LivingGLP1
Study S001370

A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of HRS-7535 in Adults With Diabetic Kidney Disease in Type 2 Diabetes

Registration

Registration
NCT06415214
Acronym
SOLID-DKD
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE2
Masking
QUADRUPLE
Status
COMPLETED
Enrollment
281
Start
2024-06-21
Primary completion
2025-07-15
Lead sponsor
Shandong Suncadia Medicine Co., Ltd.
Conditions
Diabetic Kidney Disease, Type 2 Diabetes
Interventions
DRUG:Placebo; DRUG:HRS-7535
Results posted
FALSE
Individual participant data sharing
UNDECIDED

Registered primary outcomes

  • Ratio of UACR at week 16 to UACR at baseline [at Week 16]

Linked records (2)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0004355Efficacy and safety of HRS-7535, an oral small-molecule GLP-1 receptor agonist, in patients with diabetic kidney disease (SOLID-DKD): a randomised, double-blind, placebo-controlled, phase 2 trial.
Lv R, EClinicalMedicine
2026Randomized trialPMID 42472282DOIcites ClinicalTrials.gov:NCT06415214; registry reference DERIVED:42472282
R0045356Efficacy and Safety of the Oral Small-Molecule GLP-1 Receptor Agonist HRS-7535 in Patients with Diabetic Kidney Disease
Xiaoying Du, Journal of the American Society of Nephrology
2025Randomized trialDOIcites ClinicalTrials.gov:NCT06415214