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.
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 65 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Injections
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "DA-1726 will be administered via subcutaneous (SC) injection within the clinic setting."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests DA-1726 in humans for the first time. It will check its safety and how well people handle one dose or several doses. It is for adults ages 18 to 65 with obesity who are otherwise healthy or have stable, well-controlled health problems linked to obesity.
This is a First in Human study to evaluate the safety and tolerability of DA-1726 following single and multiple doses in participants with obesity, but otherwise healthy subjects.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be willing and able to give informed consent, meaning you agree to join after learning about the study.
- Be 18 to 65 years old with a BMI of 30 to 45. BMI is a weight measure based on height. A skinfold test must also confirm obesity.
- Be otherwise healthy, or have stable, well-controlled health problems linked to obesity, as judged by the study doctor.
- Have less than a 5% change in body weight during the 3 months before screening.
- Keep your usual diet and activity level and eat the study center's standard meals. People getting several doses may eat less if their appetite drops.
- Women must be unable to become pregnant because of menopause or an accepted surgery. Removal of both fallopian tubes alone does not qualify.
- Men must use an accepted birth control method during the study and for a set time after the last dose.
Who can't join
- Diabetes or blood sugar above the study limits; a personal or family history of a certain thyroid cancer called MTC or the hormone disorder MEN2; uncontrolled thyroid disease; or obesity caused by another hormone disorder.
- Past pancreatitis (swelling of the pancreas), gallbladder removal within 6 months, weight-loss surgery, or certain gut problems that affect how food moves through the body.
- Significant heart, blood vessel, liver, or kidney disease; certain blood pressure or heartbeat problems; or other illnesses that could make the study unsafe or change how the drug works.
- HIV, hepatitis B or C, or certain positive tests for these infections; cancer within 5 years except basal cell skin cancer; or blood test results outside the study's limits.
- Mental health problems that could affect safety or following study steps; any past suicide attempt or suicidal behavior; substance abuse within 12 months; or a positive alcohol or drug test.
- More than 3 cups of caffeinated drinks daily, or tobacco use now or within the past 6 months.
- Certain medicines within 3 months, including medicines that may cause weight gain; a recent weight-loss program; or current or recent use of listed weight-loss or diabetes medicines.
- Current or recent participation in another drug or device study; a vaccine within 30 days before check-in; or serious drug reactions or allergies that could raise study risks.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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. * 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 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.
Study sites (1)
FL
- Clinical Pharmacology of Miami, LLC · Miami, FL 33172Alexander N Prezioso, MD · Study contact · 201-320-6446 · aprezioso@ergclinical.comMore trials in Miami