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COMPLETED
NCT05881837
PHASE2

A Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes

Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

This study aims to evaluate the efficacy and dose-response relationship of HRS9531 injection compared with placebo in reducing body weight in obese subjects without diabetes after 24 weeks of treatment.

Official title: A Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled, Phase II Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

249

Start Date

2023-06-13

Completion Date

2024-10-13

Last Updated

2026-10-22

Healthy Volunteers

No

Interventions

DRUG

HRS9531 injection

HRS9531 injection: dose level 1 for 32 weeks; level 2 for 20 weeks

DRUG

HRS9531 injection

HRS9531 injection: dose level 2

DRUG

HRS9531 injection

HRS9531 injection: dose level 3

DRUG

HRS9531 injection

HRS9531 injection: dose level 4

DRUG

HRS9531 injection Placebo

Placebo arm matching active arm HRS9531 injection dose level 1 for 32 weeks; HRS9531 injection level 2 for 20 weeks

DRUG

HRS9531 injection Placebo

Placebo arm matching active arm HRS9531 injection dose level 2 for 32 weeks; HRS9531 injection level 2 for 20 weeks

DRUG

HRS9531 injection Placebo

Placebo arm matching active arm HRS9531 injection dose level 3 for 32 weeks; HRS9531 injection level 2 for 20 weeks

DRUG

HRS9531 injection Placebo

Placebo arm matching active arm HRS9531 injection dose level 4 for 32 weeks; HRS9531 injection level 2 for 20 weeks

Locations (25)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Huadu District People's Hospital of Guangzhou

Guangzhou, Guangdong, China

The People's Hospital of Longhua. Shenzhen

Shenzhen, Guangdong, China

Sencond Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

The First Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology

Luoyang, Henan, China

The First Affiliated Hospital of Nanyang Medical College

Nanyang, Henan, China

The Central Hospital Of Huangshi

Huangshi, Hubei, China

The Third People's Hospital of Hubei Province

Wuhan, Hubei, China

Baotou Central Hospital

Baotou, Inner Mongolia, China

Lianyungang Hospital of TCM

Lianyungang, Jiangsu, China

The First People's Hospital Of Lianyungang

Lianyungang, Jiangsu, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

North Jiangsu People's Hospital

Yangzhou, Jiangsu, China

The Second Hospital of Jilin University

Changchun, Jilin, China

Shengjing Hospital Of China Medical University

Shenyang, Liaoning, China

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Second Hospttoal of Shanxi Medical University

Taiyuan, Shanxi, China

The First Affiliated Hospital of Xi'an Medical College

Xian, Shanxi, China

Chengdu Second People's Hospital

Chengdu, Sichuan, China

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

The First People's Hospital of Hangzhou

Hangzhou, Zhejiang, China