CompletedPhase 2

Efficacy and Safety of HRS9531 Tablet in Obese Subjects

China166 participantsStarted 2025-04-07

Plain-language summary

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

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

✕. Uncontrollable hypertension;
✕. 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;
✕. PHQ-9 score ≥15;
✕. Medical history or illness that affects body weight;
✕. History of diabetes;
✕. Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening;
✕. History of severe cardiovascular and cerebrovascular diseases within 6 months prior to screening;
✕. Any organ-system malignancies developed within 5 years;

Percentage Change from baseline in body weight after 26 weeks of treatment

Timeframe: after 26 weeks of treatment

NCT IDNCT06841445

SponsorFujian Shengdi Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01-08