baseline in scores in Enhanced Liver Fibrosis (ELF)
Time frame: Baseline, Week 12, Week 24, Week 48
Change from baseline in scores in NAFLD Fibrosis Score (NFS)
Time frame: Baseline, Week 12, Week 24, Week 48
Change from baseline in scores in AST-to-Platelet Ratio Index (APRI)
Time frame: Baseline, Week 12, Week 24, Week 48

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 3 Nov 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.

Haiyan Zhang contact

+86 189 9816 5570

zhanghy@tul.com.cn

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 UBT251 in people with Metabolic Dysfunction-associated Steatohepatitis (MASH), run by The United Bio-Technology (Hengqin) 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 17 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 3 Nov 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 Haiyan Zhang (+86 189 9816 5570, zhanghy@tul.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With MASH resolution With no Worsening of Fibrosis on Liver Histology (time frame: Baseline, Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07145151.

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 3 Nov 2026.