Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic(PK/PD) Profile of ACT500 in Metabolic D… (NCT07462455) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic(PK/PD) Profile of ACT500 in Metabolic Dysfunction-Associated Steatotic Liver Disease(MASLD)
China24 participantsStarted 2026-03-31
Plain-language 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.
Who can participate
Age range
18 Years – 69 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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%;
. Fasting serum high-density lipoprotein cholesterol (HDL-C) ≤ 1.0 mmol/L (males) and ≤ 1.3 mmol/L (females), OR currently receiving a stable dose of lipid-lowering medication;
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse Event#AE#
Timeframe: Day1-112
2
Serious Adverse Event
Timeframe: Day1-112
3
body temperature
Timeframe: Day 1,14,29,56,84,112
4
Number of participants with treatment-related adverse events as assessed by NCI-CTCAE v6.0
Timeframe: Day 1,14,29,56,84,112
5
pulse
Timeframe: Day 1,14,29,56,84,112
6
heart rate
Timeframe: Day 1,14,29,56,84,112
7
blood pressure
Timeframe: Day 1,14,29,56,84,112
8
Number of Participants with Abnormal Laboratory Parameters Findings
. For male participants: Agreement to use reliable contraceptive measures and refrain from sperm donation from signing the informed consent form until 3 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 3 months after the last dose.
9
Number of participants with clinically significant change from baseline in physical examination