Clinical trial

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

Opening soon · Phase 3 · 1 countries · Registry ID NCT06738979

Opening soonPhase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity

Full registry criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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: 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.

Treatments and study arms

TQF3510 (Semaglutide Injection)

Drug

Semaglutide injection is a long-acting Glucagon-like peptide-1 (GLP-1) receptor agonist.

Wegovy®

Drug

Active Comparator

Primary outcomes

Percentage (%) of body weight lossBaseline to week 44

Percentage (%) of body weight loss relative to baseline in both groups at week 44.

Study locations

66 locations were listed when this page was built. The first 40 are shown.

Anyang District Hospitai🇨🇳 Anyang, Henan, China
Dezeng Tian, MasterContact
Binzhou medical college affiliated hospital🇨🇳 Binzhou, Shandong, China
Haibo Xue, DoctorContact
CangZhou Hospital of Integrated TCM-WM·HEBEI🇨🇳 Cangzhou, Hebei, China
Xiuhai Su, BachelorContact
Cangzhou Central Hospital🇨🇳 Cangzhou, Hebei, China
Jiarui Li, MasterContact
The First Hospital of Jilin University🇨🇳 Changchun, Jilin, China
Xiaokun Gang, DoctorContact
The Second Hospital of Jilin University🇨🇳 Changchun, Jilin, China
Hanqing Cai, MasterContact
The Fourth Hospital of Changsha🇨🇳 Changsha, Hunan, China
Junhua Song, MasterContact
Heping Hospital Affiliated to Changzhi Medical College🇨🇳 Changzhi, Shanxi, China
Feifei Wu, DoctorContact
The Affiliated Hospital of Chengde Medical College🇨🇳 Chengde, Hebei, China
Xiaoyan Liu, BachelorContact
Fuling Hospital affiliated to Chongqing University🇨🇳 Chongqing, Chongqing Municipality, China
Guangxiu Wu, BachelorContact
The First Affiliated Hospital of Chongqing Medical University🇨🇳 Chongqing, Chongqing Municipality, China
Qifu Li, DoctorContact
The Southwest Hospital of Amu🇨🇳 Chongqing, Chongqing Municipality, China
Lei Chen, DoctorContact
Fujian Provincial Hospital🇨🇳 Fuzhou, Fujian, China
Junping Wen, DoctorContact
Mengchao Hepatobiliary Hospital Of Fujian Medical University🇨🇳 Fuzhou, Fujian, China
Liqing Zheng, BachelorContact
The First Affiliated Hospital of Fujian Medical University🇨🇳 Fuzhou, Fujian, China
Lingning Huang, DoctorContact
First Affiliated Hospital Of Gannan Medical University🇨🇳 Ganzhou, Jiangxi, China
Rong Xu, MasterContact
Nanxishan Hospital of Guangxi Zhuang Autonomous Region🇨🇳 Guilin, Guangxi, China
Xiaochang Bin, MasterContact
Heilongjiang provincial hospital🇨🇳 Haerbin, Heilongjiang, China
Binhong Duan, MasterContact
Handan First Hospital🇨🇳 Handan, Hebei, China
Haifang Wang, MasterContact
The First People's Hospital of Xiaoshan District🇨🇳 Hangzhou, Zhejiang, China
Jun Chen, MasterContact
Hefei Third People's Hospital🇨🇳 Hefei, Anhui, China
Yingchuan Yin, MasterContact
Huzhou Center Hostipal🇨🇳 Huzhou, Zhejiang, China
Jianping Yao, MasterContact
Jiaxing Second Hospital🇨🇳 Jiaxing, Zhejiang, China
Pengfei Du, MasterContact
Jinan Central Hospital🇨🇳 Jinan, Shandong, China
Xiaolin Dong, DoctorContact
Affiliated Hospital of Jining Medical College🇨🇳 Jining, Shandong, China
Mei Zhang, MasterContact
Hebei Petro China Central Hospital🇨🇳 Langfang, Hebei, China
Jie Han, MasterContact
Gansu Provincial Hospital🇨🇳 Lanzhou, Gansu, China
Jinyang Wang, DoctorContact
Lanzhou University Second Hospital🇨🇳 Lanzhou, Gansu, China
Xuejian Hu, MasterContact
The Second People Hospital of Lianyungang🇨🇳 Lianyungang, Jiangsu, China
Yunming Gao, BachelorContact
Liuzhou People'S Hospital🇨🇳 Liuzhou, Guangxi, China
Xiaojuan Peng, DoctorContact
Loudi Central Hospital🇨🇳 Loudi, Hunan, China
Weiping Sun, DoctorContact
Luoyang Third People'S Hospital🇨🇳 Luoyang, Henan, China
Junhang Tian, BachelorContact
The Affiliated Hospital of Southwet Medical University🇨🇳 Luzhou, Sichuan, China
Qin Wan, MasterContact
The first Affiliated Hospital of GUANGXI medical university🇨🇳 Nanning, Guangxi, China
Xinghuan Liang, DoctorContact
The First affiliated Hospital of Nanyang Medical College🇨🇳 Nanyang, Henan, China
Yueyue Zheng, MasterContact
Genertec Liaoyou Gem Flower Hospiital🇨🇳 Panjin, Liaoning, China
Xin Zhang, MasterContact
The Third Affiliated Hospital of Qiqihar Medical College🇨🇳 Qiqihar, Heilongjiang, China
Li Jin, MasterContact
Shanghai Jiading Central Hospital🇨🇳 Shanghai, Shanghai Municipality, China
Lixia Suo, MasterContact
Shanghai Pudong New Area People's Hospital🇨🇳 Shanghai, Shanghai Municipality, China
Ying Wang, DoctorContact
The sixth people's hospital at of Shenyang🇨🇳 Shenyang, Liaoning, China
Xia Tian, MasterContact