NCT07527078 Evaluate the Efficacy and Safety of GZR33 Injection in Patients With Type 2 Diabetes
| NCT ID | NCT07527078 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Gan & Lee Pharmaceuticals. |
| Condition | Type 2 Diabetes (T2DM) |
| Study Type | INTERVENTIONAL |
| Enrollment | 350 participants |
| Start Date | 2026-04-07 |
| Primary Completion | 2026-04-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 350 participants in total. It began in 2026-04-07 with a primary completion date of 2026-04-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Evaluate the efficacy of GZR33 Injection and Insulin Degludec Injection (Tresiba®) in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Oral Antidiabetic Drugs.
Eligibility Criteria
Inclusion Criteria: 1. 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. 2. Male or female, aged ≥18 years at the time of informed consent.. 3. Body mass index (BMI) ≥18.5 and ≤35.0 kg/m2 at screening. 4. 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. 5. Stable treatment with oral antidiabetic drugs for ≥ 90 days prior to screening. Exclusion Criteria: 1. History of hypersensitivity to ≥ 2 drugs with distinct mechanisms of action, or known hypersensitivity, allergic reactions, or intolerance to the investigational medicinal products or their excipients (glycerol, phenol, metacresol, zinc acetate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide). 2. Female subjects who are pregnant, lactating at screening, or planning a pregnancy during the trial period. 3. Confirmed or suspected type 1 diabetes mellitus or specific types of diabetes due to other causes (monogenic diabetes syndrome, cystic fibrosis-related diabetes, pancreatitis-induced diabetes, drug- or chemical-induced diabetes, etc.) prior to screening. 4. Presence of any diseases that may affect HbA1c testing at screening, such as hemolytic anemia, aplastic anemia, hemoglobinopathy, etc., and in the investigator's judgment unsuitable for participation; or blood donation, blood loss \> 400 mL, or blood transfusion within 90 days prior to screening. 5. History of severe cardiovascular and cerebrovascular diseases within 180 days prior to screening. 6. Significant hepatic or renal dysfunction or active infectious diseases at screening. 7. Lifestyle (diet, exercise, work circadian rhythm, etc.) expected to change significantly during the trial and affect glycemic control; irregular three-meal intake (e.g., habitual skipping of breakfast); or unwillingness to comply with relevant lifestyle restrictions during the trial. 8. Any other conditions that, in the investigator's judgment, may compromise subject safety or interfere with trial conduct, progress, or outcome.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07527078 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Type 2 Diabetes (T2DM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07527078 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 350 participants.
Is NCT07527078 currently recruiting?
Yes, NCT07527078 is actively recruiting participants. Contact the research team at yuchi.liu@ganlee.com for enrollment information.
Where is the NCT07527078 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07527078 clinical trial?
NCT07527078 is sponsored by Gan & Lee Pharmaceuticals.. The trial plans to enroll 350 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.