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New injection aims to tackle high cholesterol in early human trial

NCT ID NCT07634510

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests a single injection of MWX205 in 37 adults with high cholesterol or blood fats (dyslipidemia). Researchers will check if the drug is safe, how the body processes it, and how it affects cholesterol levels compared to a placebo. The goal is to find the right dose for future studies.

What this could mean

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

Active substance
MWX205 (small nucleic acid injection)
What this could lead to
If successful, this could lead to a new injectable treatment for managing high cholesterol and fat levels in the blood.
What could go wrong
This is a very early Phase 1 trial with only 37 participants, so safety and effectiveness are not yet known. The drug may not work or could have 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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 37 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Nov 2027

An estimate. End dates often move.

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 60 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. Adult participants with dyslipidemia will be enrolled in this study. 2. The absence of clinically significant illness and surgery within 4 weeks prior to study drug administration. 3. Participants must have fasting triglycerides greater than or equal to 150 mg/dL (1.7 mmol/L) and less than 500 mg/dL (5.7 mmol/L), and LDL-C greater than or equal to 70 mg/dL (1.8 mmol/L) at pre-screening and confirmation within 7 days before randomization. 4. Have a body mass index within the range 18.5 to 40.0 kg/m2 (inclusive), with no plans to significantly alter diet or BMI over the course of study. 5. Females of childbearing potential and males who are not surgically sterile (\> 90 days since vasectomy with no viable sperm) will agree to use contraception from Screening until 6 months after the administration, OR females of non-reproductive potential Exclusion Criteria: 1. Positive pregnancy test or lactating female participant. 2. Systolic BP lower than 90 or over 140 mmHg, diastolic BP lower than 40 or over 90 mmHg, HR less than 40 or over 100 bpm at screening. 3. QTcF over 450 ms at screening. 4. Consume more than 7 units for women or 14 units for men of alcohol per week within 8 weeks prior to screening (1 unit = 285 mL of beer 3.5%, 75 mL of wine 13.5%, or 25 mL of distilled alcohol 40%). 5. Participants with established coronary artery disease, peripheral arterial disease, prior stroke, or other clinically significant atherosclerotic cardiovascular disease (such as stent placement or heart bypass, unstable angina or last known ejection fraction of \<50%). 6. History of intolerance to SC injection or relevant abdominal scarring (surgical, burns, etc.), or any skin conditions, including infections or open wounds, or dermatitis at the injection site that could interfere with the evaluation of injection reaction. 7. Have taken any prescription medications that are specifically indicated for lowering serum TGs (e.g., fibric acid derivatives, niacin, and omega-3 fatty acids \[\>1 g/day\]) or medications that interfere with absorption of dietary cholesterol or fats (e.g., bile acid sequestrants, orlistat) within 2 months prior to screening. 8. Have received treatment with any liver-targeted siRNA therapy or ASO (Antisense Oligonucleotide) within12 months prior to screening. 9. Use of ANGPTL3 or PCSK9-inhibiting monoclonal antibodies within 90 days prior to screening. 10. Use of systemic glucocorticoid therapy for more than 14 consecutive days in the past year, or any glucocorticoid therapy (excluding topical, intra-ocular, intra-articular, intranasal, or inhaled preparations) within 1 month before screening.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.