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

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT06252220

Run by

NeuroBo Pharmaceuticals Inc.

People needed

139

Starts

2024-03-25

Expected to finish

2026-11-09

Last updated by the study team

2026-04-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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, who have been diagnosed with obesity, defined by BMI.
• 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.
• 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).
• Has maintained a stable body weight during the 3 months prior to Screening (<5% body weight change).
• 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.
• 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.
• 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)

You may not qualify if…

• History or clinical evidence of diabetes mellitus, including a fasting glucose of ≥ 120 mg/dL and/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 <= 6 months prior to screening.
• Subjects with screening calcitonin level of ≥15 pg/mL (calcitonin levels will be monitored during the study).
• Triglycerides ≥500 mg/dL at Screening.
• History of pancreatitis.
• 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
• Regular consumption of caffeine-containing beverages, including coffee, tea, energy drinks, and caffeinated sodas, exceeding 3 cups per day.
• Current use of tobacco products or having a history of tobacco use within the past 6 months.
• 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.
• 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).

Where it is running

• Clinical Pharmacology of Miami, LLC — Miami, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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