GZR101-80 injection for type 2 diabetes not well controlled by current treatment
Tests GZR101-80 injection in adults whose type 2 diabetes is not well controlled.
Plain-language title generated from the registry record
Registry title: Evaluate the Efficacy and Safety of GZR101-80 Injection in Patients With Type 2 Diabetes
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07387003, who can take part
Where in China
- Gan & Lee PharmaceuticalsBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Gan & Lee Pharmaceuticals.
- Trial code
- NCT07387003
- Record updated
- 15 April 2026
- Original description
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 full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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; 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; 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.