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A Study of Chiglitazar in Patients With Metabolic Dysfunction-associated Steatohepatitis and Type 2 Diabetes Mellitus

ConditionsMASH - Metabolic Dysfunction-Associated SteatohepatitisT2DM (Type 2 Diabetes Mellitus)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Jiao Tong University School of Medicine

About this trial

This trial aims to evaluate the efficacy and safety of chiglitazar as a combination therapy for patients with MASH and T2DM.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 biopsy not more than 6 months prior to screening)

Disqualifiers

Alcohol consumption >20g ethyl alcohol/day for women and >40g ethyl alcohol/day for men.

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),

Trial design

Design model

Parallel

Treatments tested in this trial

  • Chiglitazar Placebo

    Drug

    Chiglitazar Placebo 48mg/day

  • Chiglitazar

    Drug

    Chiglitazar 48mg/day

  • vitamin E

    Drug

    Vitamin E 100mg/three times a day

  • Polyene Phosphatidyl choline

    Drug

    Polyene Phosphatidyl choline 456mg/three times a day

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Chiglitazar Placebo + vitamin E + polyene phosphatidyl cholinePlacebo comparator 3 interventions
Group B: 48mg Chiglitazar + vitamin E + polyene phosphatidyl cholineExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Percentage of participants with resolution of steatohepatitis and no worsening of liver fibrosis

The definition of resolution of steatohepatitis was based on the following criteria: ballooning=0, inflammation=0,1 and any level of steatosis in NAS

Time frame
week 72

Secondary outcomes

1

Percentage of participants with an improvement in liver fibrosis by ≥ 1 stage (NASH CRN fibrosis score) and no worsening of steatohepatitis

Evaluation of fibrosis stage was based on the nonalcoholic steatohepatitis clinical research network (NASH CRN) fibrosis staging system, participants were evaluated with the NASH CRN scoring system with ≥1-point reduction without worsening of MASH (defined as no increase in the NAS score).

Time frame
week 72
2

Percentage of participants with resolution of steatohepatitis and improvement in liver fibrosis

Participants were evaluated with the NASH CRN scoring system with ≥1-point reduction and with resolution of steatohepatitis

Time frame
week 72
3

Change in body mass index from baseline

The body mass index = weight (kg) / height (m)².

Time frame
Week 4, 8, 12, 24, 36, 48, 60, 72
4

Changes in liver stiffness values assessed by transient elastography from baseline

Measured by Fibroscan, to evlaute the severity of liver fibrosis

Time frame
Week 4, 8, 12, 24, 36, 48, 60, 72

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Jiao Tong University School of Medicine

Lead sponsor

Shanghai Punan Hospital of Pudong New District

Sponsor institution

Chipscreen Biosciences, Ltd.

Collaborator

Source ClinicalTrials.gov
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