UBT251 Injection Phase Ⅲ Study (OSA-NPAP)

1. GLP-1 receptor agonists or similar drugs;

2. biguanides, SGLT-2 inhibitors, DPP-4 inhibitors, or any other hypoglycemic agents;

3. weight-influencing medications (including systemic glucocorticoids, tricyclic antidepressants, antipsychotics, mood stabilizers);

4. over-the-counter weight-loss drugs, prescription weight-loss drugs (e.g., orlistat), or lipolytic injections; stimulants, sedative-hypnotics, opioids, trazodone, or muscle relaxants;

5. medications that may affect excessive daytime sleepiness assessment.

1. Diagnosed with type 1 diabetes, type 2 diabetes, or other types of diabetes (except history of gestational diabetes);

2. History of acute or chronic pancreatitis, or pancreatic surgery;

3. History of symptomatic gallbladder disease within 1 year prior to screening;

4. Personal or family history (first-degree relatives, i.e., parents, children, or siblings) of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2);

5. Presence of endocrine diseases that may significantly affect body weight;

6. History of bariatric surgery or planned weight-loss procedures (with specific exceptions for procedures >1 year prior);

7. Previous history of depression, or Patient Health Questionnaire-9 (PHQ-9) score ≥ 15 at screening, or history of severe mental illness;

8. positive C-SSRS for suicidal ideation/behavior;

9. History of clinically significant cardiovascular or cerebrovascular disease within 6 months;

10. History or presence of severe retinal or macular lesions;

11. History of sleep apnea surgery or major ENT surgery that may still affect breathing;

12. History or presence at screening of clinically relevant medical conditions (other than OSA) or psychiatric disorders related to insomnia or excessive sleepiness;

13. Receiving other active device therapies for OSA;

14. Presence of other sleep disorders besides OSA;

15. History or diagnosis of obesity hypoventilation syndrome or diurnal hypercapnia;

16. Requirement for supplemental oxygen therapy;

17. Severe craniofacial bony deformities or abnormalities significantly affecting the airway;

18. Presence of gastrointestinal motility disorders, gastrointestinal diseases increasing post-dose risks, or history of major gastrointestinal surgery;

19. malignancy within 5 years (except cured skin, cervical, or prostate in situ);

20. Major surgery, severe trauma, or severe infection within 1 month;

21. Concomitant diseases affecting participant safety, efficacy evaluation, or compliance.

1. HbA1c ≥6.5% or FPG ≥7.0 mmol/L;

2. ALT/AST ≥3×ULN or total bilirubin ≥1.5×ULN or eGFR <60 mL/min/1.73m²;

3. calcitonin ≥50 pg/mL;

4. uncontrolled thyroid dysfunction or TI-RADS ≥4a nodules;

5. fasting TG ≥5.6 mmol/L;

6. amylase/lipase >2×ULN;

7. INR >ULN;

8. hemoglobin <90 g/L;

9. untreated hypertension (SBP ≥160 and/or DBP ≥100 mmHg);

10. clinically significant ECG abnormalities (2nd/3rd degree AV block, QTcF >470ms female/>450ms male, WPW, HR <50 or >110);

11. positive HBV-DNA, HCV-RNA, HIV, or dual-positive syphilis;

12. Physical examination, vital signs, laboratory tests, or other assessments showing clinically significant abnormalities that pose a significant risk to the participant or interfere with the evaluation of safety or PK results, rendering the participant unsuitable for the trial.