A Clinical Study Comparing Semaglutide Injection and Wegovy® for Weight Management in Obese Subjects
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
1 other identifier
interventional
408
1 country
66
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 obesity
Started Mar 2025
Shorter than P25 for phase_3 obesity
66 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2024
CompletedFirst Posted
Study publicly available on registry
December 18, 2024
CompletedStudy Start
First participant enrolled
March 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
December 18, 2024
November 1, 2024
1.3 years
December 13, 2024
December 13, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage (%) of body weight loss
Percentage (%) of body weight loss relative to baseline in both groups at week 44.
Baseline to week 44
Secondary Outcomes (2)
Proportion of subjects with a body weight loss of ≥5%
Baseline to week 44
Waist circumference change from baseline
Baseline to week 44
Study Arms (2)
TQF3510
EXPERIMENTALTQF3510: The drug treatment cycle was 44 weeks, including a dose escalation period of 16w and a stable dose period of 28w.
Wegovy®
ACTIVE COMPARATORWegovy® : The drug treatment cycle consisted of a dose escalation period of 16w and a stable dose period of 28w.
Interventions
Semaglutide injection is a long-acting Glucagon-like peptide-1 (GLP-1) receptor agonist.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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);
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (66)
Hefei Third People's Hospital
Hefei, Anhui, 230000, China
Xuancheng People'S Hospital
Xuancheng, Anhui, 242000, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010, China
The Southwest Hospital of Amu
Chongqing, Chongqing Municipality, 400038, China
Fuling Hospital affiliated to Chongqing University
Chongqing, Chongqing Municipality, 408107, China
Fujian Provincial Hospital
Fuzhou, Fujian, 350001, China
Mengchao Hepatobiliary Hospital Of Fujian Medical University
Fuzhou, Fujian, 350001, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350001, China
Gansu Provincial Hospital
Lanzhou, Gansu, 730700, China
Lanzhou University Second Hospital
Lanzhou, Gansu, 730700, China
Nanxishan Hospital of Guangxi Zhuang Autonomous Region
Guilin, Guangxi, 541000, China
Liuzhou People'S Hospital
Liuchow, Guangxi, 545000, China
The first Affiliated Hospital of GUANGXI medical university
Nanning, Guangxi, 530021, China
Wuzhou GongRen Hospital
Wuzhou, Guangxi, 543001, China
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000, China
Cangzhou Central Hospital
Cangzhou, Hebei, 061012, China
CangZhou Hospital of Integrated TCM-WM·HEBEI
Cangzhou, Hebei, 061012, China
The Affiliated Hospital of Chengde Medical College
Chengde, Hebei, 067000, China
Handan First Hospital
Handan, Hebei, 056000, China
Hebei Petro China Central Hospital
Langfang, Hebei, 065000, China
The Second Hospital Of Hebei Medical University
Shijiazhuang, Hebei, 050061, China
Tangshan GongRen Hospital
Tangshan, Hebei, 63000, China
Heilongjiang provincial hospital
Haerbin, Heilongjiang, 150036, China
The Third Affiliated Hospital of Qiqihar Medical College
Qiqihar, Heilongjiang, 161000, China
Anyang District Hospitai
Anyang, Henan, 455000, China
Luoyang Third People'S Hospital
Luoyang, Henan, 471002, China
The First affiliated Hospital of Nanyang Medical College
Nanyang, Henan, 473007, China
The Second Affiliated Hospital of Zhengzhou Univerisity
Zhengzhou, Henan, 450014, China
People'S Hospital of Zhengzhou
Zhengzhou, Henan, 451100, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 434000, China
Yichang Central People's Hospital
Yichang, Hubei, 443008, China
Yichang Central People's Hospital
Yichang, Hubei, 443100, China
The Fourth Hospital of Changsha
Changsha, Hunan, 410023, China
Loudi Central Hospital
Loudi, Hunan, 417000, China
The Second People Hospital of Lianyungang
Lianyungang, Jiangsu, 222000, China
Wuxi People's Hospital
Wuxi, Jiangsu, 214023, China
Jiangyin People' Hospital
Wuxi, Jiangsu, 214411, China
Jiangyin Hospital of Traditional Chinese Medicine
Wuxi, Jiangsu, 214499, China
XuZhou Cancer Hospital
Xuzhou, Jiangsu, 221018, China
XuZhou Central Hospital
Xuzhou, Jiangsu, 221018, China
First Affiliated Hospital Of Gannan Medical University
Ganzhou, Jiangxi, 341000, China
Xinyu People's Hospital
Xinyu, Jiangxi, 338000, China
The First Hospital of Jilin University
Changchun, Jilin, 130000, China
The Second Hospital of Jilin University
Changchun, Jilin, 130000, China
Genertec Liaoyou Gem Flower Hospiital
Panjin, Liaoning, 124000, China
The sixth people's hospital at of Shenyang
Shenyang, Liaoning, 110006, China
Shanxi Provincial People's Hospital
Xi'an, Shaanxi, 710068, China
Xi'An International Medical Center Hospital
Xi'an, Shaanxi, 710100, China
Binzhou medical college affiliated hospital
Binzhou, Shandong, 256603, China
Jinan Central Hospital
Jinan, Shandong, 250013, China
Affiliated Hospital of Jining Medical College
Jining, Shandong, 272001, China
Zibo Central Hospital
Zibo, Shandong, 255020, China
Shanghai Pudong New Area People's Hospital
Shanghai, Shanghai Municipality, 201299, China
Shanghai Jiading Central Hospital
Shanghai, Shanghai Municipality, 201800, China
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi, 046000, China
FIRST HOSPITAL OF SHANXI Medical
Taiyuan, Shanxi, 30012, China
The Affiliated Hospital of Southwet Medical University
Luzhou, Sichuan, 646000, China
Suining Central Hospital
Suining, Sichuan, 629000, China
The Second People's Hospital of Yibin City
Yibin, Sichuan, 644000, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
The First Affiliated Hospital of Shihezi University
Shihezi, Xinjiang, 832008, China
The Second Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000, China
The First People's Hospital of Xiaoshan District
Hangzhou, Zhejiang, 311200, China
Huzhou Center Hostipal
Huzhou, Zhejiang, 313000, China
Jiaxing Second Hospital
Jiaxing, Zhejiang, 314000, China
Ruian People's Hospital
Wenzhou, Zhejiang, 325200, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2024
First Posted
December 18, 2024
Study Start
March 1, 2025
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
December 18, 2024
Record last verified: 2024-11