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Metabolic Dysfunction-associated SteatohepatitisPhase 1NCT07462455

Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic(PK/PD) Profile of ACT500 in Metabolic Dysfunction-Associated Steatotic Liver Disease(MASLD)

A Phase 1 study testing ACT500 tablets in people with Metabolic Dysfunction-associated Steatohepatitis, run by Xiamen Amoytop Biotech Co., Ltd. at 4 sites 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 is a multicenter, open-label, dose-escalation trial designed to evaluate the safety, tolerability, PK, and PD profiles of ACT500 in participants with metabolic dysfunction-associated steatotic liver disease (MASLD). Read more about this study

Who is it for?
Ages 18 to 69 years
What is being tested?
ACT500 tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
4 sitesChina
Study dates
31 Oct 2026to 30 Apr 2027
Phase
Phase 1
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 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The participant fully understands the purpose, nature, methods, and possible adverse reactions of the study, voluntarily participates in this study, and has signed the informed consent form.
  • Male or female participants aged between 18 and 69 years (inclusive of 18 and 69 years) at the time of signing the informed consent form.
  • Liver fat content (LFC) ≥10% as assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) during the screening period.
  • Liver stiffness measurement (LSM) assessed by FibroScan during the screening period meets the criteria of 8 kPa ≤ LSM ≤ 15 kPa, OR a liver biopsy pathological result of F2/F3 fibrosis within 6 months prior to screening.
  • Serum alanine aminotransferase (ALT) <5×ULN at screening.
  • Presence of at least one of the following metabolic risk factors:
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  • BMI ≥ 24.0 kg/m^2, or waist circumference ≥ 90 cm (males) and ≥ 85 cm (females);
  • Presence of prediabetes: fasting blood glucose ≥ 6.1 mmol/L, or glycated hemoglobin (HbA1c) ≥ 5.7%;
  • History of type 2 diabetes mellitus;
  • Fasting serum triglycerides (TG) ≥ 1.70 mmol/L but < 5.6 mmol/L;
  • Fasting serum high-density lipoprotein cholesterol ≤ 1.0 mmol/L (males) or ≤ 1.3 mmol/L (females), or on stable-dose lipid-lowering medication (excluding statins);
  • Systolic blood pressure (SBP) ≥ 130 mmHg or diastolic blood pressure (DBP) ≥ 85 mmHg, while simultaneously meeting SBP ≤ 160 mmHg and DBP ≤ 100 mmHg, OR currently receiving a stable dose of antihypertensive medication and meeting SBP ≤ 160 mmHg and DBP ≤ 100 mmHg.
  • Both male and female participants must agree to use appropriate contraceptive methods, as follows:
  • For male participants: Agreement to use reliable contraceptive measures and refrain from sperm donation from signing the informed consent form until 1 months after the last dose.
  • For female participants: Female participants of non-childbearing potential; OR female participants of childbearing potential who are not pregnant or breastfeeding, have a negative serum pregnancy test at screening and within 1 day prior to the first dose, and agree to use reliable contraceptive measures and refrain from egg donation from signing the informed consent form until 1 months after the last dose.

Who cannot join

  • [1] Combined with other liver diseases, including but not limited to hepatitis B, hepatitis C, drug-induced liver disease, alcoholic liver disease, autoimmune liver disease, suspected or confirmed hepatocellular carcinoma, etc.
  • [2] Have a history of or currently have other malignancies, liver cirrhosis (including confirmed or suspected liver cirrhosis by imaging examination, or liver cirrhosis confirmed by liver biopsy), or have evidence of decompensated liver disease (such as ascites, esophageal and gastric variceal bleeding, or hepatic encephalopathy, etc.), or have a history of liver transplantation.
  • [3] Have a history of or current symptoms of severe cardiovascular and cerebrovascular diseases, including but not limited to uncontrolled or severe arrhythmias (ventricular fibrillation, atrial fibrillation, etc.), myocardial infarction, coronary heart disease, etc.
  • [4] Have a history of persistent, clinically significant respiratory, neurological, gastrointestinal, immunological, hematological, or psychiatric diseases, which, in the investigator's judgment, would pose additional risk to the participant.
  • [5] Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (fasting plasma glucose >9 mmol/L within 3 months prior to screening, or glycated hemoglobin >9.5% at screening); or patients with diabetes receiving anti-hyperglycemic medications other than metformin and insulin.
  • [6] Have an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m² at screening or a history of severe renal impairment.
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  • [7] Have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia; or have hemoglobin <105 g/L for female participants or <115 g/L for male participants at screening; or any other condition known to interfere with hemoglobin measurement as judged by the investigator.
  • [8] Any of the following laboratory abnormalities at screening: alkaline phosphatase (ALP) >2×upper limit of normal (ULN); total serum bilirubin (TBIL) >1.5×ULN (excluding participants with benign unconjugated hyperbilirubinemia deemed eligible for enrollment by the Investigator, with total bilirubin <2×ULN and direct bilirubin <ULN); international normalized ratio (INR) >1.3.
  • [9] Have had a body weight change (increase or decrease) of >5% within 3 months prior to screening, or have undergone dieting, bariatric surgery, or used medications approved for weight loss indications.
  • [10] Have a history of major trauma or surgery within 3 months prior to screening, or plan to undergo surgery during the study period.
  • [11] Have a history of excessive alcohol consumption for 3 consecutive months or more within 1 year prior to screening, defined as a weekly ethanol intake of ≥210 g for males and ≥140 g for females; or have a history of drug abuse/dependence or a history of illicit drug inhalation/injection within 1 year prior to screening.
  • [12] Have used medications that may have a therapeutic effect on MASLD/MASH (e.g., GLP-1 receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors, FGF21 analogs, resmetirom, etc.) or medications that may cause MASLD/MASH (e.g., amiodarone, methotrexate, tetracyclines, tamoxifen, estrogens at doses greater than hormone replacement therapy, anabolic steroids, valproic acid, other known hepatotoxic drugs, etc.) within 3 months prior to screening, or other medications that the investigator considers may affect the trial.
  • [13] Have participated in another drug clinical trial within 3 months prior to screening.
  • [14]Positive human immunodeficiency virus antibody (HIV-Ab) at screening; or positive treponema pallidum antibody together with positive rapid plasma reagin (RPR) test (RPR shall only be performed when treponema pallidum antibody is positive).
  • [15] Have a known allergy to the excipients of ACT500 or to drugs with a similar chemical structure to ACT500, or have other drug allergies that, in the investigator's judgment, preclude participation in the study.
  • [16] Have any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in this study, or are unable to participate in the trial due to the participant's own reasons after signing the informed consent form (ICF).

Trial locations and contacts

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

Lai Wei contact

01056118930

weelai@163.com

China4 sites

  • Beijing Tsinghua Changgeng Hospital

    Beijing

    Lai Wei

  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai

    Jiangao Fan

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

    Yingli He

  • The First Affiliated Hospital of Xiamen University

    Xiamen

    Xiulan Xue

Other trials in China

About this study

Official title: A Multicenter, Open-label, Multiple-dose Escalation Phase Ⅰb Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of ACT500 in Participants With Metabolic Dysfunction-associated Steatotic Liver Disease

This study is a multicenter, open-label, dose-escalation trial designed to evaluate the safety, tolerability, PK, and PD profiles of ACT500 in participants with metabolic dysfunction-associated steatotic liver disease (MASLD). The trial plans to enroll approximately 24 MASLD participants across four dose cohorts, each consisting of 6 participants who will receive oral ACT500 once daily.

Being tested
ACT500 tablets
Keywords
Metabolic Dysfunction-associated Steatohepatitis, ACT500, NM6606

What participants receive

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

  • ACT500 tabletsDrug

    Once daily, orally

Study groups in NCT07462455
Study groupRoleWhat they receive
60 mg ACT500 tablet groupExperimentalNot described
Receives: Drug: ACT500 tablets
160 mg ACT500 tablet groupExperimentalNot described
Receives: Drug: ACT500 tablets
300 mg ACT500 tablet groupExperimentalNot described
Receives: Drug: ACT500 tablets
400 mg ACT500 tablet groupExperimentalNot described
Receives: Drug: ACT500 tablets

What is being measured

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

  1. Adverse Event#AE#

    Measured: Day1-112

  2. Serious Adverse Event

    Measured: Day1-112

  3. body temperature

    Measured: Day 1,14,29,56,84,112

  4. Number of participants with treatment-related adverse events as assessed by NCI-CTCAE v6.0

    Measured: Day 1,14,29,56,84,112

  5. pulse

    Measured: Day 1,14,29,56,84,112

  6. heart rate

    Measured: Day 1,14,29,56,84,112

  7. blood pressure

    Measured: Day 1,14,29,56,84,112

  8. Number of Participants with Abnormal Laboratory Parameters Findings

    Measured: Day 1,14,29,56,84,112

  9. Number of participants with clinically significant change from baseline in physical examination

    Measured: Day 1,14,29,56,84,112

  10. Heart Rate

    Measured: Day 14,29,56,84,112,

  11. PR Interval

    Measured: Day 14,29,56,84,112,

  12. QRS Interval

    Measured: Day 14,29,56,84,112,

  13. QT Interval

    Measured: Day 14,29,56,84,112,

  14. QTc Interval

    Measured: Day 14,29,56,84,112,

Secondary outcomes (45)

  1. Area Under Curve（0-t）

    Measured: Day 1,2,14,28,29

  2. Area Under the Concentration-time curve from time zero to τ at steady state

    Measured: Day 1,2,14,28,29

  3. Area Under Curve（0-∞）

    Measured: Day 1,2,14,28,29

  4. Maximum Plasma Concentration

    Measured: Day 1,2,14,28,29

  5. Time to Maximum (plasma) Concentration

    Measured: Day 1,2,14,28,29

  6. Elimination Half-Life

    Measured: Day 1,2,14,28,29

  7. CL/F

    Measured: Day 1,2,14,28,29

  8. Apparent Volume of Distribution

    Measured: Day 1,2,14,28,29

  9. Cmin,ss

    Measured: Day 1,2,14,28,29

  10. Cav,ss

    Measured: Day 1,2,14,28,29

  11. Rac_Cmax

    Measured: Day 1,2,14,28,29

  12. Rac_AUC0-tau

    Measured: Day 1,2,14,28,29

  13. DF

    Measured: Day 1,2,14,28,29

  14. MRI-PDFF-determined liver fat content (LFC)

    Measured: Day 29,112

  15. Fibroscan-measured liver stiffness measurement (LSM)

    Measured: Day 29,112

  16. AST/PLT Ratio Index，APRI

    Measured: Day 1,14,29,56,84,112

  17. absolute change from baseline in ELF

    Measured: Day 1,14,29,56,84,112

  18. percent change from baseline in ELF

    Measured: Day 1,14,29,56,84,112

  19. Total Cholesterol

    Measured: Day 1,14,29,56,84,112

  20. Triglyceride

    Measured: Day 1,14,29,56,84,112

  21. Low-Density Lipoprotein Cholesterol

    Measured: Day 1,14,29,56,84,112

  22. High-Density Lipoprotein Cholesterol

    Measured: Day 1,14,29,56,84,112

  23. apolipoprotein A1

    Measured: Day 1,14,29,56,84,112

  24. apolipoprotein B

    Measured: Day 1,14,29,56,84,112

  25. absolute change from baseline in lipoprotein(a)

    Measured: Day 1,14,29,56,84,112

  26. percent change from baseline in lipoprotein(a)

    Measured: Day 1,14,29,56,84,112

  27. Alanine Aminotransferase

    Measured: Day 1,14,29,56,84,112

  28. Aspartate Aminotransferase

    Measured: Day 1,14,29,56,84,112

  29. Gamma-Glutamyl Transferase（GGT）

    Measured: Day 1,14,29,56,84,112

  30. absolute change from baseline in GGT

    Measured: Day 1,14,29,56,84,112

  31. percent change from baseline in GGT

    Measured: Day 1,14,29,56,84,112

  32. body weight

    Measured: Day 1,14,29,56,84,112

  33. body Mass Index

    Measured: Day 1,14,29,56,84,112

  34. waist circumference

    Measured: Day 1,14,29,56,84,112

  35. absolute change from baseline in hip circumference

    Measured: Day 1,14,29,56,84,112

  36. High-sensitivity C-reactive protein

    Measured: Day 1,2,14,28,29

  37. Tumor Necrosis Factor alpha

    Measured: Day 1,2,14,28,29

  38. Cytokeratin 18 （M30）

    Measured: Day 1,2,14,28,29

  39. N-terminal propeptide of type III collagen (Pro-C3)

    Measured: Day 1,14,29

  40. absolute change from baseline in Pro-C3

    Measured: Day 1,1429

  41. percent change from baseline in Pro-C3

    Measured: Day 1,14,29

  42. Insulin-like Growth Factors-1

    Measured: Day 1,14,29

  43. Insulin-like Growth Factor Binding Protein 3 (IGFBP-3)

    Measured: Day 1,29

  44. absolute change from baseline in IGFBP-3

    Measured: Day 1,29

  45. percent change from baseline in IGFBP-3

    Measured: Day 1,29

Timeline

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

  1. First posted10 Mar 2026
  2. Study start31 Oct 2026 (estimated)
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion30 Apr 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
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07462455
Sponsor's protocol ID
ACT500-4-1-002
Status last verified
Sep 2026
First submitted
4 Mar 2026
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ACT500 tablets in people with Metabolic Dysfunction-associated Steatohepatitis, run by Xiamen Amoytop Biotech Co., Ltd. at 4 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 15 inclusion and 16 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 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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. 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 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.

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 Lai Wei (01056118930, weelai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Event#AE# (time frame: Day1-112). The study lists 14 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 NCT07462455.

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 14 Sep 2026.

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