drugset / Trial / NCT06649344

A Study of HRS9531 Versus Semaglutide Once Weekly as Add-on Therapy to Metformin Monotherapy or in Combination With SGLT2 Inhibitors in Participants With Type 2 Diabetes

NCT06649344 ↗

Phase 3 Active not recruiting 884 enrolled Fujian Shengdi Pharmaceutical Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

The study is being conducted to evaluate the efficacy and safety of HRS9531 once weekly (QW) in subjects with type 2 diabetes mellitus not adequately controlled with metformin monotherapy or in combination with SGLT2 inhibitors compared to Semaglutide QW for 36 weeks and 52 weeks.

Timeline

Start
2024-10-31
Primary completion
2026-09-30
Completion
2026-09-30

Outcome

Met primary endpoint

release “(HRS9531-303)取得积极顶线结果 1 。瑞普泊肽注射液4 mg和2 mg两个剂量组均达到预设的主要终点” hengrui.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject HRS9531 Unknown — Subcutaneous
Comparator Semaglutide Peptide — Subcutaneous