Type 2 DiabetesPhase 2NCT06256549
A Study of GZR18 Injection in Chinese Patients With Type 2 Diabetes Mellitus
A Phase 2 study testing GZR18 and Semaglutide in people with Type 2 Diabetes, run by Gan and Lee Pharmaceuticals, USA at 1 site in China.
Trial summary
This study was a multicenter, randomized, parallel and controlled study in adult patients with T2DM to evaluate the efficacy, safety (including immunogenicity) and pharmacokinetics of GZR18 injection in adult patients with T2DM. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- GZR18 and Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 1 siteChina
- Study dates
- 9 Aug 2023to 20 Jul 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
- (1) Chinese adults, male or female aged between 18 and 75 (including both ends).
- According to the diagnostic and classification criteria of diabetes issued by the World Health Organization (WHO) in 1999, and the supplementary diagnostic criteria of WHO in 2011, type 2 diabetes was diagnosed for more than 3 months.
- Lifestyle intervention and / or unregulated use of antidiabetic drugs within 3 months before screening, or stable use of less than 3 oral hypoglycemic drugs within 3 months before screening.
- HbA1c (HbA1c) ≥ 7.0% and ≤ 11% during screening.
- Body mass index (BMI) ≥ 18.5 kg/m2.
- There is no birth plan within 6 months from the signing of informed consent to the last administration, and those who voluntarily take effective contraceptive measures and have no sperm donation plan. Fertile women are not breastfeeding, and the screening and baseline pregnancy tests must be negative.
- Patients fully understand the purpose, nature, methods and possible adverse reactions of the trial, can communicate well with researchers, and can understand and comply with the requirements of this study. During the study, they can maintain a stable diet and exercise lifestyle, and voluntarily sign an informed consent form to enter this study.
Who cannot join
- (1) Known or suspected to be allergic to GLP-1 drugs or their excipients, or have contraindications to their use.
- Those who participated in clinical trials of other drugs or devices within 3 months before were screened and given treatment.
- Surgery that can lead to weight instability was performed within 2 months before screening, or non-diabetic drugs that affect weight are currently being used or are in the weight loss program and are not in the maintenance stage.
- History of alcohol or drug abuse, or positive results of pre-random drug abuse screening (urine screening).
- Continuous use of insulin for more than 14 days in one year before screening (the time for gestational diabetes to receive insulin treatment is not within this limit); GLP-1RA drugs were used in the first 6 months; dipeptidyl peptidase-4 (DPP-4) inhibitors were used in the first month.
- Growth hormone and other drug treatments determined by researchers to affect insulin levels were performed within 3 months before screening.
- Diabetic ketoacidosis, diabetic lactic acidosis or hyperosmotic nonketotic diabetic coma within 6 months before screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of GZR18 Injection in Chinese Patients With Type 2 Diabetes Mellitus
This study was a multicenter, randomized, parallel and controlled study in adult patients with T2DM to evaluate the efficacy, safety (including immunogenicity) and pharmacokinetics of GZR18 injection in adult patients with T2DM.
- Conditions
- Type 2 Diabetes
- Being tested
- GZR18, Semaglutide
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GZR18Drug
Titrated to low dose or middle or high dose
SemaglutideDrug
Titrated to 1.0 mg once a week
| Study group | Role | What they receive |
|---|---|---|
| GZR18 | Experimental | GZR18 injection s.c. Receives: Drug: GZR18 |
| Semaglutide | Active comparator | Semaglutide injection s.c. Receives: Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compared with Semaglutide, the changes of HbA1c compared with baseline after continuous administration of GZR18 injection for 24 weeks
Measured: 24 weeks
Secondary outcomes (2)
HbA1c compliance rate (< 7.0% and ≤ 6.5% of patients)
Compared with Semaglutide injection, GZR18 injection after continuous administration for 24 weeks
Measured: 24 weeks
The overall incidence of adverse events and the incidence of serious adverse events
Compared with Semaglutide injection, GZR18 injection after continuous administration for 24 weeks
Measured: 27 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 start9 Aug 2023
- Primary completion20 Jul 2024 (estimated)
- Study completion20 Jul 2024 (estimated)
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 Type 2 DiabetesStudies 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
- None (open label)
- Enrolment
- 272 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
- NCT06256549
- Sponsor's protocol ID
- GL-GLP-CH2004
- Status last verified
- Jan 2024
- First submitted
- 5 Feb 2024
- Last updated
- 23 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu M, Cheng Z, Lu L, Cai H, Liu J, Liu J, Zheng Y, Wang S, Zhao J, Yang W, Xie T, Li Y, He A, Rodbard HW, Chen W. Weekly and Biweekly Treatment With Bofanglutide Versus Semaglutide in Chinese Patients With Type 2 Diabetes : A Phase 2b Randomized Clinical Trial. Ann Intern Med. 2026 Aug;179(8):1107-1116. doi: 10.7326/ANNALS-25-04623. Epub 2026 Jun 30.
PubMed 42372276
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, Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of GZR18 Injection in Chinese Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06256549
- Acronym / sponsor ID
- GL-GLP-CH2004
- Conditions
- Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Gan and Lee Pharmaceuticals, USAIndustry (pharma, biotech, devices)
- Study start
- 9 Aug 2023 (actual)
- Primary completion
- 20 Jul 2024 (estimated)
- Study completion
- 20 Jul 2024 (estimated)
- 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 was a multicenter, randomized, parallel and controlled study in adult patients with T2DM to evaluate the efficacy, safety (including immunogenicity) and pharmacokinetics of GZR18 injection in adult patients with T2DM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GZR18 | Experimental | Drug: GZR18GZR18 injection s.c. |
| Semaglutide | Active comparator | Drug: SemaglutideSemaglutide 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 (7 listed)
- (1) Chinese adults, male or female aged between 18 and 75 (including both ends).
Key exclusion criteria (7 listed)
- (1) Known or suspected to be allergic to GLP-1 drugs or their excipients, or have contraindications to their use.
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 low dose or middle or high dose | Drug | GZR18 |
| SemaglutideTitrated to 1.0 mg once a week | Drug | Semaglutide |
Primary outcome
Compared with Semaglutide, the changes of HbA1c compared with baseline after continuous administration of GZR18 injection for 24 weeks
Time frame: 24 weeks
2 secondary outcomes
HbA1c compliance rate (< 7.0% and ≤ 6.5% of patients)
Time frame: 24 weeks
The overall incidence of adverse events and the incidence of serious adverse events
Time frame: 27 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Derived from this study: PubMed 42372276Liu M, Cheng Z, Lu L, Cai H, Liu J, Liu J, Zheng Y, Wang S, Zhao J, Yang W, Xie T, Li Y, He A, Rodbard HW, Chen W. Weekly and Biweekly Treatment With Bofanglutide Versus Semaglutide in Chinese Patients With Type 2 Diabetes : A Phase 2b Randomized Clinical Trial. Ann Intern Med. 2026 Aug;179(8):1107-1116. doi: 10.7326/ANNALS-25-04623. Epub 2026 Jun 30.
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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 and Semaglutide in people with Type 2 Diabetes, 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 7 inclusion and 7 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: status not confirmed, 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. 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?
Results are not available in the source record.
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?
Compared with Semaglutide, the changes of HbA1c compared with baseline after continuous administration of GZR18 injection for 24 weeks (time frame: 24 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 NCT06256549, 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.