DiabetesPhase 3NCT06767735
A Phase III Clinical Study to Assess the Efficacy and Safety of GZR4 in Insulin-naive Subjects With Type 2 Diabetes Mellitus (T2DM)
A Phase 3 study testing GZR4 and Insulin Glargine U100 in people with Diabetes, run by Gan & Lee Pharmaceuticals. at 1 site in China.
Trial summary
This study will be conducted to compare the efficacy, safety and patient-reported outcome of once-weekly GZR4 and once-daily Insulin Glargine U100 with Non-Insulin Antidiabetic Agents in Insulin-naive Subjects with Type 2 Diabetes Mellitusin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- GZR4 and Insulin Glargine U100
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 580 participants
- Where
- 1 siteChina
- Study dates
- 17 Feb 2025to 17 Aug 2026
- 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
- Sign the Informed Consent Form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and be able to follow the contraindications and restrictions specified in this protocol.
- Males and females age ≥ 18 years at the time of informed consent.
- The pregnancy test for β-human chorionic gonadotropin (hCG) must be negative for women of childbearing potential during the screening period and prior to randomization.
- From signing the Informed Consent Form until 3 weeks after the end of treatment, female subjects of childbearing potential and male subjects and their partners must agree to use reliable contraceptive measures and not donate eggs (ova, oocytes) or sperm for assisted reproductive purposes.
- According to the diagnostic criteria and classification of diabetes mellitus issued by the World Health Organization (WHO) in 1999, and the supplementary diagnostic criteria recommended by WHO for diagnosis with Hemoglobin A1c (HbA1c) (2011), the time to diagnose T2DM is ≥ 180 days at screening.
- Naive to insulin treatment.
Who cannot join
- A history of allergy to drugs with two or more mechanisms of action in the past, or known allergies, hypersensitivity, or intolerance to the investigational medicinal product or its excipients (glycerol, phenol, m-cresol, zinc acetate dihydrate, sodium chloride, citric acid monohydrate, or zinc chloride).
- Subjects who are pregnant, lactating or planning to become pregnant during the study at screening.
- Participated in any drug clinical study (received non-placebo medication during the study) within a recent period of time (90 days or 5 half-lives of the previous investigational medicinal product, whichever is longer), or plans to participate in another clinical study before completing all scheduled assessments in this clinical study.
- Underwent invasive cardiovascular or cerebrovascular procedures within 180 days before screening; or experienced acute heart failure, myocardial infarction, stroke, or hospitalization due to angina unstable, transient ischaemic attack, or other acute cardiovascular events within 180 days before screening; or have a history of chronic cardiac failure classified as New York Heart Association Class III or IV at screening; or plan to undergo coronary, carotid, or peripheral arterial revascularisation procedures during the study; or have clinically significant abnormalities on the electrocardiogram (ECG) that require treatment at screening (such as second-degree type II or third-degree atrioventricular block, ventricular fibrillation, ventricular flutter, atrial fibrillation, atrial flutter, Wolff-Parkinson-White syndrome, etc.).
- History of malignant tumors before screening (excluding adequately treated or resected non-metastatic basal or squamous cell skin cancer, cervical carcinoma in situ, or prostate cancer in situ) or the presence of underlying malignancy at screening.
- The patient with SBP ≥ 160 mmHg or DBP ≥ 100 mmHg during screening.
- Subjects who are unable to comply with the requirements of this protocol as judged by the investigator, or have any other conditions that the investigator considers inappropriate to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Gan & Lee Pharmaceuticals Shandong Co., Ltd.
Linyi, Shandong, 276000
About this study
Official title: A Phase III Clinical Study Comparing the Efficacy and Safety of GZR4 QW Versus Insulin Glargine U100 QD+ Non-Insulin Antidiabetic Agents in Insulin-naive Subjects With Type 2 Diabetes Mellitus
This study will be conducted to compare the efficacy, safety and patient-reported outcome of once-weekly GZR4 and once-daily Insulin Glargine U100 with Non-Insulin Antidiabetic Agents in Insulin-naive Subjects with Type 2 Diabetes Mellitusin.
- Conditions
- Diabetes
- Being tested
- GZR4, Insulin Glargine U100
- Keywords
- GZR4, insulin
- Medical subject headings
- Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GZR4Drug
GZR4 s.c., once-weekly，treat-to-target dose
Insulin Glargine U100Drug
Insulin Glargine U100 s.c.,once-daily，treat-to-target dose
| Study group | Role | What they receive |
|---|---|---|
| GZR4 group | Experimental | Not described Receives: Drug: GZR4 |
| Insulin Glargine U100 group | Active comparator | Not described Receives: Drug: Insulin Glargine U100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Measured: From baseline (week 0) to week 26
Secondary outcomes (4)
Change in HbA1c
Measured: From baseline (week 0) to week 52
hypoglycaemia events
Measured: From baseline (week 0) to week 26/52
adverse events
Measured: From baseline (week 0) to week 26/52
Change in weight
Measured: From baseline (week 0) to week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start17 Feb 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion17 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Gan & Lee Pharmaceuticals.The sponsor's other registered studies.
- 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
- 580 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
- NCT06767735
- Sponsor's protocol ID
- GZR4-T2D-301
- Status last verified
- Nov 2025
- First submitted
- 5 Jan 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Clinical Study Comparing the Efficacy and Safety of GZR4 QW Versus Insulin Glargine U100 QD+ Non-Insulin Antidiabetic Agents in Insulin-naive Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06767735
- Acronym / sponsor ID
- GZR4-T2D-301
- Conditions
- Diabetes
- Keywords
- GZR4, insulin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 580 participants (estimated)
- Lead sponsor
- Gan & Lee Pharmaceuticals.Industry (pharma, biotech, devices)
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 17 Aug 2026 (estimated)
- First posted
- 10 Jan 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 will be conducted to compare the efficacy, safety and patient-reported outcome of once-weekly GZR4 and once-daily Insulin Glargine U100 with Non-Insulin Antidiabetic Agents in Insulin-naive Subjects with Type 2 Diabetes Mellitusin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GZR4 group | Experimental | Drug: GZR4 |
| Insulin Glargine U100 group | Active comparator | Drug: Insulin Glargine U100 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Sign the Informed Consent Form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and be able to follow the contraindications and restrictions specified in this protocol.
- Males and females age ≥ 18 years at the time of informed consent.
- The pregnancy test for β-human chorionic gonadotropin (hCG) must be negative for women of childbearing potential during the screening period and prior to randomization.
- From signing the Informed Consent Form until 3 weeks after the end of treatment, female subjects of childbearing potential and male subjects and their partners must agree to use reliable contraceptive measures and not donate eggs (ova, oocytes) or sperm for assisted reproductive purposes.
- According to the diagnostic criteria and classification of diabetes mellitus issued by the World Health Organization (WHO) in 1999, and the supplementary diagnostic criteria recommended by WHO for diagnosis with Hemoglobin A1c (HbA1c) (2011), the time to diagnose T2DM is ≥ 180 days at screening.
Key exclusion criteria (7 listed)
- A history of allergy to drugs with two or more mechanisms of action in the past, or known allergies, hypersensitivity, or intolerance to the investigational medicinal product or its excipients (glycerol, phenol, m-cresol, zinc acetate dihydrate, sodium chloride, citric acid monohydrate, or zinc chloride).
- Subjects who are pregnant, lactating or planning to become pregnant during the study at screening.
- Participated in any drug clinical study (received non-placebo medication during the study) within a recent period of time (90 days or 5 half-lives of the previous investigational medicinal product, whichever is longer), or plans to participate in another clinical study before completing all scheduled assessments in this clinical study.
- Underwent invasive cardiovascular or cerebrovascular procedures within 180 days before screening; or experienced acute heart failure, myocardial infarction, stroke, or hospitalization due to angina unstable, transient ischaemic attack, or other acute cardiovascular events within 180 days before screening; or have a history of chronic cardiac failure classified as New York Heart Association Class III or IV at screening; or plan to undergo coronary, carotid, or peripheral arterial revascularisation procedures during the study; or have clinically significant abnormalities on the electrocardiogram (ECG) that require treatment at screening (such as second-degree type II or third-degree atrioventricular block, ventricular fibrillation, ventricular flutter, atrial fibrillation, atrial flutter, Wolff-Parkinson-White syndrome, etc.).
- History of malignant tumors before screening (excluding adequately treated or resected non-metastatic basal or squamous cell skin cancer, cervical carcinoma in situ, or prostate cancer in situ) or the presence of underlying malignancy 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 |
|---|---|---|
| GZR4GZR4 s.c., once-weekly，treat-to-target dose | Drug | GZR4 group |
| Insulin Glargine U100Insulin Glargine U100 s.c.,once-daily，treat-to-target dose | Drug | Insulin Glargine U100 group |
Primary outcome
Change in HbA1c
Time frame: From baseline (week 0) to week 26
4 secondary outcomes
Change in HbA1c
Time frame: From baseline (week 0) to week 52
hypoglycaemia events
Time frame: From baseline (week 0) to week 26/52
adverse events
Time frame: From baseline (week 0) to week 26/52
Change in weight
Time frame: From baseline (week 0) to week 26
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 28 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 GZR4 and Insulin Glargine U100 in people with Diabetes, 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 6 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: under way, not looking for participants, as of the sponsor's last update on 28 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?
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?
Change in HbA1c (time frame: From baseline (week 0) to week 26). 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 28 Nov 2025.