Actively Recruiting
A Phase IIIb Clinical Study to Assess the Efficacy and Safety of GZR4 in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin
Led by Gan & Lee Pharmaceuticals. · Updated on 2025-11-25
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy, safety, and patient-reported outcomes of GZR4 compared to Insulin Icodec in adults with Type 2 Diabetes Mellitus (T2DM) who are already being treated with basal insulin. This Phase IIIb clinical study aims to better understand how these treatments perform, either alone or with other non-insulin antidiabetic agents, in managing blood sugar levels in this population. The study involves two groups: one receiving GZR4 and the other receiving Insulin Icodec. Both treatments are administered subcutaneously once weekly using a treat-to-target dosing approach. Participants will continue their basal insulin treatment during the study period. Participants will be monitored over 26 weeks, with researchers measuring changes in HbA1c levels from baseline to week 26 as the primary outcome. Secondary outcomes include tracking hypoglycemia events, adverse events, and changes in weight. Safety and treatment effects will be assessed through regular visits and evaluations throughout the study period.
CONDITIONS
Brief Title
A Phase IIIb Clinical Study to Assess the Efficacy and Safety of GZR4 in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Sign the Informed Consent Form and understand the study details and possible risks.
- Males and females aged 18 years or older at the time of consent.
- Negative pregnancy test for women of childbearing potential during screening and before randomization.
- Agree to use reliable contraception from consent until 3 weeks after treatment ends.
- Diagnosed with Type 2 Diabetes Mellitus for at least 180 days according to WHO criteria.
- Receiving basal insulin once or twice daily or insulin Icodec once weekly before screening.
You will not qualify if you...
- History of allergy or intolerance to drugs with two or more mechanisms of action or to the study drug or its ingredients.
- Pregnant, breastfeeding, or planning pregnancy during the study.
- Participated in another drug clinical trial involving active medication within 90 days or 5 half-lives before screening, or plans to join another trial before this one ends.
- Recent invasive cardiovascular or cerebrovascular procedures within 180 days before screening; recent acute heart events or hospitalizations within 180 days; chronic heart failure classified as NYHA Class III or IV.
- Plans for arterial revascularization during the study or significant ECG abnormalities unsuitable for participation.
- History of malignant tumors within 5 years before screening, except certain treated skin or cervical cancers.
- Systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg during screening.
- Unable to comply with study requirements or with other conditions deemed inappropriate by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 26 weeks
Participants receive once-weekly injections of either GZR4 or insulin Icodec at treat-to-target doses to manage Type 2 Diabetes Mellitus.
Weekly visits for up to 26 weeks
Trial Site Locations
Total: 1 location
1
Gan & Lee Pharmaceuticals Shandong Co., Ltd.
Linyi, Shandong, China, 276000
Actively Recruiting
Research Team
J
juan wu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here