A Study to Evaluate the Efficacy and Safety of HRS-4729 Injection in Obesity

Korábbi kezelés

• Prior or planned organ or bone marrow transplantation during the study period;
• Use of any medication or treatment likely to cause clinically significant weight gain or weight loss within 3 months prior to screening;
• Participation in any clinical trial of an investigational drug or medical device within 3 months prior to screening;
• Blood donation or blood loss ≥400 mL, or receipt of a blood transfusion, within 3 months prior to screening;

Más betegség

• Endocrine disease or history that may have a significant effect on body weight;
• History of diabetes mellitus (gestational diabetes excepted);
• Malignancy of any organ system within the past 5 years, irrespective of evidence of local recurrence or metastasis, except for adequately treated localized basal cell carcinoma of the skin, carcinoma in situ of the cervix, and prostate carcinoma in situ;
• Presence or suspicion of depression, anxiety disorder, bipolar disorder, suicidal ideation, schizophrenia, or other clinically significant psychiatric disorder, or a history of suicide attempt;
• Known or suspected excessive alcohol use, or a history of alcohol, drug, or substance abuse;
• Acute or chronic hepatitis, or a history of severe hepatic disease other than metabolic dysfunction-associated fatty liver disease;
• An autoimmune disease for which systemic corticosteroid or immunosuppressive therapy is planned during the study period;
• Mental incapacity or language impairment sufficient to preclude adequate understanding of, or participation in, the trial procedures;
• Any condition that, in the investigator's judgment, would compromise participant safety or otherwise interfere with the assessment of study results.

Laborértékek

• Any hematologic disorder that may interfere with the determination of HbA1c;

Egyéb

• Investigators, site staff, or other personnel directly involved in conduct of the study, and their immediate family members; employees of the Sponsor;

• Able and willing to provide a written informed consent.
• Male or female adults aged 18 to 65 years.
• BMI: 28.0 to 40.0 kg/m2.
• Self-reported diet and exercise control for at least 3 months before screening, with body weight change of no more than 5 kg during the previous 3 months.