NASHPhase 2NCT05193916
A Phase II Clinical Trial of Chiglitazar for NASH
A Phase 2 study testing chiglitazar sodium tablets in people with NASH, run by Chipscreen Biosciences, Ltd. at 15 sites in China.
Trial summary
The study is to evaluate the efficacy and safety of chiglitazar monotherapy in patients with non-clcoholic steatohepatitis (NASH). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NASH
- What is being tested?
- chiglitazar sodium tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 15 sitesChina
- Study dates
- 21 Mar 2022to 2 Jan 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Before any evaluation, an informed consent form voluntarily signed by the patient must be obtained;
- 18 -75 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.
Who cannot join
- 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
Show all 31Show fewer
- 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;
- Donated blood or lost blood >400 ml within 8 weeks before the first medication;
- With MRI scan contraindications;
- In the past 5 years, there was a history of malignant tumors of any organ system;
- Human immunodeficiency virus ( HIV ) test is positive;
- Heavy drinking of alcohol for more than 3 months in a year;
- Heavy smoking >30 per day within 1 year;
- History of drug abuse in 12 months;
- Drugs cumulatively for more than 1 month in the previous 3 months before screening, such as obeticholic acid ( OCA ), berberine;
- Drugs that may cause liver damage for more than 2 weeks within 1 year before screening;
- 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;
- The calculated eGFR < 60 mL/(min*1.73m^2 );
- There is clinical evidence of liver decompensation or severe liver damage;
- Low density lipoprotein cholesterol (LDL-C) ≥ 3.4 mmol/L during screening ;
- Platelet < 100×10^9 /L ;
- Patient participating in other clinical trials of drugs or medical devices within 3 months prior to screening ;
- Pregnant or breastfeeding women.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Beijing Youan Hospital, Capital Medical University
Beijing, Beijing Municipality
Peking University People's Hospital
Beijing, Beijing Municipality
The First Hospital of Jilin University
Ch’ang-ch’un, Jilin
Foshan First People's Hospital
Foshan, Guangdong
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang
First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
The First Affiliated Hospital of Anhui Medical University
Hefei, Jiangsu
The First Hospital of Lanzhou University
Lanzhou, Gansu
Nanjing Second Hospital
Nanjing, Jiangsu
Shanghai Tongren Hospital
Shanghai, Shanghai Municipality
The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi
Henan Provincial People's Hospital
Zhengzhou, Henan
About this study
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
The study is to evaluate the efficacy and safety of chiglitazar monotherapy in patients with non-clcoholic steatohepatitis (NASH).
Read the 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.
- Conditions
- NASH
- Being tested
- chiglitazar sodium tablets, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chiglitazar sodium tabletsDrug
Also called Bilessglu®, CS-038, Carfloglitazar
the drugs will be given orally once a day
PlaceboDrug
Also called simulant of chiglitazar
no active drug contained
| Study group | Role | What they receive |
|---|---|---|
| Chiglitazar low dose | Experimental | 3 tablets of drug and 1 tablet of placebo p.o. per day Receives: Drug: chiglitazar sodium tablets |
| Chiglitazar high dose | Experimental | 4 tablets p.o. per day Receives: Drug: chiglitazar sodium tablets |
| control group | Placebo comparator | 4 placebo tablets p.o. per day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 weeks
Secondary outcomes (9)
the change in liver fat content from baseline as shown by MRI-PDFF after 18 weeks treatment
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
Measured: 18 weeks
ALT changes from baseline
changes from baseline in liver enzymes
Measured: 6,12,18 weeks
FIB-4 changes from baseline
changes from baseline in Fibrosis 4 Score
Measured: 6,12,18 weeks
insulin resistance changes
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Measured: 6,12,18 weeks
Changes from baseline in TG
blood sample
Measured: 6,12,18 weeks
change from baseline in Liver stiffness measurement (LSM) with Fibroscan
to evlaute the severity of liver fibrosis
Measured: 6,12,18 weeks
change from baseline in Cytokeratin18 (CK-18)
to evaluate the severity of liver damage
Measured: 6,12,18 weeks
Maximum Plasma Concentration [Cmax] of chiglitazar after 1 dose, 6 weeks and 12 weeks of treatment
population PK
Measured: 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
population PK
Measured: 0, 6,12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start21 Mar 2022
- Primary completion2 Jan 2024
- Study completion2 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASHStudies of the same condition, open and under way.
- More trials run by Chipscreen Biosciences, Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chipscreen Biosciences, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193916
- Sponsor's protocol ID
- CGZ203
- Other IDs
- CINAR
- Status last verified
- May 2024
- First submitted
- 3 Dec 2021
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05193916
- Acronym / sponsor ID
- CGZ203
- Conditions
- NASH
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Chipscreen Biosciences, Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 2 Jan 2024 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is to evaluate the efficacy and safety of chiglitazar monotherapy in patients with non-clcoholic steatohepatitis (NASH).
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chiglitazar low dose | Experimental | Drug: chiglitazar sodium tablets3 tablets of drug and 1 tablet of placebo p.o. per day |
| Chiglitazar high dose | Experimental | Drug: chiglitazar sodium tablets4 tablets p.o. per day |
| control group | Placebo comparator | Drug: Placebo4 placebo tablets p.o. per day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Before any evaluation, an informed consent form voluntarily signed by the patient must be obtained;
- 18 -75 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;
Key exclusion criteria (31 listed)
- Type 1 diabetes;
- Any of the following for type 2 diabetes:
- 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 ；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chiglitazar sodium tabletsAlso: Bilessglu®, CS-038, Carfloglitazarthe drugs will be given orally once a day | Drug | Chiglitazar high dose, Chiglitazar low dose |
| PlaceboAlso: simulant of chiglitazarno active drug contained | Drug | control group |
Primary outcome
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
9 secondary outcomes
the change in liver fat content from baseline as shown by MRI-PDFF after 18 weeks treatment
Time frame: 18 weeks
ALT changes from baseline
Time frame: 6,12,18 weeks
FIB-4 changes from baseline
Time frame: 6,12,18 weeks
insulin resistance changes
Time frame: 6,12,18 weeks
Changes from baseline in TG
Time frame: 6,12,18 weeks
change from baseline in Liver stiffness measurement (LSM) with Fibroscan
Time frame: 6,12,18 weeks
change from baseline in Cytokeratin18 (CK-18)
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Individual participant dataSharing planned: No
Related trials for NASH
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing chiglitazar sodium tablets in people with NASH, run by Chipscreen Biosciences, Ltd. at 15 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.