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RecruitingPhase 3

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

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

NCT IDNCT07150975
Org study IDGZR18-BWM-302

Timeline

Milestones

Study first posted2025-09-02actual
Study start2025-09-23actual
Last update posted2025-11-25actual
Primary completion2027-06-30estimated
Study completion2027-06-30estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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:

Comorbidity of one or more of the following: hyperglycemia (see Appendix 1 for definition), hypertension, dyslipidemia (see Appendix 2 for definition), or fatty liver; ②Weight-bearing joint pain;
Weight-related obstructive sleep apnea syndrome.

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:

Fasting plasma glucose ≥ 7.0 mmol/L or glycated hemoglobin (HbA1c) ≥ 6.5% as measured by the central laboratory at screening.
Diagnosis of any type of diabetes (excluding gestational diabetes) prior to screening.
Use of glucagon-like peptide-1 receptor (GLP-1R) agonists or drugs with a GLP-1R agonist mechanism of action (e.g., GLP-1R/glucagon receptor (GCGR) agonists, glucose-dependent insulinotropic polypeptide receptor (GIPR)/GLP-1R agonists, or GIPR/GLP-1R/GCGR agonists, etc.) prior to screening.

2. For subjects with type 2 diabetes at screening, the following situations are excluded:

Use of glucagon-like peptide-1 receptor (GLP-1R) agonists or drugs with a GLP-1R agonist mechanism of action (e.g., GLP-1R/glucagon receptor (GCGR) agonists, glucose-dependent insulinotropic polypeptide receptor (GIPR)/GLP-1R agonists, or GIPR/GLP-1R/GCGR agonists, etc.) within 180 days prior to screening; or a history of poor blood glucose control efficacy or intolerance to the above-mentioned drugs (as assessed by the investigator).
A history of diabetic ketoacidosis, lactic acidosis, or hyperosmolar hyperglycemic state within 180 days prior to screening.
Presence of severe chronic diabetic complications at screening (e.g., proliferative retinopathy or macular edema, painful diabetic neuropathy, intermittent claudication, or diabetic foot).
A history of refractory or complicated urinary tract infections/genital infections within 6 months prior to screening.

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
Cardiometabolic biomarkers
6
Glycemic / diabetes
3

Weight & body composition

9 endpoints
Primary/protocol endpoint

Percentage 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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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 endpoints
Secondary/protocol endpoint

Efficacy 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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

Efficacy Outcome Measure :Changes from baseline in fasting insulin

Time frame:From Week 0 to Week 52

change from baseline, improvement

Cardiometabolic biomarkers

6 endpoints
Secondary/protocol endpoint

Efficacy 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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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 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.