A Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Tablets in Overweight or Obese Subjects

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFujian Shengdi Pharmaceutical Co., Ltd.

About this trial

This study aims to evaluate the efficacy and safety of HRS9531 tablets compared with placebo in reducing body weight in overweight or obese subjects after 52 weeks of treatment.

Eligibility criteria

Qualifiers

Male or female subjects, 18-75 years of age at the time of signing informed consent;

At screening visit, BMI ≥ 28 kg/m2 or ≥ 24 kg/m2 with at least one weight-related comorbidity;

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;

Able and willing to provide a written informed consent.

Disqualifiers

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 severe hypertension;

PHQ-9 score ≥ 15;

Medical history or illness that affects body weight;

Trial design

Treatments tested in this trial

  • HRS9531 Tablet
  • HRS9531 Tablet Placebo

Treatment groups

425 Participants
are divided into 2 treatment groups