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New injection shows promise for dangerous fat levels

NCT ID NCT06555640

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested a new drug called DR10624 in 79 adults with severely high triglycerides, a type of blood fat that raises the risk of heart problems. Participants received injections under the skin for 12 weeks. The main goal was to see if the drug safely lowers triglyceride levels compared to a placebo.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

79 people

The number who actually took part.

Started

Aug 2024

Finished

Aug 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

17 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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 or their legally acceptable representatives must be able to provide written informed consent, understand the procedures and methods of the study, and agree to comply with all protocol requirements. 2.Male or female, age of 18 to 75 years (inclusive) at screening. 3.Subjects must have a BMI of \>19 kg/m2 and BMI of ≤45.0 kg/m2 , and body weight ≥50 Kg at screening. 4.During screening or within 1 week prior to screening, the TG levels should meet the following criteria: 4.80 mmol/L (425 mg/dL) ≤ fasting TG \< 22.60 mmol/L (2000 mg/dL). 5.The average fasting TG level of Visit 2 and Visit 3 values must meet: 5.65 mmol/L (500 mg/dL) ≤fasting TG \<22.60 mmol/L(2000 mg/dL); or the average fasting TG level of Visit 3 and Visit 3.1 values must meet the same criteria. 6.Subjects will able to accept rencommendation on therapeutic lifestyle modificationa and maintain a stable lifestyle for the duration of the study. 7.Subjects who are receiving statins, cholesterol-absorption inhibitor (CAI), fibrates, niacin ≥500 mg/day, or prescription omega-3 fish oil must have achieved a stable dose for at least 4 weeks before screening. 8.Subjects diagnosed with type 2 diabetes(T2DM) must have a glycosylated hemoglobin level at screening of\<9.5%(80 mmol/mol)and treated with lifestyle modification or a stable doses of antidiabetic medications for at least 8 weeks prior to screening. Exclusion Criteria: * 1.Subjects with known familial hyperchylomicronemia (Fredrickson type 1) ,apo c-II deficiency,or familial β-lipoprotein dyslipidemia (Fredrickson type 3); or subjects with a high suspicion of having this three conditions. 2.Subjects who have lost ≥5% of body weight within 3 months prior to screening, or who lose ≥5% of body weight during screening, or who plan to lose body weight during the study. 3.Subjects with type 1 diabetes, or nephrotic syndrome. 4.Subjects with cirrhosis, alcoholic liver disease, liver failure, liver cancer, or autoimmune hepatitis. 5.Subjects type 2 diabetes with a duration of less than 12 weeks or with severe complications. 6.Uncontrolled hypertension at screening, defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg under medication conditions. 7.Subjects with an active or untreated malignancy or who have been in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for \<5 years prior to screening. 8.Subjects with a family or personal history of medullary thyroid carcinoma (MTC),multiple endocrine neoplasia syndrome type 2 (MEN2),severe active or unstable major depressive disorder (MDD), or other serious mental disorders (such as schizophrenia, bipolar disorder, or other severe mood or anxiety disorders) or suicidal. 9.Subjects with a known clinically significant gastric emptying abnormality (e.g. severe diabetic gastroparesis), and who have undergone or plan to undergo gastric bypass surgery or gastric banding surgery during the study, or those who chronically take drugs that directly affect GI motility. 10.New York Heart Association Functional Classification III or IV CHF. 11.In the opinion of the investigator, the subjects are likely to require concurrent treatment with systemic glucocorticoids during the trial due to comorbidities. 12.Subjects with a history of acute pancreatitis within 1 year prior to screening, or a history of chronic pancreatitis, or symptomatic of gallbladder disease (e.g. choledocholithiasis, gallbladder multiple stones, unless treated with cholecystectomy). 13.Subjects with any of the following cardiovascular (CV) conditions within 6 months prior to screening: acute myocardial infarction, cerebral hemorrhage or cerebral infarction (except lacunar infarction), or hospitalization due to CHF, unstable angina pectoris or transient ischemic attack, or cardiac surgery such as percutaneous coronary intervention and coronary artery bypass grafting,or subjects who have been treated with GLP-1R agonists, or have participated in a clinical study involving GLP-1R and received the study drug within 6 months prior to screening. 14.Subjects who have undergone large-sized surgery,have been treated with GCGR or multiple target point and agonists containing FGF-21R targets;have been treated with SiRNA type and monoclonal antibody type of PCSK9 inhibitors;or who have participated in a clinical study related to above all the types of drug within 3 months prior to screening. 15.Subjects with severe trauma, severe infection who have not recoveredwithin 4 weeks prior to screening,who have been treated with DPP-4 inhibitors, or have participated in a clinical study related to DPP-4 inhibitors and received the study product;who have undergone lipid apheresis or plasma exchange treatment within the last 4 weeks or plan to undergo apheresis or plasma exchange during the study period. 16.Subjects with hyperthyroidism or hypothyroidism who have the stable dose of therapeutic drugs less than 3 months prior to screening. 17.Subjects with Cushing's syndrome or who have continuously or cumulatively used systemic glucocorticoids for more than 14 days within 6 months before screening, Inhaled or topical corticosteroids are permitted. 18.Subjects who do not agree to discontinue medications, supplements, or nutraceuticals that have lipid-altering effects other than those specified in the protocol. 19.Subjects who are taking insulin or second-generation antipsychotics and cannot stop taking them. 20.Serum calcitonin ≥20 ng/L (pg/mL) in subjects with eGFR≥60 mL/min/1.73 m2 , or serum calcitonin ≥35 ng/L (pg/mL) in subjects with eGFR \<60 mL/min/1.73 m2. 21.Alanine aminotransferase\>3.0 × upper limit of normal value (ULN) and/or aspartate aminotransferase\>3.0 × ULN and/or total bilirubin\>1.5 × ULN. 22.Glomerular filtration rate eGFR \< 45 mL/min/1.73 m2 23.TSH \> upper normal limit or \< lower normal limit. 24.Serum amylase or lipase \> 2.0 × ULN. 25.Hemoglobin \< 110 g/L (males) or \< 100 g/L (females). 26.Test positive for Human Immunodeficiency Virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV), HBV and HCV determined by antibodies first and, if positive, by DNA/ribonucleic acid (RNA). 27.Clinically significant 12-lead electrocardiogram (ECG) abnormalities at the time of screening. 28.History of drug abuse or excessive alcohol consumption within 3 months prior to screening. 29.Presence of potential allergies to the study drug, its ingredients, or drugs of the same class. 30.Pregnant or lactating women;as well as men and women of childbearing potential who are unwilling to prevent pregnancy throughout the study and within the specified time after the study. 31.Blood donation and/or blood loss ≥400 mL, or bone marrow donation within 3 months prior to screening. 32.Subjects in which the investigator deems to that there are any other factors may affect the efficacy or safety evaluation of this study(including medical, psychological, social, or geographical considerations) .

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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

  • Baoding No.1 Central Hospital

    Baoding, China

  • Chifeng Municipal Hospital

    Chifeng, China

  • Daqing People's Hospital

    Daqing, China

  • Huzhou Central Hospital

    Huzhou, China

  • Inner Mongolia People's Hospital.

    Hohhot, China

  • Lishui Municipal Central Hospital

    Lishui, China

  • Luoyang Third Peoples Hospital

    Luoyang, China

  • Meihekou Central Hospital

    Meihekou, China

  • Nanyang Central Hospital

    Nanyang, China

  • Panjin Liaoyou Baoshihua Hospital

    Panjin, China

  • Peking University First Hospital

    Beijing, China

  • Pingxiang People's Hospital

    Pingxiang, China

  • Second Xiangya Hospital of Central South University

    Changsha, China

  • Shaanxi Provincial People's Hospital

    Xi'an, China

  • The Affiliated Hospital of Hangzhou Normal University

    Hangzhou, China

  • The Affiliated Hospital of Nantong University

    Nantong, China

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, China

  • The First Affiliated Hospital of Baotou Medical College

    Baotou, China

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu, China

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, China

  • The First Affiliated Hospital of South China University

    Hengyang, China

  • The First Hospital of Jilin University

    Changchun, China

  • The Fourth Hospital of Harbin Medical University

    Harbin, China

  • The People's Hospital of Liaoning Province

    Shenyang, China

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, China

  • The Second Affiliated Hospital to Nanchang University

    Nanchang, China

  • The Second Hospital of Jilin University

    Changchun, China

  • The Third Affiliated Hospital of Xinjiang Medical University

    Xinxiang, China

  • The Third Hospital of Nanchang

    Nanchang, China

  • Yancheng First People's Hospital

    Yancheng, China

  • Yixing People's Hospital

    Yixing, China

  • Yiyang Central Hospital

    Yiyang, China

  • Yueyang Central Hospital

    Yueyang, China

  • Yuncheng Central Hospital

    Yuncheng, China

  • Zibo Municipal Hospital

    Zibo, China

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