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Metabolic Dysfunction-Associated Steatohepatitis (MASH)Phase 1/2NCT07016633

To Evaluate the Tolerability, Pharmacokinetics, and Pharmacodynamics of IMM-H014 in Patients With MASH

A Phase 1/2 study testing IMM-H014 in people with Metabolic Dysfunction-Associated Steatohepatitis (MASH), run by Changchun Intellicrown Pharmaceutical Co. LTD at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study will evaluate the tolerability, pharmacokinetics, and pharmacodynamics of consecutive Multiple treatment for 12 weeks（84 Days） in Adult Patients with Metabolic Dysfunction-Associated Steatohepatitis. Participants will receive either IMM-H014 or placebo. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
IMM-H014
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteChina
Study dates
10 Jun 2025to 1 Dec 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Sign an informed consent form before the experiment and fully understand the content, process, and potential adverse reactions of the experiment;
  • Voluntarily comply with the experimental requirements and conduct follow-up visits on designated dates, demonstrating good adherence to the protocol; And voluntarily maintain the original lifestyle (diet and exercise habits) during the study period without changing.
  • Participants (including partners) agree to take effective contraceptive measures throughout the study period until 6 months after discontinuation of medication;
  • Male and female patients aged 18 to 65 years old (including 18 and 65 years old);
  • If suffering from hypertension, blood pressure should be stabilized at 160/100mmHg or below under monotherapy control;
  • If the patient has type 2 diabetes, the patient must have not taken any medicine, or has received metformin, sulfonylurea or α - glycosidase inhibitor treatment, and the dose should be stable for at least 3 months;
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  • The presence of hepatic steatosis accompanied by at least one of the following cardiovascular metabolic risk factors (guidelines for the prevention and treatment of metabolism related (non-alcoholic) fatty liver disease 2024).
  • BMI ≥ 24.0 kg/m2, or waist circumference ≥ 90cm (male) and 85cm (female), or excessive body fat content and percentage.
  • Arterial blood pressure ≥ 130/85 mmHg, or under treatment with antihypertensive drugs.
  • Fasting blood glucose ≥ 6 1mmol /L, Or blood glucose level ≥ 7 2 hours after glucose load 8 mmol/L or HbA1c ≥ 5.7%, or history of type 2 diabetes, or HOMA-IR ≥ 2.5.
  • Fasting serum TG ≥ 1.70 mmol/L, or currently receiving lipid-lowering medication treatment.
  • Serum high-density lipoprotein ≤ 1 0 mmol/L (male) and 1 3 mmol/L (female), or currently being treated with lipid-lowering drugs.
  • Screening period ALT ≥ ULN. Or histological evidence of NASH (NAS score ≥ 4, with inflammation and ballooning at least 1 point each, fibrosis level ≤ F3, scoring criteria in Appendix 6) obtained through liver pathological biopsy within the 6 months prior to screening or during the screening period, and no treatment or weight loss within 6 months (weight change<5% within 6 months);
  • MRI-PDFF ≥ 10% within 28 days prior to enrollment.

Who cannot join

  • Excessive alcohol consumption for three consecutive months or more within the year prior to screening (men consume an average of over 30 grams of ethanol per day, equivalent to 3.75 units of alcohol, and women consume over 20 grams, equivalent to 2.5 units of alcohol: 1 unit=285 mL of beer, 25 mL of spirits, or 100 mL of wine);
  • Individuals with allergies (to multiple drugs or foods);
  • Donate blood or experience significant blood loss (>450 mL) within the first three months of screening;
  • Individuals with a history of weight loss surgery or those who are planning to undergo weight loss surgery recently;
  • History of liver transplantation surgery or planned liver transplantation;
  • Suffering from any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers;
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  • Liver biopsy indicates cirrhosis or previous clinical diagnosis of cirrhosis;
  • Patients with type 1 diabetes;
  • Uncontrolled type 2 diabetes patients (HbA1c ≥ 8.0%);
  • Other clinically significant diseases (including but not limited to respiratory system, circulatory system, digestive system, endocrine system, rheumatic and immune system, nervous system, hematological system diseases, and psychiatric/psychological diseases) that are found to be unstable or untreated before screening;
  • History of swallowing difficulties or any gastrointestinal diseases or surgeries that affect drug absorption;
  • Existence of any of the following diseases or medical histories: unstable angina, myocardial infarction, percutaneous coronary intervention (allowing diagnostic angiography), coronary artery bypass surgery, heart failure, transient ischemic attack, cerebrovascular accident, etc;
  • Currently taking medications that may cause steatosis/steatohepatitis (including amiodarone, methotrexate, steroid hormones, tetracycline, tamoxifen, valproic acid, etc.);
  • Newly taken or irregularly taken hypoglycemic drugs (excluding metformin, sulfonylureas, or alpha glucosidase inhibitors), hepatoprotective drugs (including but not limited to reduced glutathione, glucuronide, glycyrrhetinic acid preparations, ursodeoxycholic acid, niacinamide, biphenyl diesters, liver protection tablets, silibinin, etc.), and lipid-lowering drugs (including but not limited to fibrates, statins, niacin, colexamine, etc.) within 90 days before enrollment;
  • Currently receiving treatment with anti TNF - α drugs such as adalimumab, etanercept, etc;
  • 28 days prior to screening or during the study period, any drugs that alter liver enzyme activity CYP3A4, including strong inhibitors and inducers that affect liver metabolic enzymes, are planned to be taken concurrently;
  • Individuals who have consumed a special diet (including dragon fruit, mango, grapefruit, etc.) or engaged in vigorous exercise or other factors that affect drug absorption, distribution, metabolism, excretion, etc. within 2 weeks prior to enrollment;
  • Individuals who have participated in clinical trials of other drugs within 3 months prior to medication use;
  • Abnormal electrocardiogram with clinical significance, QTcF>450ms;
  • Suspected liver and gallbladder diseases with other causes based on medical history and laboratory tests, including but not limited to: hepatitis B or C virus infection, chronic alcoholic liver disease, drug-induced liver disease, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, Wilson's liver disease, alpha and alpha antitrypsin deficiency, liver cancer, significant liver dysfunction (ALT or AST ≥ 5 × ULN or TBIL ≥ 1.5 × ULN), etc;
  • Positive for HIV infection;
  • Kidney disease or renal dysfunction with clinical significance, blood creatinine>1.5 × ULN, eGFR<60 mL/min/1.73m2 [calculation formula: eGFR=186 × Scr-1.154 × Age-0.203 × (0.742 female)], etc;
  • Platelet count<100 × 109/L;
  • Confirmation of positive and clinically significant anti nuclear antibody (ANA);
  • TSH abnormality with clinical significance;
  • Pregnant and lactating women or those with positive serum pregnancy tests;
  • Patients with contraindications to MRI scanning;
  • Have taken any alcoholic products within 24 hours prior to taking the study medication;
  • Consumed chocolate, any caffeinated or xanthine rich food or beverage 24 hours prior to taking the study drug;
  • Acute illness occurs from the screening stage to the study medication;
  • Individuals who have tested positive in urine drug screening or have a history of drug abuse or use of drugs within the past five years.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Shiqi Bai contact

18943642700

baishiqi@intelli-crown.com

China1 site

  • The first Bethune hospital of Jilin University

    Changchun, Jilin

    Yanhua Ding

    Qinglong Jin

Other trials in China

About this study

Official title: A Phase Ib/IIa, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Tolerability, Pharmacokinetics, and Pharmacodynamics of IMM-H014 Consecutive Multiple Treatment for 12 Weeks in Adult Patients With MASH

This study will evaluate the tolerability, pharmacokinetics, and pharmacodynamics of consecutive Multiple treatment for 12 weeks（84 Days） in Adult Patients with Metabolic Dysfunction-Associated Steatohepatitis. Participants will receive either IMM-H014 or placebo.

Read the detailed description

The study is a randomized, double-blind phase Ib/IIa trial. Subjects will receive 125mg, 225mg, 325mg and 400mg (Group 1, Group 2, Group 3 and Group 4). Each group will consist of 10 participants who will be randomly assigned to receive IMM-H014 and placebo in a ratio of 4:1(8 receiving the investigational drug and 2 receiving placebo). Administer D1-D84 on an empty stomach or after breakfast once a day for 84 consecutive days (12 weeks).

Being tested
IMM-H014, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMM-H014Drug

    Each group will consist of 10 participants who will be randomly assigned to receive IMM-H014 and placebo in a ratio of 4:1, once a day for a total of 12 weeks.

  • PlaceboDrug

    Each group will consist of 10 participants who will be randomly assigned to receive IMM-H014 and placebo in a ratio of 4:1, once a day for a total of 12 weeks.

Study groups in NCT07016633
Study groupRoleWhat they receive
IMM-H014 /Placebo(multiple dose) 125mg (Cohort 1)ExperimentalIMM-H014 /Placebo tablets administered orally once daily under fasted condition for84 Days(a total of 84 doses)
Receives: Drug: IMM-H014; Drug: Placebo
IMM-H014 /Placebo(multiple dose)225mg (Cohort 1)ExperimentalIMM-H014 /Placebo tablets administered orally once daily under fasted condition for84 Days(a total of 84 doses)
Receives: Drug: IMM-H014; Drug: Placebo
IMM-H014 /Placebo(multiple dose) 325mg (Cohort 1)ExperimentalIMM-H014 /Placebo tablets administered orally once daily under fasted condition for84 Days(a total of 84 doses)
Receives: Drug: IMM-H014; Drug: Placebo
IMM-H014 /Placebo(multiple dose)400mg (Cohort 1)ExperimentalIMM-H014 /Placebo tablets administered orally once daily under fasted condition for84 Days(a total of 84 doses)
Receives: Drug: IMM-H014; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events following oral doses of IMM-H014 and placebo

    the adverse events are recorded according to the actual occurrence

    Measured: through study completion, up to 94 days

  2. Number of participants with abnormal laboratory tests results and abnormal physical exam findings

    the adverse events are recorded according to the actual occurrence

    Measured: through study completion, up to 87days

  3. PK parameters: AUCinf（AUC0-∞）

    AUClast is defined as the concentration of drug from time zero to the last quantifiable concentration.

    Measured: Up to 87days

  4. PK parameters: Cmax

    Cmax is defined as the maximum observed concentration of drug in plasma.

    Measured: Up to 87days

  5. PK parameter: Rac

    Rac (Accumulation Index) is defined as the ratio between AUC0-XX in Day XX and AUC0-XX in Day1

    Measured: Up to 87days

  6. PK parameter: DF

    DF is defined as the percentage of fluctuation in steady state is 100 * (Cmax, ss - Cmin, ss)/Cavg, ss

    Measured: Up to 87days

  7. Efficacy indicators：Proton Density Fat Fraction（MRI-PDFF）

    MRI-PDFF can objectively assess the total fat content of the liver and has been used in clinical trials to evaluate changes in liver fat content.

    Measured: Up to 85days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2025
  2. Study start10 Jun 2025 (estimated)
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07016633
Sponsor's protocol ID
2022-I-IMM-H014-02
Status last verified
May 2025
First submitted
26 May 2025
Last updated
13 Jun 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IMM-H014 in people with Metabolic Dysfunction-Associated Steatohepatitis (MASH), run by Changchun Intellicrown Pharmaceutical Co. LTD at 1 site 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 14 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: opening soon, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shiqi Bai (18943642700, baishiqi@intelli-crown.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events following oral doses of IMM-H014 and placebo (time frame: through study completion, up to 94 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07016633.

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 13 Jun 2025.

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