A Clinical Study Comparing Semaglutide Injection and Wegovy® for Weight Management in Obese Subjects
NCT ID: NCT06738979
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
408 participants
INTERVENTIONAL
2025-03-31
2026-08-31
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TQF3510
TQF3510: The drug treatment cycle was 44 weeks, including a dose escalation period of 16w and a stable dose period of 28w.
TQF3510 (Semaglutide Injection)
Semaglutide injection is a long-acting Glucagon-like peptide-1 (GLP-1) receptor agonist.
Wegovy®
Wegovy® : The drug treatment cycle consisted of a dose escalation period of 16w and a stable dose period of 28w.
Wegovy®
Active Comparator
Interventions
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TQF3510 (Semaglutide Injection)
Semaglutide injection is a long-acting Glucagon-like peptide-1 (GLP-1) receptor agonist.
Wegovy®
Active Comparator
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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:
1. Alanine aminotransferase (ALT)\> 2.5× upper limit of normal (ULN), aspartate aminotransferase (AST)\>2.5 ULN;
2. Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2;
3. calcitonin ≥ 50 ng/L (pg/mL);
4. Triglyceride (TG) ≥500 mg/dl (5.7mmol/L);
5. 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:
1. Hepatitis C virus (HCV) antibody positive, and HCV virus titer detection value exceeds the upper limit of normal value;
2. HBsAg positive and Hepatitis B virus (HBV) DNA test value exceeds the upper limit of normal value;
3. HIV positive;
4. 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.
18 Years
70 Years
ALL
No
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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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 Municipality, China
The Southwest Hospital of Amu
Chongqing, Chongqing Municipality, China
Fuling Hospital affiliated to Chongqing University
Chongqing, Chongqing Municipality, 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
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
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
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 Municipality, China
Shanghai Jiading Central Hospital
Shanghai, Shanghai Municipality, 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 Municipality, 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
Countries
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Central Contacts
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Facility Contacts
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Yingchuan Yin, Master
Role: primary
Chongbing Huang, Master
Role: primary
Qifu Li, Doctor
Role: primary
Lei Chen, Doctor
Role: primary
Guangxiu Wu, Bachelor
Role: primary
Junping Wen, Doctor
Role: primary
Liqing Zheng, Bachelor
Role: primary
Lingning Huang, Doctor
Role: primary
Jinyang Wang, Doctor
Role: primary
Xuejian Hu, Master
Role: primary
Xiaochang Bin, Master
Role: primary
Xiaojuan Peng, Doctor
Role: primary
Xinghuan Liang, Doctor
Role: primary
Suping Wu, Bachelor
Role: primary
Xin Liao, Doctor
Role: primary
Jiarui Li, Master
Role: primary
Xiuhai Su, Bachelor
Role: primary
Xiaoyan Liu, Bachelor
Role: primary
Haifang Wang, Master
Role: primary
Jie Han, Master
Role: primary
Lihui Zhang, Master
Role: primary
Hui Fang, Doctor
Role: primary
Binhong Duan, Master
Role: primary
Li Jin, Master
Role: primary
Dezeng Tian, Master
Role: primary
Junhang Tian, Bachelor
Role: primary
Yueyue Zheng, Master
Role: primary
Qingju Li, Bachelor
Role: primary
Qijuan Dong, Bachelor
Role: primary
Zhe Dai, Doctor
Role: primary
Chaoyang Zeng, bachelor
Role: primary
Jun Zeng, Doctor
Role: primary
Junhua Song, Master
Role: primary
Weiping Sun, Doctor
Role: primary
Yunming Gao, Bachelor
Role: primary
Xiaowei Zhu, Doctor
Role: primary
Wenlong Huang, Bachelor
Role: primary
Zhenguo Zhao, Master
Role: backup
Hui Jin, Master
Role: primary
Chunrong Xu, Master
Role: primary
Jun Liang, Doctor
Role: primary
Houfa Geng, Doctor
Role: backup
Rong Xu, Master
Role: primary
Qingmei Huang, Bachelor
Role: primary
Xiaokun Gang, Doctor
Role: primary
Hanqing Cai, Master
Role: primary
Xin Zhang, Master
Role: primary
Xia Tian, Master
Role: primary
Junkui Wang, Doctor
Role: primary
Yan Zhou, Master
Role: primary
Haibo Xue, Doctor
Role: primary
Xiaolin Dong, Doctor
Role: primary
Mei Zhang, Master
Role: primary
Xiaodong Zhao, Master
Role: primary
Ying Wang, Doctor
Role: primary
Lixia Suo, Master
Role: primary
Feifei Wu, Doctor
Role: primary
Yan Wang, Doctor
Role: primary
Qin Wan, Master
Role: primary
Yan Wu, Master
Role: primary
Junling Gu, Doctor
Role: primary
Ming Liu, Doctor
Role: primary
Yin Yin, Bachelor
Role: primary
Yao Lu, Master
Role: primary
Jun Chen, Master
Role: primary
Jianping Yao, Master
Role: primary
Pengfei Du, Master
Role: primary
Hong Yang, Bachelor
Role: primary
Other Identifiers
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TQF3510-III-02
Identifier Type: -
Identifier Source: org_study_id