A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS9531 Injection in Adolescents With Obesity

Официальное название

A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dosing of HRS9531 Injection in Chinese Adolescents With Obesity

Обзор

The aim of this trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS9531 injection compared with placebo in adolescents with obesity

Вмешательства

• Препарат HRS9531 injection；Placebo
  Drug: HRS9531 injection; low dose Drug: Placebo
• Препарат HRS9531 injection；Placebo
  Drug: HRS9531 injection; medium dose Drug: Placebo
• Препарат HRS9531 injection；Placebo
  Drug: HRS9531 injection; high dose Drug: Placebo

Первичные конечные точки

• Adverse Events (AEs) [Срок оценки: up to Week 28]

Вторичные конечные точки (7)

• Maximum concentration (Cmax) of HRS9531 [Срок оценки: up to Week 28]
• Trough concentration (Ctrough) of HRS9531 [Срок оценки: up to Week 28]
• Area under the curve from time zero to end of dosing interval (AUC0-tau) [Срок оценки: up to Week 28]
• Changes from baseline in BMI [Срок оценки: up to Week 24]
• Change from baseline in body weight [Срок оценки: up to Week 24]
• Change from baseline in waist circumference [Срок оценки: up to Week 24]
• Anti-HRS9531 antibodies (ADA) [Срок оценки: up to Week 28]

Критерии участия

Критерии включения

• Male or female subjects who are aged ≥12 years and <18 years at the time of signing the informed consent;
• At screening, the BMI meets the obesity criteria according to "WS/T586-2018 Screening Criteria for Overweight and Obesity in School-age Children and Adolescents";
• Subjects who have maintained a controlled diet and exercise for at least 12 weeks prior to screening, with no more than a 5% decrease in BMI (as reported by the subject, parent, or legal guardian);

Критерии исключения

• Presence of clinically significant lab results at screening visit;
• Uncontrollable hypertension;
• Medical history or illness that affects your weight;
• History of diabetes;
• Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening;
• Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;
• Use of drugs or treatments that may have caused significant weight gain or loss within the 3 months prior to screening;
• Pre-adolescent participants (Tanner phase I);
• Patients with blood donation or blood loss ≥400 mL or receiving blood transfusion within 3 months before screening.
• Surgery is planned during the tria;
• Mentally incapacitated or speech-impaired subjects are unable to fully understand or participate in the test process；
• In the investigator's judgment, there are circumstances that affect subject safety or any other conditions that interfere with the evaluation of the test 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

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Ухань

Идентификаторы

NCT: NCT07559136 · HRS9531-111

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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