Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Subcutaneous Injections of HRS9531 in Patients With Type 2 Diabetes Mellitus

NCT05516966 · Completed

Last updated 2026-05-28

This clinical trial tests the safety and tolerability of multiple injections of the experimental drug HRS9531 in adults with type 2 diabetes.

Status Completed The study has finished.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 64 people

Who can join Ages 18–65 · all sexes

Timeline Started 2022-10 · est. completion 2023-05

Where 1 site · China

What this study is testing ClinicalTrials.gov NCT05516966 ↗

Description as written by the study sponsor.

The main purpose of this study is to assess the safety and tolerability of multiple subcutaneous injections of HRS9531 in patients with type 2 diabetes mellitus who have suboptimal glycaemic control after conventional lifestyle or metformin intervention.

Treatments tested

HRS9531 Drug

Administrated SC
Placebo Drug

Administrated SC
Dulaglutide Injection Drug

Administrated SC

Main thing measured	Incidence of Adverse Events (Safety and Tolerability)
Sponsor	Fujian Shengdi Pharmaceutical Co., Ltd.
Conditions studied	Diabetes Mellitus, Type 2
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05516966 ↗