Study to Evaluate the Efficacy and Safety of KDS2010 in Overweight or Obese Patients (NCT07009171) | Clinical Trial Compass
RecruitingPhase 2
Study to Evaluate the Efficacy and Safety of KDS2010 in Overweight or Obese Patients
South Korea75 participantsStarted 2025-07-29
Plain-language summary
This is a randomized, double-blind, placebo-controlled, dose-finding, Phase 2a study designed to evaluate the safety and efficacy of KDS2010 in overweight or obese patients. Based on preliminary efficacy observed in the Phase 1 study, this clinical trial is being conducted in Korea.
After a minimum 2-week run-in period, subjects who meet the inclusion and exclusion criteria will be randomized to the treatment group or placebo group at a 2:1 ratio in each stage.
Subjects will receive the investigational product for 12 weeks following randomization. The study will be conducted in three stages.
Approximately 75 subjects will be enrolled, with 6 subjects in the KDS2010 120 mg group and 3 subjects in the placebo group in Stage 1, 22 subjects in the KDS2010 180 mg group and 11 subjects in the placebo group in Stage 2, and 22 subjects in the KDS2010 240 mg group and 11 subjects in the placebo group in Stage 3.
The primary objectives are to assess the efficacy and safety of KDS2010 in overweight or obese patients. Exploratory objectives include evaluating the proportion of subjects achieving a weight reduction of more than 25% from baseline at Week 12 and assessing changes in MAO-B specific activity and adiponectin levels.
Based on nonclinical and Phase 1 clinical data, KDS2010 will be administered orally once daily at doses of 120 mg, 180 mg, and 240 mg throughout the study.
Who can participate
Age range
18 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:
* Adult males and females aged 18 years or older (or the legal age of adulthood in the respective country) as of the date of written consent
* Subjects with BMI ≥30 kg/m² or BMI ≥27 kg/m² with at least one weight-related comorbidity (hypertension, dyslipidemia, cardiovascular disease, obstructive sleep apnea) at screening and baseline
* Hypertension: under treatment or have Systolic Blood Pressure (SBP) ≥130 mmHg or Diastolic Blood Pressure (DBP) ≥80 mmHg
* Dyslipidemia: under treatment or LDL \> 160 mg/dL or TG \> 200 mg/dL or HDL \< 40 mg/dL
* Cardiovascular diseases (e.g., ischemic cardiovascular disease, NYHA Class I to III heart failure, Peripheral vascular disease (PVD), Abdominal aortic aneurysm (AAA), etc.)
* Obstructive sleep apnoea
* Subjects who have documented a 500 kcal reduction/day in calorie intake and ≥150 minutes of physical activity/week for ≥50% of the time during the run-in period
* Subjects who have voluntarily provided written consent to participate after being informed about this clinical trial
Exclusion Criteria:
* Subjects with a weight change of 5% or more within 12 weeks before screening
* Subjects with less than 80% or more than 120% compliance during the Run-in period
* Subjects with obesity due to secondary causes (neurological disorders, endocrine disorders, genetic disorders, congenital disorders, etc.)
* Subjects with following medical history,
* Type 1 or Type 2 diabetes
* History of bariatric/metabolic s…
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.