A Clinical Study Comparing Semaglutide Injection and Wegovy® for Weight Management in Obese Subjects

Официальное название

A Multicenter, Randomized, Open, Parallel Controlled Phase III Study Comparing the Efficacy and Safety of Semaglutide Injection and Wegovy® for Weight Management in Obese Subjects

Обзор

This is a multicenter, randomized, open, parallel, positive-controlled clinical study to evaluate the efficacy and safety of Semaglutide injection (TQF3510) developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. in obese subjects (BMI≥28 kg/m2). Equivalence tests were performed for the percentage (%) of weight loss at 44w relative to baseline at the primary endpoint. A meta-analysis was performed based on multiple registration studies of the original drug Wegovy® (semaglutide), and the final equivalence threshold was determined (-4.16%, 4.16%). It was assumed that the sample size ratio of the experimental group and the control group was 1:1, the overall difference between the experimental group and the control group was 0, the standard deviation of the reference original drug was 11%, and the degree of assurance (1-β) was 85%. Double unilateral t test was adopted, and double unilateral α=0.025. The sample size was 326 cases by the Power Analysis \& Sample Size (PASS) 2019 Software. Considering the 20% shedding rate, 408 patients were enrolled in this study, 204 in each group.

Вмешательства

• Препарат TQF3510 (Semaglutide Injection)
  Semaglutide injection is a long-acting Glucagon-like peptide-1 (GLP-1) receptor agonist.
• Препарат Wegovy®
  Active Comparator

Первичные конечные точки

• Percentage (%) of body weight loss [Срок оценки: Baseline to week 44]

Вторичные конечные точки (2)

• Proportion of subjects with a body weight loss of ≥5% [Срок оценки: Baseline to week 44]
• Waist circumference change from baseline [Срок оценки: Baseline to week 44]

Критерии участия

Критерии включения

• Age 18-70 years old, gender is not limited;
• Body mass index (BMI) ≥ 28 kg/m2;
• Self-report at least one unsuccessful diet and weight loss history;
• Patients must give informed consent to this study before the trial and sign the informed consent voluntarily.

Критерии исключения

• Pregnant or lactating women or men or women of childbearing age who had a pregnancy plan during the study period (including a spouse), or who refused to take the contraceptive measures specified in the programme during the study period;
• Have a history of diabetes of any type;
• Patients who had used any hypoglycemic drugs within 90 days before screening;
• Personal or first-degree relatives have a personal or family history of thyroid C-cell tumor or multiple endocrine tumor syndrome type 2;
• Use of any drugs for weight management within 90 days prior to screening;
• Previous or planned weight loss related treatment through surgery or other weight loss means during the study period;
• Have a history of major depression or serious mental illness;
• Mental Health Scale (PHQ-9) score ≥ 15 during screening;
• History of acute pancreatitis within 180 days prior to screening;
• Have a history of chronic pancreatitis or pancreatic surgery;
• Laboratory tests during screening meet any of the following criteria:

• Alanine aminotransferase (ALT)> 2.5× upper limit of normal (ULN), aspartate aminotransferase (AST)>2.5 ULN;
• Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2;
• calcitonin ≥ 50 ng/L (pg/mL);
• Triglyceride (TG) ≥500 mg/dl (5.7mmol/L);
• Thyroid stimulating hormone (TSH) >6 mIU/L or <0.4 mIU/L.
• When virological tests at the time of screening show any of the following:

• Hepatitis C virus (HCV) antibody positive, and HCV virus titer detection value exceeds the upper limit of normal value;
• HBsAg positive and Hepatitis B virus (HBV) DNA test value exceeds the upper limit of normal value;
• HIV positive;
• Active syphilis: the screening period of treponema pallidum antibody positive and non-Treponema pallidum serum test (RPR or TRUST) positive;
• Uncontrolled or poorly treated hypertension;
• Clinically significant cardiovascular and cerebrovascular disease in the 6 months prior to screening;
• People who are allergic to Semaglutide injection or any component of Wegovy®, or to other GLP-1 receptor agonists, or who have a pre-existing allergic disorder;
• Participated in any other clinical trial within 3 months prior to screening;
• The subject is unable to comply with the treatment plan and diet and exercise plan established by the investigator;
• There are secondary causes affecting body weight;
• There is hypothyroidism at the time of screening that is not controlled with stable drug dosages;
• Have a history of major surgery within 6 months prior to screening;
• A history of drug abuse or alcohol dependence within the 6 months prior to screening;
• History of malignant tumor within 5 years before screening;
• Patients with other diseases that the researchers assessed would affect the safety of the subjects, affect the efficacy evaluation or compliance, or other conditions that the researchers considered unsuitable for enrollment.

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

Открытое

Основная цель

Лечение

Центры проведения

Китай · 66 центров

• Hefei Third People's Hospital — Хэфэй
• Xuancheng People'S Hospital — Xuancheng
• The First Affiliated Hospital of Chongqing Medical University — Чунцин
• The Southwest Hospital of Amu — Чунцин
• Fuling Hospital affiliated to Chongqing University — Чунцин
• Fujian Provincial Hospital — Фучжоу
• Mengchao Hepatobiliary Hospital Of Fujian Medical University — Фучжоу
• The First Affiliated Hospital of Fujian Medical University — Фучжоу
• … и ещё 58 центров

Идентификаторы

NCT: NCT06738979 · TQF3510-III-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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