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New treatment option for MASH - Metabolic Dysfunction-Associated Steatohepatitis
Official title A Study of Chiglitazar in Patients With Metabolic Dysfunction-associated Steatohepatitis and Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT07303803
What this study is testing
What is Chiglitazar?
Chiglitazar is an investigational medicine, given as an once-daily, being studied as a potential treatment for mash - metabolic dysfunction-associated steatohepatitis.
Also referred to as Carfloglitazar.
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 trial aims to evaluate the efficacy and safety of chiglitazar as a combination therapy for patients with MASH and T2DM.
- 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
- Men and women aged at least 18 years and under 75 years (inclusive) at the time of obtaining consent.
- Participants must be diagnosed as T2DM and HbA1c ≤ 9.5% at time of screening.
- Participants must take Fibroscan examination with the result of CAP ≥ 238 dB/m and LSM\>8.5 kPa.
- Diagnosis of MASH by liver biopsy, with NAFLD Activity Score (NAS) ≥4 with ≥1 point for each component, and fibrosis stage 1b or more over according...
- Stable body weight (≤10% body weight change) for at least 3 months.
You likely can't join if
- Alcohol consumption \>20g ethyl alcohol/day for women and \>40g ethyl alcohol/day for men.
- Evidence of other forms of chronic liver disease:
- Alcoholic liver disease,
- Hepatitis B as defined by presence of hepatitis B surface antigen (HBsAg) or hepatitis B DNA,
- Hepatitis C as defined by presence of hepatitis C virus (HCV) RNA or positive hepatitis C antibody (anti-HCV),
- Evidence of autoimmune liver disease as defined by compatible liver histology,
See the full eligibility criteria
- Men and women aged at least 18 years and under 75 years (inclusive) at the time of obtaining consent.
- Participants must be diagnosed as T2DM and HbA1c ≤ 9.5% at time of screening.
- Participants must take Fibroscan examination with the result of CAP ≥ 238 dB/m and LSM\>8.5 kPa.
- Diagnosis of MASH by liver biopsy, with NAFLD Activity Score (NAS) ≥4 with ≥1 point for each component, and fibrosis stage 1b or more over according to the NASH Clinical Research Network (CRN) scoring system. (or liver...
- Stable body weight (≤10% body weight change) for at least 3 months.
- Possess good understanding and behavior and be able to take the medication daily as required by the trial.
- Willing to sign the informed consent.
- Alcohol consumption \>20g ethyl alcohol/day for women and \>40g ethyl alcohol/day for men.
- Evidence of other forms of chronic liver disease:
- Alcoholic liver disease,
- Hepatitis B as defined by presence of hepatitis B surface antigen (HBsAg) or hepatitis B DNA,
- Hepatitis C as defined by presence of hepatitis C virus (HCV) RNA or positive hepatitis C antibody (anti-HCV),
- Evidence of autoimmune liver disease as defined by compatible liver histology,
- Current drug-induced liver disease as defined on the basis of typical exposure and history,
- Suspected or proven liver cancer,
- Any other type of liver disease other than MASH.
- Uncontrolled T2DM defined as HbA1c \>9.5% at time of screening or Type 1 diabetes mellitus (T1DM).
- Patients with T2DM who have a history of diabetic ketoacidosis, proliferative diabetic retinopathy, diabetic maculopathy or severe non-proliferative diabetic retinopathy that requires acute treatment.
- Any of the following cardiovascular conditions within 6 months prior to screening:
- acute myocardial infarction (MI),
- cerebrovascular accident (stroke),
- unstable angina,
- hospitalization due to congestive heart failure (CHF)
- New York Heart Association Functional Classification IV CHF
- History of an active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for...
- Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥ 100 mm Hg).
- Renal impairment measured as estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2.
- Known clinically significant gastric emptying abnormality (for example, severe diabetic gastroparesis or gastric outlet obstruction) or chronically take drugs that directly affect gastrointestinal motility.
- Have a known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma (MTC).
- Evidence of untreated hypothyroidism or hyperthyroidism based on clinical or laboratory evaluation.
- A transplanted organ (corneal transplants allowed) or awaiting an organ transplant.
- Women of childbearing potential: positive pregnancy test during screening or at randomization or unwillingness to use an effective form of birth control during the trial (at least include one barrier contraceptive...
- Use of drugs associated with hepatic steatosis (e.g., amiodarone, methotrexate, tamoxifen) for more than 2 weeks in the 3 months prior to screening.
- Current use of medication is associated with weight gain, except when on stable dose for at least 3 months prior to screening and remaining on stable dose during the study.
- Receiving or having received (within 3 months of screening) chronic (\>2 weeks) systemic glucocorticoid therapy.
- Use of treatment targeting MASH for more than 2 weeks in the 3 months prior to screening (GLP-1 receptor agonists or PPAR pan agonists).
- Any other condition which in the opinion of investigator would impede compliance or hinder completion of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Wuhan, Hebei, China
- Shiyan, Hubei, China
- Changsha, Hunan, China
- Changchun, Jilin, China
- Shanghai, Shanghai Municipality, China
- Xi’an, Shanxi, China
- Tianjin, Tianjin Municipality, China
- Ürümqi, Xinjiang, China
- Hangzhou, Zhejiang, 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; Chongqing, Chongqing Municipality, China; Fuzhou, Fujian, China; Guangzhou, Guangdong, China; Wuhan, Hebei, China; Shiyan, Hubei, China and 7 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.