An interventional study of DR10624 Injection； and DR10624 Injection Placebo (referred to as placebo) in Hypertriglyceridemia and Carotid Atherosclerotic Plaques, sponsored by Junbo Ge. Enrolling by invitation at 4 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by Junbo Ge · Not applicable, Interventional, and Treatment
This is a researcher-initiated study to evaluate the effect of DR10624 injection on carotid atherosclerotic plaques in patients with hypertriglyceridemia and carotid atherosclerotic plaques. The study adopts a randomized, double-blind, placebo-controlled design. The treatment group has one dose group, with titration administration. The administration starts at 12.5 mg QW for 4 weeks, then titrates to 25 mg QW for 4 weeks, and finally to 50 mg QW for 16 weeks, totaling 24 administrations. The control group receives placebo treatment with the same volume and administration method as the treatment group.
The study is divided into a screening period (3 weeks), a treatment period (24 weeks), and a follow-up period (4 weeks).
Screening period (W-3 to W-1):
Before participating in the screening, the subjects must fully understand all the risks and possible benefits of the trial and sign a written informed consent form voluntarily. Subjects entering the screening period will also receive therapeutic lifestyle guidance. Two fasting serum triglyceride tests are required during the screening period, with one test completed within one week before the first administration and an interval of at least one week between the two tests. On the day before the treatment period (D-1), eligible subjects will be randomly assigned and receive a randomization number.
Treatment period (W0 to W24):
Subjects who pass the screening will enter the treatment period and receive the target dose through titration. They will receive DR10624 injection at 12.5 mg QW or placebo QW for 4 weeks (W0 to W3), then at 25 mg QW or placebo QW for 4 weeks (W4 to W7), and finally at 50 mg QW or placebo QW for 16 weeks (W8 to W23), totaling 24 administrations over 24 weeks. Subjects need to return to the research center weekly for drug administration during W0 to W23. After each administration, injection site observations are required (30 minutes (±10 minutes) and 1 hour (±10 minutes) after each administration to check for injection site reactions), and corresponding efficacy and safety evaluations are completed as per the visit schedule. The last administration is on D162, and the end of treatment is defined as one week after the last administration (W24, D169). All subjects will return to the research center on D169 for the last efficacy and safety evaluations during the treatment period.
Safety follow-up period (W25 to W28):
All subjects who complete the treatment will enter a 4-week safety follow-up period. The final visit is on D197, and all subjects will return to the research center on D197 for the final assessment of this study.
324 studies on the registry are indexed under Hypertriglyceridemia; 38 are open to participants now.
This study's planned enrollment of 40 is below the median of 66 across 288 interventional studies indexed under Hypertriglyceridemia.
Browse Hypertriglyceridemia studies →Junbo Ge is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
(1) >3.0× (ULN) and/or AST>3.0×ULN and/or >1.5×ULN; (2) Creatinine>1.5×upper limit of normal; or \<45 mL/min/1.73m². (3) Serum calcium≥35 ng/mL (pg/mL); (4) TSH\<lower limit of normal, or>10 U/ml; (5) Serum amylase or lipase>2.0×ULN; (6) \<110 g/L (male) or\<100 g/L (female); (7) Positive - Ab test; (8) ≥9.0% during screening. 20. Participants with any clinically significant 12 - lead (ECG) abnormalities at screening:
21. A history of drug abuse or excessive alcohol consumption within 3 months prior to screening. [Excessive alcohol consumption is defined as an average weekly intake of more than 21 units for men and more than 14 units for women (1 unit=360 mL beer, or 150 mL wine, or 45 mL spirits with 40% alcohol).] 22. Pregnant or breastfeeding women, or men or women with who are unwilling to use throughout the study and for a specified period after the study ends [30 days after the last dose for women or 90 days for men].
23. Blood donation or blood loss of≥400 mL or donation within 3 months prior to screening.
24. Participants with other factors that the investigator considers unsuitable for study participation.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The experimental group uses a titration administration method: starting with 12.5 mg QW for 4 weeks, then titrating to 25 mg QW for another 4 weeks, and finally increasing to 50 mg QW, which is maintained for 16 weeks, for a total of 24 doses.
Drug: DR10624 Injection；
Drug: DR10624 Injection Placebo (referred to as placebo)
The experimental group(Trial Drug) * Name: DR10624 Injection (referred to as DR10624) * Specification: 60mg (1mL)/vial * Active Ingredient: DR10624 * Route of Administration: Subcutaneous injection * Packaging: Vial * Expiry Date: See the drug label * Storage Conditions: 2\~8℃, protected from light * Manufacturer: Zhixiang Bio (Suzhou) Co., Ltd. * Supplier: Zhejiang Daor Biotechnology Co., Ltd.
(The control group)Placebo: Name: DR10624 Injection Placebo (referred to as placebo) Specification: 0mg (1mL)/vial (no active ingredient) Main Component: Normal saline Route of Administration: Subcutaneous injection Packaging: Vial Expiry Date: See the drug label Storage Conditions: 2\~8℃, protected from light Manufacturer: Zhixiang Bio (Suzhou) Co., Ltd. Supplier: Zhejiang Daor Biotechnology Co., Ltd.
Change in carotid intima-media thickness (IMT) from baseline at treatment week 24 (W24).
Time frame: 24weeks
Change in IMT from baseline at W12
Time frame: 12weeks
Change in carotid plaque length from baseline at W12 and W24
Time frame: 12weeks，24weeks
Percentage change in carotid plaque area (TPA) from baseline at W12 and W24
Time frame: 12weeks，24weeks
Change in maximum carotid plaque thickness from baseline at W12 and W24
Time frame: 12weeks,24weeks
Change in carotid plaque ultrasound echo intensity from baseline at W12 and W24
Time frame: 12weeks and 24weeks
Change in VAP - detected lipoprotein subfraction analysis from baseline at W24
Time frame: 24weeks
Change in plasma concentration lysophosphatidylcholine and lysophosphatidylcholine from baseline at W12 and W24
Time frame: 12weeks and 24weeks
Percentage change in four blood lipid parameters (triglycerides, total cholesterol, LDL - C, HDL - C) from baseline at W12 and W24
Time frame: 12weeks and 24weeks
Safety evaluation
Vital signs (body temperature)
Time frame: 28weeks
Safety evaluation
Vital signs ：Heart rate（beats per minute）
Time frame: 28weeks
safety evaluation
Vital signs ：blood pressure（mmHg）
Time frame: 28weeks
safety evaluation
Vital signs :respiratory rate (breaths per minute)
Time frame: 28weeks
Number of participants with Physical examination
Physical examination: including general appearance, skin and mucous membranes, head and neck, thyroid gland, chest and abdomen, spine and limbs, nervous system, and lymphatic system.
Time frame: 28weeks
safety evaluation
ECG：PR interval（ms）
Time frame: 28weeks
safety evaluation
ECG:heart rate(bpm)
Time frame: 28weks
safety evaluation
ECG:QT interval(ms)
Time frame: 28weeks
safety evaluation
ECG: QTcF(ms)
Time frame: 28weeks
Number of Participants With Abnormal Laboratory Values
Laboratory tests ： blood routine test（WBC、RBC、PLT、HGB、HCT、NEUT、BASO、EOS、MONO、LYM）； blood biochemistry test （ALT、AST、TBIL、DBIL、ALB、TP、GGT、ALP、LDH、K⁺、Na⁺、Ca²⁺、Cl-、P、UA、Urea/BUN、Cr、GLU、CK）； urine routine（pH、PRO、GLU、RBC、WBC、KET）
Time frame: 28weeks
safety evaluation checklist
Injection site reaction（Subcutaneous injection - the injection site is on both sides of the abdominal wall, more than 5cm away from the umbilicus.）
Time frame: 28weeks
Plan to share: No
Started Jul 2025 (actual). Primary completion is estimated for Dec 2026, 17 months after the start.
Of 42 non-industry interventional studies with no phase under Hypertriglyceridemia, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 39. This study's planned 17 months is below that.
Counting every sponsor, half of 45 studies reached it within 23 months; a quarter within 7 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Studies of the drug tested here: DR10624
Junbo Ge