New Gene-Targeting shot shows promise for cholesterol control

NCT ID NCT07412080

What the study statuses mean

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This early-stage study tested a single injection of EDP167, a new drug that uses RNA technology to lower certain blood fats. The study included 40 healthy adults and people with mild dyslipidemia (abnormal cholesterol levels). The main goal was to check the drug's safety and how the body processes it, not to prove it works as a treatment.

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

40 people

The number who actually took part.

Started

Jul 2025

Finished

Dec 2025

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

Accepted

You do not need to have the condition being studied to take part.

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. Subjects aged 18 to 60 years (inclusive) at the time of signing the informed consent form, male or female. 2. Male subjects weighing ≥50.0 kg, female subjects weighing ≥45.0 kg, and body mass index (BMI) between 18.0 and 35.0 kg/m² (inclusive). 3. Subjects with fasting serum TG ≥1.13 mmol/L and \<5.6 mmol/L, and LDL-C ≥1.8 mmol/L and \<4.9 mmol/L at screening. 4. Subjects with no abnormalities or only minor abnormalities judged by the investigator as clinically insignificant (excluding lipid laboratory tests) upon physical examination, vital signs, 12-lead ECG, posteroanterior and lateral chest X-rays, abdominal ultrasound, and laboratory tests at screening. 5. Subjects who have maintained a stable dietary habit for at least 4 weeks before dose administration, and have no plans to significantly change their diet or body weight during the study. 6. Female subjects of childbearing potential or male subjects with partners of childbearing potential must agree to use highly effective contraception from signing the informed consent form until 6 months after dosing and refrain from donating sperm or eggs. 7. Subjects who voluntarily sign the written informed consent form, understand the study procedures and content, are able to communicate well with the investigator, and are willing to comply with the relevant study regulations. Exclusion Criteria: 1. Subjects with known allergy/hypersensitivity to the investigational drug, its components, or drugs of the same class. 2. Subjects with a history or current presence of serious or clinically significant diseases/abnormalities, including but not limited to cardiovascular, respiratory, endocrine, gastrointestinal, renal, hepatic, biliary, dermatologic, hematologic, immunologic, neurologic, or psychiatric diseases/abnormalities, , or any diseases (except for dyslipidemia) that the investigator considers to pose safety concerns or interfere with the pharmacokinetic evaluation. 3. Subjects who have undergone major surgery within 3 months prior to screening, or have undergone surgery that may significantly affect drug absorption, distribution, metabolism, or excretion, or who plan to undergo elective surgery during the study. 4. Subjects with any of the following laboratory abnormalities at screening: total bilirubin (TBIL), gamma-glutamyl transferase (GGT), or alkaline phosphatase (ALP) \>1.5×ULN; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>ULN. 5. Subjects with any of the following 12-lead ECG findings: QTcF \>450 ms or any other clinically significant abnormal ECG result. 6. Subjects with tattoos, scars, or birthmarks on the abdomen, upper arms, or thighs that may interfere with the assessment of injection site reactions. 7. Subjects who have used any prescription drugs, over-the-counter (OTC) medications, Chinese herbal medicines, or health supplements within 14 days prior to dosing; or for whom administration occurs within 5 half-lives of any prior medication (based on the longer period); or who have used any medication known to affect lipid metabolism within 90 days prior to screening. 8. Subjects who have received any live vaccine within 4 weeks prior to screening, or who plan to receive any live vaccine during the study. 9. Subjects who have used any antisense oligonucleotide (ASO) or small interfering RNA (siRNA) therapy within 12 months prior to screening. 10. Subjects with a history of drug abuse/substance abuse, or a positive result for the specified drugs (ketamine, marijuana, morphine, MDMA, methamphetamine, cocaine) in the urine drug screen at screening. 11. Subjects who regularly consumed alcohol within 3 months prior to screening (defined as \>14 units of alcohol per week; 1 unit = 360 mL of beer, or 45 mL of spirits with 40% alcohol, or 150 mL of wine), or are unwilling to abstain from alcohol during the study, or have a breath alcohol test result \>0 mg/100 mL. 12. Subjects who consumed excessive amounts of tea, coffee, or caffeinated beverages (defined as \>8 cups per day; 1 cup = 250 mL) within 3 months prior to screening, or consumed any such beverages within 48 hours prior to dosing, or are unwilling to abstain from them during the study. 13. Current smokers, or subjects with a positive urine nicotine test at screening, or former smokers who have quit smoking for less than 6 months. 14. Subjects with positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), human immunodeficiency virus (HIV) antibody, or specific treponemal antibody (for syphilis) at screening. 15. Subjects with intolerance to venipuncture, difficulty in blood sampling, or a history of needle or blood syncope. 16. Subjects who have donated blood or experienced significant blood loss (≥400 mL) within 3 months prior to screening. 17. Subjects who have participated in, or are currently participating in, another clinical trial and have received the investigational product/device or placebo within 3 months prior to screening. 18. Female subjects with a positive pregnancy test at screening, or who are breastfeeding, or who plan to become pregnant during the study period. 19. Any other condition that the investigator deems inappropriate for the subject to participate in this clinical trial.

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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.

Contacts and locations

Locations

  • Guangdong Provincial People's Hospital

    Guangzhou, China

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, China

More trials for these conditions

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