New injection aims to tackle high cholesterol in early human trial
NCT ID NCT07634510
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 37 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
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