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ObesityPhase 3NCT06738979

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

A Phase 3 study testing TQF3510 (Semaglutide Injection) and Wegovy® in people with Obesity, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 66 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Obesity
What is being tested?
TQF3510 (Semaglutide Injection) and Wegovy®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
408 participants
Where
66 sitesChina
Study dates
20 Mar 2025to 26 May 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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);
  • 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:
  • 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;
  • 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.

Trial locations and contacts

66 sites in 1 country.

66 sites in 1 country

China66 sites

  • Anyang District Hospitai

    Anyang, Henan, 455000

  • Binzhou medical college affiliated hospital

    Binzhou, Shandong, 256603

  • Cangzhou Central Hospital

    Cangzhou, Hebei, 061012

  • CangZhou Hospital of Integrated TCM-WM·HEBEI

    Cangzhou, Hebei, 061012

  • The First Hospital of Jilin University

    Changchun, Jilin, 130000

  • The Second Hospital of Jilin University

    Changchun, Jilin, 130000

  • The Fourth Hospital of Changsha

    Changsha, Hunan, 410023

  • Heping Hospital Affiliated to Changzhi Medical College

    Changzhi, Shanxi, 046000

  • The Affiliated Hospital of Chengde Medical College

    Chengde, Hebei, 067000

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400010

  • The Southwest Hospital of Amu

    Chongqing, Chongqing Municipality, 400038

  • Fuling Hospital affiliated to Chongqing University

    Chongqing, Chongqing Municipality, 408107

  • Fujian Provincial Hospital

    Fuzhou, Fujian, 350001

  • Mengchao Hepatobiliary Hospital Of Fujian Medical University

    Fuzhou, Fujian, 350001

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350001

  • First Affiliated Hospital Of Gannan Medical University

    Ganzhou, Jiangxi, 341000

  • Nanxishan Hospital of Guangxi Zhuang Autonomous Region

    Guilin, Guangxi, 541000

  • Heilongjiang provincial hospital

    Haerbin, Heilongjiang, 150036

  • Handan First Hospital

    Handan, Hebei, 056000

  • The First People's Hospital of Xiaoshan District

    Hangzhou, Zhejiang, 311200

  • Hefei Third People's Hospital

    Hefei, Anhui, 230000

  • Huzhou Center Hostipal

    Huzhou, Zhejiang, 313000

  • Jiaxing Second Hospital

    Jiaxing, Zhejiang, 314000

  • Jinan Central Hospital

    Jinan, Shandong, 250013

  • Affiliated Hospital of Jining Medical College

    Jining, Shandong, 272001

  • Hebei Petro China Central Hospital

    Langfang, Hebei, 065000

  • Gansu Provincial Hospital

    Lanzhou, Gansu, 730700

  • Lanzhou University Second Hospital

    Lanzhou, Gansu, 730700

  • The Second People Hospital of Lianyungang

    Lianyungang, Jiangsu, 222000

  • Liuzhou People'S Hospital

    Liuzhou, Guangxi, 545000

  • Loudi Central Hospital

    Loudi, Hunan, 417000

  • Luoyang Third People'S Hospital

    Luoyang, Henan, 471002

  • The Affiliated Hospital of Southwet Medical University

    Luzhou, Sichuan, 646000

  • The first Affiliated Hospital of GUANGXI medical university

    Nanning, Guangxi, 530021

  • The First affiliated Hospital of Nanyang Medical College

    Nanyang, Henan, 473007

  • Genertec Liaoyou Gem Flower Hospiital

    Panjin, Liaoning, 124000

  • The Third Affiliated Hospital of Qiqihar Medical College

    Qiqihar, Heilongjiang, 161000

  • Shanghai Pudong New Area People's Hospital

    Shanghai, Shanghai Municipality, 201299

  • Shanghai Jiading Central Hospital

    Shanghai, Shanghai Municipality, 201800

  • The sixth people's hospital at of Shenyang

    Shenyang, Liaoning, 110006

  • The First Affiliated Hospital of Shihezi University

    Shihezi, Xinjiang, 832008

  • The Second Hospital Of Hebei Medical University

    Shijiazhuang, Hebei, 050061

  • Suining Central Hospital

    Suining, Sichuan, 629000

  • FIRST HOSPITAL OF SHANXI Medical

    Taiyuan, Shanxi, 30012

  • Tangshan GongRen Hospital

    Tangshan, Hebei, 63000

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

  • The Second Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830000

  • Ruian People's Hospital

    Wenzhou, Zhejiang, 325200

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 434000

  • Wuxi People's Hospital

    Wuxi, Jiangsu, 214023

  • Jiangyin People' Hospital

    Wuxi, Jiangsu, 214411

  • Jiangyin Hospital of Traditional Chinese Medicine

    Wuxi, Jiangsu, 214499

  • Wuzhou GongRen Hospital

    Wuzhou, Guangxi, 543001

  • Shanxi Provincial People's Hospital

    Xi'an, Shaanxi, 710068

  • Xi'An International Medical Center Hospital

    Xi'an, Shaanxi, 710100

  • Xinyu People's Hospital

    Xinyu, Jiangxi, 338000

  • Xuancheng People'S Hospital

    Xuancheng, Anhui, 242000

  • XuZhou Cancer Hospital

    Xuzhou, Jiangsu, 221018

  • XuZhou Central Hospital

    Xuzhou, Jiangsu, 221018

  • The Second People's Hospital of Yibin City

    Yibin, Sichuan, 644000

  • Yichang Central People's Hospital

    Yichang, Hubei, 443008

  • Yichang Central People's Hospital

    Yichang, Hubei, 443100

  • The Second Affiliated Hospital of Zhengzhou Univerisity

    Zhengzhou, Henan, 450014

  • People'S Hospital of Zhengzhou

    Zhengzhou, Henan, 451100

  • Zibo Central Hospital

    Zibo, Shandong, 255020

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou, 563000

Other trials in China

About this study

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

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.

Conditions
Obesity
Being tested
TQF3510 (Semaglutide Injection), Wegovy®
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TQF3510 (Semaglutide Injection)Drug

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

  • Wegovy®Drug

    Active Comparator

Study groups in NCT06738979
Study groupRoleWhat they receive
TQF3510ExperimentalTQF3510: The drug treatment cycle was 44 weeks, including a dose escalation period of 16w and a stable dose period of 28w.
Receives: Drug: TQF3510 (Semaglutide Injection)
Wegovy®Active comparatorWegovy® : The drug treatment cycle consisted of a dose escalation period of 16w and a stable dose period of 28w.
Receives: Drug: Wegovy®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage (%) of body weight loss

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

    Measured: Baseline to week 44

Secondary outcomes (2)

  1. Proportion of subjects with a body weight loss of ≥5%

    Proportion of subjects with a body weight loss of ≥5% from baseline at week 44.

    Measured: Baseline to week 44

  2. Waist circumference change from baseline

    Waist circumference change from baseline at week 44.

    Measured: Baseline to week 44

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2024
  2. Study start20 Mar 2025
  3. Primary completion7 Mar 2026
  4. Study completion26 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
408 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06738979
Sponsor's protocol ID
TQF3510-III-02
Status last verified
Nov 2024
First submitted
13 Dec 2024
Last updated
25 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TQF3510 (Semaglutide Injection) and Wegovy® in people with Obesity, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 66 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage (%) of body weight loss (time frame: Baseline to week 44). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06738979.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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