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

NCT07848880 | Not Yet Recruiting Phase 2

• 1 other identifier: DR10624-204
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 2

Brief 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 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

Outcome Measures

Primary Outcomes (1)

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

  Baseline up to Week 26 of double-blind treatment period

Secondary Outcomes (9)

• Percentage change in fasting TG from baseline

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

• Percentage change in lipid profile from baseline

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

• Change in urine albumin-to-creatinine ratio (UACR) from baseline

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

• Change in eGFR from baseline

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

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

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

Study Arms (4)

Dose 1 DR10624 Group

EXPERIMENTAL

Subcutaneous injection of DR10624 once weekly

Drug: DR10624 Injection

Dose 2 DR10624 Group

EXPERIMENTAL

Subcutaneous injection of DR10624 once weekly

Drug: DR10624 Injection

Dose 3 DR10624 Group

EXPERIMENTAL

Subcutaneous injection of DR10624 once weekly

Drug: DR10624 Injection

Placebo Group

PLACEBO COMPARATOR

Subcutaneous injection of placebo once weekly

Drug: Placebo

Interventions

Placebo DRUG

Placebo

Placebo Group

DR10624 Injection DRUG

DR10624 Injection

Dose 1 DR10624 Group; Dose 2 DR10624 Group; Dose 3 DR10624 Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Zhejiang Doer Biologics Co., Ltd.: lead

Study Sites (2)

Peking University First Hospital

Beijing, China

Location

Peking University Third Hospital

Beijing, China

Location

MeSH Terms

Conditions

Hypertriglyceridemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Yongliang Fang

CONTACT

+86 057128256206; yf@dorebio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: September 30, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: September 30, 2026

Record last verified: 2026-08

Locations

CN (2)