Extension Study of the Phase 3 Clinical Study of GZR18 Injection for Weight Loss

Официальное название

A Multicenter Extension Study of the Phase 3 Clinical Study of GZR18 Injection for Weight Loss

Обзор

This is a Phase 3 extension study conducted in subjects who have received GZR18 Injection once every 2 weeks (Q2W) for weight loss treatment for 52 weeks, aiming to explore the effect and safety of continuous injection of GZR18 Injection once every 4 weeks (Q4W) for 24 weeks on body weight. In this study, it is planned to include subjects who have participated in the original study and completed the study contents of the original protocol. All subjects will maintain a regular diet and exercise lifestyle during the study.

Вмешательства

• Препарат GZR18 injection
  Used as specified in the protocol
• Другое Placebo
  Administered the same volume as GZR18

Первичные конечные точки

• Percent change (%) from baseline in body weight [Срок оценки: from Week 0 (W0) to Week 24 (W24)]

Вторичные конечные точки (12)

• Changes from baseline in weight; [Срок оценки: from Week 0 (W0) to Week 24 (W24)]
• Changes from baseline body mass index (BMI)； [Срок оценки: from Week 0 (W0) to Week 24 (W24)]
• Changes from baseline in waist circumference, hip circumference, and waist-hip ratio (waist circumference/hip circumference)； [Срок оценки: from Week 0 (W0) to Week 24 (W24)]
• Changes from baseline in hemoglobin A1c (HbA1c) ; [Срок оценки: from Week 0 (W0) to Week 24 (W24)]
• Changes from baseline in fasting plasma glucose (FPG); [Срок оценки: from Week 0 (W0) to Week 24 (W24)]
• Changes from baseline in blood pressure (SBP and DBP); [Срок оценки: from Week 0 (W0) to Week 24 (W24)]
• Changes from baseline in total cholesterol (TC); [Срок оценки: from Week 0 (W0) to Week 24 (W24)]
• Changes from baseline in low-density lipoprotein cholesterol (LDL-C); [Срок оценки: from Week 0 (W0) to Week 24 (W24)]
• Changes from baseline in high-density lipoprotein cholesterol (HDL-C); [Срок оценки: from Week 0 (W0) to Week 24 (W24)]
• Changes from baseline in triglyceride (TG); [Срок оценки: from Week 0 (W0) to Week 24 (W24)]
• Changes from baseline in free fatty acids. [Срок оценки: from Week 0 (W0) to Week 24 (W24)]
• Treatment-Emergent Adverse Events (TEAEs); [Срок оценки: from Week 0 (W0) to Week 25 (W25)]

Критерии участия

Критерии включения

• Subjects who participated in the original study, completed the last dose at W50, EOT visit at W52 and safety follow-up visit at W55 of either original study, with last dose at W50 ≥ 24 mg (including blinded dose of placebo).
• Subjects with BMI > 18.5 kg/m² at W55 of the original study and before randomization at Visit 2 (V2) of this study, who are assessed by the investigator as suitable for participating in this study.
• Subjects of childbearing potential with no birth plan from the signing of ICF to 8 weeks after the last dose, willingness to take effective contraceptive measures, and no plan for sperm or ovum donation. Non-lactating women of childbearing potential (WOCBP) with a negative pregnancy test result before randomization at V2 in this study.
• Able to understand the procedures and methods of this study, willing and able to maintain a regular diet and exercise lifestyle during the study period, willing and able to undergo subcutaneous injections of the investigational medicinal product (IMP), and willing to sign the ICF voluntarily.

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Критерии исключения

• Subjects who used Semaglutide (Wegovy®) in the original study.
• Subjects with a previous diagnosis of any type of diabetes mellitus (excluding gestational diabetes mellitus).
• Subjects with FPG ≥ 7.0 mmol/L or HbA1c ≥ 6.5% in the central laboratory test at W52 visit of the original study.
• Subjects who plan to participate in another clinical study of an investigational medicinal product or device, or receive drug or non-drug therapies that affect body weight (excluding diet and exercise control) before completing all scheduled assessments in this clinical study.
• Subjects with any other factors (including but not limited to previous compliance in the original study) that may affect the efficacy or safety evaluation of this study as judged by the investigator.

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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 · 2 центра

• Study site 01 — Пекин
• Study site 01 — Пекин

Идентификаторы

NCT: NCT07292441 · GZR18-BWM-303

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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