search
Back to results

Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes

Primary Purpose

Overweight or Obesity

Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HRS9531 injection
HRS9531 injection
HRS9531 injection
HRS9531 injection
HRS9531 injection Placebo
HRS9531 injection Placebo
HRS9531 injection Placebo
HRS9531 injection Placebo
Sponsored by
Fujian Shengdi Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight or Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Able and willing to provide a written informed consent; Male or female subjects, 18-65 years of age at the time of signing informed consent; At screening visit, 28.0 ≤BMI≤ 40.0 kg/m2; 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: 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; Uncontrollable hypertension; PHQ-9 score ≥15; Medical history or illness that affects your weight; History of diabetes; Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening; History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening; 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; Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness; History of alcohol and/or substance abuse or drug abuse within 1 year prior to screening; Use of any medication or treatment that may have caused significant weight change within 3 months; History of bariatric surgery; Known or suspected hypersensitivity to trial product(s) or related products; 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; history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening; Surgery is planned during the trial; Mentally incapacitated or speech-impaired; Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method; Researchers and relevant staff of the research Centre or other people directly involved in the implementation of the programme, and their immediate family members.

Sites / Locations

  • Zhongshan Hospital Affiliated to Fudan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Placebo Comparator

Placebo Comparator

Arm Label

Treatment group A

Treatment group B

Treatment group C

Treatment group D

Treatment group E

Treatment group F

Treatment group G

Treatment group H

Arm Description

HRS9531 injection

HRS9531 injection

HRS9531 injection

HRS9531 injection

HRS9531 injection Placebo

HRS9531 injection Placebo

HRS9531 injection Placebo

HRS9531 injection Placebo

Outcomes

Primary Outcome Measures

Percentage change in body weight
Percentage Change from baseline in body weight after 24 weeks of treatment

Secondary Outcome Measures

Proportion of subjects with weight loss of ≥5% from baseline in body weight after 24 weeks of treatment
Proportion of subjects with weight loss of ≥10% from baseline in body weight after 24 weeks of treatment
Change from baseline in body weight after 24 weeks of treatment
Change from baseline in waist circumference after 24 weeks of treatment
Change from baseline in BMI after 24 weeks of treatment
Change from baseline in blood pressure after 24 weeks of treatment
Change from baseline in total cholesterol after 24 weeks of treatment
Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment
Change from baseline in glycosylated haemoglobin (HbA1c) after 24 weeks of treatment
Number of AEs During the Trial

Full Information

First Posted
May 17, 2023
Last Updated
July 31, 2023
Sponsor
Fujian Shengdi Pharmaceutical Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT05881837
Brief Title
Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 13, 2023 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Shengdi Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight or Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A multicenter, randomized, double-blind, placebo- parallel controlled Phase II clinical study
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
249 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group A
Arm Type
Experimental
Arm Description
HRS9531 injection
Arm Title
Treatment group B
Arm Type
Experimental
Arm Description
HRS9531 injection
Arm Title
Treatment group C
Arm Type
Experimental
Arm Description
HRS9531 injection
Arm Title
Treatment group D
Arm Type
Experimental
Arm Description
HRS9531 injection
Arm Title
Treatment group E
Arm Type
Placebo Comparator
Arm Description
HRS9531 injection Placebo
Arm Title
Treatment group F
Arm Type
Placebo Comparator
Arm Description
HRS9531 injection Placebo
Arm Title
Treatment group G
Arm Type
Placebo Comparator
Arm Description
HRS9531 injection Placebo
Arm Title
Treatment group H
Arm Type
Placebo Comparator
Arm Description
HRS9531 injection Placebo
Intervention Type
Drug
Intervention Name(s)
HRS9531 injection
Intervention Description
HRS9531 injection: dose level 1
Intervention Type
Drug
Intervention Name(s)
HRS9531 injection
Intervention Description
HRS9531 injection: dose level 2
Intervention Type
Drug
Intervention Name(s)
HRS9531 injection
Intervention Description
HRS9531 injection: dose level 3
Intervention Type
Drug
Intervention Name(s)
HRS9531 injection
Intervention Description
HRS9531 injection: dose level 4
Intervention Type
Drug
Intervention Name(s)
HRS9531 injection Placebo
Intervention Description
Placebo arm matching active arm HRS9531 injection dose level 1
Intervention Type
Drug
Intervention Name(s)
HRS9531 injection Placebo
Intervention Description
Placebo arm matching active arm HRS9531 injection dose level 2
Intervention Type
Drug
Intervention Name(s)
HRS9531 injection Placebo
Intervention Description
Placebo arm matching active arm HRS9531 injection dose level 3
Intervention Type
Drug
Intervention Name(s)
HRS9531 injection Placebo
Intervention Description
Placebo arm matching active arm HRS9531 injection dose level 4
Primary Outcome Measure Information:
Title
Percentage change in body weight
Description
Percentage Change from baseline in body weight after 24 weeks of treatment
Time Frame
Week 0, Week 24
Secondary Outcome Measure Information:
Title
Proportion of subjects with weight loss of ≥5% from baseline in body weight after 24 weeks of treatment
Time Frame
Week 24
Title
Proportion of subjects with weight loss of ≥10% from baseline in body weight after 24 weeks of treatment
Time Frame
Week 24
Title
Change from baseline in body weight after 24 weeks of treatment
Time Frame
Week 0, Week 24
Title
Change from baseline in waist circumference after 24 weeks of treatment
Time Frame
Week 0, Week 24
Title
Change from baseline in BMI after 24 weeks of treatment
Time Frame
Week 0, Week 24
Title
Change from baseline in blood pressure after 24 weeks of treatment
Time Frame
Week 0, Week 24
Title
Change from baseline in total cholesterol after 24 weeks of treatment
Time Frame
Week 0, Week 24
Title
Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment
Time Frame
Week 0, Week 24
Title
Change from baseline in glycosylated haemoglobin (HbA1c) after 24 weeks of treatment
Time Frame
Week 0, Week 24
Title
Number of AEs During the Trial
Time Frame
Week 0 to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able and willing to provide a written informed consent; Male or female subjects, 18-65 years of age at the time of signing informed consent; At screening visit, 28.0 ≤BMI≤ 40.0 kg/m2; 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: 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; Uncontrollable hypertension; PHQ-9 score ≥15; Medical history or illness that affects your weight; History of diabetes; Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening; History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening; 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; Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness; History of alcohol and/or substance abuse or drug abuse within 1 year prior to screening; Use of any medication or treatment that may have caused significant weight change within 3 months; History of bariatric surgery; Known or suspected hypersensitivity to trial product(s) or related products; 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; history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening; Surgery is planned during the trial; Mentally incapacitated or speech-impaired; Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method; Researchers and relevant staff of the research Centre or other people directly involved in the implementation of the programme, and their immediate family members.
Facility Information:
Facility Name
Zhongshan Hospital Affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
20032
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes

We'll reach out to this number within 24 hrs