A Phase II Clinical Trial of Chiglitazar for NASH

May 24, 2024 updated by: Chipscreen Biosciences, Ltd.

A Multi-Center, Randomised, Double-blind, Placebo Controlled Phase II Clinical Study of Chiglitazar in Patients With Nonalcoholic Steatohepatitis Accompanied by Elevated Triglycerides and Insulin Resistance

The study is to evaluate the efficacy and safety of chiglitazar monotherapy in patients with non-clcoholic steatohepatitis (NASH).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study is a non-invasive exploratory phase II trial in patients who were clinically diagnosed as non-alcoholic steatohepatitis (NASH) with liver fibrosis accompanied by elevated triglycerides (TG) and insulin resistance. The efficacy and safety of chiglitazar tablets 48mg and 64mg will be compared with placebo in the 18-week-treament.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Beijing Friendship hospital, Capital Medical University
      • Beijing, Beijing, China
        • Beijing Youan Hospital, Capital Medical University
      • Beijing, Beijing, China
        • Peking University People's Hospital
    • Gansu
      • Lanzhou, Gansu, China
        • The First Hospital of Lanzhou University
    • Guangdong
      • Foshan, Guangdong, China
        • Foshan First People's Hospital
      • Guangzhou, Guangdong, China
        • The First Affiliated Hospital of Sun Yat-sen University
    • Henan
      • Zhengzhou, Henan, China
        • Henan Provincial People's Hospital
    • Jiangsu
      • Hefei, Jiangsu, China
        • The First Affiliated Hospital of Anhui Medical University
      • Nanjing, Jiangsu, China
        • Nanjing Second Hospital
    • Jilin
      • Ch'ang-ch'un, Jilin, China
        • The First Hospital of Jilin University
    • Shaanxi
      • Xi'an, Shaanxi, China
        • The First Affiliated Hospital of Xi'an Jiaotong University
    • Shanghai
      • Shanghai, Shanghai, China
        • Shanghai Tongren Hospital
      • Shanghai, Shanghai, China
        • The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • First Affiliated Hospital of Zhejiang University School of Medicine
      • Hangzhou, Zhejiang, China
        • Affiliated Hospital of Hangzhou Normal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Before any evaluation, an informed consent form voluntarily signed by the patient must be obtained;
  2. 18 -75 years old (at the time of screening visit V1), male or female;
  3. MRI-PDFF ≥ 8% ;
  4. Liver stiffness value ( LSM ) 7.0-11.0kPa ;
  5. Triglyceride ( TG ) ≥1.7mmol/L and ≤5.6 mmol/L;
  6. HOMA-IR ≥ 2.5 ;
  7. Serum Alanine aminotransferease (ALT) ≥ the upper limit of normal during screening.

Exclusion Criteria:

  1. Type 1 diabetes;

  2. Any of the following for type 2 diabetes:

    • HbA1c ≥ 8.5% during screening
    • At the time of screening, ≥ 2 oral hypoglycemic drugs combinations
    • Receiving any of the following medications at screening: Thiazolidinediones (TZD) drugs, fibrates, glucagon-like peptide-1 (GLP-1) receptor agonists, insulin
  3. Existing other liver diseases or history of liver diseases
  4. History of transient ischemic attack or cerebrovascular accident;
  5. History of myocardial infarction, or coronary angioplasty or coronary artery bypass surgery, unstable angina, heart failure (New York Heart Association NYHA grade III / IV ), or ECG signs of left ventricular hypertrophy, or serious arrhythmias ；
  6. During screening, blood pressure ≥ 160/100 mmHg ;
  7. Previous or planned ( during the study period) bariatric surgery;
  8. Liver transplantation history or planned liver transplantation;
  9. Liver biopsy show liver cirrhosis or clinically diagnosed as cirrhosis;
  10. Weight loss of more than 5% in 6 months before screening;
  11. History of edema of lower limbs or whole body;
  12. diagnosed as osteoporosis or any other known bone disease;
  13. Donated blood or lost blood >400 ml within 8 weeks before the first medication;
  14. With MRI scan contraindications;
  15. In the past 5 years, there was a history of malignant tumors of any organ system;
  16. Human immunodeficiency virus ( HIV ) test is positive;
  17. Heavy drinking of alcohol for more than 3 months in a year;
  18. Heavy smoking >30 per day within 1 year;
  19. History of drug abuse in 12 months;
  20. Drugs cumulatively for more than 1 month in the previous 3 months before screening, such as obeticholic acid ( OCA ), berberine;
  21. Drugs that may cause liver damage for more than 2 weeks within 1 year before screening;
  22. Patients received the following medications unless they have received a stable dose for at least 1 month before screening :Beta-blockers, thiazide diuretics, statins, niacin, ezetimibe, thyroid hormone;
  23. The calculated eGFR < 60 mL/(min*1.73m^2 );
  24. There is clinical evidence of liver decompensation or severe liver damage;
  25. Low density lipoprotein cholesterol (LDL-C) ≥ 3.4 mmol/L during screening ;
  26. Platelet < 100×10^9 /L ;
  27. Patient participating in other clinical trials of drugs or medical devices within 3 months prior to screening ;
  28. Pregnant or breastfeeding women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Chiglitazar low dose
3 tablets of drug and 1 tablet of placebo p.o. per day
Drug: chiglitazar sodium tablets
the drugs will be given orally once a day
Other Names:
  • Bilessglu®
  • CS-038
  • Carfloglitazar
Experimental: Chiglitazar high dose
4 tablets p.o. per day
Drug: chiglitazar sodium tablets
the drugs will be given orally once a day
Other Names:
  • Bilessglu®
  • CS-038
  • Carfloglitazar
Placebo Comparator: control group
4 placebo tablets p.o. per day
Drug: Placebo
no active drug contained
Other Names:
  • simulant of chiglitazar

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage change from baseline to week 18 in liver fat content as measured by MRI using the proton density fat fraction (MRI-PDFF)
Time Frame: 18 weeks
center reading for the primary endpoint
18 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
the change in liver fat content from baseline as shown by MRI-PDFF after 18 weeks treatment
Time Frame: 18 weeks
Absolute decrease in liver fat content Proportion of patients with Liver fat content absolute decrease ≥5% Proportion of patients with Liver fat content relative decrease ≥30% proportion
18 weeks
ALT changes from baseline
Time Frame: 6,12,18 weeks
changes from baseline in liver enzymes
6,12,18 weeks
FIB-4 changes from baseline
Time Frame: 6,12,18 weeks
changes from baseline in Fibrosis 4 Score
6,12,18 weeks
insulin resistance changes
Time Frame: 6,12,18 weeks
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
6,12,18 weeks
Changes from baseline in TG
Time Frame: 6,12,18 weeks
blood sample
6,12,18 weeks
change from baseline in Liver stiffness measurement (LSM) with Fibroscan
Time Frame: 6,12,18 weeks
to evlaute the severity of liver fibrosis
6,12,18 weeks
change from baseline in Cytokeratin18 (CK-18)
Time Frame: 6,12,18 weeks
to evaluate the severity of liver damage
6,12,18 weeks
Maximum Plasma Concentration [Cmax] of chiglitazar after 1 dose, 6 weeks and 12 weeks of treatment
Time Frame: 0, 6,12 weeks
population PK
0, 6,12 weeks
The area under the plasma drug concentration-time curve [AUC] of chiglitazar after 1 dose, 6 weeks and 12 weeks of treatment
Time Frame: 0, 6,12 weeks
population PK
0, 6,12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chipscreen Biosciences, Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 21, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 2, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 2, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CGZ203
  • CINAR (Other Identifier: Chipscreen)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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