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

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

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

NCT07462455•Xiamen Amoytop Biotech Co., Ltd.

View on ClinicalTrials.gov

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). 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.

Eligibility

Age

18 - 69 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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) levels meeting 2×ULN ≤ ALT ≤ 5×ULN at screening.
•Presence of at least one of the following metabolic risk factors:
•1. BMI ≥ 24.0 kg/m\^2, or waist circumference ≥ 90 cm (males) and ≥ 85 cm (females);
•2. Presence of prediabetes: fasting blood glucose ≥ 6.1 mmol/L, or glycated hemoglobin (HbA1c) ≥ 5.7%;
•3. History of type 2 diabetes mellitus;
•4. Fasting serum triglycerides (TG) ≥ 1.70 mmol/L but \< 5.6 mmol/L;
+5 more criteria

Exclusion Criteria

•\[1\] 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.
•\[5\] Have type 1 diabetes or uncontrolled type 2 diabetes (fasting blood glucose \>9 mmol/L within 3 months prior to screening, or HbA1c \>9.5% at screening), or are diabetic patients using glucose-lowering medications other than metformin.
•\[6\] Have an estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m² at screening or a history of severe renal impairment.
•\[7\] 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.
•\[8\] Have any of the following laboratory abnormalities at screening: alkaline phosphatase (ALP) \> 2 × upper limit of normal (ULN), serum total bilirubin (TBIL) \> 1.5 × ULN, or 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.
+6 more criteria

Locations (4)

Beijing Tsinghua Changgeng Hospital

Beijing, China

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

The First Affiliated Hospital of Xiamen University

Xiamen, China

Key Dates

Start Date

March 31, 2026

Primary Completion Date

February 28, 2027

Completion Date

April 30, 2027

Last Updated

March 17, 2026

Enrollment

ESTIMATED participants

Conditions

Metabolic Dysfunction-associated Steatohepatitis

Interventions

ACT500 tablets

DRUG

Contacts

Lai Wei

CONTACT

01056118930 weelai@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Study of the Link Between MASH ( Metabolic Dysfunction-Associated Steatohepatitis) and MAMs (Mitochondria-Associated Membranes ) Alteration in Patients Undergoing Bariatric Surgery - MAMBA

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