NCT07165223 A Phase IIIb Clinical Study to Assess the Efficacy and Safety of GZR4 in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin
| NCT ID | NCT07165223 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Gan & Lee Pharmaceuticals. |
| Condition | Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-10-17 |
| Primary Completion | 2026-11-10 |
Eligibility & Interventions
Eligibility Fast-Check
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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 300 participants in total. It began in 2025-10-17 with a primary completion date of 2026-11-10.
⚠ 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
This study will be conducted to compare the efficacy, safety and patient-reported outcome of GZR4 and Insulin Icodec with or without Non-Insulin Antidiabetic Agents in subjects with Type 2 Diabetes Mellitus (T2DM) treated with basal insulin.
Eligibility Criteria
Inclusion Criteria: * 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. * Before screening, basal insulin was given once or twice a day. Or Insulin Icodec was given once-weeekly before screening. Exclusion Criteria: * 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. * 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 the investigator considers inappropriate to participate in this study (such as second-degree type II or third-degree atrioventricular block, ventricular fibrillation, etc.). * History of malignant tumors within 5 years 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07165223 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetes. 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 NCT07165223 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 300 participants.
Is NCT07165223 currently recruiting?
Yes, NCT07165223 is actively recruiting participants. Contact the research team at juan.wu@ganlee.com for enrollment information.
Where is the NCT07165223 trial being conducted?
This trial is being conducted at Linyi, China.
Who is sponsoring the NCT07165223 clinical trial?
NCT07165223 is sponsored by Gan & Lee Pharmaceuticals.. The trial plans to enroll 300 participants.
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