A Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes

Korábbi kezelés

• 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;
• Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening;
• History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening;
• History of alcohol and/or substance abuse or drug abuse within 1 year prior to screening;
• Use of any medication or treatment that may have caused significant weight change within 3 months;
• Participation in other clinical trials for any weight-loss indication within 3 months prior to screening, or participation in other clinical trials for any drug or medical device within 1 month prior to screening;
• 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;

Más betegség

• Uncontrollable hypertension;
• Medical history or illness that affects your weight;
• History of diabetes;
• Any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin and in-situ cancer of the cervix;
• Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;
• History of bariatric surgery;
• Known or suspected hypersensitivity to trial product(s) or related products;

Egyéb

• PHQ-9 score ≥15;
• Mentally incapacitated or speech-impaired;
• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;
• Researchers and relevant staff of the research Centre or other people directly involved in the implementation of the programme, and their immediate family members.

• 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 less than 5 kg self-reported change within the last 3 months.