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Efficacy and Safety of HRS9531 Tablet in Obese Subjects

F

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

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

Trial contacts and locations

1

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Central trial contact

Qiannan Zhou

Data sourced from clinicaltrials.gov

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