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Recruiting NCT07670884

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

Phase III Interventional Chronic Management of Body Weight

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HRS9531 Tablet, HRS9531 Tablet Placebo.
Who it may be relevant to
Registry conditions: Chronic Management of Body Weight. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Tablets in Overweight or Obese Subjects

Overview

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.

Interventions

  • Drug HRS9531 Tablet
    HRS9531 tablet.
  • Drug HRS9531 Tablet Placebo
    HRS9531 tablet placebo.

Primary outcome measures

  • Percentage change from baseline in body weight after 52 weeks of treatment [Time frame: After 52 weeks of treatment.]
  • Proportion of subjects with weight loss of ≥ 5% from baseline in body weight after 52 weeks of treatment [Time frame: After 52 weeks of treatment.]
Secondary outcome measures (12)
  • Proportion of subjects with weight loss of ≥ 10% from baseline in body weight after 52 weeks of treatment [Time frame: After 52 weeks of treatment.]
  • Proportion of subjects with weight loss of ≥ 15% from baseline in body weight after 52 weeks of treatment [Time frame: After 52 weeks of treatment.]
  • Proportion of subjects with weight loss of ≥ 20% from baseline in body weight after 52 weeks of treatment [Time frame: After 52 weeks of treatment.]
  • Change from baseline in waist circumference after 52 weeks of treatment [Time frame: After 52 weeks of treatment.]
  • Change from baseline in body weight after 52 weeks of treatment [Time frame: After 52 weeks of treatment.]
  • Change from baseline in BMI (Body Mass Index) after 52 weeks of treatment [Time frame: After 52 weeks of treatment.]
  • Change from baseline in blood pressure after 52 weeks of treatment [Time frame: After 52 weeks of treatment.]
  • Change from baseline in fasting plasma glucose after 52 weeks of treatment [Time frame: After 52 weeks of treatment.]
  • Change from baseline in fasting serum insulin after 52 weeks of treatment [Time frame: After 52 weeks of treatment.]
  • Change from baseline in glycosylated hemoglobin after 52 weeks of treatment [Time frame: After 52 weeks of treatment.]
  • Change from baseline in blood lipid after 52 weeks of treatment [Time frame: After 52 weeks of treatment.]
  • Change from baseline in blood uric acid after 52 weeks of treatment [Time frame: After 52 weeks of treatment.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • History of diabetes;
  • Acute or chronic hepatitis;
  • History of severe cardiovascular and cerebrovascular diseases within 6 months prior to screening;
  • Any organ-system malignancies developed within 5 years;
  • Acute infection, acute trauma, or medium to large surgery within 30 days prior to screening;
  • Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness, mentally incapacitated or speech-impaired;
  • Use of any medication or treatment that may have caused significant weight change within 90 days;
  • History of bariatric surgery;
  • Known or suspected hypersensitivity to trial product(s) or related products;
  • History of alcohol and/or substance abuse or drug abuse;
  • History of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;
  • Surgery is planned during the trial;
  • The investigators determined that other conditions were inappropriate for participation in this clinical trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 2 centers
  • Henan Provincial People's Hospital — Zhengzhou
  • Nanjing Drum Tower hospital — Nanjing

Identifiers

NCT: NCT07670884 · HRS9531-T-301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗