A Phase 2 interventional study of KDS2010 and KDS2010 in Overweight, Obesity and Obese Patients, sponsored by NeuroBiogen Co., Ltd. Recruiting at 3 sites in South Korea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by NeuroBiogen Co., Ltd · Phase 2, Interventional, and Treatment
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.
This Phase 2a, 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.
The study consists of three stages and will enroll approximately 75 subjects. In Stage 1, 9 subjects were 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) assessed cumulative safety data and determined that the study may proceed to Stage 2.
Stage 2 is currently being prepared for subject recruitment and will proceed with 33 subjects randomized in a 2:1 ratio to receive KDS2010 180 mg or placebo. Upon completion of the Week 13 visit for the last ongoing subject in Stage 2, the SRC will review the safety data collected up to that time to determine whether the study may proceed to Stage 3. Stage 3 will proceed with 33 subjects randomized in a 2:1 ratio to receive KDS2010 240 mg or placebo.
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 aged 19 years or older, 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 28 months from IRB approval, with individual subject participation lasting up to 17 weeks. This trial aims to evaluate the safety, efficacy, and pharmacokinetics of KDS2010 for future development in the treatment of obesity.
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's planned enrollment of 75 is close to the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →NeuroBiogen Co., Ltd is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
Subjects with following medical history,
Subjects with a history of the following drug administration,
-- Anti-obesity agents or weight-loss medications (including dietary supplements and herbal medicine) within 12 weeks before screening
Serotonergic drugs within 2 weeks before baseline,
Selective Serotonin Reuptake Inhibitors (SSRI), ② Serotonin-Norepinephrine Reuptake Inhibitors (SNRI),
Subjects who meet following criteria based on the tests conducted at Screening
Severe renal impairment (eGFR \<30 mL/min/1.73 m² calculated using the MDRD formula*),
* eGFR = 175 X (Serum creatinine)-1.154 X (Age)-0.203 X (0.742 (for females)) X (1.212 (for African Americans))
Females of childbearing potential and males who do not agree to use adequate contraception# until at least 2 weeks after the last dose of the IP or who plan to conceive during the study period,
Adequate contraception is defined as double contraception using both barrier methods (male condom or female condom) and one of the contraceptive methods ①-③.
Administer orally three tablets once daily for 12 weeks (three tablets of 60mg placebo). This group will match the investigational drug in appearance but contain no active ingredients to maintain blinding.
Drug: Placebo
Administer orally three tablets once daily for 12 weeks (two tablets of KDS2010 60mg and one tablet of 60mg placebo). This group will receive the active investigational drug to evaluate its safety and efficacy.
Drug: KDS2010 · Drug: Placebo
Administer orally three tablets once daily for 12 weeks (three tablets of 60mg placebo). This group will match the investigational drug in appearance but contain no active ingredients to maintain blinding.
Drug: Placebo
Administer orally three tablets once daily for 12 weeks (three tablets of KDS2010 60mg). This group will receive the active investigational drug to evaluate its safety and efficacy.
Drug: KDS2010
Administer orally four tablets once daily for 12 weeks (four tablets of 60mg placebo). This group will match the investigational drug in appearance but contain no active ingredients to maintain blinding.
Drug: Placebo
Administer orally four tablets once daily for 12 weeks (four tablets of KDS2010 60mg). This group will receive the active investigational drug to evaluate its safety and efficacy.
Drug: KDS2010
KDS2010 will be administered orally once daily, two tablets per day, for 12 weeks. Dosage will be 120 mg depending on the assigned group.
KDS2010 will be administered orally once daily, three tablets per day, for 12 weeks. Dosage will be 180 mg depending on the assigned group
KDS2010 will be administered orally once daily, four tablets per day, for 12 weeks. Dosage will be 240mg depending on the assigned group.
Placebo matching the investigational product in appearance but containing no active ingredient, administered orally once daily, one tablets per day, for 12 weeks.
Placebo matching the investigational product in appearance but containing no active ingredient, administered orally once daily, three tablets per day, for 12 weeks.
Placebo matching the investigational product in appearance but containing no active ingredient, administered orally once daily, four tablets per day, for 12 weeks.
Percentage Change in Body Weight from Baseline
The percentage change in body weight from baseline to Week 12 after administration of the investigational product (KDS2010).
Time frame: Baseline to Week 12
Proportion of Subjects with ≥5%, ≥10%, ≥15%, and ≥20% weight loss from baseline (%)
Proportion (%) of subjects with ≥5%, ≥10%, ≥15%, and ≥20% weight loss at week 12 after IP administration compared to baseline
Time frame: Baseline to Week 12
Change from baseline in Waist Circumference
Waist circumference will be measured to the nearest 0.1 cm using a tape measure while the participant stands with feet approximately 25-30 cm apart, distributes body weight evenly, and exhales comfortably. Changes will be assessed up to Week 12.
Time frame: Screening(Week -4 to -2), Run-in(Week -2), Baseline(Week 0), Week 4, 8, 12
Change from baseline in Body Mass Index (BMI)
Change from baseline to Week 12 in BMI, calculated as weight in kilograms divided by height in meters squared (kg/m²).
Time frame: Screening(Week -4 to -2), Run-in(Week -2), Baseline(Week 0), Week 4, 8, 12
Change from baseline in Systolic and Diastolic Blood Pressure
Change from baseline in systolic and diastolic blood pressure measured in mmHg.
Time frame: Screening(Week -4 to -2), Run-in(Week -2), Baseline(Week 0), Week 4, 8, 12, 13
Change from baseline in Impact of Weight on Quality of Life Questionnaire-Lite Clinical Trials version (IWQOL-Lite-CT) Total and Domain Scores
Change from baseline to Week 12 in the total score and domain-specific scores of the IWQOL-Lite-CT. IWQOL-Lite-CT is a questionnaire used to assess weight-related quality of life, consisting of 20 items. Each of the 20 items is evaluated on a scale of 0 to 5 points. Higher scores indicate better quality of life.
Time frame: Baseline(Week 0), Week 12
Change from baseline in Body Fat Composition via Dual-energy X-ray absorptiometry (DEXA) Scan
Change from baseline to Week 12 in percent body fat composition(changes in body fat mass and lean muscle mass) measured by DEXA scan.
Time frame: Baseline(Week 0), Week 12
Change from baseline in Lipid Profile
Change from baseline in lipid parameters, including Total Cholesterol (TC), Triglycerides (TG), High-density lipoprotein cholesterol (HDL-C), Low-density lipoprotein cholesterol (LDL-C), Very low-density lipoprotein cholesterol (VLDL-C) and Free Fatty Acids.
Time frame: Screening(Week -4 to -2), Baseline(Week 0), Week 4, 8, 12, 13
Change from baseline in Glycemic Parameters: HbA1c (%)
Change from baseline in Hemoglobin A1c (HbA1c) (percentage)
Time frame: Screening(Week -4 to -2), Baseline(Week 0), Week 4, 8, 12, 13
Change from baseline in Glycemic Parameters: Fasting Glucose (mg/dL)
Change from baseline in fasting glucose levels (mg/dL).
Time frame: Screening(Week -4 to -2), Baseline(Week 0), Week 4, 8, 12, 13
Change from baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Change from baseline to Week 12 in HOMA-IR index. HOMA-IR is calculated using fasting insulin and fasting glucose levels to predict insulin resistance.
Time frame: Baseline(Week 0), Week 12
Change from baseline in Liver Steatosis (Abdominal CT)
Change from baseline to Week 12 in liver fat content assessed by Abdominal CT.
Time frame: Baseline(Week 0), Week 12
Number of subjects with treatment-related Adverse Events (AEs)
AEs will be coded using MedDRA and assessed for severity and causality using CTCAE v5.0. The number of subjects affected and the incidence rates will be presented for each treatment group.
Time frame: Conducted from screening (Week -4 to -2) through Treatment (Week 0 to 12) and Follow-up (Week 13)
Change from baseline in laboratory test results
Laboratory parameters including routine hematology, blood chemistry, urinalysis, lipid, coagulation, hormone will be measured. Change from baseline will be analyzed.
Time frame: Screening(Week -4 to -2), Baseline(Week 0), Week 4, 8, 12, 13
Change from baseline in pulse rate
Pulse rate will be measured in beats per minute.
Time frame: Screening(Week -4 to -2), Run-in(Week -2), Baseline(Week 0), Week 4, 8, 12, 13
Change from baseline in body temperature
Body temperature will be measured using a standard thermometer.
Time frame: Screening(Week -4 to -2), Run-in(Week -2), Baseline(Week 0), Week 4, 8, 12, 13
Change from baseline in Electrocardiogram(ECG)
For ECG results, the proportion of subjects whose status changed from 'Normal or Abnormal Not Clinically Significant (Abnormal NCS)' before the IP administration to 'Abnormal Clinically Significant (Abnormal CS)' after IP administration will be summarized and presented in a table.
Time frame: Screening(Week -4 to -2), Week 12, 13
Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) total score
C-SSRS is used to assess the risk of suicide through interviews with the subject. The scores of each question are summed to range from 0 to 25 points. If "yes" from questions 4 or 5, categorize a subject as high-risk, requiring further evaluation, while other scores indicate a lower risk.
Time frame: Screening(Week -4 to -2), Baseline(Week 0), Week 4, 8, 12
Change from baseline in Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a validated self-report tool used to screen for and assess the severity of depressive symptoms. It consists of nine items, each rated on a 4-point scale from 0 ("not at all") to 3 ("nearly every day"), with a total possible score ranging from 0 to 27. Higher scores indicate greater severity of depressive symptoms.
Time frame: Screening(Week -4 to -2), Baseline(Week 0), Week 4, 8, 12
Proportion of Subjects with ≥25% Weight Loss at Week 12
Proportion (%) of subjects with ≥25% weight loss at week 12 after IP administration compared to baseline.
Time frame: Baseline to Week 12
Percentage Change in Monoamine Oxidase B (MAO-B) Specific Activity
Percentage change in MAO-B specific activity compared to baseline (%)
Time frame: Baseline(Week 0), Week 12
Percentage Change in Adiponectin Levels
Percentage change in Adiponectin compared to baseline (%)
Time frame: Screening(Week -4 to -2), Baseline(Week 0), Week 4, 8, 12, 13
Pharmacokinetic Parameters: Area Under the Plasma Concentration-Time Curve over the dosing interval (τ) (AUCtau) at steady-state
AUCtau is the area under the plasma concentration-time curve over the dosing interval (τ) at steady-state, and it reflects the extent of drug exposure within a dosing cycle.
Time frame: Baseline(Week 0), Week 4, 8, 12
Pharmacokinetic Parameters: Peak Plasma Concentration at Steady State (Cmax,ss)
The highest plasma drug concentration observed during a dosing interval at steady-stat
Time frame: Baseline(Week 0), Week 4, 8, 12
Pharmacokinetic Parameters: Minimum Plasma Concentration at Steady State (Cmin,ss)
The lowest plasma drug concentration during a dosing interval at steady-state, usually occurring right before the next dose.
Time frame: Baseline(Week 0), Week 4, 8, 12
Pharmacokinetic Parameters: Average Plasma Concentration at Steady State (Cav,ss)
The average plasma concentration over the dosing interval at steady-state. Calculated as: Cav, ss = AUCtau/τ
Time frame: Baseline(Week 0), Week 4, 8, 12
Pharmacokinetic Parameters: Time to Maximum Plasma Concentration at Steady State (Tmax,ss)
The time taken to reach the maximum plasma concentration after dosing at steady-state.
Time frame: Baseline(Week 0), Week 4, 8, 12
Pharmacokinetic Parameters: Terminal Elimination Half-life (t1/2)
The time required for the plasma concentration of the drug to decrease by half.
Time frame: Baseline(Week 0), Week 4, 8, 12
Pharmacokinetic Parameters: Peak-Trough Fluctuation at Steady State (PTF)
A measure of the fluctuation between the peak (Cmax,ss) and trough (Cmin,ss) plasma concentrations during a dosing interval.
Time frame: Baseline(Week 0), Week 4, 8, 12
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
NeuroBiogen Co., Ltd