BridgeMD
New treatment option for Metabolic Dysfunction-associated Steatohepatitis (MASH)
Official title A Study of UBT251 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)
ClinicalTrials.gov ID: NCT07145151
What this study is testing
What is UBT251?
UBT251 is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for metabolic dysfunction-associated steatohepatitis (mash).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age 18-75 years (inclusive) at screening; sex unrestricted. people with centrally confirmed MASH (metabolic dysfunction-associated steatohepatitis)...
- 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)...
- 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;
You likely can't join if
- Known hypersensitivity to the investigational product or any of its excipients, or allergy to other GLP-1 receptor agonists, or clinically...
- 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...
- Chronic liver disease other than MASH (e.g., autoimmune liver disease, primary biliary cholangitis, primary sclerosing cholangitis, chronic liver...
- 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...
- Personal or family history (first-degree relatives-parents, children, or siblings) of medullary thyroid carcinoma (MTC) or multiple endocrine...
See the full eligibility criteria
Who can join
- Age 18-75 years (inclusive) at screening; sex unrestricted. people 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...
- 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.people with type 2...
- 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. people (including partners) must...
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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 people or \<2.8 mmol/L for non-T2DM...
- Gastroparesis or other gastrointestinal motility disorders (e.g., pyloric obstruction, intestinal obstruction, etc.), uncontrolled gastroesophageal reflux disease, or gastrointestinal conditions deemed by the...
- 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...
- Concurrent diseases deemed by the investigator to affect subject safety, how well it works evaluation, or compliance, e.g., neurological, endocrine, psychiatric, etc. ; 4.Laboratory abnormalities at screening meeting...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.