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A Phase III Study Comparing the Weight Loss Effects of Semaglutide Injection and Wegovy®
A Multicenter, Randomized, Open-label, Parallel-controlled Phase III Study Comparing the Efficacy and Safety of Semaglutide Injection and Wegovy® for Weight Loss in Obese Subjects
Lead sponsor
Asset
Semaglutide
GLP-1 agonist
Listed sites
14
Recruiting sites
—
Enrollment
370
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Voluntarily participate in this trial and sign the informed consent form.
2. Male or female, aged 18-75 years (inclusive) at the time of signing the informed consent form.
3. Body mass index (BMI) ≥28.0 kg/m2 at screening. (4)At least one self-reported unsuccessful weight loss history.
Exclusion criteria
1. Glycated hemoglobin (HbA1c) level ≥6.5% at screening.
2. History of type 1 or type 2 diabetes.
3. Received hypoglycemic drug treatment within 90 days prior to screening.
4. Received GLP-1 receptor agonist treatment within 180 days prior to screening.
(5)Self-reported weight change \>5 kg within 90 days prior to screening, regardless of medical history.
(6)Received any drug treatment for obesity within 90 days prior to screening. (7)Previous or planned surgical or device treatment for obesity during the trial period, except for the following: (1) liposuction and/or abdominal lipolysis performed \>1 year prior to screening; (2) gastric banding with the band removed \>1 year prior to screening; (3) intragastric balloon placement with the balloon removed \>1 year prior to screening.
(8)History of severe depression or a Patient Health Questionnaire-9 (PHQ-9) score ≥15 at screening.
(9)Diagnosed with other severe mental illnesses, including schizophrenia, schizoaffective disorder, paranoid psychosis, bipolar (affective) disorder, epilepsy-induced mental disorder, and mental retardation with mental disorders.
(10)History of suicidal behavior. (11)Suicidal ideation corresponding to type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening.
(12) Thyroid diseases: Including a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2); or calcitonin (CT) ≥50ng/L at screening; or thyroid-stimulating hormone (TSH) \>6.0mIU/L or \<0.4mIU/L at screening; or concurrent hyperthyroidism.
(13) History of acute or chronic pancreatitis, or blood amylase ≥3×ULN at screening, or triglycerides (TG) ≥5.65 mmol/L (500 mg/dL) at screening.
(14) Alanine aminotransferase (ALT) ≥3×ULN, aspartate aminotransferase (AST) ≥3×ULN, or total bilirubin (TBiL) ≥3×ULN at screening.
(15) Serum creatinine level ≥1.5 mg/dL (132μmol/L) in males or ≥1.4 mg/dL (123μmol/L) in females at screening.
(16) Untreated or poorly controlled hypertension (defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg).
(17) Severe cardiac history, defined as New York Heart Association (NYHA) class III and IV at screening, and/or hospitalization for unstable angina pectoris or transient ischemic attack within 60 days prior to screening, and/or stroke (except lacunar infarction) or myocardial infarction within 180 days prior to screening.
(18) Gastrointestinal diseases assessed by the investigator to potentially increase the risk after medication (such as obstructive diseases: pyloric obstruction and intestinal obstruction; or gastrointestinal motility disorders: postoperative gastroparesis, idiopathic gastroparesis; or severe active ulcers, etc.).
(19) Known or suspected allergy to any component of semaglutide injection or other GLP-1 receptor agonists.
(20) Use of drugs that may cause significant weight gain within 90 days prior to screening or expected during the trial, including systemic glucocorticoid therapy for more than 1 week; tricyclic antidepressants (such as amitriptyline, imipramine, clomipramine, doxepin); antipsychotic or antiepileptic drugs (such as mirtazapine, paroxetine, phenelzine, chlorpromazine hydrochloride, chlorpromazine, olanzapine, valproic acid and its derivatives, lithium preparations, methimazole).
(21) Obesity caused by other endocrine diseases, including hypothalamic obesity, pituitary obesity, hypothyroid obesity, Cushing\'s syndrome, insulinoma, acromegaly, pseudohypoparathyroidism, and hypogonadism.
(22) Known subjects planned for hospitalization for any surgical treatment during the trial at screening.
(23) Participated in other clinical trials and used investigational drugs within 90 days prior to screening.
(24) History of drug abuse (including drug addiction) and/or alcohol dependence within 180 days prior to screening.
(25) Diagnosed with malignant tumors within 5 years prior to screening (except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery).
(26) Pregnant or lactating women, females or males with reproductive plans during the trial period or unwilling to use effective contraceptive methods.
(27) Subjects who, in the investigator\'s judgment, have any disease or other conditions that may endanger their safety or affect their compliance with the protocol, making them unsuitable for participation in this study.
Endpoints (9)
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.
Coverage by outcome category
Weight & body composition
7 endpointsChange in body weight
Time frame:From baseline at week 0 to week 44
Body weight, % change
percent change from baseline, improvement
Change in body weight
Time frame:From baseline at week 0 to week 28
Body weight, % change
percent change from baseline, improvement
Subjects who achieve body weight reduction equal to or above 5%
Time frame:From baseline at week 0 to week 44
≥5% weight-loss responders
threshold achievement, improvement
Subjects who achieve body weight reduction equal to or above 10%
Time frame:From baseline at week 0 to week 44
≥10% weight-loss responders
threshold achievement, improvement
Subjects who achieve body weight reduction equal to or above 15%
Time frame:From baseline at week 0 to week 44
≥15% weight-loss responders
threshold achievement, improvement
Change in body mass index (BMI)
Time frame:From baseline at week 0 to week 44
BMI, change
change from baseline, improvement
Change in waist circumference
Time frame:From baseline at week 0 to week 44
Waist circumference, change
change from baseline, improvement
Cardiometabolic biomarkers
2 endpointsChange in systolic blood pressure and diastolic blood pressure
Time frame:From baseline at week 0 to week 44
change from baseline, improvement
componentsSystolic BP, change, Diastolic BP, change
Change in lipids
Time frame:From baseline at week 0 to week 44
change from baseline, improvement
Provenance
Sources
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.