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Not yet recruitingPhase 3

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

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

66

Recruiting sites

Enrollment

408

estimated

Study population

Obesity / overweight

Key I/E criterion

BMI ≥28

Primary endpoint

Body weight, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06738979
Org study IDTQF3510-III-02

Timeline

Milestones

Study first posted2024-12-18actual
Last update posted2024-12-18actual
Study start2025-03estimated (month precision)
Primary completion2026-07estimated (month precision)
Study completion2026-08estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Weight & body composition

3 endpoints
Primary/protocol endpoint

Percentage (%) of body weight loss

Time frame:Baseline to week 44

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline to week 44

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Waist circumference change from baseline

Time frame:Baseline to week 44

Waist circumference, change

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.