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New treatment option for Metabolic Dysfunction-associated Steatohepatitis (MASH)
Official title A Study of CS060380 Tablets in Patients With MASH and Obesity
ClinicalTrials.gov ID: NCT07466017
What this study is testing
What is semaglutide?
semaglutide is an investigational medicine, given as a pill taken by mouth, 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 study is looking at a new investigational medicine called CS060380, when used together with semaglutide, in adults who have both metabolic dysfunction-associated steatohepatitis (MASH) and obesity. MASH is a condition where too much fat builds up in the liver, leading to inflammation and damage.
- 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 65
You may be able to join if
- Age 18 to 65 years (inclusive), male or female.
- Liver fat content ≥10% as measured by MRI-PDFF at screening.
- BMI ≥30 kg/m².
- Body weight change ≤5% during the 3 months prior to screening with only diet and exercise control (self-reported). The weight change is calculated...
- Glycated hemoglobin (HbA1c) \<6.5% at screening.
You likely can't join if
- Diagnosis of type 2 diabetes mellitus, type 1 diabetes mellitus, monogenic diabetes, diabetes due to pancreatic injury (e.g., post-pancreatitis...
- ≥2 episodes of hypoglycemia (blood glucose ≤2.8 mmol/L in non-diabetic patients) within 6 months before screening.
- Impaired gastrointestinal function or gastrointestinal disease that may affect the absorption of oral medications, such as severe gastrointestinal...
- Thyroid diseases including hyperthyroidism and hypothyroidism [participants with benign thyroid lesions (e.g., thyroid nodules) may participate in...
- Previous diagnosis of obesity caused by endocrine diseases or single-gene mutations, including but not limited to hypothalamic obesity, pituitary...
- Previous bariatric surgery (including sleeve gastrectomy, Roux-en-Y gastric bypass, or combined procedures, etc.) or use of medical devices for...
See the full eligibility criteria
Who can join
- Age 18 to 65 years (inclusive), male or female.
- Liver fat content ≥10% as measured by MRI-PDFF at screening.
- BMI ≥30 kg/m².
- Body weight change ≤5% during the 3 months prior to screening with only diet and exercise control (self-reported). The weight change is calculated as: (Maximum weight - Minimum weight within 3 months before screening) /...
- Glycated hemoglobin (HbA1c) \<6.5% at screening.
- Fasting venous blood glucose \<7 mmol/L at screening.
- All participants of childbearing potential agree to use effective physical and/or pharmacological contraceptive measures from the screening period until 3 months after the end of the trial, and have no recent plans for...
- Voluntary consent to participate in this clinical trial and provide written informed consent.
What rules you out
- Diagnosis of type 2 diabetes mellitus, type 1 diabetes mellitus, monogenic diabetes, diabetes due to pancreatic injury (e.g., post-pancreatitis diabetes), or other secondary diabetes prior to randomization.
- ≥2 episodes of hypoglycemia (blood glucose ≤2.8 mmol/L in non-diabetic patients) within 6 months before screening.
- Impaired gastrointestinal function or gastrointestinal disease that may affect the absorption of oral medications, such as severe gastrointestinal diseases (peptic ulcer, erosive or atrophic gastritis), partial...
- Thyroid diseases including hyperthyroidism and hypothyroidism [participants with benign thyroid lesions (e.g., thyroid nodules) may participate in this study] or pituitary diseases, or long-term use of thyroid hormone...
- Previous diagnosis of obesity caused by endocrine diseases or single-gene mutations, including but not limited to hypothalamic obesity, pituitary obesity, hypothyroid obesity, Cushing's syndrome, insulinoma, acromegaly...
- Previous bariatric surgery (including sleeve gastrectomy, Roux-en-Y gastric bypass, or combined procedures, etc.) or use of medical devices for obesity treatment, or planned such procedures during the trial; except for...
- Any contraindication to MRI scanning (including but not limited to severe claustrophobia, coronary artery stents, coronary implant devices, waist circumference exceeding scanner capacity making MRI-PDFF examination...
- Blood donation within 3 months before screening, or total blood loss (excluding female physiological bleeding) due to blood donation or other reasons reaching or exceeding 400 mL within 6 months.
- Use of glucagon-like peptide-1 receptor agonists (GLP-1 RA) or compound preparations containing GLP-1 RA components within 3 months before randomization.
- Use of any approved or unapproved weight-loss drugs (e.g., orlistat, lorcaserin, phentermine/topiramate, naltrexone/bupropion, etc.) or drugs affecting body weight (including Chinese herbal medicines), health products...
- Use of drugs that may cause significant weight gain: systemic glucocorticoid therapy for more than 1 week; tricyclic antidepressants; antipsychotic or antiepileptic drugs (e.g., imipramine, amitriptyline, mirtazapine...
- History of treatment for more than 1 week such as total parenteral nutrition (TPN), amiodarone, methotrexate, tetracycline, tamoxifen, estrogens in excess of hormone replacement doses, anabolic steroids, valproic acid...
- Use of vitamin E (≥800-1000 IU/day), polyunsaturated fatty acids, ursodeoxycholic acid, fibrates, statins within 3 months before randomization, unless the participant had a stable dose for 3 months before screening...
- Use of metformin, SGLT2 inhibitors, and other hypoglycemic agents within 3 months before randomization.
- Use of strong inhibitors of CYP3A enzymes, strong inducers of CYP3A enzymes, or inhibitors of P-gp or BCRP transporters that may affect the metabolism or absorption of the study drug within 14 days before randomization...
- Use of hepatoprotective drugs not permitted by the protocol within 4 weeks before randomization or planned use during the clinical study, including silymarin, bicyclol, glycyrrhizin preparations (magnesium...
- Anticoagulant therapy within 2 weeks before randomization: drugs that increase INR (e.g., FXa inhibitors, warfarin, heparin, etc.).
- History of heavy alcohol consumption for more than 3 consecutive months within 1 year before screening. Note: Heavy alcohol consumption is defined as an average weekly alcohol intake of more than approximately 7...
- Hemoglobin ≤90 g/L at screening.
- ALT ≥2.5×ULN at screening.
- AST ≥2.5×ULN at screening.
- Serum albumin (ALB) \<35 g/L at screening.
- International normalized ratio (INR) \>1.2 at screening.
- Total bilirubin (TBil) \>1.2×ULN at screening (except for Gilbert's syndrome).
- Serum amylase or lipase ≥3×ULN at screening.
- Calcitonin ≥50 ng/L at screening.
- Estimated glomerular filtration rate (eGFR) \<50 mL/min/1.73m² at screening.
- Clinically relevant abnormalities on 12-lead ECG that, in the investigator's judgment, may affect participant safety or the interpretation of study results, such as: at screening, QTcF interval corrected by Fridericia...
- Uncontrolled hypertension: sitting systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg.
- Previous history of acute or chronic pancreatitis, or acute or chronic pancreatitis at screening.
- History of liver cirrhosis (e.g., the participant has undergone liver histopathological examination showing cirrhosis, or endoscopic examination suggesting esophageal and gastric varices).
- Other liver diseases or history of liver diseases, including but not limited to: primary biliary cholangitis, primary sclerosing cholangitis, alcoholic liver disease, definite autoimmune liver disease or superimposed...
- Patients with multiple endocrine neoplasia type 2 or medullary thyroid carcinoma, or a family history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
- History of the following cardiovascular and cerebrovascular diseases within 6 months before screening: decompensated cardiac insufficiency (NYHA class III or IV), arrhythmia requiring treatment, unstable angina or...
- History of malignant tumor within 5 years (excluding clinically cured cervical epithelial carcinoma, squamous cell carcinoma, or basal cell carcinoma of the skin).
- History of major depression or anxiety disorder within 2 years before screening, or current diagnosis of other mental illnesses (e.g., schizophrenia, bipolar disorder) that, in the investigator's assessment, are not...
- PHQ-9 questionnaire (Depression Screening Scale) score ≥15 at screening.
- Previous suicide attempt or suicidal behavior.
- Known hypersensitivity to any ingredient in semaglutide injection or to other GLP-1 RA drugs or drugs with GLP-1 receptor agonist mechanism.
- History of human immunodeficiency virus (HIV) infection at screening; history of Treponema pallidum (TP) infection (except those with stable conditions judged by the investigator as suitable for inclusion in this...
- Unwilling to cooperate, or unable to cooperate, or incapable of completing the clinical trial.
- Suspected or confirmed history of drug or substance abuse.
- Pregnant or lactating women; female participants of childbearing potential or those with menopause less than 12 months must have a negative pregnancy test during the screening period.
- Participation in other drug clinical trials within the last 3 months.
- In the investigator's judgment, the participant is not suitable to participate in this clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Guangzhou, Guangdong, China
- Shijiazhuang, Hebei, China
- Nanjing, Jiangsu, China
- Shanghai, Shanghai Municipality, China
- Hangzhou, Zhejiang, China
- Ningbo, Zhejiang, China
- Wenzhou, Zhejiang, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Guangzhou, Guangdong, China; Shijiazhuang, Hebei, China; Nanjing, Jiangsu, China; Shanghai, Shanghai Municipality, China; Hangzhou, Zhejiang, China and 2 more location(s). 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.