Evaluate the Efficacy and Safety of GZR101-80 Injection in Patients With Type 2 Diabetes

Starting soon · Phase 2

Conditions studied: Type 2 Diabetes (T2DM)

In brief

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.

Key facts

Study ID

NCT07387003

Run by

Gan & Lee Pharmaceuticals.

People needed

345

Starts

2026-04-10

Expected to finish

2027-09-23

Last updated by the study team

2026-04-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Gan & Lee Pharmaceuticals — Beijing, China

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.