Efficacy and Safety of HRS9531 Tablet in Obese Subjects

Fujian Shengdi Pharmaceutical

Status and phase: Active, not recruiting; Phase 2

Conditions: Chronic Management of Body Weight

Treatments: Drug: HRS9531 Tablet; Drug: HRS9531 Tablet placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06841445

HRS9531-T-201

Details and patient eligibility

About

To evaluate the efficacy of HRS9531 tablet compared with placebo in reducing body weight in obese subjects after 26 weeks of treatment.

Enrollment: 166 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 the weight change does not exceed 5% within the last 3 months;
5. Non-pregnant or lactating women. Fertile male and female (including partners) agree to use highly effective contraceptive methods.

Exclusion criteria

1. Uncontrollable hypertension;
2. 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;
3. PHQ-9 score ≥15;
4. Medical history or illness that affects body weight;
5. History of diabetes;
6. Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening;
7. History of severe cardiovascular and cerebrovascular diseases within 6 months prior to screening;
8. Any organ-system malignancies developed within 5 years;
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;
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. history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;
15. Surgery is planned during the trial;
16. Mentally incapacitated or speech-impaired;
17. Acute or chronic hepatitis;
18. The investigators determined that other conditions were inappropriate for participation in this clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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166 participants in 4 patient groups, including a placebo group

Treatment group A: HRS9531 Tablet

Experimental group

Treatment:

Drug: HRS9531 Tablet

Drug: HRS9531 Tablet

Drug: HRS9531 Tablet

Treatment group B: HRS9531 Tablet

Experimental group

Treatment:

Drug: HRS9531 Tablet

Drug: HRS9531 Tablet

Drug: HRS9531 Tablet

Treatment group C: HRS9531 Tablet

Experimental group

Treatment:

Drug: HRS9531 Tablet

Drug: HRS9531 Tablet

Drug: HRS9531 Tablet

Treatment group D: HRS9531 Tablet Placebo

Placebo Comparator group

Treatment:

Drug: HRS9531 Tablet placebo