Can a single injection quiet harmful blood fats?
NCT ID NCT07799025
First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time
Summary
This early-stage trial tests whether a single injection of MWX203 is safe and tolerable in healthy adults aged 18 to 55. Participants must have slightly elevated cholesterol and triglycerides, but not high enough to require medication. The study gives different doses to different groups and compares them against a placebo, watching for side effects and how the drug moves through the body.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MWX203 injection
- What this could lead to
- If MWX203 proves safe and tolerable, it could advance to larger studies aimed at lowering cholesterol or triglycerides.
- What could go wrong
- This is an early, small phase 1 trial focused on safety, not effectiveness. The drug may cause side effects or fail to show promise in later trials.
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
-
54 people
The number who actually took part.
- Started
-
Jul 2025
- Expected to finish
-
Jan 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 55 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
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. Healthy male and female subjects aged 18 to 55 years (inclusive) at the time of signing the informed consent form (ICF). 2. Fasting serum LDL-C ≥ 2.6 mmol/L (100 mg/dL) and \< 4.1 mmol/L (158 mg/dL), and fasting triglycerides ≥ 1.1 mmol/L (100 mg/dL) and \< 5.7 mmol/L (500 mg/dL) at screening; no lipid-regulating drugs used within the past 3 months. 3. Body mass index (BMI) from 19.0 to 30.0 kg/m², inclusive, at screening; male subjects must have a body weight ≥ 50.0 kg and female subjects must have a body weight ≥ 45.0 kg. 4. Stable diet and physical-activity habits for 4 weeks prior to screening; no major changes to diet or exercise are planned during the study, and participants will not follow any weight-loss plan. 5. Subjects or their partners have no plans for pregnancy, sperm donation, or egg donation from the time of signing the ICF until at least 6 months after dosing, and agree to use medically-recognized, effective non-pharmacological contraceptive methods throughout the study. 6. Voluntarily participate in the study; able to read, understand, and sign the ICF before study participation; willing to comply with the study protocol and expected to complete the study. Exclusion Criteria: 1. Any infectious disease within 4 weeks prior to screening (as judged by the investigator to affect the subject's ability to participate in the study). 2. Serious trauma or major surgery (requiring general anesthesia) within 6 months prior to screening, or planned major surgery during the study. 3. At screening, any of the following laboratory abnormalities: alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), or total bilirubin \> 1.5 × ULN; serum creatinine \> 1.2 × ULN; or estimated glomerular filtration rate (eGFR) \< 90 mL/min/1.73 m² (calculated using the CKD-EPI equation, Appendix 4). 4. QTcF ≥ 450 ms (male) or ≥ 470 ms (female) at screening; or clinically-significant abnormalities on the 12-lead electrocardiogram. 5. HbA1c \> ULN. 6. Overall atherosclerotic cardiovascular disease (ASCVD) risk assessed by the investigator as moderate or high risk at screening. 7. Use of any liver-targeted oligonucleotide drug within 1 year prior to screening. 8. Pregnant or lactating female subjects at screening. 9. Difficult venous access, difficult subcutaneous injection, or intolerance to repeated venipuncture; or clinically significant needle phobia or blood phobia history as judged by the investigator. 10. Use of any over-the-counter medications, prescription medications, traditional Chinese medicine, vitamins, or health supplements within 2 weeks prior to screening or within 5 half-lives of any prior medication (whichever is longer). 11. Receipt of any live vaccine, live attenuated vaccine, or vaccines containing live viral components within 3 months prior to screening or planned vaccination during the study. 12. Any other condition judged by the investigator to make the subject unsuitable for participation in this study.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
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