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First in Human Study in Subjects With Obesity, But Otherwise Healthy
A Phase 1, Randomized, Placebo-Controlled, Double-Blind First in Human, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DA-1726 in Participants With Obesity.
Lead sponsor
Asset
DA-1726
Subcutaneous · GLP-1 / glucagon dual
Listed sites
1
Recruiting sites
1
Enrollment
139
estimated
Study population
Obesity / overweight
Key I/E criterion
—
Primary endpoint
•Treatment-emergent AEs (any)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Willing and able to provide informed consent prior to initiation of any study specific procedures/activities.
2. Males and females ≥18 to <=65 years of age, at the time of signing informed consent, who have been diagnosed with obesity, defined by BMI.
3. Except for obesity, otherwise healthy or with stable, well controlled obesity-related conditions as determined by the investigator based on a medical evaluation including physical exam, medical history, laboratory tests, and ECGs.
4. Body mass index (BMI) ≥ 30.0 kg/m2 to 45.0 kg/m2 (Obesity to be confirmed by Caliper test showing body fat percentage with the average or above the average level).
5. Has maintained a stable body weight during the 3 months prior to Screening (<5% body weight change).
6. Willing to maintain current diet and physical activity regimen.
7. Females must be of non-reproductive potential:
8. Males must agree to practice an acceptable method of effective birth control while on study through 5 half-lives plus one week after receiving last dose of DA-1726. Acceptable methods of birth control include:
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 :
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:
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.
Endpoints (4)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Safety / tolerability / PK
3 endpointsNumber of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame:From date of randomization (baseline) until the discontinuation (up to 24 weeks post-dose baseline)
Treatment-emergent AEs (any)
event count, event
Pharmacokinetic
Time frame:From date of randomization (baseline) until the study discontinuation (up to 24 weeks post-dose baseline)
Plasma concentration (steady state)
concentration, descriptive
Immunogenicity
Time frame:From date of randomization (baseline) until the end of the study (up to 24 weeks post-dose baseline)
Immunogenicity (ADA)
descriptive
Other (unclassified)
1 endpointPharmacodynamics
Time frame:From date of randomization (baseline) until the discontinuation (up to 24 weeks post-dose baseline)
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.