Type 2 Diabetes Mellitus (T2DM)Phase 3Optimum 2NCT06778967
A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Adult Type 2 Diabetes Mellitus
A Phase 3 study testing GZR18 and semaglutide in people with Type 2 Diabetes Mellitus (T2DM), run by Gan & Lee Pharmaceuticals. at 1 site in China.
Trial summary
The main purpose of this study is to investigate the Efficacy and Safety of GZR18 Injection in Chinese Subjects with Type 2 Diabetes Mellitus and Poor Blood Glucose Control by Metformin Monotherapy or in Combination with Sodium-dependent Glucose Transporter 2 (SGLT2) Inhibitors or Sulfonylureas Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- 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
- 1,100 participants
- Where
- 1 siteChina
- Study dates
- 13 Feb 2025to 11 Dec 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
- T2DM is diagnosed for at least 12 weeks according to the diagnostic criteria of diabetes mellitus issued by the World Health Organization (WHO) in 1999 and the supplementary diagnostic criteria of WHO in 2011 (HbA1c diagnosis is recommended).
- Antidiabetic drugs that meet any of the following within 8 weeks before screening:
- A stable dose of metformin hydrochloride monotherapy at a dose of ≥ 1500 mg/day or the maximum tolerated dose ;
- A stable dose of metformin (≥ 1500 mg/day or the maximum tolerated dose ) in combination with SGLT2 inhibitors;
- A stable dose of metformin (≥1500 mg/day or a maximum tolerated dose < 1500 but ≥ 1000 mg/day) in combination with a stable daily dose of sulfonylureas.
- HbA1c ≥ 7.5% and ≤ 11% at screening (central laboratory).
- BG < 15 mmol/L at screening (central laboratory).
Who cannot join
- Type 1 diabetes mellitus or special type of diabetes mellitus.
- Diabetic ketoacidosis, diabetic lactic acidosis or hyperosmolar state within 6 months before screening, or diabetic ketosis at screening/before randomization.
- Severe chronic complications of diabetes (such as proliferative retinopathy or maculopathy, diabetic painful neuropathy, intermittent claudication, or diabetic foot) at screening or before randomization.
- History of acute or chronic pancreatitis and pancreatic injury before screening.
- History or relevant family history of medullary thyroid cancer, multiple endocrine neoplasia (MEN) 2A or 2B before screening.
- Any laboratory test indicator meeting the following criteria at screening or before randomization:
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- Calcitonin level ≥ 50 ng/L (pg/mL) at screening.
- ALT ≥ 3.0 × upper limit of normal (ULN) or AST ≥ 3.0 × ULN or total bilirubin ≥ 2.0 × ULN.
- Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2, calculated using CKD-EPI equation (see Appendix 3).
- Fasting triglyceride (TG) ≥ 5.7 mmol/L or 500 mg/dL.
- Blood amylase or lipase > 1.5 × ULN.
- Hemoglobin ≤ 100 g/L for women and ≤ 110 g/L for men.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Active-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Chinese Subjects With Type 2 Diabetes Mellitus and Poor Blood Glucose Control by Metformin Monotherapy or in Combination With Sodium-dependent Glucose Transporter 2 (SGLT2) Inhibitors or Sulfonylureas
The main purpose of this study is to investigate the Efficacy and Safety of GZR18 Injection in Chinese Subjects with Type 2 Diabetes Mellitus and Poor Blood Glucose Control by Metformin Monotherapy or in Combination with Sodium-dependent Glucose Transporter 2 (SGLT2) Inhibitors or Sulfonylureas
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- 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
Administered SC
semaglutideDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| GZR18 Dose 1 | Experimental | Participants will receive GZR18 subcutaneously (SC). Receives: Drug: GZR18 |
| GZR18 Dose 2 | Experimental | Participants will receive GZR18 subcutaneously (SC). Receives: Drug: GZR18 |
| semaglutide | Active comparator | Participants will receive semaglutide subcutaneously (SC). Receives: Drug: semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Hemoglobin A1c (HbA1c)(%)
Measured: Baseline, Week 44
Secondary outcomes (6)
Change from baseline in mean 7-point self-measured blood glucose (SMBG)
Measured: week 44
Proportion of subjects with salvage therapy.
Measured: week 44
Change from baseline in weight (kg)
Measured: week 44
Percent change in weight from baseline (%)
Measured: week 44
Proportion of subjects with ≥ 5% and 10% decrease in weight from baseline.
Measured: week 44
Treatment emergent adverse events (TEAEs)
Measured: week 44
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start13 Feb 2025
- Primary completion11 Dec 2026 (estimated)
- Study completion11 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies 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
- 1,100 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
- NCT06778967
- Sponsor's protocol ID
- GZR18-T2DM-302
- Acronym
- Optimum 2
- Status last verified
- Oct 2025
- First submitted
- 3 Jan 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, Active-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Chinese Subjects With Type 2 Diabetes Mellitus and Poor Blood Glucose Control by Metformin Monotherapy or in Combination With Sodium-dependent Glucose Transporter 2 (SGLT2) Inhibitors or Sulfonylureas
- ClinicalTrials.gov ID
- NCT06778967
- Acronym / sponsor ID
- Optimum 2 / GZR18-T2DM-302
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Gan & Lee Pharmaceuticals.Industry (pharma, biotech, devices)
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- 11 Dec 2026 (estimated)
- Study completion
- 11 Dec 2026 (estimated)
- First posted
- 16 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.
The main purpose of this study is to investigate the Efficacy and Safety of GZR18 Injection in Chinese Subjects with Type 2 Diabetes Mellitus and Poor Blood Glucose Control by Metformin Monotherapy or in Combination with Sodium-dependent Glucose Transporter 2 (SGLT2) Inhibitors or Sulfonylureas
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GZR18 Dose 1 | Experimental | Drug: GZR18Participants will receive GZR18 subcutaneously (SC). |
| GZR18 Dose 2 | Experimental | Drug: GZR18Participants will receive GZR18 subcutaneously (SC). |
| semaglutide | Active comparator | Drug: semaglutideParticipants will receive semaglutide subcutaneously (SC). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- T2DM is diagnosed for at least 12 weeks according to the diagnostic criteria of diabetes mellitus issued by the World Health Organization (WHO) in 1999 and the supplementary diagnostic criteria of WHO in 2011 (HbA1c diagnosis is recommended).
- Antidiabetic drugs that meet any of the following within 8 weeks before screening:
- HbA1c ≥ 7.5% and ≤ 11% at screening (central laboratory).
- BG < 15 mmol/L at screening (central laboratory).
Key exclusion criteria (12 listed)
- Type 1 diabetes mellitus or special type of diabetes mellitus.
- Diabetic ketoacidosis, diabetic lactic acidosis or hyperosmolar state within 6 months before screening, or diabetic ketosis at screening/before randomization.
- Severe chronic complications of diabetes (such as proliferative retinopathy or maculopathy, diabetic painful neuropathy, intermittent claudication, or diabetic foot) at screening or before randomization.
- History of acute or chronic pancreatitis and pancreatic injury before screening.
- History or relevant family history of medullary thyroid cancer, multiple endocrine neoplasia (MEN) 2A or 2B before 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 |
|---|---|---|
| GZR18Administered SC | Drug | GZR18 Dose 1, GZR18 Dose 2 |
| semaglutideAdministered SC | Drug | semaglutide |
Primary outcome
Change from Baseline in Hemoglobin A1c (HbA1c)(%)
Time frame: Baseline, Week 44
6 secondary outcomes
Change from baseline in mean 7-point self-measured blood glucose (SMBG)
Time frame: week 44
Proportion of subjects with salvage therapy.
Time frame: week 44
Change from baseline in weight (kg)
Time frame: week 44
Percent change in weight from baseline (%)
Time frame: week 44
Proportion of subjects with ≥ 5% and 10% decrease in weight from baseline.
Time frame: week 44
Treatment emergent adverse events (TEAEs)
Time frame: week 44
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. 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 GZR18 and semaglutide in people with Type 2 Diabetes Mellitus (T2DM), 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 7 inclusion and 12 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 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?
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 from Baseline in Hemoglobin A1c (HbA1c)(%) (time frame: Baseline, Week 44). 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; AzTrials last refreshed its copy on 31 Oct 2026.