A Phase III Study Comparing the Weight Loss Effects of Semaglutide Injection and Wegovy®

Официальное название

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

Обзор

The purpose of the study is to compare the effect on body weight in subjects taking semaglutide injection or subjects taking Wegovy®.

Подробное описание

The study will involve participants engaging in discussions with study staff regarding healthy dietary choices, strategies for increasing physical activity, and additional methods for achieving weight loss, alongside the administration of the study medication. Participants will be randomly assigned to receive either semaglutide injection or Wegovy®. The study medication will be administered via a weekly subcutaneous injection using a fine needle in the abdominal skinfold. The duration of the study will be approximately 2 years, during which participants will attend 13 clinic visits with the study physician.

Вмешательства

• Препарат Semaglutide
  The dose escalation phase, starting with 0.25mg once weekly and increasing every 4 weeks (0.5mg, 1.0mg, 1.7mg), is expected to last 16 weeks; In the dose maintenance phase, the target dose of 2.4mg was maintained for 28 weeks.Treatment duration 44 weeks.
• Препарат Semaglutide
  The dose escalation phase, starting with 0.25mg once weekly and increasing every 4 weeks (0.5mg, 1.0mg, 1.7mg), is expected to last 16 weeks; In the dose maintenance phase, the target dose of 2.4mg was maintained for 28 weeks.Treatment duration 44 weeks.

Первичные конечные точки

• Change in body weight [Срок оценки: From baseline at week 0 to week 44]

Вторичные конечные точки (8)

• Change in body weight [Срок оценки: From baseline at week 0 to week 28]
• Subjects who achieve body weight reduction equal to or above 5% [Срок оценки: From baseline at week 0 to week 44]
• Subjects who achieve body weight reduction equal to or above 10% [Срок оценки: From baseline at week 0 to week 44]
• Subjects who achieve body weight reduction equal to or above 15% [Срок оценки: From baseline at week 0 to week 44]
• Change in body mass index (BMI) [Срок оценки: From baseline at week 0 to week 44]
• Change in waist circumference [Срок оценки: From baseline at week 0 to week 44]
• Change in systolic blood pressure and diastolic blood pressure [Срок оценки: From baseline at week 0 to week 44]
• Change in lipids [Срок оценки: From baseline at week 0 to week 44]

Критерии участия

Критерии включения

• Voluntarily participate in this trial and sign the informed consent form.
• Male or female, aged 18-75 years (inclusive) at the time of signing the informed consent form.
• Body mass index (BMI) ≥28.0 kg/m2 at screening. （4）At least one self-reported unsuccessful weight loss history.

Критерии исключения

• Blood Glucose-Related:

• Glycated hemoglobin (HbA1c) level ≥6.5% at screening.
• History of type 1 or type 2 diabetes.
• Received hypoglycemic drug treatment within 90 days prior to screening.
• Received GLP-1 receptor agonist treatment within 180 days prior to screening.
• Obesity-Related:

（5）Self-reported weight change \>5 kg within 90 days prior to screening, regardless of medical history.

（6）Received any drug treatment for obesity within 90 days prior to screening. （7）Previous or planned surgical or device treatment for obesity during the trial period, except for the following: (1) liposuction and/or abdominal lipolysis performed \>1 year prior to screening; (2) gastric banding with the band removed \>1 year prior to screening; (3) intragastric balloon placement with the balloon removed \>1 year prior to screening.

• Psychological Health-Related:

（8）History of severe depression or a Patient Health Questionnaire-9 (PHQ-9) score ≥15 at screening.

（9）Diagnosed with other severe mental illnesses, including schizophrenia, schizoaffective disorder, paranoid psychosis, bipolar (affective) disorder, epilepsy-induced mental disorder, and mental retardation with mental disorders.

（10）History of suicidal behavior. （11）Suicidal ideation corresponding to type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening.

• General Safety:

（12） Thyroid diseases: Including a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2); or calcitonin (CT) ≥50ng/L at screening; or thyroid-stimulating hormone (TSH) \>6.0mIU/L or \<0.4mIU/L at screening; or concurrent hyperthyroidism.

(13) History of acute or chronic pancreatitis, or blood amylase ≥3×ULN at screening, or triglycerides (TG) ≥5.65 mmol/L (500 mg/dL) at screening.

(14) Alanine aminotransferase (ALT) ≥3×ULN, aspartate aminotransferase (AST) ≥3×ULN, or total bilirubin (TBiL) ≥3×ULN at screening.

(15) Serum creatinine level ≥1.5 mg/dL (132μmol/L) in males or ≥1.4 mg/dL (123μmol/L) in females at screening.

(16) Untreated or poorly controlled hypertension (defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg).

(17) Severe cardiac history, defined as New York Heart Association (NYHA) class III and IV at screening, and/or hospitalization for unstable angina pectoris or transient ischemic attack within 60 days prior to screening, and/or stroke (except lacunar infarction) or myocardial infarction within 180 days prior to screening.

(18) Gastrointestinal diseases assessed by the investigator to potentially increase the risk after medication (such as obstructive diseases: pyloric obstruction and intestinal obstruction; or gastrointestinal motility disorders: postoperative gastroparesis, idiopathic gastroparesis; or severe active ulcers, etc.).

(19) Known or suspected allergy to any component of semaglutide injection or other GLP-1 receptor agonists.

(20) Use of drugs that may cause significant weight gain within 90 days prior to screening or expected during the trial, including systemic glucocorticoid therapy for more than 1 week; tricyclic antidepressants (such as amitriptyline, imipramine, clomipramine, doxepin); antipsychotic or antiepileptic drugs (such as mirtazapine, paroxetine, phenelzine, chlorpromazine hydrochloride, chlorpromazine, olanzapine, valproic acid and its derivatives, lithium preparations, methimazole).

(21) Obesity caused by other endocrine diseases, including hypothalamic obesity, pituitary obesity, hypothyroid obesity, Cushing\'s syndrome, insulinoma, acromegaly, pseudohypoparathyroidism, and hypogonadism.

(22) Known subjects planned for hospitalization for any surgical treatment during the trial at screening.

(23) Participated in other clinical trials and used investigational drugs within 90 days prior to screening.

(24) History of drug abuse (including drug addiction) and/or alcohol dependence within 180 days prior to screening.

(25) Diagnosed with malignant tumors within 5 years prior to screening (except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery).

(26) Pregnant or lactating women, females or males with reproductive plans during the trial period or unwilling to use effective contraceptive methods.

(27) Subjects who, in the investigator\'s judgment, have any disease or other conditions that may endanger their safety or affect their compliance with the protocol, making them unsuitable for participation in this study.

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 · 14 центров

• Xuancheng People's Hospital — Xuancheng
• Huizhou Central People's Hospital — Huizhou
• Luoyang Third People's Hospital — Luoyang
• The First Affiliated Hospital of Henan University of Science and Technology — Luoyang
• The First Affiliated Hospital of Nanyang Medical College — Nanyang
• The Second Affiliated Hospital of Zhengzhou University — Чжэнчжоу
• Yichang Central People's Hospital — Yichang
• Huai an First People's Hospital — Huaian
• … и ещё 6 центров

Идентификаторы

NCT: NCT06633783 · JY29-2-302

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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