Efficacy and Safety of HRS9531 Injections in Overweight or Obese Subjects

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 alcohol , medication or drug abuse within 1 year prior to screening.
• Use of any medication or treatment that may cause significant weight change within 3 months.
• Participation in other clinical trials within 3 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

• poor-controlled hypertension.
• Medical history of illness that affects weight.
• History of diabetes.
• History of acute cardiovascular and cerebrovascular diseases.
• Any organ-system malignancies developed within 5 years except cured local basal cell carcinoma of skin and cervical carcinoma in situ.
• Confirmed or suspected depression, bipolar disorder, suicidal tendency, schizophrenia, or other serious mental illness.
• History of bariatric surgery.
• Known or suspected hypersensitivity to trial product(s) or related products.

Laborértékek

• Subjects participating in QT/QTc studies need to comply with relevant examinations.

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.
• In the judgment of the investigator, there are circumstances that affect the safety of the subject or any other interference with the evaluation of the test results.

• 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.
• 28.0 ≤BMI≤ 40.0 kg/m2 or 24 ≤BMI< 28.0 kg/m2 with at least 1 weight-related comorbidity at screening visit.
• 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.