Metabolic Dysfunction-associated Steatotic Liver DiseasePhase 1NCT07589400

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of ACT500 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease Complicated With Chronic Hepatitis B

A Phase 1 study testing ACT500 Tablets in people with Metabolic Dysfunction-associated Steatotic Liver Disease and Chronic Hepatitis b, 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

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Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Metabolic Dysfunction-associated Steatotic Liver Disease, Chronic Hepatitis b
What is being tested?: ACT500 Tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 4 sitesChina
Study dates: 30 Oct 2026to 30 Jun 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 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

The participant fully understands the purpose, nature, methods of the trial, and the potential adverse reactions, voluntarily agrees to participate in this study, and signs the informed consent form.
Male or female participants aged between 18 and 60 years (inclusive) at the time of signing the informed consent form.
Liver fat content ≥10% as assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) during the screening period.
Liver stiffness measurement (LSM) by FibroScan during the screening period meets 8 kPa ≤ LSM < 12 kPa, or liver biopsy results within 6 months prior to screening show stage F2/F3 liver fibrosis.
Hepatitis B surface antigen (HBsAg) positive for >6 months at screening, or other evidence of chronic hepatitis B (CHB), with HBV DNA < 20 IU/mL.
Serum alanine aminotransferase (ALT) < 5×ULN at screening.

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Received nucleos(t)ide analog (NAs) therapy for at least 1 year prior to screening and are currently on stable NA therapy (including entecavir, tenofovir disoproxil fumarate, tenofovir alafenamide fumarate, and tenofovir amibufenamide). Stable NAs therapy is defined as receiving the same treatment regimen within 3 months prior to screening.
Have at least one of the following metabolic disease risk factors:
BMI ≥24.0 kg/m^2, or waist circumference ≥90 cm (male) and ≥85 cm (female); Prediabetes: fasting blood glucose ≥6.1 mmol/L, or glycated hemoglobin (HbA1c) ≥5.7%; History of type 2 diabetes mellitus; 1.70 mmol/L ≤ fasting serum triglycerides < 5.6 mmol/L; Fasting serum high-density lipoprotein cholesterol ≤1.0 mmol/L (male) and ≤1.3 mmol/L (female), or receiving stable-dose lipid-lowering therapy(excluding statins); Systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg, with systolic blood pressure ≤160 mmHg and diastolic blood pressure ≤100 mmHg; or receiving stable-dose antihypertensive therapy with systolic blood pressure ≤160 mmHg and diastolic blood pressure ≤100 mmHg.
Both male and female participants must agree to use adequate contraceptive methods, where:
Male participants: agree to use reliable contraceptive measures from the time of signing the informed consent form until 1 months after the last dose, and have no sperm donation plans; Female participants: women of non-childbearing potential; or women of childbearing potential who are not pregnant or breastfeeding, must have a negative serum pregnancy test result at screening and within 1 day prior to the first dose, agree to use reliable contraceptive measures from the time of signing the informed consent form until 1 months after the last dose, and have no oocyte donation plans.

Who cannot join

Concurrent other liver diseases, including but not limited to hepatitis C, hepatitis D, drug-induced liver disease, alcoholic liver disease, autoimmune liver disease, suspected or confirmed liver cancer, etc.
Participants with a previous or current history of other malignant tumors, liver cirrhosis (including imaging-confirmed or suspected cirrhosis, and liver biopsy-confirmed cirrhosis), or evidence of decompensated liver disease (such as ascites, esophagogastric variceal bleeding, hepatic encephalopathy), or with a history of liver transplantation.
Participants with a history or current symptoms of severe cardiovascular and cerebrovascular diseases, including but not limited to uncontrolled or severe arrhythmia (ventricular fibrillation, atrial fibrillation, etc.), myocardial infarction, coronary heart disease, uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg).
Participants with persistent and clinically significant medical history of respiratory, nervous, gastrointestinal, immune, hematological or psychiatric diseases, which, in the opinion of the investigator, may impose additional risks on the participant.
Participants with type 1 diabetes or poorly controlled type 2 diabetes (fasting blood glucose >9 mmol/L within 3 months prior to screening or glycated hemoglobin >9.5% at screening), or diabetic patients using hypoglycemic drugs other than metformin and insulin.
Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m² (calculated by the CKD-EPI formula) at screening, or with a history of severe renal impairment.

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Known hemoglobinopathy, hemolytic anemia, sickle cell anemia; or hemoglobin <115 g/L in female participants and <130 g/L in male participants at screening; or any other conditions judged by the investigator to interfere with hemoglobin detection.
Any of the following laboratory abnormalities at screening: alkaline phosphatase (ALP) >2 times the upper limit of normal (ULN), total bilirubin (TBIL) >1.5 times the ULN(excluding participants with benign unconjugated hyperbilirubinemia who are deemed eligible for enrollment by the Investigator, with total bilirubin <2×ULN and direct bilirubin <ULN);, international normalized ratio (INR) >1.3, albumin <35 g/L, platelet count <125×10⁹/L, and serum triglycerides >5.6 mmol/L.
Participants with body weight gain or loss >5% within 3 months prior to screening, or those receiving diet control, bariatric surgery, or using approved anti-obesity medications for weight loss indications.
Participants with a history of major trauma or surgery within 3 months prior to screening, or those scheduled to undergo surgery during the study period.
Excessive alcohol consumption for 3 consecutive months or more within 1 year prior to screening. Excessive drinking is defined as weekly ethanol intake ≥210 g for males and ≥140 g for females; or with a history of drug abuse/dependence or drug inhalation/injection within 1 year prior to screening.
Use of drugs with potential therapeutic effects on MASLD/MASH within 3 months prior to screening (e.g., GLP-1 receptor agonists, DPP4 inhibitors, SGLT2 inhibitors, FGF21 analogues, resmetirom, etc.), or drugs that may induce MASLD/MASH (e.g., amiodarone, methotrexate, tetracyclines, tamoxifen, estrogen at doses exceeding hormone replacement therapy, anabolic steroids, valproic acid, and other known hepatotoxic drugs); use of drugs that may affect the efficacy of hepatitis B treatment within 6 months prior to screening (e.g., anti-HBV drugs other than NAs, interferons, systemic immunomodulators, hepatitis B vaccines, etc.), or any other medications deemed by the investigator to interfere with the study.
Participation in other clinical drug trials within 6 months prior to screening.
Positive human immunodeficiency virus antibody (HIV-Ab) at screening; positive hepatitis C virus antibody (if positive, HCV-RNA must be below the lower limit of quantitation of the study site assay); positive hepatitis D virus antibody; or positive treponema pallidum antibody together with positive rapid plasma reagin (RPR) test (RPR shall only be performed when treponema pallidum antibody is positive).
Participants with allergic reactions to excipients of ACT500 or drugs with similar chemical structures to ACT500, or other drug allergies deemed ineligible for study participation by the investigator.
Any other conditions that render the participant unsuitable for this study as determined by the investigator, or participants who are unable to complete the trial due to personal 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.

Jidong Jia, Ph.D contact

13501378269

jia_jd@ccmu.edu.cn

China4 sites

Beijing Friendship Hospital, Capital Medical University
Beijing
Jidong Jia, 13501378269, jia_jd@ccmu.edu.cn
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Qing Xie
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi
Xiaobo Lu
Xiamen Hospital of Traditional Chinese Medicine
Xiamen
Huiqing Liang

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Multiple Ascending Dose, Placebo-controlled Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of ACT500 in Participants With Metabolic Dysfunction-associated Steatotic Liver Disease Complicated With Chronic Hepatitis B.

This study is a Phase Ib, multicenter randomized, double-blind, dose-escalation, placebo-controlled trial designed to evaluate the safety, tolerability, PK, and PD profiles of multiple-dose ACT500 in participants with metabolic dysfunction-associated steatotic liver disease (MASLD) complicated with chronic hepatitis B (CHB). The trial plans to enroll 24 participants with MASLD complicated with CHB across three dose cohorts initially, each consisting of 8 participants who will receive oral ACT500 tablets once daily.

Conditions: Metabolic Dysfunction-associated Steatotic Liver Disease, Chronic Hepatitis b
Being tested: ACT500 Tablets, ACT500 Placebo Tablets
Keywords: Metabolic Dysfunction-associated Steatotic Liver Disease, Chronic Hepatitis b, ACT500, NM6606
Medical subject headings: Hepatitis B, Chronic

What participants receive

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

ACT500 TabletsDrug
Once daily, orally
ACT500 TabletsDrug
Once daily, orally
ACT500 TabletsDrug
Once daily, orally
ACT500 Placebo TabletsDrug
Once daily, orally
ACT500 Placebo TabletsDrug
Once daily, orally
ACT500 Placebo TabletsDrug
Once daily, orally

Study groups in NCT07589400
Study group	Role	What they receive
100 mg ACT500 tablet group	Experimental	Not described Receives: Drug: ACT500 Tablets
300 mg ACT500 tablet group	Experimental	Not described Receives: Drug: ACT500 Tablets
400 mg ACT500 tablet group	Experimental	Not described Receives: Drug: ACT500 Tablets
100 mg ACT500 Placebo tablet group	Placebo comparator	Not described Receives: Drug: ACT500 Placebo Tablets
300 mg ACT500 Placebo tablet group	Placebo comparator	Not described Receives: Drug: ACT500 Placebo Tablets
400 mg ACT500 Placebo tablet group	Placebo comparator	Not described Receives: Drug: ACT500 Placebo Tablets

What is being measured

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

Adverse Event
Measured: Day1-112
Serious Adverse Event
Measured: Day1-112
body temperature
Measured: Day1,14,29,56,84,112
breathe
Measured: Day1,14,29,56,84,112
pulse
Measured: Day1,14,29,56,84,112
blood pressure
Measured: Day1,14,29,56,84,112
Number of Participants with Abnormal Laboratory Parameters Findings
Measured: Day1,14,29,56,84,112
Number of participants with clinically significant change from baseline in physical examination
Measured: Day1,14,29,56,84,112
PR Interval
Measured: Day14,29,56,84,112
QRS Interval
Measured: Day14,29,56,84,112
QT Interval
Measured: Day14,29,56,84,112
QTc Interval
Measured: Day14,29,56,84,112

Secondary outcomes (41)

Area Under Curve#0-t#
Measured: Day1,2,14,28,29
Area Under the Concentration-time curve from time zero to τ at steady state
Measured: Day1,2,14,28,29
Area Under Curve#0-∞#
Measured: Day1,2,14,28,29
Maximum Plasma Concentration
Measured: Day1,2,14,28,29
Time to Maximum (plasma) Concentration
Measured: Day1,2,14,28,29
Elimination Half-Life
Measured: Day1,2,14,28,29
CL/F
Measured: Day1,2,14,28,29
Apparent Volume of Distribution
Measured: Day1,2,14,28,29
Cmin,ss
Measured: Day1,2,14,28,29
Cav,ss
Measured: Day1,2,14,28,29
Rac_Cmax
Measured: Day1,2,14,28,29
Rac_AUC0-tau
Measured: Day1,2,14,28,29
DF
Measured: Day1,2,14,28,29
MRI-PDFF-determined liver fat content (LFC)
Measured: Day29,112
Fibroscan-measured liver stiffness measurement (LSM)
Measured: Day29,112
AST/PLT Ratio Index
Measured: Day1,14,29,56,112
Triglyceride
Measured: Day1,14,29,56,84,112
Total Cholesterol
Measured: Day1,14,29,56,84,112
Low-Density Lipoprotein Cholesterol
Measured: Day1,14,29,56,84,112
High-Density Lipoprotein Cholesterol
Measured: Day1,14,29,56,84,112
Apolipoprotein A1
Measured: Day1,14,29,56,84,112
Apolipoprotein B
Measured: Day1,14,29,56,84,112
Lipoprotein(a)
Measured: Day1,14,29,56,84,112
Alanine Aminotransferase
Measured: Day1,14,29,56,84,112
Aspartate Aminotransferase
Measured: Day1,14,29,56,84,112
Gamma-Glutamyl Transferase
Measured: Day1,14,29,56,84,112
body weight
Measured: Day1,14,29,56,84,112
body Mass Index
Measured: Day1,14,29,56,84,112
waist circumference
Measured: Day1,14,29,56,84,112
hip circumference
Measured: Day1,14,29,56,84,112
Hepatitis B surface antigen
Measured: Day1,14,29,56,84,112
high-sensitivity C-reactive protein
Measured: Day1,2,14,28,29
Tumor necrosis factor-α
Measured: Day1,2,14,28,29
Cytokeratin-18 fragment M30
Measured: Day1,2,14,28,29
Procollagen type III N-terminal peptide(Pro-C3)
Measured: Day1,2,14,28,29
percent change from baseline in Pro-C3
Measured: Day1,2,14,28,29
Insulin-like Growth Factors-1
Measured: Day1,29
Insulin-like Growth Factor Binding Protein 3 (IGFBP-3)
Measured: Day1,29
percent change from baseline in IGFBP-3
Measured: Day1,29
FIB-4
Measured: Day1,14,29,56,112
Enhanced Liver Fibrosis
Measured: Day1,14,29

Timeline

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

30 Oct 202630 Jun 2027

First posted15 May 2026
Study start30 Oct 2026 (estimated)
Primary completion30 Mar 2027 (estimated)
Study completion30 Jun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Metabolic Dysfunction-associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
More trials run by Xiamen Amoytop Biotech Co., 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 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 24 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07589400
Sponsor's protocol ID: ACT500-4/003
Status last verified: Sep 2026
First submitted: 5 May 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

Interested in taking part?

Jidong Jia, Ph.D

13501378269

jia_jd@ccmu.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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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
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Enrolling by invitation
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MASLD

All Metabolic Dysfunction-associated Steatotic Liver Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Multiple Ascending Dose, Placebo-controlled Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of ACT500 in Participants With Metabolic Dysfunction-associated Steatotic Liver Disease Complicated With Chronic Hepatitis B.
ClinicalTrials.gov ID: NCT07589400
Acronym / sponsor ID: ACT500-4/003
Conditions: Metabolic Dysfunction-associated Steatotic Liver Disease, Chronic Hepatitis b
Keywords: Metabolic Dysfunction-associated Steatotic Liver Disease, Chronic Hepatitis b, ACT500, NM6606
Phase: Phase 1
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 24 participants (estimated)
Lead sponsor: Xiamen Amoytop Biotech Co., Ltd.Industry (pharma, biotech, devices)
Study start: 30 Oct 2026 (estimated)
Primary completion: 30 Mar 2027 (estimated)
Study completion: 30 Jun 2027 (estimated)
First posted: 15 May 2026 (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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
100 mg ACT500 tablet group	Experimental	Drug: ACT500 Tablets
300 mg ACT500 tablet group	Experimental	Drug: ACT500 Tablets
400 mg ACT500 tablet group	Experimental	Drug: ACT500 Tablets
100 mg ACT500 Placebo tablet group	Placebo comparator	Drug: ACT500 Placebo Tablets
300 mg ACT500 Placebo tablet group	Placebo comparator	Drug: ACT500 Placebo Tablets
400 mg ACT500 Placebo tablet group	Placebo comparator	Drug: ACT500 Placebo Tablets

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (11 listed)

The participant fully understands the purpose, nature, methods of the trial, and the potential adverse reactions, voluntarily agrees to participate in this study, and signs the informed consent form.
Male or female participants aged between 18 and 60 years (inclusive) at the time of signing the informed consent form.
Liver fat content ≥10% as assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) during the screening period.
Liver stiffness measurement (LSM) by FibroScan during the screening period meets 8 kPa ≤ LSM < 12 kPa, or liver biopsy results within 6 months prior to screening show stage F2/F3 liver fibrosis.
Hepatitis B surface antigen (HBsAg) positive for >6 months at screening, or other evidence of chronic hepatitis B (CHB), with HBV DNA < 20 IU/mL.

Key exclusion criteria (16 listed)

Concurrent other liver diseases, including but not limited to hepatitis C, hepatitis D, drug-induced liver disease, alcoholic liver disease, autoimmune liver disease, suspected or confirmed liver cancer, etc.
Participants with a previous or current history of other malignant tumors, liver cirrhosis (including imaging-confirmed or suspected cirrhosis, and liver biopsy-confirmed cirrhosis), or evidence of decompensated liver disease (such as ascites, esophagogastric variceal bleeding, hepatic encephalopathy), or with a history of liver transplantation.
Participants with a history or current symptoms of severe cardiovascular and cerebrovascular diseases, including but not limited to uncontrolled or severe arrhythmia (ventricular fibrillation, atrial fibrillation, etc.), myocardial infarction, coronary heart disease, uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg).
Participants with persistent and clinically significant medical history of respiratory, nervous, gastrointestinal, immune, hematological or psychiatric diseases, which, in the opinion of the investigator, may impose additional risks on the participant.
Participants with type 1 diabetes or poorly controlled type 2 diabetes (fasting blood glucose >9 mmol/L within 3 months prior to screening or glycated hemoglobin >9.5% at screening), or diabetic patients using hypoglycemic drugs other than metformin and insulin.

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
ACT500 TabletsOnce daily, orally	Drug	100 mg ACT500 tablet group
ACT500 TabletsOnce daily, orally	Drug	300 mg ACT500 tablet group
ACT500 TabletsOnce daily, orally	Drug	400 mg ACT500 tablet group
ACT500 Placebo TabletsOnce daily, orally	Drug	100 mg ACT500 Placebo tablet group
ACT500 Placebo TabletsOnce daily, orally	Drug	300 mg ACT500 Placebo tablet group
ACT500 Placebo TabletsOnce daily, orally	Drug	400 mg ACT500 Placebo tablet group

Primary outcome

Adverse Event
Time frame: Day1-112
Serious Adverse Event
Time frame: Day1-112
body temperature
Time frame: Day1,14,29,56,84,112
breathe
Time frame: Day1,14,29,56,84,112
pulse
Time frame: Day1,14,29,56,84,112
blood pressure
Time frame: Day1,14,29,56,84,112
Number of Participants with Abnormal Laboratory Parameters Findings
Time frame: Day1,14,29,56,84,112
Number of participants with clinically significant change from baseline in physical examination
Time frame: Day1,14,29,56,84,112
PR Interval
Time frame: Day14,29,56,84,112
QRS Interval
Time frame: Day14,29,56,84,112
QT Interval
Time frame: Day14,29,56,84,112
QTc Interval
Time frame: Day14,29,56,84,112

41 secondary outcomes

Area Under Curve#0-t#
Time frame: Day1,2,14,28,29
Area Under the Concentration-time curve from time zero to τ at steady state
Time frame: Day1,2,14,28,29
Area Under Curve#0-∞#
Time frame: Day1,2,14,28,29
Maximum Plasma Concentration
Time frame: Day1,2,14,28,29
Time to Maximum (plasma) Concentration
Time frame: Day1,2,14,28,29
Elimination Half-Life
Time frame: Day1,2,14,28,29
CL/F
Time frame: Day1,2,14,28,29
Apparent Volume of Distribution
Time frame: Day1,2,14,28,29
Cmin,ss
Time frame: Day1,2,14,28,29
Cav,ss
Time frame: Day1,2,14,28,29
Rac_Cmax
Time frame: Day1,2,14,28,29
Rac_AUC0-tau
Time frame: Day1,2,14,28,29
DF
Time frame: Day1,2,14,28,29
MRI-PDFF-determined liver fat content (LFC)
Time frame: Day29,112
Fibroscan-measured liver stiffness measurement (LSM)
Time frame: Day29,112
AST/PLT Ratio Index
Time frame: Day1,14,29,56,112
Triglyceride
Time frame: Day1,14,29,56,84,112
Total Cholesterol
Time frame: Day1,14,29,56,84,112
Low-Density Lipoprotein Cholesterol
Time frame: Day1,14,29,56,84,112
High-Density Lipoprotein Cholesterol
Time frame: Day1,14,29,56,84,112
Apolipoprotein A1
Time frame: Day1,14,29,56,84,112
Apolipoprotein B
Time frame: Day1,14,29,56,84,112
Lipoprotein(a)
Time frame: Day1,14,29,56,84,112
Alanine Aminotransferase
Time frame: Day1,14,29,56,84,112
Aspartate Aminotransferase
Time frame: Day1,14,29,56,84,112
Gamma-Glutamyl Transferase
Time frame: Day1,14,29,56,84,112
body weight
Time frame: Day1,14,29,56,84,112
body Mass Index
Time frame: Day1,14,29,56,84,112
waist circumference
Time frame: Day1,14,29,56,84,112
hip circumference
Time frame: Day1,14,29,56,84,112
Hepatitis B surface antigen
Time frame: Day1,14,29,56,84,112
high-sensitivity C-reactive protein
Time frame: Day1,2,14,28,29
Tumor necrosis factor-α
Time frame: Day1,2,14,28,29
Cytokeratin-18 fragment M30
Time frame: Day1,2,14,28,29
Procollagen type III N-terminal peptide(Pro-C3)
Time frame: Day1,2,14,28,29
percent change from baseline in Pro-C3
Time frame: Day1,2,14,28,29
Insulin-like Growth Factors-1
Time frame: Day1,29
Insulin-like Growth Factor Binding Protein 3 (IGFBP-3)
Time frame: Day1,29
percent change from baseline in IGFBP-3
Time frame: Day1,29
FIB-4
Time frame: Day1,14,29,56,112

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
Individual participant dataSharing planned: No

Related trials for Metabolic Dysfunction-associated Steatotic Liver Disease

Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
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Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
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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.

Jidong Jia, Ph.D contact

13501378269

jia_jd@ccmu.edu.cn

Jidong Jia, Ph.D principal investigator

Beijing Friendship Hospital

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ACT500 Tablets in people with Metabolic Dysfunction-associated Steatotic Liver Disease and Chronic Hepatitis b, 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 11 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. 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 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 Jidong Jia, Ph.D (13501378269, jia_jd@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Event (time frame: Day1-112). The study lists 12 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 NCT07589400.

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.