drugset / Trial / NCT06589765

A Study of HRS-7535 Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequately Controlled With Metformin

NCT06589765 ↗

Phase 3 Completed 810 enrolled Shandong Suncadia Medicine Co., Ltd.
RandomizedParallel-groupDouble-blindTreatment

Summary

The aim of this trial is to evaluate the efficacy and safety of HRS-7535 compared with dapagliflozin in subjects with type 2 diabetes mellitus with inadequate glycemic control using metformin.

Timeline

Start
2024-09-27
Primary completion
2026-05-29
Completion
2026-05-29

Outcome

Met primary endpoint

release “OUTSTAND-2 met its primary endpoint, non-inferiority to dapagliflozin across all HRS-7535 dose levels (30 mg, 60 mg, and 90 mg) at Week 32” kailera.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dapagliflozin Small molecule — Oral
Subject HRS-7535 Small molecule — Oral