Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes

Study Overview
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Brief Summary
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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
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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

Conditions
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Overweight or Obesity

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A multicenter, randomized, double-blind, placebo- parallel controlled Phase II clinical study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group A<br>HRS9531 injection | Drug: HRS9531 injection<br>* HRS9531 injection: dose level 1 for 32 weeks、level 2 for 20 weeks<br>|
| Experimental: Treatment group B<br>HRS9531 injection | Drug: HRS9531 injection<br>* HRS9531 injection: dose level 2<br>|
| Experimental: Treatment group C<br>HRS9531 injection | Drug: HRS9531 injection<br>* HRS9531 injection: dose level 3<br>|
| Experimental: Treatment group D<br>HRS9531 injection | Drug: HRS9531 injection<br>* HRS9531 injection: dose level 4<br>|
| Placebo Comparator: Treatment group E<br>HRS9531 injection Placebo | Drug: HRS9531 injection Placebo<br>* Placebo arm matching active arm HRS9531 injection dose level 1 for 32 weeks、HRS9531 injection level 2 for 20 weeks<br>|
| Placebo Comparator: Treatment group F<br>HRS9531 injection Placebo | Drug: HRS9531 injection Placebo<br>* Placebo arm matching active arm HRS9531 injection dose level 2 for 32 weeks、HRS9531 injection level 2 for 20 weeks<br>|
| Placebo Comparator: Treatment group G<br>HRS9531 injection Placebo | Drug: HRS9531 injection Placebo<br>* Placebo arm matching active arm HRS9531 injection dose level 3 for 32 weeks、HRS9531 injection level 2 for 20 weeks<br>|
| Placebo Comparator: Treatment group H<br>HRS9531 injection Placebo | Drug: HRS9531 injection Placebo<br>* Placebo arm matching active arm HRS9531 injection dose level 4 for 32 weeks、HRS9531 injection level 2 for 20 weeks<br>|

What is the study measuring?
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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 | Measure Description | 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 |