Clinical trial NCT06738979: A Clinical Study Comparing Semaglutide Injection and Wegovy® for Weight Management in Obese Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Obesity
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-12-18
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Percentage (%) of body weight loss
timeFrame: Baseline to week 44
Secondary outcomes:
measure: Proportion of subjects with a body weight loss of ≥5%
timeFrame: Baseline to week 44
measure: Waist circumference change from baseline
timeFrame: Baseline to week 44
Other outcomes:
Locations:
city: Hefei
country: China
facility: Hefei Third People's Hospital
state: Anhui
city: Xuancheng
country: China
facility: Xuancheng People'S Hospital
state: Anhui
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Chongqing
country: China
facility: The Southwest Hospital of Amu
state: Chongqing
city: Chongqing
country: China
facility: Fuling Hospital affiliated to Chongqing University
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
city: Fuzhou
country: China
facility: Mengchao Hepatobiliary Hospital Of Fujian Medical University
state: Fujian
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Lanzhou
country: China
facility: Gansu Provincial Hospital
state: Gansu
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Guilin
country: China
facility: Nanxishan Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Liuzhou
country: China
facility: Liuzhou People'S Hospital
state: Guangxi
city: Nanning
country: China
facility: The first Affiliated Hospital of GUANGXI medical university
state: Guangxi
city: Wuzhou
country: China
facility: Wuzhou GongRen Hospital
state: Guangxi
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical University
state: Guizhou
city: Cangzhou
country: China
facility: Cangzhou Central Hospital
state: Hebei
city: Cangzhou
country: China
facility: CangZhou Hospital of Integrated TCM-WM·HEBEI
state: Hebei
city: Chengde
country: China
facility: The Affiliated Hospital of Chengde Medical College
state: Hebei
city: Handan
country: China
facility: Handan First Hospital
state: Hebei
city: Langfang
country: China
facility: Hebei Petro China Central Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: The Second Hospital Of Hebei Medical University
state: Hebei
city: Tangshan
country: China
facility: Tangshan GongRen Hospital
state: Hebei
city: Haerbin
country: China
facility: Heilongjiang provincial hospital
state: Heilongjiang
city: Qiqihar
country: China
facility: The Third Affiliated Hospital of Qiqihar Medical College
state: Heilongjiang
city: Anyang
country: China
facility: Anyang District Hospitai
state: Henan
city: Luoyang
country: China
facility: Luoyang Third People'S Hospital
state: Henan
city: Nanyang
country: China
facility: The First affiliated Hospital of Nanyang Medical College
state: Henan
city: Zhengzhou
country: China
facility: The Second Affiliated Hospital of Zhengzhou Univerisity
state: Henan
city: Zhengzhou
country: China
facility: People'S Hospital of Zhengzhou
state: Henan
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Yichang
country: China
facility: Yichang Central People's Hospital
state: Hubei
city: Yichang
country: China
facility: Yichang Central People's Hospital
state: Hubei
city: Changsha
country: China
facility: The Fourth Hospital of Changsha
state: Hunan
city: Loudi
country: China
facility: Loudi Central Hospital
state: Hunan
city: Lianyungang
country: China
facility: The Second People Hospital of Lianyungang
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi People's Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Jiangyin People' Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Jiangyin Hospital of Traditional Chinese Medicine
state: Jiangsu
city: Xuzhou
country: China
facility: XuZhou Cancer Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: XuZhou Central Hospital
state: Jiangsu
city: Ganzhou
country: China
facility: First Affiliated Hospital Of Gannan Medical University
state: Jiangxi
city: Xinyu
country: China
facility: Xinyu People's Hospital
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Panjin
country: China
facility: Genertec Liaoyou Gem Flower Hospiital
state: Liaoning
city: Shenyang
country: China
facility: The sixth people's hospital at of Shenyang
state: Liaoning
city: Xi'an
country: China
facility: Shanxi Provincial People's Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Xi'An International Medical Center Hospital
state: Shaanxi
city: Binzhou
country: China
facility: Binzhou medical college affiliated hospital
state: Shandong
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Jining
country: China
facility: Affiliated Hospital of Jining Medical College
state: Shandong
city: Zibo
country: China
facility: Zibo Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Pudong New Area People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Jiading Central Hospital
state: Shanghai
city: Changzhi
country: China
facility: Heping Hospital Affiliated to Changzhi Medical College
state: Shanxi
city: Taiyuan
country: China
facility: FIRST HOSPITAL OF SHANXI Medical
state: Shanxi
city: Luzhou
country: China
facility: The Affiliated Hospital of Southwet Medical University
state: Sichuan
city: Suining
country: China
facility: Suining Central Hospital
state: Sichuan
city: Yibin
country: China
facility: The Second People's Hospital of Yibin City
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Shihezi
country: China
facility: The First Affiliated Hospital of Shihezi University
state: Xinjiang
city: Ürümqi
country: China
facility: The Second Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Hangzhou
country: China
facility: The First People's Hospital of Xiaoshan District
state: Zhejiang
city: Huzhou
country: China
facility: Huzhou Center Hostipal
state: Zhejiang
city: Jiaxing
country: China
facility: Jiaxing Second Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: Ruian People's Hospital
state: Zhejiang
Study officials:
References: