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Can a new pill tame high cholesterol?

NCT ID NCT03381287

Disease control Sponsor: HighTide Therapeutics (Hong Kong) Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This trial evaluates an experimental drug called HTD1801 in overweight or obese adults with high cholesterol. The study aims to see if the drug is safe and tolerable when taken daily at different doses, and how the body processes it. Participants are randomly assigned to receive either HTD1801 or a placebo, and researchers monitor for side effects and measure drug levels in the blood.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HTD1801 tablets
What this could lead to
If successful, HTD1801 could become a new oral treatment to help manage high cholesterol, potentially reducing the risk of heart disease.
What could go wrong
This is an early-stage trial focused on safety and dosing, not proof of effectiveness. The drug may not lower cholesterol as hoped or may cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

50 people

The number who actually took part.

Started

Apr 2018

Finished

Dec 2018

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Have given written informed consent 2. Males or females aged 18 to 70 years old at the time of first dosing 3. Have a body mass index (BMI) of \>25.0 and ≤ 45.0 kg/m2 at Screening 4. Have a documented history of hypercholesterolemia, defined as LDL-C ≥ 2.59 mmol/L Exclusion Criteria: 1. The use of any anti-dyslipidemia agent within 28 days prior to dosing 2. History of a total cholesterol ≥ 10.35 mmol/L or triglyceride ≥ 11.3 mmol/L 3. History of a clinically significant cardiac arrhythmia or clinically significant abnormal ECG results at Screening 4. Significant peripheral or coronary vascular disease 5. Clinically significant abnormal blood pressure at Screening or Baseline, defined as supine blood pressure ≥160/100 mmHg, or ≤ 90/60 mmHg 6. 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 7. Glucose-6-phosphate dehydrogenase (G6PD) deficiency

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Conditions

The condition(s) this trial relates to.

Hypercholesterolemia hyperlipidemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypercholesterolemia

Contacts and locations

Locations

  • CMAX Clinical Research Pty Ltd

    Adelaide, South Australia, 5000, Australia

  • Linear Clinical Research

    Nedlands, Western Australia, 6009, Australia

  • Q-Pharm Pty Ltd.

    Herston, Queensland, 4006, Australia

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