NCT07009171

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

A Randomized, Double-blind, Placebo-controlled, Dose Finding, Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of KDS2010 in Overweight or Obese Patients

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: NeuroBiogen Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This Phase 2a, multinational, randomized, double-blind, placebo-controlled, dose-finding clinical trial is designed to evaluate the efficacy, safety, and pharmacokinetics of KDS2010, a novel, reversible monoamine oxidase-B (MAO-B) inhibitor, in overweight or obese adult patients. The clinical trial is conducted at selected sites in Korea and the United States. The study consists of two stages and will enroll approximately 75 subjects. In Stage 1, 9 subjects will be randomized in a 2:1 ratio (KDS2010 120 mg: placebo) to evaluate initial safety and tolerability. Upon completion of the week 13 visit for the last subject in Stage 1, a Safety Review Committee (SRC) will assess cumulative safety data to determine the appropriateness of dose escalation and progression to Stage 2. If cleared by the SRC, Stage 2 will proceed with 66 subjects randomized equally across three arms in a 1:1:1 ratio: KDS2010 120 mg, KDS2010 180 mg, and placebo. Randomization will consider stratification by region (Korea/USA). All subjects will undergo a 2-week run-in period prior to randomization to confirm eligibility based on adherence to lifestyle modification (documented reduction of ≥500 kcal/day and ≥150 minutes of physical activity per week for ≥50% of the run-in period). The treatment period consists of 12 weeks of once-daily oral administration of the investigational product (IP), followed by a 1-week post-treatment safety follow-up (week 13). During treatment, subjects will visit the site at Weeks 4, 8, and 12, with a telephone visit at Week 2. Safety follow-up will be conducted by phone at Week 13. The primary efficacy endpoint is the percentage change in body weight from baseline to Week 12. Secondary efficacy endpoints include the proportion of subjects achieving ≥5%, ≥10%, ≥15%, and ≥20% weight loss and changes in waist circumference, BMI, blood pressure (SBP/DBP), quality of life (IWQOL-Lite-CT), body composition (DEXA), lipid profile, glycemic parameters (HbA1c, fasting glucose, HOMA-IR), and liver steatosis. Exploratory endpoints assess the proportion of subjects with ≥25% weight loss, as well as changes in MAO-B specific activity and adiponectin levels. Safety will be evaluated through monitoring of adverse events (AEs), laboratory tests, vital signs, ECGs, and psychological assessments, including the Columbia-Suicide Severity Rating Scale (C-SSRS) and Patient Health Questionnaire-9 (PHQ-9). Pharmacokinetic parameters (AUCtau, Cmax,ss, Cmin,ss, Cav,ss, Tmax,ss, t1/2, PTF, etc.) will be measured to assess systemic exposure to KDS2010. Subjects must be adults (≥18 years), have a BMI ≥30 kg/m² or ≥27 kg/m² with at least one weight-related comorbidity, and demonstrate compliance with lifestyle modification during the run-in. Major exclusion criteria include recent significant weight change (≥5% within 12 weeks), use of anti-obesity drugs or MAO inhibitors, type 1 or 2 diabetes, bariatric surgery, uncontrolled hypertension, hepatic or renal dysfunction, significant psychiatric disorders, or suicidal ideation/attempts. The total study duration is expected to be approximately 24 months from the IRB/IEC approval, with individual subject participation lasting up to 17 weeks. This trial aims to evaluate the safety, efficacy, and pharmacokinetic of KDS2010 for future development in the treatment of obesity.

Conditions

• Overweight
• Obesity
• Obese Patients

Interventions

Type	Name	Description
DRUG	KDS2010	KDS2010 will be administered orally once daily, three tablets per day, for 12 weeks. Dosage will be either 120 mg or 180 mg depending on the assigned group.
DRUG	Placebo	Placebo matching the investigational product in appearance but containing no active ingredient, administered orally once daily, three tablets per day, for 12 weeks.

Timeline

• Start date: 2025-07-29
• Primary completion: 2027-01-31
• Completion: 2027-06-30
• First posted: 2025-06-06
• Last updated: 2025-07-30

Locations

3 sites across 1 country: South Korea