ObesityPhase 1/2NCT06256536
A Study of GZR18 Injection in Chinese Obese/Overweight Patients
A Phase 1/2 study testing GZR18 in people with Obesity and Overweight, run by Gan and Lee Pharmaceuticals, USA at 1 site in China.
Trial summary
The study was a multicenter, randomized, double-blind, placebo-controlled phase Ib/IIa clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy of GZR18 injection in Chinese adult obese/overweight patients. This study is divided into Part A and Part B, which are to be conducted simultaneously. Read more about this study
- Who is it for?
- Ages 18 to 65 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
- 60 participants
- Where
- 1 siteChina
- Study dates
- 14 Jul 2022to 22 Oct 2023
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Male or female aged 18-65 years (inclusive);
- 2. Obese subjects: BMI ≥ 28.0 kg/m2; or overweight subjects: 24.0 ≤ BMI < 28.0 kg/m2 with at least one comorbidity;
- 3. Able to understand the procedures and methods in this study; willing to complete the study in strict accordance with the clinical study protocol and sign the ICF voluntarily.
Who cannot join
- 1. Suspicion that the subject may be allergic to any study drug or ingredient or congener from the investigator.
- 2. Subjects with body weight change > 5.0% for any reason (diet, exercise, etc.) within 12 weeks prior to screening.
- 3. Heart rate < 50 beats/min or > 100 beats/min on 12-lead ECG at screening.
- 4. Presence of the following clinically significant 12-lead ECG abnormalities at screening.
- 5. Alcohol abuse within 6 months prior to screening, or reluctance to stop alcohol abuse throughout the study, or a positive breath alcohol test result at screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ib/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GZR18 Injection in Chinese Obese/Overweight Patients
The study was a multicenter, randomized, double-blind, placebo-controlled phase Ib/IIa clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy of GZR18 injection in Chinese adult obese/overweight patients. This study is divided into Part A and Part B, which are to be conducted simultaneously.
- 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
0.6 mg-30 mg
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.
Incidence of adverse events and serious adverse events
Measured: 38 weeks
Changes in weight from baseline to the end of treatment
Measured: 35 weeks
Secondary outcomes (5)
trough concentrations following consecutive doses
Measured: 35 weeks
Changes in Body mass index (BMI) from baseline to the end of treatment
Measured: 35 weeks
Changes in Percentage of reduction in weight (%) from baseline to the end of treatment
Measured: 35 weeks
Changes in Waist circumference from baseline to the end of treatment
Measured: 35 weeks
Proportion of subjects with ≥5% reduction in body weight from baseline.
Measured: 35 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 start14 Jul 2022
- Primary completion22 Oct 2023
- Study completion22 Oct 2023
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 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
- NCT06256536
- Sponsor's protocol ID
- GL-GLP-CH2002
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 23 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ji L, Gao L, Dong R, Yuan M, Zhao D, Pang S, Zhao J, Zhao L, Chen W. GZR18, a GLP-1 analog with once-weekly or bi-weekly dosing for body weight management: A randomized, placebo-controlled, phase 1b/2a trial. Cell Rep Med. 2026 Apr 21;7(4):102743. doi: 10.1016/j.xcrm.2026.102743. Epub 2026 Apr 8.
PubMed 41956096
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ib/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GZR18 Injection in Chinese Obese/Overweight Patients
- ClinicalTrials.gov ID
- NCT06256536
- Acronym / sponsor ID
- GL-GLP-CH2002
- Conditions
- Obesity, Overweight
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gan and Lee Pharmaceuticals, USAIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 22 Oct 2023 (actual)
- Study completion
- 22 Oct 2023 (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.
The study was a multicenter, randomized, double-blind, placebo-controlled phase Ib/IIa clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy of GZR18 injection in Chinese adult obese/overweight patients. This study is divided into Part A and Part B, which are to be conducted simultaneously.
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 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Male or female aged 18-65 years (inclusive);
- 2. Obese subjects: BMI ≥ 28.0 kg/m2; or overweight subjects: 24.0 ≤ BMI < 28.0 kg/m2 with at least one comorbidity;
- 3. Able to understand the procedures and methods in this study; willing to complete the study in strict accordance with the clinical study protocol and sign the ICF voluntarily.
Key exclusion criteria (5 listed)
- 1. Suspicion that the subject may be allergic to any study drug or ingredient or congener from the investigator.
- 2. Subjects with body weight change > 5.0% for any reason (diet, exercise, etc.) within 12 weeks prior to screening.
- 3. Heart rate < 50 beats/min or > 100 beats/min on 12-lead ECG at screening.
- 4. Presence of the following clinically significant 12-lead ECG abnormalities at screening.
- 5. Alcohol abuse within 6 months prior to screening, or reluctance to stop alcohol abuse throughout the study, or a positive breath alcohol test result at screening.
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 |
|---|---|---|
| GZR180.6 mg-30 mg | Drug | GZR18 |
| Placeboadministered the same volume as GZR18 | Other | Placebo |
Primary outcome
Incidence of adverse events and serious adverse events
Time frame: 38 weeks
Changes in weight from baseline to the end of treatment
Time frame: 35 weeks
5 secondary outcomes
trough concentrations following consecutive doses
Time frame: 35 weeks
Changes in Body mass index (BMI) from baseline to the end of treatment
Time frame: 35 weeks
Changes in Percentage of reduction in weight (%) from baseline to the end of treatment
Time frame: 35 weeks
Changes in Waist circumference from baseline to the end of treatment
Time frame: 35 weeks
Proportion of subjects with ≥5% reduction in body weight from baseline.
Time frame: 35 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 23 Feb 2024.
- Derived from this study: PubMed 41956096Ji L, Gao L, Dong R, Yuan M, Zhao D, Pang S, Zhao J, Zhao L, Chen W. GZR18, a GLP-1 analog with once-weekly or bi-weekly dosing for body weight management: A randomized, placebo-controlled, phase 1b/2a trial. Cell Rep Med. 2026 Apr 21;7(4):102743. doi: 10.1016/j.xcrm.2026.102743. Epub 2026 Apr 8.
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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 1/2 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 5 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 23 Feb 2024. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Incidence of adverse events and serious adverse events (time frame: 38 weeks). The study lists 2 primary outcomes in all. 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 NCT06256536, 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 23 Feb 2024.