New injection for high cholesterol begins first human safety tests
NCT ID NCT07241923
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 1 trial is testing a new injection called SYH2070 in 48 healthy adults to see if it is safe and how the body processes it. Participants will receive either the drug or a placebo, and researchers will monitor for side effects and measure blood fat levels. This is an early step to see if the drug might one day help lower high triglycerides and cholesterol.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SYH2070 injection
- What this could lead to
- If this early study shows the drug is safe, it could lead to larger trials testing whether SYH2070 can lower high triglycerides and cholesterol.
- What could go wrong
- This is a very early, small phase 1 trial in healthy people, not patients. The drug may not work or could have side effects. Many drugs fail at this stage.
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 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- 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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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. Subjects must provide informed consent before the trial, fully understand its content, procedures, and potential adverse reactions, and voluntarily sign the written ICF; 2. Sex: Male or female; 3. Age: 18-60 years (inclusive); 4. Body mass index (BMI) in the range of 19 to 30 kg•m\^2 \[BMI = weight/height\^2 (kg•m\^2)\] (inclusive), with a weight of no less than 50 kg for males (inclusive) and no less than 45 kg for females (inclusive); 5. Fasting serum TG ≥150 mg/dL (1.7 mmol/L) and ≤ 500 mg/dL (5.6 mmol/L), and LDL-C ≥70 mg/dL (1.8 mmol/L) and \< 190 mg/dL (4.9 mmol/L) during the screening and baseline periods; 6. Subjects must maintain stable die, exercise, and other lifestyle habits from 4 weeks prior to screening until the end of the study, with no planned changes to diet, exercise or weight loss programs; 7. Subjects must be able to communicate well with the investigator and can complete the study according to the protocol requirements. Exclusion Criteria: 1. History of severe allergic diseases or allergic constitution (≥ 3 drug or food allergies), or known history of allergy to the investigational drug components (N-acetylgalactosamine, sodium hydroxide, phosphoric acid) or oligonucleotide drugs; 2. Use of antibody drugs and/or oligonucleotide drugs targeting PCSK9/ANGPTL3/ApoC-III within 12 months prior to screening; 3. Current and/or history of clinically significant medical conditions, including but not limited to circulatory, hematological or hematopoietic, respiratory, endocrine, urinary, digestive system diseases, neurological or psychiatric disorders, infections, tumors, severe trauma, or any other disease that should be excluded or may interfere with the interpretation of the study results, as judged by the investigator; 4. History of major surgery within 6 months prior to screening, or are scheduled to undergo major surgery during the course of the study; 5. History of bariatric surgery within 12 months prior to screening; 6. Have clinically significant abnormalities in vital signs, physical examination, electrocardiogram, and laboratory tests (excluding lipid parameters); 7. Estimated glomerular filtration rate (eGFR) \<90 mL/min/1.73 m\^2 at screening; 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), gamma-glutamyl transferase (GGT), or alkaline phosphatase (ALP) \>1.5× upper limit of normal (ULN) at screening (one retest allowed within 1 week); 9. Prolonged QT / QTc interval at screening or baseline (QTcF \> 450 ms); 10. Positive result for any of HBsAg, HCV antibody, syphilis antibody, and HIV antibody; 11. Blood loss or donation \>200 mL within 3 months prior to screening (excluding menstruation for females), and/or platelet donation within 2 weeks; 12. Use of any drugs, health supplements, vitamins, or dietary supplements known to affect lipid metabolism within the longer of either: (a) 28 days prior to dosing; (b) 7 half-lives of the drug; (3) the duration of the agent's pharmacological effect, including but not limited to statins, fish oil, high-purity omega-3, prescription-dose niacin, fibrates, or anti-estrogen therapy;
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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 places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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Clinical Trials Information Group
RECRUITINGShijiazhuang, Hebei, China
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