Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes

Fujian Shengdi Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Overweight or Obesity

Treatments: Drug: HRS9531 injection Placebo; Drug: HRS9531 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT05881837

HRS9531-201

Details and patient eligibility

About

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.

Enrollment: 249 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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249 participants in 8 patient groups, including a placebo group

Treatment group A

Experimental group

Description:

HRS9531 injection

Treatment:

Drug: HRS9531 injection

Drug: HRS9531 injection

Drug: HRS9531 injection

Drug: HRS9531 injection

Treatment group B

Experimental group

Description:

HRS9531 injection

Treatment:

Drug: HRS9531 injection

Drug: HRS9531 injection

Drug: HRS9531 injection

Drug: HRS9531 injection

Treatment group C

Experimental group

Description:

HRS9531 injection

Treatment:

Drug: HRS9531 injection

Drug: HRS9531 injection

Drug: HRS9531 injection

Drug: HRS9531 injection

Treatment group D

Experimental group

Description:

HRS9531 injection

Treatment:

Drug: HRS9531 injection

Drug: HRS9531 injection

Drug: HRS9531 injection

Drug: HRS9531 injection

Treatment group E

Placebo Comparator group

Description:

HRS9531 injection Placebo

Treatment:

Drug: HRS9531 injection Placebo

Drug: HRS9531 injection Placebo

Drug: HRS9531 injection Placebo

Drug: HRS9531 injection Placebo

Treatment group F

Placebo Comparator group

Description:

HRS9531 injection Placebo

Treatment:

Drug: HRS9531 injection Placebo

Drug: HRS9531 injection Placebo

Drug: HRS9531 injection Placebo

Drug: HRS9531 injection Placebo

Treatment group G

Placebo Comparator group

Description:

HRS9531 injection Placebo

Treatment:

Drug: HRS9531 injection Placebo

Drug: HRS9531 injection Placebo

Drug: HRS9531 injection Placebo

Drug: HRS9531 injection Placebo

Treatment group H

Placebo Comparator group

Description:

HRS9531 injection Placebo

Treatment:

Drug: HRS9531 injection Placebo

Drug: HRS9531 injection Placebo

Drug: HRS9531 injection Placebo

Drug: HRS9531 injection Placebo