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Tests treatment safety and results for Chronic Management of Body Weight
Official title A Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Tablets in Overweight or Obese Subjects
ClinicalTrials.gov ID: NCT07670884
What this study is testing
What is HRS9531 Tablet?
HRS9531 Tablet is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic management of body weight.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Male or female people, 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.
You likely can't join if
- Presence of clinically significant lab or ECG results that may affect the evaluation of the how well it works or safety of the study drug at...
- Uncontrollable severe hypertension;
- PHQ-9 score ≥ 15;
- Medical history or illness that affects body weight;
- History of diabetes;
- Acute or chronic hepatitis;
See the full eligibility criteria
- Male or female people, 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.
- Presence of clinically significant lab or ECG results that may affect the evaluation of the how well it works 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.
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, China; Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.