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Severe HypertriglyceridemiaPhase 2NCT06555640

A Phase II Study to Evaluate the Efficacy and Safety of of DR10624 in Subjects With Severe Hypertriglyceridemia

A Phase 2 study testing DR10624 Injection in people with Severe Hypertriglyceridemia, run by Zhejiang Doer Biologics Co., Ltd. at 35 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

DR10624 is an Fc fusion protein tri-agonist with balanced glucagon-like peptide-1 receptor (GLP-1R)/glucagon receptor (GCGR)/ fibroblast growth factor 21 receptor (FGF21R) agonizing activities. Read more about this study

Who is it for?
Ages 17 to 75 years
Conditions the study is for
Severe Hypertriglyceridemia
What is being tested?
DR10624 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
79 participants
Where
35 sitesChina
Study dates
1 Aug 2024to 29 Aug 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 32Show fewer
  • 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) .

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

China35 sites

  • Baoding No.1 Central Hospital

    Baoding

  • The First Affiliated Hospital of Baotou Medical College

    Baotou

  • Peking University First Hospital

    Beijing

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu

  • The First Hospital of Jilin University

    Changchun

  • The Second Hospital of Jilin University

    Changchun

  • Second Xiangya Hospital of Central South University

    Changsha

  • Chifeng Municipal Hospital

    Chifeng

  • Daqing People's Hospital

    Daqing

  • The Affiliated Hospital of Hangzhou Normal University

    Hangzhou

  • The Fourth Hospital of Harbin Medical University

    Harbin

  • The First Affiliated Hospital of South China University

    Hengyang

  • Inner Mongolia People's Hospital.

    Hohhot

  • Huzhou Central Hospital

    Huzhou

  • Lishui Municipal Central Hospital

    Lishui

  • Luoyang Third Peoples Hospital

    Luoyang

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

    Luoyang

  • Meihekou Central Hospital

    Meihekou

  • The Second Affiliated Hospital to Nanchang University

    Nanchang

  • The Third Hospital of Nanchang

    Nanchang

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing

  • The Affiliated Hospital of Nantong University

    Nantong

  • Nanyang Central Hospital

    Nanyang

  • Panjin Liaoyou Baoshihua Hospital

    Panjin

  • Pingxiang People's Hospital

    Pingxiang

  • The People's Hospital of Liaoning Province

    Shenyang

  • Shaanxi Provincial People's Hospital

    Xi'an

  • The Third Affiliated Hospital of Xinjiang Medical University

    Xinxiang

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou

  • Yancheng First People's Hospital

    Yancheng

  • Yixing People's Hospital

    Yixing

  • Yiyang Central Hospital

    Yiyang

  • Yueyang Central Hospital

    Yueyang

  • Yuncheng Central Hospital

    Yuncheng

  • Zibo Municipal Hospital

    Zibo

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of Subcutaneous Injection of DR10624 in Subjects With Severe Hypertriglyceridemia

DR10624 is an Fc fusion protein tri-agonist with balanced glucagon-like peptide-1 receptor (GLP-1R)/glucagon receptor (GCGR)/ fibroblast growth factor 21 receptor (FGF21R) agonizing activities. The objectives of the planned clinical investigation will be to evaluate the efficacy of DR10624 on fasting serum triglyceride (TG) levels after 12 weeks of treatment in subjects with severe hypertriglyceridemia (SHTG).

Read the detailed description

The subjects will be randomly assigned to experimental groups and placebo-controlled groups. Each participant will be enrolled in only one cohort.

Being tested
DR10624 Injection, Placebo
Medical subject headings
Hypertriglyceridemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DR10624 InjectionDrug

    Drug: DR10624 injection

  • PlaceboDrug

    Drug: placebo

Study groups in NCT06555640
Study groupRoleWhat they receive
Cohort 1: DR10624 injectionExperimentalDR10624 injection administered weekly (QW)
Receives: Drug: DR10624 Injection
Cohort 1: PlaceboPlacebo comparatorPlacebo administered weekly (QW)
Receives: Drug: Placebo
Cohort 2: DR10624 injectionExperimentalDR10624 injection administered weekly (QW)
Receives: Drug: DR10624 Injection
Cohort 2: PlaceboPlacebo comparatorPlacebo administered weekly (QW)
Receives: Drug: Placebo
Cohort 3: DR10624 injectionExperimentalDR10624 injection administered weekly (QW)
Receives: Drug: DR10624 Injection
Cohort 3: PlaceboPlacebo comparatorPlacebo administered weekly (QW)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of fasting TG

    The percentage change of fasting TG in all the participants from baseline to Week 12

    Measured: From baseline to Week 12

Secondary outcomes (9)

  1. Change of lipid profile and lipoprotein profile

    The percentage change of fasting total cholesterol (TC), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), non-high density lipoprotein cholesterol (non-HDL-C), very low density lipoprotein cholesterol (VLDL-C), free fatty acid (FFA), triglyceride rich lipoprotein cholesterol (TRL-C), lipoprotein (a) [Lp(a)], apolipoprotein C3 (Apo C3), apolipoprotein B (Apo B), apolipoprotein B48 (Apo B48), apolipoprotein B100 (Apo B100), apolipoprotein A1 (Apo A1) and apolipoprotein A5 (Apo A5)

    Measured: From baseline to Week 12

  2. Number of participants whose fasting TG lowered by at least 50%

    The number of participants whose fasting TG decreased by at least 50% from baseline

    Measured: From baseline to Week 12

  3. Change of glycosylated hemoglobin (HbA1C)

    The change of glycosylated hemoglobin (HbA1C) in all participants

    Measured: From baseline to Week 12

  4. Change of liver fat content

    Measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF)

    Measured: From baseline to week 12

  5. Change of liver stiffness measurements (LSM)

    The change of liver stiffness in subjects with baseline hepatic fat fraction of at least 8% measured by FibroScan

    Measured: From baseline to week 12

  6. Change of controlled decay index (CAP)

    The change of CAP in subjects with baseline hepatic fat fraction of at least 8% measured by MRI-PDFF

    Measured: From baseline to week 12

  7. Incidence and severity of adverse events

    The number of participants with treatment-related adverse events as assessed by CTCAE V5.0, such outcomes are included but not limited to hypoglycemia events, injection site reactions, 12-lead Electrocardiogram (ECG) QTc intervals and vital signs (blood pressure, heart rate, respiratory rate and body temperature), physical examinations and safety laboratory tests, etc.

    Measured: through study completion, up to 17 weeks

  8. Anti-drug antibody（ADA）

    Anti-drug antibody（ADA）

    Measured: through study completion, up to 17 weeks

  9. Pharmacokinetic Ctrough blood concentration of DR10624

    Pharmacokinetic Ctrough blood concentration of DR10624

    Measured: through study completion, up to 17 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2024
  2. Study start1 Aug 2024
  3. Primary completion30 Jun 2025
  4. Study completion29 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06555640
Sponsor's protocol ID
DR10624-201
Status last verified
Jan 2026
First submitted
30 Jul 2024
Last updated
13 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DR10624 Injection in people with Severe Hypertriglyceridemia, run by Zhejiang Doer Biologics Co., Ltd. at 35 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of fasting TG (time frame: From baseline to Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06555640.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026; AzTrials last refreshed its copy on 2 Nov 2026.

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