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Phase III Clinical Study Comparing the Efficacy and Safety of GZR18 Injection and Semaglutide (Wegovy®) in Adult Obese or Overweight Subjects
A Multicenter, Randomized, Open-Label, Parallel-Group Phase III Clinical Study Comparing the Efficacy and Safety of GZR18 Injection and Semaglutide(Wegovy®) in Adult Obese or Overweight Subjects
Lead sponsor
Assets
GZR18 / Semaglutide
Listed sites
1
Recruiting sites
1
Enrollment
420
estimated
Study population
Obesity / overweight, Type 2 diabetes
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. Aged ≥ 18 years old (based on the date of signing the informed consent form), male or female.
2. For subjects not diagnosed with type 2 diabetes at screening, the following criteria must be met:
At screening and Visit 2 (before randomization), the subject must be either obese (BMI ≥ 28 kg/m²) or overweight (24 kg/m² ≤ BMI < 28 kg/m²), and concurrently present with at least one of the following conditions:
3. For subjects with type 2 diabetes at screening, the following criteria must be met simultaneously:
Body mass index (BMI) ≥ 24 kg/m² at both screening and Visit 2 (before randomization); A confirmed diagnosis of type 2 diabetes for at least 90 days at screening, in accordance with the World Health Organization (WHO) 1999 diabetes diagnostic criteria and the 2011 supplementary diagnostic criteria (HbA1c-based diagnosis is recommended); Within 90 days prior to screening: ① Management through diet and exercise alone, with no use of any antidiabetic medications; or ② Treatment of type 2 diabetes with a stable dose of metformin monotherapy, where the metformin dose is ≥ 1500 mg/day or the maximum tolerated dose (< 1500 mg/day but ≥ 1000 mg/day); or ③ Treatment of type 2 diabetes with a stable dose of metformin (≥ 1500 mg/day or the maximum tolerated dose (< 1500 mg/day but ≥ 1000 mg/day)) combined with a stable dose of sodium-glucose cotransporter 2 inhibitor (SGLT2i); Glycated hemoglobin (HbA1c) measured by the central laboratory at screening is 7.0-10.5% (inclusive of both endpoints); Fasting plasma glucose measured by the central laboratory at screening is < 15 mmol/L.
4. Prior to screening, the subject has been managed by diet and exercise alone for at least 12 weeks, and the body weight change has been < 5% within the past 12 weeks (based on self-report).
5. Subjects of childbearing potential must have no childbearing plans from the time of signing the informed consent form to 8 weeks after the last dose, and voluntarily adopt effective contraceptive measures, with no plans for sperm/egg donation. Females of childbearing potential must not be breastfeeding, and the pregnancy test results must be negative at both screening and Visit 2 (before randomization).
6. The subject must be able to understand the procedures and methods of this study, be willing and able to maintain a regular diet and exercise lifestyle during the study period, be willing and able to receive subcutaneous injection of the investigational product, and voluntarily sign the informed consent form.
Exclusion criteria
1. For subjects without type 2 diabetes at screening, the following situations are excluded:
2. For subjects with type 2 diabetes at screening, the following situations are excluded:
3. Subjects with known or suspected allergies to glucagon-like peptide-1 (GLP-1) receptor agonists or their excipients.
4. A history of substance abuse prior to screening.
5. A history of alcohol abuse within 180 days prior to screening, defined as an average weekly alcohol intake exceeding 14 units (for males)/7 units (for females) (1 standard unit is equivalent to 360 mL of beer, 150 mL of wine with 12% alcohol content, or 45 mL of spirits with 40% alcohol content).
6. Presence of limb deformities or disabilities that affect height measurement.
7. Previous receipt of bariatric surgery prior to screening, or planned receipt of bariatric surgery during the study period (exceptions include acupuncture for weight loss, liposuction, or abdominal liposuction performed more than 1 year prior to screening; and removal (or expulsion) of intragastric balloons more than 1 year prior to screening).
8. Obesity caused by secondary diseases or medications, including: elevated cortisol (e.g., Cushing's syndrome), obesity due to pituitary or hypothalamic damage, etc.
9. A history of severe hypoglycemia or grade 3 hypoglycemia within 180 days prior to screening.
10. A personal history or relevant family history of medullary thyroid carcinoma, multiple endocrine neoplasia (MEN) type 2A or 2B prior to screening; or a history of malignant tumors within the past 5 years (excluding cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix).
11. The investigator deems that the subject has any other factors that may affect the evaluation of efficacy or safety in this study, making them unsuitable for participation.
Endpoints (18)
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
9 endpointsPercentage change in body weight from baseline after 52 weeks (W) of treatment.
Time frame:From Week 0 to Week 52
Body weight, % change
percent change from baseline, improvement
Efficacy Outcome Measure :Percentage of subjects with body weight reduction ≥ 5% from baseline
Time frame:From Week 0 to Week 52
≥5% weight-loss responders
threshold achievement, improvement
Efficacy Outcome Measure :Percentage of subjects with body weight reduction ≥ 10% from baseline
Time frame:From Week 0 to Week 52
≥10% weight-loss responders
threshold achievement, improvement
Efficacy Outcome Measure :Percentage of subjects with body weight reduction ≥ 15% from baseline
Time frame:From Week 0 to Week 52
≥15% weight-loss responders
threshold achievement, improvement
Efficacy Outcome Measure :Percentage of subjects with body weight reduction ≥ 20% from baseline
Time frame:From Week 0 to Week 52
≥20% weight-loss responders
threshold achievement, improvement
Efficacy Outcome Measure :Percentage of subjects with body weight reduction ≥ 25% from baseline
Time frame:From Week 0 to Week 52
≥25% weight-loss responders
threshold achievement, improvement
Efficacy Outcome Measure :Changes in body weight from baseline
Time frame:From Week 0 to Week 52
Body weight, absolute change (kg)
change from baseline, improvement
Efficacy Outcome Measure :Changes in body mass index (BMI) from baseline
Time frame:From Week 0 to Week 52
BMI, change
change from baseline, improvement
Efficacy Outcome Measure :Changes in waist circumference from baseline
Time frame:From Week 0 to Week 52
Waist circumference, change
change from baseline, improvement
Glycemic / diabetes
3 endpointsEfficacy Outcome Measure :Changes from baseline in glycated hemoglobin (HbA1c)
Time frame:From Week 0 to Week 52
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Efficacy Outcome Measure :Changes from baseline in fasting plasma glucose
Time frame:From Week 0 to Week 52
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Efficacy Outcome Measure :Changes from baseline in fasting insulin
Time frame:From Week 0 to Week 52
change from baseline, improvement
Cardiometabolic biomarkers
6 endpointsEfficacy Outcome Measure :Changes insystolic blood pressure from baseline
Time frame:From Week 0 to Week 52
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
Efficacy Outcome Measure :Changes in diastolic blood pressure from baseline
Time frame:From Week 0 to Week 52
Diastolic BP, change
change from baseline, improvement
LOINC 8462-4
Efficacy Outcome Measure :Changes from baseline in total cholesterol (TC)
Time frame:From Week 0 to Week 52
Total cholesterol, change
change from baseline, improvement
LOINC 2093-3
Efficacy Outcome Measure :Changes from baseline in low-density lipoprotein cholesterol (LDL-C)
Time frame:From Week 0 to Week 52
LDL-C, change
change from baseline, improvement
LOINC 13457-7
Efficacy Outcome Measure :Changes from baseline in high-density lipoprotein cholesterol (HDL-C)
Time frame:From Week 0 to Week 52
HDL-C, change
change from baseline, improvement
LOINC 2085-9
Efficacy Outcome Measure :Changes from baseline in triglycerides (TG)
Time frame:From Week 0 to Week 52
Triglycerides, change
change from baseline, improvement
LOINC 2571-8
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.