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A Phase II Clinical Trial of Chiglitazar for NASH

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ClinicalTrials.gov Identifier: NCT05193916
Recruitment Status : Recruiting
First Posted : January 18, 2022
Last Update Posted : August 28, 2023
Sponsor:
Information provided by (Responsible Party):
Chipscreen Biosciences, Ltd.

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

Condition or disease Intervention/treatment Phase
NASH Drug: chiglitazar sodium tablets Drug: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 21, 2022
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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 Name: simulant of chiglitazar


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. ALT changes from baseline [ Time Frame: 6,12,18 weeks ]
    changes from baseline in liver enzymes

  3. FIB-4 changes from baseline [ Time Frame: 6,12,18 weeks ]
    changes from baseline in Fibrosis 4 Score

  4. insulin resistance changes [ Time Frame: 6,12,18 weeks ]
    Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

  5. Changes from baseline in TG [ Time Frame: 6,12,18 weeks ]
    blood sample

  6. change from baseline in Liver stiffness measurement (LSM) with Fibroscan [ Time Frame: 6,12,18 weeks ]
    to evlaute the severity of liver fibrosis

  7. change from baseline in Cytokeratin18 (CK-18) [ Time Frame: 6,12,18 weeks ]
    to evaluate the severity of liver damage

  8. Maximum Plasma Concentration [Cmax] of chiglitazar after 1 dose, 6 weeks and 12 weeks of treatment [ Time Frame: 0, 6,12 weeks ]
    population PK

  9. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05193916


Contacts
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Contact: Hong You, Phd 86-10-63139019 youhong30@sina.com

Locations
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China, Beijing
Beijing Friendship Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100050
Contact: Hong You, Phd    86-10-63139019    youhong30@sina.com   
Beijing Youan Hospital, Capital Medical University Not yet recruiting
Beijing, Beijing, China
Contact: Yali Liu         
Peking University People's Hospital Not yet recruiting
Beijing, Beijing, China
Contact: Huiying Rao         
China, Gansu
The First Hospital of Lanzhou University Not yet recruiting
Lanzhou, Gansu, China
Contact: Xiaorong Mao         
China, Guangdong
Foshan First People's Hospital Not yet recruiting
Foshan, Guangdong, China
Contact: Lixian Wu         
The First Affiliated Hospital of Sun Yat-sen University Not yet recruiting
Guangzhou, Guangdong, China
Contact: Bihui Zhong         
China, Henan
Henan Provincial People's Hospital Not yet recruiting
Zhengzhou, Henan, China
Contact: Jia Shang         
China, Jiangsu
The First Affiliated Hospital of Anhui Medical University Not yet recruiting
Hefei, Jiangsu, China
Contact: Yufeng Gao         
Nanjing Second Hospital Not yet recruiting
Nanjing, Jiangsu, China
Contact: Weiwei Sun         
China, Jilin
The First Hospital of Jilin University Not yet recruiting
Ch'ang-ch'un, Jilin, China
Contact: Junqi Niu         
China, Shaanxi
The First Affiliated Hospital of Xi'an Jiaotong University Not yet recruiting
Xi'an, Shaanxi, China
Contact: Yingren Zhao         
China, Shanghai
Shanghai Tongren Hospital Not yet recruiting
Shanghai, Shanghai, China
Contact: Qin Zhang         
The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine Not yet recruiting
Shanghai, Shanghai, China
Contact: Jie Xu         
China, Zhejiang
Affiliated Hospital of Hangzhou Normal University Not yet recruiting
Hangzhou, Zhejiang, China
Contact: Junping Shi         
First Affiliated Hospital of Zhejiang University School of Medicine Not yet recruiting
Hangzhou, Zhejiang, China
Contact: Zhaohui Yu         
Sponsors and Collaborators
Chipscreen Biosciences, Ltd.
More Information
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Responsible Party: Chipscreen Biosciences, Ltd.
ClinicalTrials.gov Identifier: NCT05193916    
Other Study ID Numbers: CGZ203
CINAR ( Other Identifier: Chipscreen )
First Posted: January 18, 2022    Key Record Dates
Last Update Posted: August 28, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No