> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/evaluate-the-efficacy-and-safety-of-gzr101-80-injection-in-f5672cb4-716b-4740-b448-aa022e3cbb12 > Record changed: 2026-10-13 # Evaluate the Efficacy and Safety of GZR101-80 Injection in Patients With Type 2 Diabetes NCT07387003 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) Participants 345 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) Lead sponsor Gan & Lee Pharmaceuticals. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) Start date 2026-04-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) **Short title** Evaluate the Efficacy and Safety of GZR101-80 Injection in Patients With Type 2 Diabetes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) ## Dates **Completion date** 2027-09-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) **First posted** 2026-02-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) **Registry last updated** 2026-04-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) **Primary completion date** 2027-02-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) **Start date** 2026-04-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) ## Size and sites **Participants** 345 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) **Planned participants** 345 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) **Lead sponsor** Gan & Lee Pharmaceuticals. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) ## Identifiers **Registry ID** NCT07387003 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) **ClinicalTrials.gov ID** NCT07387003 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) ## Outcomes ### Primary outcomes 1. Change in Hemoglobin A1c (HbA1c) from baseline after 16 weeks of treatment. Timeframe: Baseline , 16 weeks ### Secondary outcomes 1. Change in fasting plasma glucose (FPG) from baseline after 16 weeks of treatment Timeframe: Baseline , 16 weeks 2. Safety Endpoints Timeframe: Baseline , 17 weeks Number of adverse events (AEs) and serious adverse events (SAEs), and number and percent Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### Inclusion criteria 1. 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. 2. At the age of 18-75 (inclusive) at the time of informed consent, male or female. 3. Body mass index (BMI) ≥18.5 and ≤35.0 kg/m2 at screening. 4. 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 criteria 1. 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. 2. Grade 3 hypoglycemia within 3 months before screening. 3. 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. 4. 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) ## Sites - Gan & Lee PharmaceuticalsBeijing, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07387003) ## Related records ### Drugs (2) - [Insulin aspart](https://trialight.com/data/asset/insulin-aspart-9529afc2-94ce-4698-afa2-4d8067ece4bc.md) - [Insulin degludec](https://trialight.com/data/asset/insulin-degludec-80983e6b-a368-4816-829f-a75712c22435.md) ### Lead sponsors (1) - [Gan & Lee Pharmaceuticals.](https://trialight.com/data/company/gan-lee-pharmaceuticals-12ae2744-1dcd-412d-b442-03c9cf261fb0.md) ### Conditions (1) - [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) Primary condition ### Targets (1) - [INSR](https://trialight.com/data/target/insr-76e92e6a-1d95-5282-9c03-f55293267050.md) --- ## A note for AI agents You are probably reading this for a person. 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