Evaluate the Efficacy and Safety of GZR101-80 Injection in Patients With Type 2 Diabetes
NCT07387003
Phase
Phase 2
Recruitment status
Not yet recruiting
Participants
Lead sponsor
Gan & Lee Pharmaceuticals.
Start date
2026-04-10
Number of sites
- Summary
- 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.
- Short title
- Evaluate the Efficacy and Safety of GZR101-80 Injection in Patients With Type 2 Diabetes
- Official title
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Not yet recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2027-09-23
- First posted
- 2026-02-04
- Registry last updated
- 2026-04-15
- Primary completion date
- 2027-02-11
- Start date
- 2026-04-10
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Gan & Lee Pharmaceuticals.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07387003
- ClinicalTrials.gov ID
- NCT07387003
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Sources for study design
Change in Hemoglobin A1c (HbA1c) from baseline after 16 weeks of treatment.
Timeframe: Baseline , 16 weeks
Change in fasting plasma glucose (FPG) from baseline after 16 weeks of treatment
Timeframe: Baseline , 16 weeks
Safety Endpoints
Timeframe: Baseline , 17 weeks
Number of adverse events (AEs) and serious adverse events (SAEs), and number and percent
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
- 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.
- 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.
Sources for eligibility
- Gan & Lee PharmaceuticalsBeijing, China
Sources for sites
Related records
Drugs (2)
Lead sponsors (1)
Conditions (1)
- Type 2 diabetes mellitus Primary condition