New shot for high cholesterol passes first safety test in humans
NCT ID NCT06541457
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-stage trial tested a single injection of HRS-7249 in 48 healthy adults with high cholesterol. The main goal was to check safety and how the drug moves through the body. Participants were randomly assigned to receive either the drug or a placebo, and researchers monitored for side effects. This is a first step to see if the drug might one day help control cholesterol levels.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HRS-7249 injection
- What this could lead to
- If successful, this could lead to a new injectable treatment for high cholesterol, offering a convenient alternative to daily pills.
- What could go wrong
- This is an early Phase 1 trial with only 48 healthy people, so it is too soon to know if it works or is safe. The drug may cause side effects or fail in later studies.
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
-
48 people
The number who actually took part.
- Started
-
Aug 2024
- Finished
-
Jul 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 65 years
- Sex
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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. Able and willing to provide a written informed consent; 2. Age ≥ 18 and ≤ 65 years old on the day of signing the informed consent ; 3. 0.9 mmol/L≤TG≤5.6 mmol/L; 4. Male or female; 5. Male subjects weigh ≥ 50 kg and \< 90 kg , female subjects weigh ≥ 45kg and \< 90 kg, and BMI is in the range of 19\~30 kg/m2 ;(including boundary values) Normal or abnormality such as vital signs, physical examination and laboratory examination have no clinical significance; 6. Subjects must be willing to use a highly effective method of contraception as deemed appropriate by the investigator throughout the study and for at least 6 months after the last study drug administration. Exclusion Criteria: 1. Those who suffer from any disease that affects drug absorption, distribution, metabolism, and excretion, or can reduce compliance determined by investigators; 2. Those who suffer from any clinical diseases such as as cardiovascular, liver, kidney, digestive tract, psychiatric, hematological, metabolic abnormalities; 3. A clinically significant history of drug allergies or atopic allergic diseases (asthma, urticaria, eczematous dermatitis); 4. Those with a history of malignant diseases; 5. Those with a history of involving clinical trials of any other drugs or medical devices within the previous 3 months of screening or planned to be conducted during the study period (excluding screening failures), or those who are still within 5 half-lives of the drugs before screening (whichever is longer); 6. Those who have experienced severe trauma or surgery within the previous 6 months, or plan to undergo surgery during the trial period; Serious infected individuals within the previous 3 months of screening; 7. Those who have used any drugs during the screening period or within 2 weeks before the baseline period; or those who are still in 5 half-lives of the drug at the time of screening (whichever is longer); 8. Serum LDL-C ≥ 4.1mmol/L; 9. Platelet count\<100 × 109/L; 10. Creatinine≥ upper limit of normal (ULN); 11. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or gamma glutamyltransferase (GGT) ≥2×ULN, or total bilirubin ≥1.5×ULN; 12. During the screening period, human immunodeficiency virus antibodies (HIV-Ab), syphilis serological tests, hepatitis B virus surface antigen (HBs-Ag), or hepatitis C virus antibodies (HCV Ab) is positive; 13. Creatine kinase (CK) ≥ 3 ×ULN; 14. Thyroid stimulating hormone (TSH)\< limit of normal (LLN) or≥ 1.5 ×ULN; 15. Glomerular filtration rate (eGFR)\<60 mL/min/1.73m2; 16. Urine drug screening positive; 17. Those with a history of blood donation within the previous three months, severe blood loss (blood loss ≥ 400 mL), or who have received a blood transfusion within four weeks; 18. Those who have received the vaccine within the previous two weeks or plan to receive it during the trial process; 19. Those who started new physical exercise or made significantly changed their previous exercise activities within the previous 4 weeks, or who were unable to maintain basic stability in exercise during the study period; 20. Those who have made significant adjustments to their previous diet within the previous 4 weeks, or those whose diet cannot maintain basic stability during the study period; 21. Those who smoke an average of 5 or more cigarettes per day within the previous 4 weeks; 22. In the four weeks before screening, women's daily alcohol intake was more than 15 g, men's more than 25 g and more than twice a week, or the screening period and baseline period alcohol breath test (alcohol blood test can be replaced) was positive; 23. Those with a history of drug use or abuse; 24. Researchers, assistant researchers, research assistants, pharmacists, research coordinators, or other directly involved protocol implementers; 25. The researchers believe that subjects with any unfavorable factors to participate in this experiment.
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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
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The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
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Other studies related to the condition(s) this trial covers.
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