Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes

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

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.

Study Overview

• Status: Completed
• Conditions: Overweight or Obesity
• Intervention / Treatment: Drug: HRS9531 injection; Drug: HRS9531 injection; Drug: HRS9531 injection; Drug: HRS9531 injection; Drug: HRS9531 injection Placebo; Drug: HRS9531 injection Placebo; Drug: HRS9531 injection Placebo; Drug: HRS9531 injection Placebo

• Study Type: Interventional
• Enrollment (Actual): 249
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230601
      • The Second Affiliated Hospital of Anhui Medical University
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital
  • Chongqing
    • Chongqing, Chongqing, China, 400010
      • The Second Affiliated Hospital of Chongqing Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510800
      • Huadu District People's Hospital of Guangzhou
    • Shenzhen, Guangdong, China, 518110
      • The people's hospital of Longhua.Shenzhen
  • Guangxi
    • Nanning, Guangxi, China, 530007
      • Department of Endocrinology，Sencond Affiliated Hospital of Guangxi Medical University
  • Hainan
    • Haikou, Hainan, China, 570102
      • The First Affiliated Hospital of Hainan Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150001
      • The Fourth Affiliated Hospital of Harbin Medical University
  • Henan
    • Luoyang, Henan, China, 471000
      • The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology
    • Nanyang, Henan, China, 473000
      • The First Affiliated Hospital of Nanyang Medical College
  • Hubei
    • Huangshi, Hubei, China, 435000
      • The Central Hospital Of Huangshi
    • Wuhan, Hubei, China, 430000
      • The Third People's Hospital of Hubei Province
  • Inner Mongolia
    • Baotou, Inner Mongolia, China, 014040
      • Baotou Central Hospital
  • Jiangsu
    • Lianyungang, Jiangsu, China, 222002
      • The first people's hospital of Lianyungang
    • Lianyungang, Jiangsu, China, 222001
      • Lianyungang Hospital of TCM
    • Xuzhou, Jiangsu, China, 221004
      • The Affiliated Hospital of Xuzhou Medical University
    • Yangzhou, Jiangsu, China, 225001
      • North Jiangsu People's Hospital
  • Jilin
    • Changchun, Jilin, China, 130022
      • The Second Hospital of Jilin University
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Shengjing Hospital of China Medical University
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Zhongshan hospital, Fudan university
    • Shanghai, Shanghai, China, 20032
      • Zhongshan Hospital Affiliated to Fudan University
  • Shanxi
    • Taiyuan, Shanxi, China, 030000
      • Second hospttoal of Shanxi medical University
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • Chengdu second people's hospital
  • Xian
    • Xian, Xian, China, 710000
      • The First Affiliated Hospital of Xi'an Medical College
  • Yunnan
    • Kunming, Yunnan, China, 650032
      • First Affiliated Hospital of Kunming Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • The First People's Hospital of Hangzhou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Able and willing to provide a written informed consent;
2. Male or female subjects, 18-65 years of age at the time of signing informed consent;
3. At screening visit, 28.0 ≤BMI≤ 40.0 kg/m2;
4. Diet and exercise control for at least 3 months before screening visit, and less than 5 kg self-reported change within the last 3 months.

Exclusion Criteria:

1. Presence of - clinically significant lab or ECG results that may affect the evaluation of the efficacy or safety of the study drug at screening visit;
2. Uncontrollable hypertension;
3. PHQ-9 score ≥15;
4. Medical history or illness that affects your weight;
5. History of diabetes;
6. Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening;
7. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening;
8. Any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin and in-situ cancer of the cervix;
9. Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;
10. History of alcohol and/or substance abuse or drug abuse within 1 year prior to screening;
11. Use of any medication or treatment that may have caused significant weight change within 3 months;
12. History of bariatric surgery;
13. Known or suspected hypersensitivity to trial product(s) or related products;
14. Participation in other clinical trials for any weight-loss indication within 3 months prior to screening, or participation in other clinical trials for any drug or medical device within 1 month prior to screening;
15. history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;
16. Surgery is planned during the trial;
17. Mentally incapacitated or speech-impaired;
18. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;
19. Researchers and relevant staff of the research Centre or other people directly involved in the implementation of the programme, and their immediate family members.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A; HRS9531 injection	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; HRS9531 injection: dose level 1 for 32 weeks、level 2 for 20 weeks
Experimental: Treatment group B; HRS9531 injection	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; HRS9531 injection: dose level 1 for 32 weeks、level 2 for 20 weeks
Experimental: Treatment group C; HRS9531 injection	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; HRS9531 injection: dose level 1 for 32 weeks、level 2 for 20 weeks
Experimental: Treatment group D; HRS9531 injection	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; HRS9531 injection: dose level 1 for 32 weeks、level 2 for 20 weeks
Placebo Comparator: Treatment group E; HRS9531 injection Placebo	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
Placebo Comparator: Treatment group F; HRS9531 injection Placebo	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
Placebo Comparator: Treatment group G; HRS9531 injection Placebo	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
Placebo Comparator: Treatment group H; HRS9531 injection Placebo	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change in body weight	Percentage Change from baseline in body weight after 24 weeks of treatment	Week 0, Week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects with weight loss of ≥5% from baseline in body weight after 24 weeks of treatment	Week 24
Proportion of subjects with weight loss of ≥10% from baseline in body weight after 24 weeks of treatment	Week 24
Change from baseline in body weight after 24 weeks of treatment	Week 0, Week 24
Change from baseline in waist circumference after 24 weeks of treatment	Week 0, Week 24
Change from baseline in BMI after 24 weeks of treatment	Week 0, Week 24
Change from baseline in blood pressure after 24 weeks of treatment	Week 0, Week 24
Change from baseline in total cholesterol after 24 weeks of treatment	Week 0, Week 24
Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment	Week 0, Week 24
Change from baseline in glycosylated haemoglobin (HbA1c) after 24 weeks of treatment	Week 0, Week 24
Number of AEs During the Trial	Week 0 to Week 56
Percentage change in body weight	Week 0, Week 32
Proportion of Subjects with weight loss of ≥5% from baseline in body weight after 32 weeks of treatment	Week 32
Proportion of Subjects with weight loss of ≥10% from baseline in body weight after 32 weeks of treatment	Week 32
Change from baseline in body weight after 32 weeks of treatment	Week 0, Week 32
Change from baseline in waist circumference after 32 weeks of treatment	Week 0, Week 32
Change from baseline in BMI after 32 weeks of treatment	Week 0, Week 32
Change from baseline in blood pressure after 32 weeks of treatment	Week 0, Week 32
Change from baseline in total cholesterol after 32 weeks of treatment	Week 0, Week 32
Change from baseline in fasting plasma glucose (FPG) after 32 weeks of treatment	Week 0, Week 32
Change from baseline in glycosylated haemoglobin (HbA1c) after 32 weeks of treatment	Week 0, Week 32

Collaborators and Investigators

• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2023
• Primary Completion (Actual): October 13, 2024
• Study Completion (Actual): October 13, 2024

Study Registration Dates

• First Submitted: May 17, 2023
• First Submitted That Met QC Criteria: May 29, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 29, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight
• Other Study ID Numbers: HRS9531-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No