Efficacy and Safety of Efsubaglutide Alfa Injection 3 Mg Q2W in T2D Patients

Inclusion Criteria:

1. Age between 18 and 75 years (inclusive) at screening, with no restriction on gender;

2. Diagnosed with Type 2 Diabetes Mellitus (T2DM) according to the 2024 ADA 3.DiabetesManagement Standards for at least 8 weeks prior to screening, and no antidiabetictreatment received within the 8 weeks prior to screening;

4.Glycated Hemoglobin (HbA1c) between ≥7.5% and ≤11.0% at screening; 5.Fasting Plasma Glucose (FPG) ≤13.9 mmol/L at screening; 6.Body Mass Index (BMI) between 19.0 and 35.0 kg/m² (inclusive) at screening; 7.Subjects must be able to understand the purpose and content of the study, willing to receive relevant treatments, voluntarily participate in the study, and provide written informed consent.

Exclusion Criteria:

1. Patients with Type 1 diabetes or other specific types of diabetes;

2. Receipt of any of the following medications or treatments: a. Use of antidiabeticmedications (including herbal medicines, other traditional medicines, and healthproducts) within 2 months prior to screening; b. Use of non-antidiabetic medicationsthat may significantly affect glucose metabolism for ≥7 days within 2 months priorto screening [e.g., glucocorticoids (excluding inhaled, ophthalmic, or topicalapplications), growth hormones, sympathomimetic agents (e.g., isoproterenol,dopamine, atropine), high-dose salicylates (e.g., aspirin >300 mg/day), danazol,octreotide, or anabolic androgenic steroids (e.g., oxymetholone, oxandrolone)].

3. Presence of any of the following medical histories or conditions: a. Knownhypersensitivity to glucagon-like peptide-1 (GLP-1) receptor agonists; b. History ofdiabetic ketoacidosis, hyperglycemic hyperosmolar state, or lactic acidosis within 6months prior to screening; c. Presence of unstable or treatment-requiringproliferative retinopathy or maculopathy, severe diabetic neuropathy, intermittentclaudication, or diabetic foot within 6 months prior to screening; d. Severehypoglycemia (Grade 3) events within 6 months prior to screening, or non-severehypoglycemia occurring 3 or more times within 1 month prior to screening; e. Historyof gastroparesis, or clinically significant gastric emptying abnormalities, orsevere gastrointestinal diseases as deemed by the investigator; f. Presence of anycondition that may cause hemolysis or erythrocyte instability affecting HbA1cmeasurements (e.g., hematologic malignancies, hemolytic anemia, sickle celldisease); g. History of acute or chronic pancreatitis; h. History of acutecholecystitis within 6 months prior to screening, or symptomatic ortreatment-requiring cholelithiasis within 6 months prior to screening (except forsubjects who have undergone cholecystectomy and are clinically stable); i. Presenceof Cushing's syndrome, hyperthyroidism, or inadequately controlled hypothyroidism atscreening (except for subjects who have subclinical hypothyroidism not requiringthyroid hormone therapy as determined by the investigator and with TSH <10 mIU/ml);j. History of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma, ora family history of these conditions in a first-degree relative; k. Presence of thefollowing cardiovascular or cerebrovascular conditions within 6 months prior toscreening: decompensated heart failure (NYHA Class III or IV), treatment-requiringarrhythmia, unstable angina or myocardial infarction, coronary artery bypassgrafting or percutaneous coronary intervention, stroke (ischemic or hemorrhagic), ortransient ischemic attack; l. History of malignancy within the past 5 years (excluding clinically cured cervical carcinoma in situ or basal cell carcinoma ofthe skin) or potential malignancy under evaluation; m. Severe trauma, severeinfection, or surgery that may affect glycemic control within 1 month prior toscreening, or planned surgery that may interfere with study completion orcompliance.

4. Presence of any of the following conditions at screening or prior to randomization:a. Sitting systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100mmHg; b. Clinically relevant abnormalities on a 12-lead electrocardiogram (ECG) thatmay affect subject safety or interpretation of study results (e.g.,treatment-requiring arrhythmia); c. Alanine aminotransferase (ALT) or aspartateaminotransferase (AST) >2.5×ULN, or total bilirubin (TBIL) >2.0×ULN; d. Estimatedglomerular filtration rate (eGFR) <60 mL/min/1.73 m² (using CKD-EPI formula); e.Serum calcitonin ≥50 ng/L (pg/mL); f. Hemoglobin <100 g/L; g. Fasting triglycerides ≥5.7 mmol/L; h. Serum amylase and/or lipase ≥3×ULN.

5. Presence of the following serological abnormalities at screening: a. Positive HIVantibody; b. Positive hepatitis C antibody (HCV-Ab); c. Positive syphilis-specificantibody; d. Positive hepatitis B surface antigen (HBsAg) and/or hepatitis B coreantibody (HBcAb); if either test is positive, HBV-DNA quantification must beperformed, and subjects with results ≥ the lower limit of detection are excludedfrom the study.

6. Receipt of blood or plasma products within 3 months prior to screening, or blooddonation or blood loss exceeding 400 mL within 3 months prior to screening.

7. Known or suspected history of alcohol abuse within the past year [defined as aweekly alcohol intake greater than 14 units (1 unit = approximately 360 mL of beer, 45 mL of spirits with 40% alcohol, or 150 mL of wine)].

8. History of drug abuse or substance dependence.

9. Pregnant or breastfeeding women at screening, or those with a positive pregnancytest.

10. Subjects of childbearing potential (or female partners of male subjects) who intendto conceive from the time of informed consent signing until 3 months after the lastdose, or who are unwilling to use effective contraceptive measures.

11. Participation in other clinical trials with investigational drugs within 3 monthsprior to screening.

12. Any other conditions deemed unsuitable for study participation by the investigator.