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
Lead sponsor
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
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
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 endpointsChange 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
Change in Liver Fat Content (LFC) Measured by MRI-PDFF
Time frame:From baseline to Week 26
change from baseline, improvement
Renal / kidney
2 endpointsChange 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
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 endpointsPercentage 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
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 endpointsProportion 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
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 endpointsPercentage 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
Serum concentration of DR10624
Time frame:First study drug injection through 4-week post-treatment safety follow-up
concentration, descriptive
Provenance
Sources
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.