Type 2 Diabetes (T2DM)Phase 2NCT07387003
Evaluate the Efficacy and Safety of GZR101-80 Injection in Patients With Type 2 Diabetes
A Phase 2 study testing GZR101-80 and GZR33 or Insulin degludec/Insulin aspart or Insulin aspart30 (NovoRapid®30) in people with Type 2 Diabetes (T2DM), run by Gan & Lee Pharmaceuticals. at 1 site in China.
Trial summary
This study will be conducted to evaluate the efficacy and safety of GZR101-80 Injection in patients with type 2 diabetes mellitus inadequately controlled on oral antidiabetic drugs or Basal Insulin. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes (T2DM)
- What is being tested?
- GZR101-80 and GZR33 or Insulin degludec/Insulin aspart or Insulin aspart30 (NovoRapid®30)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2026to 23 Sep 2027
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects sign the Informed Consent Form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and are able to follow the contraindications and restrictions specified in this protocol.
- At the age of 18-75 (inclusive) at the time of informed consent, male or female.
- Body mass index (BMI) ≥18.5 and ≤35.0 kg/m2 at screening.
- 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.
Who cannot join
- Confirmed or suspected type 1 diabetes mellitus or specific types of diabetes due to other causes (monogenic diabetes, cystic fibrosis, pancreatitis, drug- or chemical-induced diabetes, etc.) prior to screening.
- Grade 3 hypoglycemia within 3 months before screening.
- Subjects who have any diseases that may affect HbA1c testing at screening, or subjects who have donated blood, lost more than 400 mL of blood, or received blood transfusion within 3 months prior to screening.
- Diagnosis of active malignant tumor within 5 years prior to screening (excluding adequately treated or resected non-metastatic basal or squamous cell skin cancer, in situ cancer of cervix, or prostate cancer in situ), or with a high suspicion of potential malignant tumor at screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter Phase 2 Clinical Study to Evaluate the Efficacy and Safety of GZR101-80 Injection in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Oral Antidiabetic Drugs or Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin
This study will be conducted to evaluate the efficacy and safety of GZR101-80 Injection in patients with type 2 diabetes mellitus inadequately controlled on oral antidiabetic drugs or Basal Insulin.
- Conditions
- Type 2 Diabetes (T2DM)
- Being tested
- GZR101-80, GZR33 or Insulin degludec/Insulin aspart or Insulin aspart30 (NovoRapid®30)
- 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.
GZR101-80Drug
Administered SC
GZR33 or Insulin degludec/Insulin aspart or Insulin aspart30 (NovoRapid®30)Drug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| GZR101-80 | Experimental | Not described Receives: Drug: GZR101-80 |
| GZR33 or Insulin degludec/Insulin aspart or Insulin aspart 30 (NovoRapid®30) | Active comparator | Not described Receives: Drug: GZR33 or Insulin degludec/Insulin aspart or Insulin aspart30 (NovoRapid®30) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1c (HbA1c) from baseline after 16 weeks of treatment.
Measured: Baseline , 16 weeks
Secondary outcomes (2)
Change in fasting plasma glucose (FPG) from baseline after 16 weeks of treatment
Measured: Baseline , 16 weeks
Safety Endpoints
Number of adverse events (AEs) and serious adverse events (SAEs), and number and percent
Measured: Baseline , 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start10 Apr 2026 (estimated)
- Primary completion11 Feb 2027 (estimated)
- Study completion23 Sep 2027 (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 (T2DM)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 345 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
- NCT07387003
- Sponsor's protocol ID
- GZR101-T2D-203
- Status last verified
- Sep 2025
- First submitted
- 28 Jan 2026
- Last updated
- 15 Apr 2026
- 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 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase 2 Clinical Study to Evaluate the Efficacy and Safety of GZR101-80 Injection in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Oral Antidiabetic Drugs or Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin
- ClinicalTrials.gov ID
- NCT07387003
- Acronym / sponsor ID
- GZR101-T2D-203
- Conditions
- Type 2 Diabetes (T2DM)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 345 participants (estimated)
- Lead sponsor
- Gan & Lee Pharmaceuticals.Industry (pharma, biotech, devices)
- Study start
- 10 Apr 2026 (estimated)
- Primary completion
- 11 Feb 2027 (estimated)
- Study completion
- 23 Sep 2027 (estimated)
- First posted
- 4 Feb 2026 (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 evaluate the efficacy and safety of GZR101-80 Injection in patients with type 2 diabetes mellitus inadequately controlled on oral antidiabetic drugs or Basal Insulin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GZR101-80 | Experimental | Drug: GZR101-80 |
| GZR33 or Insulin degludec/Insulin aspart or Insulin aspart 30 (NovoRapid®30) | Active comparator | Drug: GZR33 or Insulin degludec/Insulin aspart or Insulin aspart30 (NovoRapid®30) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects sign the Informed Consent Form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and are able to follow the contraindications and restrictions specified in this protocol.
- At the age of 18-75 (inclusive) at the time of informed consent, male or female.
- Body mass index (BMI) ≥18.5 and ≤35.0 kg/m2 at screening.
- 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 (4 listed)
- Confirmed or suspected type 1 diabetes mellitus or specific types of diabetes due to other causes (monogenic diabetes, cystic fibrosis, pancreatitis, drug- or chemical-induced diabetes, etc.) prior to screening.
- Grade 3 hypoglycemia within 3 months before screening.
- Subjects who have any diseases that may affect HbA1c testing at screening, or subjects who have donated blood, lost more than 400 mL of blood, or received blood transfusion within 3 months prior to screening.
- Diagnosis of active malignant tumor within 5 years prior to screening (excluding adequately treated or resected non-metastatic basal or squamous cell skin cancer, in situ cancer of cervix, or prostate cancer in situ), or with a high suspicion of potential malignant tumor 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 |
|---|---|---|
| GZR101-80Administered SC | Drug | GZR101-80 |
| GZR33 or Insulin degludec/Insulin aspart or Insulin aspart30 (NovoRapid®30)Administered SC | Drug | GZR33 or Insulin degludec/Insulin aspart or Insulin aspart 30 (NovoRapid®30) |
Primary outcome
Change in Hemoglobin A1c (HbA1c) from baseline after 16 weeks of treatment.
Time frame: Baseline , 16 weeks
2 secondary outcomes
Change in fasting plasma glucose (FPG) from baseline after 16 weeks of treatment
Time frame: Baseline , 16 weeks
Safety Endpoints
Time frame: Baseline , 17 weeks
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 15 Apr 2026.
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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.
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 GZR101-80 and GZR33 or Insulin degludec/Insulin aspart or Insulin aspart30 (NovoRapid®30) in people with Type 2 Diabetes (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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 15 Apr 2026. 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?
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?
Contact Wei Zhao (010-8059-5000, wei.zhao@ganlee.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin A1c (HbA1c) from baseline after 16 weeks of treatment. (time frame: Baseline , 16 weeks). 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 15 Apr 2026.