Actively Recruiting
First in Human Study in Subjects With Obesity, But Otherwise Healthy
Led by NeuroBo Pharmaceuticals Inc. · Updated on 2026-04-09
139
Participants Needed
1
Research Sites
137 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
First in Human Study in Subjects With Obesity, But Otherwise Healthy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide informed consent prior to initiation of any study specific procedures/activities.
- Males and females 18 to 65 years of age at the time of signing informed consent, diagnosed with obesity defined by BMI.
- Otherwise healthy or with stable, well-controlled obesity-related conditions as determined by medical evaluation.
- Body mass index (BMI) of 30.0 to 45.0 kg/m2 confirmed by Caliper test showing average or above average body fat percentage.
- Stable body weight during the 3 months prior to Screening with less than 5% weight change.
- Willing to maintain current diet and physical activity regimen; SAD and MAD cohorts must be willing to eat a standard diet while in the Clinical Research Unit.
- Females must be of non-reproductive potential defined by postmenopausal status, history of hysterectomy, bilateral oophorectomy, or tubal ligation; bilateral salpingectomy is not accepted.
- Males must agree to use effective birth control methods during and after the study period.
You will not qualify if you...
- History or clinical evidence of diabetes mellitus, including fasting glucose ≥120 mg/dL or HbA1c ≥6.5% at Screening.
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).
- History of cholecystectomy within 6 months prior to screening.
- Screening calcitonin level ≥15 pg/mL.
- Triglycerides ≥500 mg/dL at Screening.
- History of pancreatitis.
- Clinically significant cardiac conditions including abnormal QTc, high blood pressure, abnormal heart rate, heart block, or other heart diseases.
- Regular consumption of more than 3 cups per day of caffeine-containing beverages.
- Current or recent (past 6 months) tobacco use.
- Significant comorbidities affecting drug absorption, metabolism, or elimination.
- History of gastrointestinal abnormalities affecting motility or cancers.
- Chronic heart, liver, or kidney conditions.
- Untreated or uncontrolled thyroid disorders.
- Obesity caused by other endocrinologic disorders.
- Evidence of HIV or hepatitis infections.
- History or presence of psychiatric disorders that impair safety or compliance.
- Any lifetime history of suicidal attempts or behavior.
- History of malignancy within 5 years except basal cell carcinoma.
- History of substance abuse within 12 months or positive drug/alcohol test at Screening.
- Previous surgical treatment for obesity or bariatric surgery.
- Current participation in another investigational drug or device study or recent investigational drug use.
- History of significant allergic or drug reactions or known allergy to DA-1726 excipients.
- Receipt of any vaccine within 30 days prior to check-in.
- Laboratory abnormalities including low albumin, elevated liver enzymes, abnormal bilirubin, low neutrophil count, low hemoglobin, abnormal kidney function, high LDL, or low platelet count.
- Current or recent use (within 3 months) of medications known to cause significant weight gain or participation in an organized weight reduction program or use of certain weight loss drugs within 3 months prior to Screening.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Clinical Pharmacology of Miami, LLC
Miami, Florida, United States, 33172
Actively Recruiting
Research Team
R
Robert Homolka, MS
CONTACT
J
Ji Eun Lee, PharmD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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