First in Human Study of DA-1726 for Obesity
This study is testing a new drug called DA-1726 in people with obesity who are otherwise healthy. It's a "first in human" study, meaning it's one of the first times this drug is being given to people. The main goal is to see how safe DA-1726 is and how well people tolerate it, compared to a placebo (an inactive substance). Researchers will be looking for any side effects. You might be able to join if you are between 18 and 65 years old and have been diagnosed with obesity. The study plans to enroll about 139 participants.
- Study design
- This is a Phase 1, randomized, placebo-controlled, double-blind study, meaning participants are randomly assigned to receive either DA-1726 or a placebo, and neither you nor the study staff will know which you are receiving. It plans to enroll about 139 participants.
- What's involved
- You would receive DA-1726 or placebo through injections under the skin within a clinic setting. The study will assess your safety from the start of the study until up to 24 weeks after your last dose.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored from the date you are randomly assigned to a group until you stop participating, which could be up to 24 weeks after your last dose.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06252220
First in Human Study in Subjects With Obesity, But Otherwise Healthy
Recruiting
PHASE1Ages 18–65InterventionalTreatmentNeuroBo Pharmaceuticals Inc.
~139 participants
Updated 2026-04-09 on ClinicalTrials.gov
What's tested:DA-1726Placebo to DA-1726
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured over From date of randomization (baseline) until the discontinuation (up to 24 weeks post-dose baseline)
Conditions
Where it's being run
1 sites across 1 statesFlorida1
Study leadership
- Robert Homolka, MS · STUDY_DIRECTOR · MetaVia
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
SAD Cohorts (Be willing to eat a standard diet while in the Clinical Research Unit).
MAD Cohorts (Be willing to eat a standard diet while in the Clinical Research Unit). If appetite decreases, participants may not maintain their current diet. 7. Females must be of non-reproductive potential:
Postmenopausal defined as:
Age of ≥55 years with no menses for at least 12 months; OR
Age \<55 years with no menses for at least 12 months AND with a follicle-stimulating hormone level \>40 IU/L or according to the definition of "postmenopausal range" for the laboratory involved; OR
History of hysterectomy; OR
History of bilateral oophorectomy
History of tubal ligation (surgically sterile)
Note: bilateral salpingectomy is not an accepted sterilization method. 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:
Sexual abstinence
Vasectomy and testing that shows there are no sperm in semen.
Condom with spermicide (male) in combination with barrier methods (diaphragm, cervical cap, or cervical sponge), hormonal birth control, or IUS (females)
Exclusion
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.
What this trial measures
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0From date of randomization (baseline) until the discontinuation (up to 24 weeks post-dose baseline)
AEs, SAEs, TEAEs and AEs leading to treatment discontinuation.