OverweightPhase 2NCT07009171
Study to Evaluate the Efficacy and Safety of KDS2010 in Overweight or Obese Patients
A Phase 2 study testing KDS2010 in people with Overweight and Obesity, run by NeuroBiogen Co., Ltd at 3 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight, Obesity, Obese Patients
- What is being tested?
- KDS2010
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 29 Jul 2025to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 surgery (e.g., adjustable gastric banding, intragastric balloon insertion, sleeve gastrectomy, Roux-en-Y gastric bypass, biliopancreatic diversion, duodenal switch) or planning to undergo such surgery during the study period
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- Heart failure classified as NYHA class IV
- Subjects with a medical history of malignant tumors within 5 years prior to screening (however, subjects with successfully treated basal cell carcinoma, squamous cell carcinoma of the skin, thyroid cancer, or other carcinoma in situ, with no recurrence for more than 3 years, may be enrolled at the investigator's discretion)
- Subjects with a medical history of hypersensitivity to MAO inhibitors
- Subjects with a medical history of cerebrovascular disease (e.g., transient ischemic attack, stroke) within 12 weeks prior to baseline, or those hospitalized for unstable angina or congestive heart failure
- Subjects with a history of depressive disorders or psychiatric disorders (e.g., schizophrenia, bipolar disorder, anxiety disorder) within 2 years prior to screening
- 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
- Corticosteroids administered for 2 consecutive weeks or more within 12 weeks before screening (however, topical preparations, including inhalants, are allowed)
- Treatment for hyperthyroidism or hypothyroidism at the time of screening (subjects on a stable dose and regimen for at least 12 weeks may be enrolled at the investigator's discretion)
- MAO inhibitors within 2 weeks before baseline
- Opioid medications (e.g., pethidine, Tramadol, Tapentadol) within 2 weeks before baseline
- Serotonergic drugs within 2 weeks before baseline,
- Selective Serotonin Reuptake Inhibitors (SSRI), ② Serotonin-Norepinephrine Reuptake Inhibitors (SNRI),
- Tricyclic or Tetracyclic antidepressant, ④ Triazolopyridine antidepressant, ⑤ Selective serotonin (5-HT1) agonists (Sumatriptan, etc.), (However, amitriptyline ≤50 mg/day, trazodone ≤100 mg/day, citalopram ≤20 mg/day, sertraline ≤100 mg/day, paroxetine ≤30 mg/day are allowed; long half-life serotonergic drugs (e.g., fluoxetine) require at least a 5-week wash out period before enrollment),
- Lithium, Bupropion, Lamotrigine, Ritonavir, Cyclobenzaprine, or St. John's wort within 2 weeks before baseline
- Hypertension crisis-inducing drugs (e.g., oxymetazoline, phentermine, phenylephrine) within 2 weeks before baseline
- Sympathomimetic agents (e.g., ephedrine, methylphenidate, amphetamine, methamphetamine, lisdexamfetamine) at the time of screening
- Dextromethorphan at the time of screening
- Subjects who meet following criteria based on the tests conducted at Screening
- Glycated hemoglobin (HbA1c) ≥6.5%
- Hepatic impairment (Child-pugh class C)
- AST or ALT > 2.5 X ULN
- Total bilirubin >1.5 X ULN (however, >3.0 mg/dL is acceptable in cases of Gilbert syndrome)
- 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))
- TSH >6.0 mIU/L or <0.4 mIU/L,
- Subjects with a lifetime history of suicide attempts
- Subjects with a PHQ-9 score of 10 or higher at screening
- Subjects who answer affirmatively to item 4 or 5 on the C-SSRS at screening
- Pregnant or breastfeeding women
- 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.
- Hormonal contraceptive (oral, injectable, implantable, etc.), ② Implantation of Intrauterine device (IUD) or intrauterine system (IUS), ③ Sterilization procedures or surgeries (bilateral tubal ligation, hysterectomy, vasectomy), ④ Complete abstinence: absolute abstinence is accepted if, in the investigator's judgment, the subject's age, occupation, lifestyle, or sexual orientation ensure compliance with contraception. However, periodic abstinence (calendar method, ovulation method, symptothermal method, etc.) withdrawal, and coitus interruptus are not considered adequate contraceptive methods.,
- Subjects who have participated in another clinical trial and received an investigational drug or device within 4 weeks prior to screening
- Other reasons (such as a medical history of alcohol or substance abuse) that the investigator deems the subject unsuitable for participation in this clinical trial
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sujeong Shin, Professor contact
South Korea3 sites, 3 recruiting
- Recruiting
Kangbuk Samsung Medical Center
Seoul, Seoul, 03181
Jaeheon Kang, Professor, +82)2-6959-9927, jenny.kim@mdnf.co.kr
Sujeong Shin, Professor
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul, Seoul, 03722
Jiwon Lee, Professor, +82)2-6959-9927, jenny.kim@mdnf.co.kr
Jia Lee, CRC
- Recruiting
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247
Sangwook Song, Professor, +82)2-6959-9927, jenny.kim@mdnf.co.kr
Hana Kim, Professor
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Overweight, Obesity, Obese Patients
- Being tested
- KDS2010, Placebo
- Keywords
- Obese Patients, Overweight, KDS2010, Obesity, MAO-B inhibitor
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KDS2010Drug
KDS2010 will be administered orally once daily, two tablets per day, for 12 weeks. Dosage will be 120 mg depending on the assigned group.
KDS2010Drug
KDS2010 will be administered orally once daily, three tablets per day, for 12 weeks. Dosage will be 180 mg depending on the assigned group
KDS2010Drug
KDS2010 will be administered orally once daily, four tablets per day, for 12 weeks. Dosage will be 240mg depending on the assigned group.
PlaceboDrug
Placebo matching the investigational product in appearance but containing no active ingredient, administered orally once daily, one tablets per day, for 12 weeks.
PlaceboDrug
Placebo matching the investigational product in appearance but containing no active ingredient, administered orally once daily, three tablets per day, for 12 weeks.
PlaceboDrug
Placebo matching the investigational product in appearance but containing no active ingredient, administered orally once daily, four tablets per day, for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 stage Control Group_Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
| 1 stage Treatment Group 1_KDS2010 120mg | Experimental | 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. Receives: Drug: KDS2010; Drug: Placebo |
| 2 stage Control Group_Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
| 2 stage Treatment Group 1_KDS2010 180mg | Experimental | 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. Receives: Drug: KDS2010 |
| 3 stage Control Group_Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
| 3 stage Treatment Group 1_KDS2010 240mg | Experimental | 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. Receives: Drug: KDS2010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to Week 12
Secondary outcomes (11)
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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline(Week 0), Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start29 Jul 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-Blind, Placebo-Controlled, Dose-Finding, Phase 2a Clinical Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeuroBiogen Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sangwook Kim, Chief Executive Officer, Study director, NeuroBiogen Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009171
- Sponsor's protocol ID
- NB_KDS_OBP2_23
- Other IDs
- KCT0010560
- Status last verified
- Jun 2026
- First submitted
- 15 May 2025
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07009171
- Acronym / sponsor ID
- NB_KDS_OBP2_23
- Conditions
- Overweight, Obesity, Obese Patients
- Keywords
- Obese Patients, Overweight, KDS2010, Obesity, MAO-B inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- NeuroBiogen Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Randomized, Double-Blind, Placebo-Controlled, Dose-Finding, Phase 2a Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| 1 stage Control Group_Placebo | Placebo comparator | Drug: PlaceboAdminister 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. |
| 1 stage Treatment Group 1_KDS2010 120mg | Experimental | Drug: KDS2010, Drug: PlaceboAdminister 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. |
| 2 stage Control Group_Placebo | Placebo comparator | Drug: PlaceboAdminister 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. |
| 2 stage Treatment Group 1_KDS2010 180mg | Experimental | Drug: KDS2010Administer 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. |
| 3 stage Control Group_Placebo | Placebo comparator | Drug: PlaceboAdminister 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. |
| 3 stage Treatment Group 1_KDS2010 240mg | Experimental | Drug: KDS2010Administer 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- 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
Key exclusion criteria (41 listed)
- 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,
- Subjects with a history of the following drug administration,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KDS2010KDS2010 will be administered orally once daily, two tablets per day, for 12 weeks. Dosage will be 120 mg depending on the assigned group. | Drug | 1 stage Treatment Group 1_KDS2010 120mg |
| KDS2010KDS2010 will be administered orally once daily, three tablets per day, for 12 weeks. Dosage will be 180 mg depending on the assigned group | Drug | 2 stage Treatment Group 1_KDS2010 180mg |
| KDS2010KDS2010 will be administered orally once daily, four tablets per day, for 12 weeks. Dosage will be 240mg depending on the assigned group. | Drug | 3 stage Treatment Group 1_KDS2010 240mg |
| PlaceboPlacebo matching the investigational product in appearance but containing no active ingredient, administered orally once daily, one tablets per day, for 12 weeks. | Drug | 1 stage Treatment Group 1_KDS2010 120mg |
| PlaceboPlacebo matching the investigational product in appearance but containing no active ingredient, administered orally once daily, three tablets per day, for 12 weeks. | Drug | 1 stage Control Group_Placebo, 2 stage Control Group_Placebo |
| PlaceboPlacebo matching the investigational product in appearance but containing no active ingredient, administered orally once daily, four tablets per day, for 12 weeks. | Drug | 3 stage Control Group_Placebo |
Primary outcome
Percentage Change in Body Weight from Baseline
Time frame: Baseline to Week 12
The percentage change in body weight from baseline to Week 12 after administration of the investigational product (KDS2010).
11 secondary outcomes
Proportion of Subjects with ≥5%, ≥10%, ≥15%, and ≥20% weight loss from baseline (%)
Time frame: Baseline to Week 12
Change from baseline in Waist Circumference
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)
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
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
Time frame: Baseline(Week 0), Week 12
Change from baseline in Body Fat Composition via Dual-energy X-ray absorptiometry (DEXA) Scan
Time frame: Baseline(Week 0), Week 12
Change from baseline in Lipid Profile
Time frame: Screening(Week -4 to -2), Baseline(Week 0), Week 4, 8, 12, 13
Change from baseline in Glycemic Parameters: HbA1c (%)
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)
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)
Time frame: Baseline(Week 0), Week 12
Change from baseline in Liver Steatosis (Abdominal CT)
Time frame: Baseline(Week 0), Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sujeong Shin, Professor contact
Sangwook Kim, Chief Executive Officer study director
NeuroBiogen Co., Ltd
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KDS2010 in people with Overweight and Obesity, run by NeuroBiogen Co., Ltd at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaeheon Kang, Professor (+82)2-6959-9927, jenny.kim@mdnf.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in Body Weight from Baseline (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.