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

Официальное название

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of HRS-4729 Injection in Participants With Obesity

Обзор

This is a multicenter, randomized, double-blind, placebo-controlled Phase II study to evaluate the efficacy and safety of once-weekly HRS-4729 injection in adults with obesity without diabetes. Approximately 252 participants will be enrolled. The primary endpoint is percent change in body weight from baseline at Week 32 versus placebo.

Вмешательства

• Препарат HRS-4729 Injection
  HRS-4729 Injection; Dose 1
• Препарат HRS-4729 Injection
  HRS-4729 Injection; Dose 2
• Препарат HRS-4729 Injection
  HRS-4729 Injection; Dose 3
• Препарат HRS-4729 Injection;
  HRS-4729 Injection; Dose 4
• Препарат HRS-4729 Injection;
  HRS-4729 Injection; Dose 5
• Препарат HRS-4729 Injection;
  HRS-4729 Injection; Dose 6
• Препарат HRS-4729 Injection Placebo
  HRS-4729 Injection Placebo

Первичные конечные точки

• Percent Change From Baseline in Body Weight [Срок оценки: Baseline, Week 32]

Вторичные конечные точки (7)

• Percent Change From Baseline in Body Weight [Срок оценки: Baseline, Week 40]
• Change From Baseline in Body Weight [Срок оценки: Baseline, Week 32 and 40]
• Change from Baseline in Body Mass Index (BMI) [Срок оценки: Baseline, Week 32 and 40]
• Change from Baseline in Waist Circumference [Срок оценки: Baseline, Week 32 and 40]
• Change from Baseline in Blood Pressure [Срок оценки: Baseline, Week 32 and 40]
• Change from Baseline in Glucose Level [Срок оценки: Baseline, Week 32 and 40]
• TEAEs [Срок оценки: Baseline, Week 44]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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;
• Prior or planned organ or bone marrow transplantation during the study period;
• Any hematologic disorder that may interfere with the determination of HbA1c;
• An autoimmune disease for which systemic corticosteroid or immunosuppressive therapy is planned 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;
• Mental incapacity or language impairment sufficient to preclude adequate understanding of, or participation in, the trial procedures;
• Investigators, site staff, or other personnel directly involved in conduct of the study, and their immediate family members; employees of the Sponsor;
• Any condition that, in the investigator's judgment, would compromise participant safety or otherwise interfere with the assessment of study results.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine — Шанхай

Идентификаторы

NCT: NCT07690826 · HRS-4729-202

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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