First in Human Study in Subjects With Obesity, But Otherwise Healthy

Exclusion Criteria

• •1. History or clinical evidence of diabetes mellitus, including a fasting glucose of ≥ 120 mg/dL and/or HbA1c ≥ 6.5% at Screening.
• •2. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).
• •3. History of cholecystectomy \<= 6 months prior to screening.
• •4. Subjects with screening calcitonin level of ≥15 pg/mL (calcitonin levels will be monitored during the study).
• •5. Triglycerides ≥500 mg/dL at Screening.
• •6. History of pancreatitis.
• •7. Have a medical history or current evidence of clinically significant cardiac condition as evidenced by any of the following at Screening :
• •* QTc at Screening from locally generated data of \>450 msec in males or \>470 msec in females or history of long QT syndrome
• •* Supine systolic BP higher than 150 mmHg and a supine diastolic BP higher than 95 mmHg at Screening or check-in
• •* Supine HR of \<50 or \>100 beats per minute on 2 of 3 triplicate ECGs at Screening or check-in
• •* Heart block of the 1st, 2nd, or 3rd degree
• •* Sick sinus syndrome (irregular heartbeat patterns)
• •* Disorders in cardiac conduction
• •* Peripheral blood circulation issues
• •* Heart valve conditions
• •* Cardiomyopathy
• •* History of myocardial infarction
• •* Unstable angina
• •* History of heart artery bypass surgery
• •* History of stroke
• •* History of heart failure
• •8. Regular consumption of caffeine-containing beverages, including coffee, tea, energy drinks, and caffeinated sodas, exceeding 3 cups per day.
• •9. Current use of tobacco products or having a history of tobacco use within the past 6 months.
• •10. Have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data.
• •11. History of GI abnormality that could affect GI motility (including small bowel or colonic resection, inflammatory bowel disease, irritable bowel syndrome, gastroparesis \[clinically significant gastric emptying abnormality\], and colon / GI tract cancer).
• •12. Have a history of chronic medical conditions involving the heart, liver, or kidneys (e.g., atherosclerotic coronary vascular disease (ASCVD), heart failure, liver cirrhosis, chronic kidney disease).
• •13. Untreated or uncontrolled hypo/hyperthyroidism defined as thyroid-stimulating hormone \>6 mIU/L or \<0.4 mIU/L.
• •14. Obesity that was induced by other endocrinologic disorders (e.g., Cushing's Syndrome).
• •15. Evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies.
• •16. Evidence of hepatitis C and/or positive hepatitis C antibody and hepatitis B, hepatitis B core antibody, and/or positive hepatitis B surface antigen.
• •17. Have a history or presence of psychiatric disorders that would present a safety risk or may significantly impair the participant's ability to comply with study procedures.
• •18. Any lifetime history of a suicidal attempt or any suicidal behavior, as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS).
• •19. History of malignancy of any type, other than basal cell carcinoma, occurring less than 5 years prior to randomization.
• •20. History of substance abuse (i.e., alcohol or illicit substances) within 12 months prior to Screening; and/or a positive test for alcohol/drugs of abuse at Screening.
• •21. Previous surgical treatment for obesity or any form of bariatric surgery.
• •22. Currently receiving treatment in another investigational drug or device study or 5 half lives or 30 days since last dose of investigational drug, whichever is longer.
• •23. Participants with a history of significant allergic or drug reactions (NSAIDs or antibiotics) or known allergy to DA 1726 excipients that would place them at increased risk.
• •24. Have received any vaccine ≤30 days prior to check-in.
• •25. Albumin level \<3.5 g/dL (\<35 g/L) at Screening.
• •26. Aspartate aminotransferase (AST) ≥1.25 × upper limit of normal (ULN) at Screening.
• •27. Alanine aminotransferase (ALT) ≥1.25 × upper limit of normal (ULN) at Screening.
• •28. Bilirubin \>1.25 upper limit of normal (ULN) at Screening.
• •29. Absolute neutrophil count \<lower limit of normal (LLN) at Screening.
• •30. Estimated glomerular filtration rate of ≤60 mL/min for women and men (based on the Chronic Kidney Disease Epidemiology Collaboration equation) at the Screening.
• •31. Fasting low-density lipoprotein ≥160 mg/dL at Screening.
• •32. Hemoglobin \<LLN at Screening.
• •33. Platelet count \<LLN at Screening.
• •34. Current or history of treatment with medications that may cause significant weight gain, within 3 months of Screening, including:
• •* Systemic corticosteroids (except for a short course of treatment, i.e., 7-10 days)
• •* Tricyclic antidepressants
• •* Atypical antipsychotics
• •* Mood stabilizers (e.g., imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, and lithium)
• •* Antidiabetic Medications (e.g., insulin or certain sulfonylureas, that may lead to weight gain)
• •* Beta-blockers (e.g., the ones used to treat conditions like hypertension that may cause weight gain)
• •* Antihistamines (particularly the first-generation ones, that may have sedative effects and could potentially contribute to weight gain)
• •* Contraceptives
• •* Any non-steroidal anti-inflammatory drugs
• •35. Current participation (or within the last 3 months) in an organized weight reduction program or currently using or has used within 3 months prior to Screening: pramlintide, sibutramine, orlistat, zonisamide, topiramate, phentermine, naltrexone, lorcaserin, liraglutide, semaglutide, tirzepatide or metformin.