First in Human Study in Subjects With Obesity, But Otherwise Healthy (NCT06252220) | Clinical Trial Compass
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 range
18 Years – 65 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)