Obesity/Overweight in AdultPhase 3NCT07150975
Phase III Clinical Study Comparing the Efficacy and Safety of GZR18 Injection and Semaglutide (Wegovy®) in Adult Obese or Overweight Subjects
A Phase 3 study testing GZR18 and Semaglutide(Wegovy® ) in people with Obesity/Overweight in Adult, run by Gan & Lee Pharmaceuticals. at 1 site in China.
Trial summary
This study is a multicenter, randomized, open-label, parallel-group phase III clinical trial comparing the efficacy and safety of GZR18 Injection and semaglutide (Wegovy®) in adult obese or overweight subjects, aiming to evaluate the efficacy and safety of GZR18 Injection in this population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity/Overweight in Adult
- What is being tested?
- GZR18 and Semaglutide(Wegovy® )
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteChina
- Study dates
- 23 Sep 2025to 30 Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years old (based on the date of signing the informed consent form), male or female.
- 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.
- For subjects with type 2 diabetes at screening, the following criteria must be met simultaneously:
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- 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.
- 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).
- 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).
- 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.
- -
Who cannot join
- 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.
- 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).
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- 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.
- Subjects with known or suspected allergies to glucagon-like peptide-1 (GLP-1) receptor agonists or their excipients.
- A history of substance abuse prior to screening.
- 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).
- Presence of limb deformities or disabilities that affect height measurement.
- 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).
- Obesity caused by secondary diseases or medications, including: elevated cortisol (e.g., Cushing's syndrome), obesity due to pituitary or hypothalamic damage, etc.
- A history of severe hypoglycemia or grade 3 hypoglycemia within 180 days prior to screening.
- 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).
- 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.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing
Beijing
jian bo Song, 010-8059-5000, jianbo.song@ganlee.com
About this study
Official title: 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
This study is a multicenter, randomized, open-label, parallel-group phase III clinical trial comparing the efficacy and safety of GZR18 Injection and semaglutide (Wegovy®) in adult obese or overweight subjects, aiming to evaluate the efficacy and safety of GZR18 Injection in this population.
- Conditions
- Obesity/Overweight in Adult
- Being tested
- GZR18, Semaglutide(Wegovy® )
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GZR18Drug
Administered SC
Semaglutide(Wegovy® )Drug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| GZR18 Dose Level 1 | Experimental | Not described Receives: Drug: GZR18 |
| GZR18 Dose Level 2 | Experimental | Not described Receives: Drug: GZR18 |
| Semaglutide(Wegovy® )2.4 mg | Active comparator | Not described Receives: Drug: Semaglutide(Wegovy® ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in body weight from baseline after 52 weeks (W) of treatment.
Measured: From Week 0 to Week 52
Secondary outcomes (17)
Efficacy Outcome Measure :Percentage of subjects with body weight reduction ≥ 5% from baseline
Measured: From Week 0 to Week 52
Efficacy Outcome Measure :Percentage of subjects with body weight reduction ≥ 10% from baseline
Measured: From Week 0 to Week 52
Efficacy Outcome Measure :Percentage of subjects with body weight reduction ≥ 15% from baseline
Measured: From Week 0 to Week 52
Efficacy Outcome Measure :Percentage of subjects with body weight reduction ≥ 20% from baseline
Measured: From Week 0 to Week 52
Efficacy Outcome Measure :Percentage of subjects with body weight reduction ≥ 25% from baseline
Measured: From Week 0 to Week 52
Efficacy Outcome Measure :Changes in body weight from baseline
Measured: From Week 0 to Week 52
Efficacy Outcome Measure :Changes in body mass index (BMI) from baseline
Measured: From Week 0 to Week 52
Efficacy Outcome Measure :Changes in waist circumference from baseline
Measured: From Week 0 to Week 52
Efficacy Outcome Measure :Changes from baseline in glycated hemoglobin (HbA1c)
Measured: From Week 0 to Week 52
Efficacy Outcome Measure :Changes from baseline in fasting plasma glucose
Measured: From Week 0 to Week 52
Efficacy Outcome Measure :Changes from baseline in fasting insulin
Measured: From Week 0 to Week 52
Efficacy Outcome Measure :Changes insystolic blood pressure from baseline
Measured: From Week 0 to Week 52
Efficacy Outcome Measure :Changes in diastolic blood pressure from baseline
Measured: From Week 0 to Week 52
Efficacy Outcome Measure :Changes from baseline in total cholesterol (TC)
Measured: From Week 0 to Week 52
Efficacy Outcome Measure :Changes from baseline in low-density lipoprotein cholesterol (LDL-C)
Measured: From Week 0 to Week 52
Efficacy Outcome Measure :Changes from baseline in high-density lipoprotein cholesterol (HDL-C)
Measured: From Week 0 to Week 52
Efficacy Outcome Measure :Changes from baseline in triglycerides (TG)
Measured: From Week 0 to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start23 Sep 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity/Overweight in AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gan & Lee Pharmaceuticals.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150975
- Sponsor's protocol ID
- GZR18-BWM-302
- Status last verified
- Aug 2025
- First submitted
- 27 Aug 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07150975
- Acronym / sponsor ID
- GZR18-BWM-302
- Conditions
- Obesity/Overweight in Adult
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Gan & Lee Pharmaceuticals.Industry (pharma, biotech, devices)
- Study start
- 23 Sep 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 2 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a multicenter, randomized, open-label, parallel-group phase III clinical trial comparing the efficacy and safety of GZR18 Injection and semaglutide (Wegovy®) in adult obese or overweight subjects, aiming to evaluate the efficacy and safety of GZR18 Injection in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GZR18 Dose Level 1 | Experimental | Drug: GZR18 |
| GZR18 Dose Level 2 | Experimental | Drug: GZR18 |
| Semaglutide(Wegovy® )2.4 mg | Active comparator | Drug: Semaglutide(Wegovy® ) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged ≥ 18 years old (based on the date of signing the informed consent form), male or female.
- 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:
- 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.
Key exclusion criteria (19 listed)
- For subjects without type 2 diabetes at screening, the following situations are excluded:
- For subjects with type 2 diabetes at screening, the following situations are excluded:
- Subjects with known or suspected allergies to glucagon-like peptide-1 (GLP-1) receptor agonists or their excipients.
- A history of substance abuse prior to screening.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GZR18Administered SC | Drug | GZR18 Dose Level 1, GZR18 Dose Level 2 |
| Semaglutide(Wegovy® )Administered SC | Drug | Semaglutide(Wegovy® )2.4 mg |
Primary outcome
Percentage change in body weight from baseline after 52 weeks (W) of treatment.
Time frame: From Week 0 to Week 52
17 secondary outcomes
Efficacy Outcome Measure :Percentage of subjects with body weight reduction ≥ 5% from baseline
Time frame: From Week 0 to Week 52
Efficacy Outcome Measure :Percentage of subjects with body weight reduction ≥ 10% from baseline
Time frame: From Week 0 to Week 52
Efficacy Outcome Measure :Percentage of subjects with body weight reduction ≥ 15% from baseline
Time frame: From Week 0 to Week 52
Efficacy Outcome Measure :Percentage of subjects with body weight reduction ≥ 20% from baseline
Time frame: From Week 0 to Week 52
Efficacy Outcome Measure :Percentage of subjects with body weight reduction ≥ 25% from baseline
Time frame: From Week 0 to Week 52
Efficacy Outcome Measure :Changes in body weight from baseline
Time frame: From Week 0 to Week 52
Efficacy Outcome Measure :Changes in body mass index (BMI) from baseline
Time frame: From Week 0 to Week 52
Efficacy Outcome Measure :Changes in waist circumference from baseline
Time frame: From Week 0 to Week 52
Efficacy Outcome Measure :Changes from baseline in glycated hemoglobin (HbA1c)
Time frame: From Week 0 to Week 52
Efficacy Outcome Measure :Changes from baseline in fasting plasma glucose
Time frame: From Week 0 to Week 52
Efficacy Outcome Measure :Changes from baseline in fasting insulin
Time frame: From Week 0 to Week 52
Efficacy Outcome Measure :Changes insystolic blood pressure from baseline
Time frame: From Week 0 to Week 52
Efficacy Outcome Measure :Changes in diastolic blood pressure from baseline
Time frame: From Week 0 to Week 52
Efficacy Outcome Measure :Changes from baseline in total cholesterol (TC)
Time frame: From Week 0 to Week 52
Efficacy Outcome Measure :Changes from baseline in low-density lipoprotein cholesterol (LDL-C)
Time frame: From Week 0 to Week 52
Efficacy Outcome Measure :Changes from baseline in high-density lipoprotein cholesterol (HDL-C)
Time frame: From Week 0 to Week 52
Efficacy Outcome Measure :Changes from baseline in triglycerides (TG)
Time frame: From Week 0 to Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GZR18 and Semaglutide(Wegovy® ) in people with Obesity/Overweight in Adult, run by Gan & Lee Pharmaceuticals. at 1 site 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 11 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianbo Song (010-56456739, jianbo.song@ganlee.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in body weight from baseline after 52 weeks (W) of treatment. (time frame: From Week 0 to Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2025.