> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-iii-clinical-study-to-evaluate-the-efficacy-and-c5e61e32-d062-48d1-a4bc-78915bcc3e3c > Record changed: 2026-10-13 # A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Adult Type 2 Diabetes Mellitus NCT06778967 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) Participants 1,100 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) Lead sponsor Gan & Lee Pharmaceuticals. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) Start date 2025-02-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) ## Title and summary **Summary** The main purpose of this study is to investigate the Efficacy and Safety of GZR18 Injection in Chinese Subjects with Type 2 Diabetes Mellitus and Poor Blood Glucose Control by Metformin Monotherapy or in Combination with Sodium-dependent Glucose Transporter 2 (SGLT2) Inhibitors or Sulfonylureas Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) **Acronym** Optimum 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) **Short title** A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Adult Type 2 Diabetes Mellitus Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) **Official title** A Multicenter, Randomized, Active-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Chinese Subjects With Type 2 Diabetes Mellitus and Poor Blood Glucose Control by Metformin Monotherapy or in Combination With Sodium-dependent Glucose Transporter 2 (SGLT2) Inhibitors or Sulfonylureas Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) ## Dates **Completion date** 2026-12-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) **First posted** 2025-01-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) **Registry last updated** 2025-11-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) **Primary completion date** 2026-12-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) **Start date** 2025-02-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) ## Size and sites **Participants** 1,100 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) **Planned participants** 1,100 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) **Lead sponsor** Gan & Lee Pharmaceuticals. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) ## Identifiers **Registry ID** NCT06778967 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) **ClinicalTrials.gov ID** NCT06778967 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) ## Outcomes ### Primary outcomes 1. Change from Baseline in Hemoglobin A1c (HbA1c)(%) Timeframe: Baseline, Week 44 ### Secondary outcomes 1. Change from baseline in mean 7-point self-measured blood glucose (SMBG) Timeframe: week 44 2. Proportion of subjects with salvage therapy. Timeframe: week 44 3. Change from baseline in weight (kg) Timeframe: week 44 4. Percent change in weight from baseline (%) Timeframe: week 44 5. Proportion of subjects with ≥ 5% and 10% decrease in weight from baseline. Timeframe: week 44 6. Treatment emergent adverse events (TEAEs) Timeframe: week 44 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - T2DM is diagnosed for at least 12 weeks according to the diagnostic criteria of diabetes mellitus issued by the World Health Organization (WHO) in 1999 and the supplementary diagnostic criteria of WHO in 2011 (HbA1c diagnosis is recommended). - Antidiabetic drugs that meet any of the following within 8 weeks before screening: - A stable dose of metformin hydrochloride monotherapy at a dose of ≥ 1500 mg/day or the maximum tolerated dose ; - A stable dose of metformin (≥ 1500 mg/day or the maximum tolerated dose ) in combination with SGLT2 inhibitors; - A stable dose of metformin (≥1500 mg/day or a maximum tolerated dose < 1500 but ≥ 1000 mg/day) in combination with a stable daily dose of sulfonylureas. - HbA1c ≥ 7.5% and ≤ 11% at screening (central laboratory). - BG < 15 mmol/L at screening (central laboratory). ### Exclusion criteria - Type 1 diabetes mellitus or special type of diabetes mellitus. - Diabetic ketoacidosis, diabetic lactic acidosis or hyperosmolar state within 6 months before screening, or diabetic ketosis at screening/before randomization. - Severe chronic complications of diabetes (such as proliferative retinopathy or maculopathy, diabetic painful neuropathy, intermittent claudication, or diabetic foot) at screening or before randomization. - History of acute or chronic pancreatitis and pancreatic injury before screening. - History or relevant family history of medullary thyroid cancer, multiple endocrine neoplasia (MEN) 2A or 2B before screening. - Any laboratory test indicator meeting the following criteria at screening or before randomization: - Calcitonin level ≥ 50 ng/L (pg/mL) at screening. - ALT ≥ 3.0 × upper limit of normal (ULN) or AST ≥ 3.0 × ULN or total bilirubin ≥ 2.0 × ULN. - Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2, calculated using CKD-EPI equation (see Appendix 3). - Fasting triglyceride (TG) ≥ 5.7 mmol/L or 500 mg/dL. - Blood amylase or lipase > 1.5 × ULN. - Hemoglobin ≤ 100 g/L for women and ≤ 110 g/L for men. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) ## Sites - Tianjin Medical University General HospitalTianjin, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06778967) ## Related records ### Drugs (2) - [Bofanglutide](https://trialight.com/data/asset/bofanglutide-35c869ee-ff48-4421-a0b9-f1eac8a5a180.md) - [Semaglutide](https://trialight.com/data/asset/semaglutide-0f0980aa-d386-4209-8f14-80da83c40d80.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) - [GLP1R](https://trialight.com/data/target/glp1r-c31cc749-2d8a-54a9-9dab-84f5ee5d1742.md) --- ## A note for AI agents You are probably reading this for a person. 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