HypertriglyceridemiaPhase 2NCT07848880
A Phase 2 Study to Evaluate the Efficacy and Safety of DR10624 in Subjects With Moderate Hypertriglyceridemia and Diabetic Kidney Disease
A Phase 2 study testing DR10624 Injection in people with Hypertriglyceridemia, run by Zhejiang Doer Biologics Co., Ltd. at 2 sites in China.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 trial in adults with moderate hypertriglyceridemia and diabetic kidney disease. Eligible participants complete a screening period and then randomized to four treatment groups: three active-dose groups of subcutaneous DR10624 and one placebo… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- 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
- 315 participants
- Where
- 2 sitesChina
- Study dates
- Oct 2026to Mar 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants, aged 18 to 75 years at screening.
- BMI 19.0-45.0 kg/m², body weight ≥50.0 kg.
- At least two triglyceride measurements of ≥2.3 mmol/L and <5.7 mmol/L during the screening period, with an interval of more than 1 week between the two measurements.
- Diagnosis of type 2 diabetes mellitus for ≥12 weeks, with stable doses of glucose-lowering medication(s) for ≥8 weeks.
- Meets the diagnostic criteria for diabetic kidney disease as defined in relevant guidelines.
- eGFR and UACR meet the thresholds specified in the protocol.
- On stable doses of renoprotective medication for ≥4 weeks.
- Able to understand study procedures, maintain consistent lifestyle and follow all protocol-specified requirements, and provide written informed consent.
Who cannot join
- Diagnosed with non-diabetic kidney disease ，history of or planned kidney transplantation，solitary kidney ；or recent dialysis due to acute renal insufficiency.
- History of NYHA Class III-IV heart failure, obstructive valvular heart disease, or hypertrophic cardiomyopathy; uncontrolled hypertension or severe arrhythmia.
- Recent acute coronary syndrome or cardiac surgery，severe diabetic events or ocular complications or bone disorders.
- Unqualified laboratory results at screening: abnormal liver or pancreatic function indexes, elevated HbA1c, elevated calcitonin, or positive HIV/HBV/HCV serology.
- Prior exposure to GLP-1R, GCGR, or FGF21R agonists; use of relevant investigational drugs or participation in other interventional trials within 3 months; or use of DPP-4 inhibitors within 4 weeks.
- History of acute pancreatitis, chronic pancreatitis or symptomatic gallbladder disease.
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- Severe psychiatric disorders, substance abuse, family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)or malignancy within the past 5 years.
- Lipid-lowering medications or medications that may exacerbate hypertriglyceridemia have not been at a stable dose for a sufficient duration.
- Pregnancy or lactation; refusal to use contraception; known hypersensitivity to the study drug; or any condition that, in the investigator's judgment, makes the participant unsuitable for the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Peking University First Hospital
Beijing
Minghui Zhao
Peking University Third Hospital
Beijing
Yida Tang
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate the Efficacy and Safety of Multiple Doses of DR10624 in Subjects With Moderate Hypertriglyceridemia and Diabetic Kidney Disease
This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 trial in adults with moderate hypertriglyceridemia and diabetic kidney disease. Eligible participants complete a screening period and then randomized to four treatment groups: three active-dose groups of subcutaneous DR10624 and one placebo group. All groups receive weekly subcutaneous injections for a total of 64 weeks of double-blind treatment, followed by a 4-week post-treatment safety follow-up. The primary objective is to evaluate the triglyceride-lowering effect of DR10624 versus placebo. Secondary assessments include other lipid parameters, renal parameters, hepatic fat fraction, overall safety, and anti-drug antibody status.
- Conditions
- Hypertriglyceridemia
- 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
DR10624 Injection
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 DR10624 Group | Experimental | Subcutaneous injection of DR10624 once weekly Receives: Drug: DR10624 Injection |
| Dose 2 DR10624 Group | Experimental | Subcutaneous injection of DR10624 once weekly Receives: Drug: DR10624 Injection |
| Dose 3 DR10624 Group | Experimental | Subcutaneous injection of DR10624 once weekly Receives: Drug: DR10624 Injection |
| Placebo Group | Placebo comparator | Subcutaneous injection of placebo once weekly Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change from baseline in fasting serum triglyceride concentration at Week 26
Measured: Baseline up to Week 26 of double-blind treatment period
Secondary outcomes (9)
Percentage change in fasting TG from baseline
Percentage change in fasting TG from baseline
Measured: From first study drug injection through the end of treatment (up to 64 weeks)
Percentage change in lipid profile from baseline
The change from baseline in the following lipid parameters will be assessed: total cholesterol (TC), non-high-density lipoprotein cholesterol (non-HDL-C), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), small dense low-density lipoprotein cholesterol (sdLDL-C), very low-density lipoprotein cholesterol (VLDL-C), triglyceride-rich lipoprotein cholesterol (TRL-C), and free fatty acids (FFA).
Measured: From first study drug injection through the end of treatment (up to 64 weeks)
Change in urine albumin-to-creatinine ratio (UACR) from baseline
Percentage change in urine albumin-to-creatinine ratio (UACR) from baseline
Measured: From first study drug injection through the end of treatment (up to 64 weeks)
Change in eGFR from baseline
The absolute change and percentage change in estimated glomerular filtration rate from baseline
Measured: From first study drug injection through the end of treatment (up to 64 weeks)
Change in Liver Fat Content (LFC) Measured by MRI-PDFF
The absolute change and percentage change in LFC from baseline measured by MRI-PDFF
Measured: From first study drug injection through the end of treatment (up to 64 weeks)
Change in Liver Fat Content (LFC) Measured by MRI-PDFF
The percentage of participants with ≥30% relative reduction in liver fat content (LFC) from baseline, ≥50% relative reduction in LFC from baseline, or absolute LFC < 5%,
Measured: From baseline to Week 26
Proportion of participants with treatment-emergent adverse events (TEAEs) throughout the study
All adverse events emerging from the first study drug injection until 4 weeks after the last injection are captured, coded by MedDRA and graded per pre-defined severity criteria. The percentage of participants experiencing any TEAE and the distribution of maximum TEAE severity will be summarized for the full safety observation window.
Measured: First study drug injection through 4-week post-treatment safety follow-up
Serum concentration of DR10624
Pharmacokinetic assessment: serum DR10624 concentration at scheduled sampling time points
Measured: First study drug injection through 4-week post-treatment safety follow-up
Positive rate of anti-drug antibody (ADA) against DR10624
Positive rate of ADA against DR10624
Measured: First study drug injection through 4-week post-treatment safety follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 315 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Doer Biologics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848880
- Sponsor's protocol ID
- DR10624-204
- Status last verified
- Aug 2026
- First submitted
- 24 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate the Efficacy and Safety of Multiple Doses of DR10624 in Subjects With Moderate Hypertriglyceridemia and Diabetic Kidney Disease
- ClinicalTrials.gov ID
- NCT07848880
- Acronym / sponsor ID
- DR10624-204
- Conditions
- Hypertriglyceridemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 315 participants (estimated)
- Lead sponsor
- Zhejiang Doer Biologics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 trial in adults with moderate hypertriglyceridemia and diabetic kidney disease. Eligible participants complete a screening period and then randomized to four treatment groups: three active-dose groups of subcutaneous DR10624 and one placebo group. All groups receive weekly subcutaneous injections for a total of 64 weeks of double-blind treatment, followed by a 4-week post-treatment safety follow-up. The primary objective is to evaluate the triglyceride-lowering effect of DR10624 versus placebo. Secondary assessments include other lipid parameters, renal parameters, hepatic fat fraction, overall safety, and anti-drug antibody status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose 1 DR10624 Group | Experimental | Drug: DR10624 InjectionSubcutaneous injection of DR10624 once weekly |
| Dose 2 DR10624 Group | Experimental | Drug: DR10624 InjectionSubcutaneous injection of DR10624 once weekly |
| Dose 3 DR10624 Group | Experimental | Drug: DR10624 InjectionSubcutaneous injection of DR10624 once weekly |
| Placebo Group | Placebo comparator | Drug: PlaceboSubcutaneous injection of placebo once weekly |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female participants, aged 18 to 75 years at screening.
- BMI 19.0-45.0 kg/m², body weight ≥50.0 kg.
- At least two triglyceride measurements of ≥2.3 mmol/L and <5.7 mmol/L during the screening period, with an interval of more than 1 week between the two measurements.
- Diagnosis of type 2 diabetes mellitus for ≥12 weeks, with stable doses of glucose-lowering medication(s) for ≥8 weeks.
- Meets the diagnostic criteria for diabetic kidney disease as defined in relevant guidelines.
Key exclusion criteria (9 listed)
- Diagnosed with non-diabetic kidney disease ，history of or planned kidney transplantation，solitary kidney ；or recent dialysis due to acute renal insufficiency.
- History of NYHA Class III-IV heart failure, obstructive valvular heart disease, or hypertrophic cardiomyopathy; uncontrolled hypertension or severe arrhythmia.
- Recent acute coronary syndrome or cardiac surgery，severe diabetic events or ocular complications or bone disorders.
- Unqualified laboratory results at screening: abnormal liver or pancreatic function indexes, elevated HbA1c, elevated calcitonin, or positive HIV/HBV/HCV serology.
- Prior exposure to GLP-1R, GCGR, or FGF21R agonists; use of relevant investigational drugs or participation in other interventional trials within 3 months; or use of DPP-4 inhibitors within 4 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DR10624 InjectionDR10624 Injection | Drug | Dose 1 DR10624 Group, Dose 2 DR10624 Group, Dose 3 DR10624 Group |
| PlaceboPlacebo | Drug | Placebo Group |
Primary outcome
Percentage change from baseline in fasting serum triglyceride concentration at Week 26
Time frame: Baseline up to Week 26 of double-blind treatment period
9 secondary outcomes
Percentage change in fasting TG from baseline
Time frame: From first study drug injection through the end of treatment (up to 64 weeks)
Percentage change in lipid profile from baseline
Time frame: From first study drug injection through the end of treatment (up to 64 weeks)
Change in urine albumin-to-creatinine ratio (UACR) from baseline
Time frame: From first study drug injection through the end of treatment (up to 64 weeks)
Change in eGFR from baseline
Time frame: From first study drug injection through the end of treatment (up to 64 weeks)
Change in Liver Fat Content (LFC) Measured by MRI-PDFF
Time frame: From first study drug injection through the end of treatment (up to 64 weeks)
Change in Liver Fat Content (LFC) Measured by MRI-PDFF
Time frame: From baseline to Week 26
Proportion of participants with treatment-emergent adverse events (TEAEs) throughout the study
Time frame: First study drug injection through 4-week post-treatment safety follow-up
Serum concentration of DR10624
Time frame: First study drug injection through 4-week post-treatment safety follow-up
Positive rate of anti-drug antibody (ADA) against DR10624
Time frame: First study drug injection through 4-week post-treatment safety follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DR10624 Injection in people with Hypertriglyceridemia, run by Zhejiang Doer Biologics Co., Ltd. at 2 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 9 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: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yongliang Fang (+86 057128256206, yf@dorebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change from baseline in fasting serum triglyceride concentration at Week 26 (time frame: Baseline up to Week 26 of double-blind treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.