ObesityPhase 2NCT06256562
A Study of GZR18 Injection in Obese/Overweight Patients
A Phase 2 study testing GZR18 in people with Obesity and Overweight, run by Gan and Lee Pharmaceuticals, USA at 1 site in China.
Trial summary
This study is a multicenter, randomized, placebo-controlled phase II clinical study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of GZR18 injection in Chinese adult obese/overweight subjects. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- GZR18
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 340 participants
- Where
- 1 siteChina
- Study dates
- 8 Jun 2023to 5 Jun 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18-75 years (inclusive).
- Obese subjects (BMI≥28 kg/m2), Or overweight subjects (24 kg/m2≤BMI<28 kg/m2) with at least one comorbidity.
- Able to understand the procedures and methods in this study; willing and able to maintain a stable diet and exercise lifestyle during the research period, and willing to sign the ICF voluntarily.
Who cannot join
- Limb deformities or defects affecting height and body weight measurement.
- Pregnant or lactating women, men or women of reproductive potential unwilling to use contraception throughout the study and for 6 months after the last dose of investigational drug.
- History of drug abuse within 1 year before screening, or positive results in drug abuse screening during screening or before randomization.
- Alcohol abuse history within 6 months prior to screening.
- Subjects who are known or suspected to be allergic to GLP-1 drugs or excipients.
- Subjects with an absolute weight change greater than 5.0% due to any reason within the 3 months prior to screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Chinese Obese/Overweight Patients
This study is a multicenter, randomized, placebo-controlled phase II clinical study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of GZR18 injection in Chinese adult obese/overweight subjects.
- Conditions
- Obesity, Overweight
- Being tested
- GZR18, Placebo
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GZR18Drug
Titrated to dose 1, dose 2, dose 3 or dose 4
PlaceboOther
Administered the same volume as GZR18
| Study group | Role | What they receive |
|---|---|---|
| GZR18 | Experimental | GZR18 injection s.c. Receives: Drug: GZR18 |
| Placebo | Placebo comparator | Placebo injection s.c. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent (%) change from baseline in body weight at the end of the study (W30)
Measured: 30 weeks
Secondary outcomes (11)
Proportion of subjects who achieved (yes/no) body weight reduction ≥5%, 10%, 15%, 20% from baseline.
Measured: 30 weeks
Weight, waist circumference, waist-to-hip ratio (waist circumference/hip circumference), and body mass index (BMI)
Changes from baseline
Measured: 30 weeks
Percentage (%) of weight
Change from baseline at the last safety follow-up visit (W33) after discontinuation
Measured: 33 weeks
Glucose metabolism indicators: glycated hemoglobin A1C (HbA1c), fasting plasma glucose (FPG), fasting insulin, insulin resistance index (HOMA-IR), and islet β cell function (HOMA-β)
Changes from baseline
Measured: 30 weeks
Cardiovascular disease risk factors: blood pressure (SBP and DBP), pulse, total cholesterol (TC), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), and triglycerides (TG)
Changes from baseline
Measured: 30 weeks
Patient-reported weight-related quality of life scores: IWQoL-Lite-CT and SF-36 scale
Changes from baseline
Measured: 30 weeks
Anti-drug antibodies (ADAs) for GZR18 and neutralizing antibodies (NAbs) following GZR18 Injection
Changes from baseline
Measured: 33 weeks
AUClast, AUC0-inf, Tmax, λz, t1/2, tlag, CL/F, Vz/F, AUC%extra, MRT, Css_min, Css_max, Css_av, DF, Css_min
Measured: 30 weeks
The number of adverse events (AEs)/serious adverse events (SAEs) /AEs of special interest (AESIs) that occurred during the study.
Measured: 33 weeks
Vital signs, physical examination, 12-lead Electrocardiogram (ECG), and clinical laboratory tests (hematology, urinalysis, blood biochemistry, blood amylase, blood lipase, coagulation function, calcitonin,TSH/FT3/FT4
Change from baseline
Measured: 33 weeks
Subject's mental health status (assessed by using the Columbia-Suicide Severity Rating Scale and Patient Health Questionnaire (PHQ-9))
Measured: 33 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start8 Jun 2023
- Primary completion5 Jun 2024
- Study completion5 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gan and Lee Pharmaceuticals, USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liyuan Zhao, Ph.D, Study director, Gan & Lee Pharmaceuticals.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256562
- Sponsor's protocol ID
- GL-GLP-CH2005
- Status last verified
- Aug 2024
- First submitted
- 5 Feb 2024
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ji L, Gao L, Tian J, Dong R, Zhang Z, Shu H, Zhao J, Zhao L, He A, Xie T, Li Y, Chen W. Efficacy and safety of bofanglutide, a GLP-1 receptor agonist, in Chinese adults with overweight or obesity: a randomized, double-blind, placebo-controlled phase 2b trial. Signal Transduct Target Ther. 2026 Feb 27;11(1):73. doi: 10.1038/s41392-026-02586-8.
PubMed 41760612
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Chinese Obese/Overweight Patients
- ClinicalTrials.gov ID
- NCT06256562
- Acronym / sponsor ID
- GL-GLP-CH2005
- Conditions
- Obesity, Overweight
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Gan and Lee Pharmaceuticals, USAIndustry (pharma, biotech, devices)
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 5 Jun 2024 (actual)
- First posted
- 13 Feb 2024 (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, placebo-controlled phase II clinical study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of GZR18 injection in Chinese adult obese/overweight subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GZR18 | Experimental | Drug: GZR18GZR18 injection s.c. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo injection s.c. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
Key exclusion criteria (6 listed)
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 |
|---|---|---|
| GZR18Titrated to dose 1, dose 2, dose 3 or dose 4 | Drug | GZR18 |
| PlaceboAdministered the same volume as GZR18 | Other | Placebo |
Primary outcome
Percent (%) change from baseline in body weight at the end of the study (W30)
Time frame: 30 weeks
11 secondary outcomes
Proportion of subjects who achieved (yes/no) body weight reduction ≥5%, 10%, 15%, 20% from baseline.
Time frame: 30 weeks
Weight, waist circumference, waist-to-hip ratio (waist circumference/hip circumference), and body mass index (BMI)
Time frame: 30 weeks
Percentage (%) of weight
Time frame: 33 weeks
Glucose metabolism indicators: glycated hemoglobin A1C (HbA1c), fasting plasma glucose (FPG), fasting insulin, insulin resistance index (HOMA-IR), and islet β cell function (HOMA-β)
Time frame: 30 weeks
Cardiovascular disease risk factors: blood pressure (SBP and DBP), pulse, total cholesterol (TC), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), and triglycerides (TG)
Time frame: 30 weeks
Patient-reported weight-related quality of life scores: IWQoL-Lite-CT and SF-36 scale
Time frame: 30 weeks
Anti-drug antibodies (ADAs) for GZR18 and neutralizing antibodies (NAbs) following GZR18 Injection
Time frame: 33 weeks
AUClast, AUC0-inf, Tmax, λz, t1/2, tlag, CL/F, Vz/F, AUC%extra, MRT, Css_min, Css_max, Css_av, DF, Css_min
Time frame: 30 weeks
The number of adverse events (AEs)/serious adverse events (SAEs) /AEs of special interest (AESIs) that occurred during the study.
Time frame: 33 weeks
Vital signs, physical examination, 12-lead Electrocardiogram (ECG), and clinical laboratory tests (hematology, urinalysis, blood biochemistry, blood amylase, blood lipase, coagulation function, calcitonin,TSH/FT3/FT4
Time frame: 33 weeks
Subject's mental health status (assessed by using the Columbia-Suicide Severity Rating Scale and Patient Health Questionnaire (PHQ-9))
Time frame: 33 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Derived from this study: PubMed 41760612Ji L, Gao L, Tian J, Dong R, Zhang Z, Shu H, Zhao J, Zhao L, He A, Xie T, Li Y, Chen W. Efficacy and safety of bofanglutide, a GLP-1 receptor agonist, in Chinese adults with overweight or obesity: a randomized, double-blind, placebo-controlled phase 2b trial. Signal Transduct Target Ther. 2026 Feb 27;11(1):73. doi: 10.1038/s41392-026-02586-8.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Liyuan Zhao, Ph.D study director
Gan & Lee Pharmaceuticals.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GZR18 in people with Obesity and Overweight, run by Gan and Lee Pharmaceuticals, USA 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 1 Oct 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent (%) change from baseline in body weight at the end of the study (W30) (time frame: 30 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06256562, which also lists 1 linked publication.
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 1 Oct 2025.