NCT07009171 Study to Evaluate the Efficacy and Safety of KDS2010 in Overweight or Obese Patients

Trial Parameters

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

Brief Summary

This is a randomized, double-blind, placebo-controlled, dose-escalation, 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, a multinational clinical trial is being conducted in both Korea and the United States. After a minimum 2-week run-in period, subjects who meet the inclusion and exclusion criteria will be randomized into each dose group at a 2:1 ratio in Stage 1 and in a 1:1:1 ratio in Stage 2, considering stratification by region (Korea/USA). Subjects will receive the investigational drug for 12 weeks following randomization. Approximately 75 subjects will be enrolled, with 6 subjects in the treatment group and 3 subjects in the control group in Stage 1, and 22 subjects per group in Stage 2. 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 and 180 mg throughout the study.

Eligibility Criteria

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 parti

Related Trials