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Not yet recruitingPhase 2

A Phase 2 Study to Evaluate the Efficacy and Safety of DR10624 in Subjects With Moderate Hypertriglyceridemia and Diabetic Kidney Disease

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

Asset

DR10624

Subcutaneous · GLP-1 / glucagon / FGF21 triple

Listed sites

2

Recruiting sites

-

Estimated enrollment

315

Study population

Dyslipidemia

Eligibility highlights

•BMI 19-45

Primary endpoint

•Fasting serum triglyceride concentration

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07848880
Org study IDDR10624-204

Timeline

Milestones

Study first posted2026-09-30actual
Last update posted2026-09-30actual
Study start2026-10estimated (month precision)
Primary completion2028-04estimated (month precision)
Study completion2029-03estimated (month precision)

Assets

Investigational agents

Who this study enrolls

Dyslipidemia

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Male or female participants, aged 18 to 75 years at screening.

2. BMI 19.0-45.0 kg/m², body weight ≥50.0 kg.

3. 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.

4. Diagnosis of type 2 diabetes mellitus for ≥12 weeks, with stable doses of glucose-lowering medication(s) for ≥8 weeks.

5. Meets the diagnostic criteria for diabetic kidney disease as defined in relevant guidelines.

6. eGFR and UACR meet the thresholds specified in the protocol.

7. On stable doses of renoprotective medication for ≥4 weeks.

8. Able to understand study procedures, maintain consistent lifestyle and follow all protocol-specified requirements, and provide written informed consent.

Exclusion criteria

1. Diagnosed with non-diabetic kidney disease ,history of or planned kidney transplantation,solitary kidney ;or recent dialysis due to acute renal insufficiency.

2. History of NYHA Class III-IV heart failure, obstructive valvular heart disease, or hypertrophic cardiomyopathy; uncontrolled hypertension or severe arrhythmia.

3. Recent acute coronary syndrome or cardiac surgery,severe diabetic events or ocular complications or bone disorders.

4. Unqualified laboratory results at screening: abnormal liver or pancreatic function indexes, elevated HbA1c, elevated calcitonin, or positive HIV/HBV/HCV serology.

5. 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.

6. History of acute pancreatitis, chronic pancreatitis or symptomatic gallbladder disease.

7. 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.

8. Lipid-lowering medications or medications that may exacerbate hypertriglyceridemia have not been at a stable dose for a sufficient duration.

9. 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.

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

MASH / liver
2
Renal / kidney
2
Cardiometabolic biomarkers
2
Safety / tolerability / PK
2
Other (unclassified)
2

MASH / liver

2 endpoints
Secondary/protocol endpoint

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 from baseline, improvement

Secondary/protocol endpoint

Change in Liver Fat Content (LFC) Measured by MRI-PDFF

Time frame:From baseline to Week 26

change from baseline, improvement

Renal / kidney

2 endpoints
Secondary/protocol endpoint

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 from baseline, improvement

Secondary/protocol endpoint

Change in eGFR from baseline

Time frame:From first study drug injection through the end of treatment (up to 64 weeks)

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints
Primary/protocol endpoint

Percentage change from baseline in fasting serum triglyceride concentration at Week 26

Time frame:Baseline up to Week 26 of double-blind treatment period

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage change in lipid profile from baseline

Time frame:From first study drug injection through the end of treatment (up to 64 weeks)

percent change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

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

threshold achievement, event

Secondary/protocol endpoint

Positive rate of anti-drug antibody (ADA) against DR10624

Time frame:First study drug injection through 4-week post-treatment safety follow-up

descriptive

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Percentage change in fasting TG from baseline

Time frame:From first study drug injection through the end of treatment (up to 64 weeks)

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Serum concentration of DR10624

Time frame:First study drug injection through 4-week post-treatment safety follow-up

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.