A Clinical Study Comparing Semaglutide Injection and Wegovy® for Weight Management in Obese Subjects
- Conditions
- Obesity
- Interventions
- Drug: TQF3510 (Semaglutide Injection)
- Registration Number
- NCT06738979
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 408
- 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.
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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;
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Have a history of diabetes of any type;
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Patients who had used any hypoglycemic drugs within 90 days before screening;
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Personal or first-degree relatives have a personal or family history of thyroid C-cell tumor or multiple endocrine tumor syndrome type 2;
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Use of any drugs for weight management within 90 days prior to screening;
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Previous or planned weight loss related treatment through surgery or other weight loss means during the study period;
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Have a history of major depression or serious mental illness;
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Mental Health Scale (PHQ-9) score ≥ 15 during screening;
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History of acute pancreatitis within 180 days prior to screening;
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Have a history of chronic pancreatitis or pancreatic surgery;
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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.
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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;
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Uncontrolled or poorly treated hypertension;
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Clinically significant cardiovascular and cerebrovascular disease in the 6 months prior to screening;
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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;
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Participated in any other clinical trial within 3 months prior to screening;
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The subject is unable to comply with the treatment plan and diet and exercise plan established by the investigator;
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There are secondary causes affecting body weight;
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There is hypothyroidism at the time of screening that is not controlled with stable drug dosages;
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Have a history of major surgery within 6 months prior to screening;
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A history of drug abuse or alcohol dependence within the 6 months prior to screening;
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History of malignant tumor within 5 years before screening;
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Wegovy® Wegovy® Wegovy® : The drug treatment cycle consisted of a dose escalation period of 16w and a stable dose period of 28w. TQF3510 TQF3510 (Semaglutide Injection) TQF3510: The drug treatment cycle was 44 weeks, including a dose escalation period of 16w and a stable dose period of 28w.
- Primary Outcome Measures
Name Time Method Percentage (%) of body weight loss Baseline to week 44 Percentage (%) of body weight loss relative to baseline in both groups at week 44.
- Secondary Outcome Measures
Name Time Method Proportion of subjects with a body weight loss of ≥5% Baseline to week 44 Proportion of subjects with a body weight loss of ≥5% from baseline at week 44.
Waist circumference change from baseline Baseline to week 44 Waist circumference change from baseline at week 44.
Related Research Topics
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Trial Locations
- Locations (65)
Hefei Third People's Hospital
🇨🇳Hefei, Anhui, China
Xuancheng People'S Hospital
🇨🇳Xuancheng, Anhui, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
The Southwest Hospital of Amu
🇨🇳Chongqing, Chongqing, China
Fuling Hospital affiliated to Chongqing University
🇨🇳Chongqing, Chongqing, China
Fujian Provincial Hospital
🇨🇳Fuzhou, Fujian, China
Mengchao Hepatobiliary Hospital Of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
Jinan Central Hospital
🇨🇳Jinan, Shandong, China
Affiliated Hospital of Jining Medical College
🇨🇳Jining, Shandong, China
Zibo Central Hospital
🇨🇳Zibo, Shandong, China
Shanghai Pudong New Area People's Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai Jiading Central Hospital
🇨🇳Shanghai, Shanghai, China
Heping Hospital Affiliated to Changzhi Medical College
🇨🇳Changzhi, Shanxi, China
FIRST HOSPITAL OF SHANXI Medical
🇨🇳Taiyuan, Shanxi, China
The Affiliated Hospital of Southwet Medical University
🇨🇳Luzhou, Sichuan, China
Suining Central Hospital
🇨🇳Suining, Sichuan, China
The Second People's Hospital of Yibin City
🇨🇳Yibin, Sichuan, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
The First Affiliated Hospital of Shihezi University
🇨🇳Shihezi, Xinjiang, China
The Second Affiliated Hospital of Xinjiang Medical University
🇨🇳Ürümqi, Xinjiang, China
The First People's Hospital of Xiaoshan District
🇨🇳Hangzhou, Zhejiang, China
Huzhou Center Hostipal
🇨🇳Huzhou, Zhejiang, China
Jiaxing Second Hospital
🇨🇳Jiaxing, Zhejiang, China
Ruian People's Hospital
🇨🇳Wenzhou, Zhejiang, China
Gansu Provincial Hospital
🇨🇳Lanzhou, Gansu, China
Lanzhou University Second Hospital
🇨🇳Lanzhou, Gansu, China
Nanxishan Hospital of Guangxi Zhuang Autonomous Region
🇨🇳Guilin, Guangxi, China
Liuzhou People'S Hospital
🇨🇳Liuzhou, Guangxi, China
The first Affiliated Hospital of GUANGXI medical university
🇨🇳Nanning, Guangxi, China
Wuzhou GongRen Hospital
🇨🇳Wuzhou, Guangxi, China
Affiliated Hospital of Zunyi Medical University
🇨🇳Zunyi, Guizhou, China
Cangzhou Central Hospital
🇨🇳Cangzhou, Hebei, China
CangZhou Hospital of Integrated TCM-WM·HEBEI
🇨🇳Cangzhou, Hebei, China
The Affiliated Hospital of Chengde Medical College
🇨🇳Chengde, Hebei, China
Handan First Hospital
🇨🇳Handan, Hebei, China
Hebei Petro China Central Hospital
🇨🇳Langfang, Hebei, China
The Second Hospital Of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Tangshan GongRen Hospital
🇨🇳Tangshan, Hebei, China
Heilongjiang provincial hospital
🇨🇳Haerbin, Heilongjiang, China
The Third Affiliated Hospital of Qiqihar Medical College
🇨🇳Qiqihar, Heilongjiang, China
Anyang District Hospitai
🇨🇳Anyang, Henan, China
Luoyang Third People'S Hospital
🇨🇳Luoyang, Henan, China
The First affiliated Hospital of Nanyang Medical College
🇨🇳Nanyang, Henan, China
The Second Affiliated Hospital of Zhengzhou Univerisity
🇨🇳Zhengzhou, Henan, China
People'S Hospital of Zhengzhou
🇨🇳Zhengzhou, Henan, China
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Yichang Central People's Hospital
🇨🇳Yichang, Hubei, China
The Fourth Hospital of Changsha
🇨🇳Changsha, Hunan, China
Loudi Central Hospital
🇨🇳Loudi, Hunan, China
The Second People Hospital of Lianyungang
🇨🇳Lianyungang, Jiangsu, China
Wuxi People's Hospital
🇨🇳Wuxi, Jiangsu, China
Jiangyin People' Hospital
🇨🇳Wuxi, Jiangsu, China
Jiangyin Hospital of Traditional Chinese Medicine
🇨🇳Wuxi, Jiangsu, China
XuZhou Cancer Hospital
🇨🇳Xuzhou, Jiangsu, China
XuZhou Central Hospital
🇨🇳Xuzhou, Jiangsu, China
First Affiliated Hospital Of Gannan Medical University
🇨🇳Ganzhou, Jiangxi, China
Xinyu People's Hospital
🇨🇳Xinyu, Jiangxi, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
The Second Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Genertec Liaoyou Gem Flower Hospiital
🇨🇳Panjin, Liaoning, China
The sixth people's hospital at of Shenyang
🇨🇳Shenyang, Liaoning, China
Shanxi Provincial People's Hospital
🇨🇳Xi'an, Shaanxi, China
Xi'An International Medical Center Hospital
🇨🇳Xi'an, Shaanxi, China
Binzhou medical college affiliated hospital
🇨🇳Binzhou, Shandong, China