A Phase II Clinical Trial of Chiglitazar for NASH
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
2 other identifiers
interventional
104
1 country
15
Brief Summary
The study is to evaluate the efficacy and safety of chiglitazar monotherapy in patients with non-clcoholic steatohepatitis (NASH).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2022
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2021
CompletedFirst Posted
Study publicly available on registry
January 18, 2022
CompletedStudy Start
First participant enrolled
March 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 2, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 2, 2024
CompletedMay 28, 2024
May 1, 2024
1.8 years
December 3, 2021
May 24, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage change from baseline to week 18 in liver fat content as measured by MRI using the proton density fat fraction (MRI-PDFF)
center reading for the primary endpoint
18 weeks
Secondary Outcomes (9)
the change in liver fat content from baseline as shown by MRI-PDFF after 18 weeks treatment
18 weeks
ALT changes from baseline
6,12,18 weeks
FIB-4 changes from baseline
6,12,18 weeks
insulin resistance changes
6,12,18 weeks
Changes from baseline in TG
6,12,18 weeks
- +4 more secondary outcomes
Study Arms (3)
Chiglitazar low dose
EXPERIMENTAL3 tablets of drug and 1 tablet of placebo p.o. per day
Chiglitazar high dose
EXPERIMENTAL4 tablets p.o. per day
control group
PLACEBO COMPARATOR4 placebo tablets p.o. per day
Interventions
the drugs will be given orally once a day
Eligibility Criteria
You may qualify if:
- Before any evaluation, an informed consent form voluntarily signed by the patient must be obtained;
- years old (at the time of screening visit V1), male or female;
- MRI-PDFF ≥ 8% ;
- Liver stiffness value ( LSM ) 7.0-11.0kPa ;
- Triglyceride ( TG ) ≥1.7mmol/L and ≤5.6 mmol/L;
- HOMA-IR ≥ 2.5 ;
- Serum Alanine aminotransferease (ALT) ≥ the upper limit of normal during screening.
You may not qualify if:
- Type 1 diabetes;
- 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
- Existing other liver diseases or history of liver diseases
- History of transient ischemic attack or cerebrovascular accident;
- 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 ；
- During screening, blood pressure ≥ 160/100 mmHg ;
- Previous or planned ( during the study period) bariatric surgery;
- Liver transplantation history or planned liver transplantation;
- Liver biopsy show liver cirrhosis or clinically diagnosed as cirrhosis;
- Weight loss of more than 5% in 6 months before screening;
- History of edema of lower limbs or whole body;
- diagnosed as osteoporosis or any other known bone disease;
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Beijing Youan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Foshan First People's Hospital
Foshan, Guangdong, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Jiangsu, China
Nanjing Second Hospital
Nanjing, Jiangsu, China
The First Hospital of Jilin University
Ch’ang-ch’un, Jilin, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Shanghai Tongren Hospital
Shanghai, Shanghai Municipality, China
The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang, China
First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2021
First Posted
January 18, 2022
Study Start
March 21, 2022
Primary Completion
January 2, 2024
Study Completion
January 2, 2024
Last Updated
May 28, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share