RecruitingPhase 1

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

United States139 participantsStarted 2024-03-25

Plain-language summary

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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. Females must be of non-reproductive potential:
✓. 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

✕. 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 :
✕. Regular consumption of caffeine-containing beverages, including coffee, tea, energy drinks, and caffeinated sodas, exceeding 3 cups per day.

What they're measuring

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Timeframe: From date of randomization (baseline) until the discontinuation (up to 24 weeks post-dose baseline)

Trial details

NCT IDNCT06252220

SponsorNeuroBo Pharmaceuticals Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-11-09

Contact for this trial

Robert Homolka, MS

8572991038 CRinfo@MetaViaTx.com

View on ClinicalTrials.gov More Obesity trials