A Multiple Ascending Dose Study of HTD1801 in Adults With Hypercholesterolemia (NCT03381287) | Clinical Trial Compass
CompletedPhase 1/2
A Multiple Ascending Dose Study of HTD1801 in Adults With Hypercholesterolemia
Australia50 participantsStarted 2018-04-13
Plain-language summary
This is a randomized, double-blind, placebo-controlled, multicenter, multiple ascending dose (MAD) study to evaluate the safety and tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of HTD1801 in overweight to obese adults with hypercholesterolemia. There were 3 cohorts of dose levels as 500, 1000 and 2000 mg/day, with 16 subjects planned for each cohort randomized 3:1 to receive either HTD1801 or Placebo.
Who can participate
Age range
18 Years – 70 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
. Have given written informed consent
. Males or females aged 18 to 70 years old at the time of first dosing
. Have a body mass index (BMI) of \>25.0 and ≤ 45.0 kg/m2 at Screening
. Have a documented history of hypercholesterolemia, defined as LDL-C ≥ 2.59 mmol/L
Exclusion criteria
. The use of any anti-dyslipidemia agent within 28 days prior to dosing
. History of a total cholesterol ≥ 10.35 mmol/L or triglyceride ≥ 11.3 mmol/L
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
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs)
. History of a clinically significant cardiac arrhythmia or clinically significant abnormal ECG results at Screening
. Significant peripheral or coronary vascular disease
. Clinically significant abnormal blood pressure at Screening or Baseline, defined as supine blood pressure ≥160/100 mmHg, or ≤ 90/60 mmHg
. Primary hypothyroidism (thyroid stimulating hormone \[TSH\] \> upper limit or normal \[ULN\] and free T4 \< lower limit of normal \[LLN\]), primary subclinical hypothyroidism (screening TSH \> ULN and free T4 within normal limits \[WNL\]), or secondary hypothyroidism (screening TSH \< LLN and free T4\< LLN) at Screening