Actively Recruiting
Study to Evaluate the Efficacy and Safety of KDS2010 in Overweight or Obese Patients
Led by NeuroBiogen Co., Ltd · Updated on 2025-07-30
75
Participants Needed
3
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study to Evaluate the Efficacy and Safety of KDS2010 in Overweight or Obese Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Body mass index (BMI) of 30 kg/m2 or higher, or BMI of 27 kg/m2 or higher with at least one weight-related condition such as hypertension, dyslipidemia, cardiovascular disease, or obstructive sleep apnea
- Documented reduction of 500 kcal/day in calorie intake and at least 150 minutes of physical activity per week for 50% or more of the run-in period
- Provided written consent to participate after being informed about the trial
You will not qualify if you...
- Weight change of 5% or more within 12 weeks before screening
- Less than 80% or more than 120% compliance during the run-in period
- Obesity caused by secondary conditions like neurological, endocrine, genetic, or congenital disorders
- History of type 1 or type 2 diabetes
- History or planned bariatric/metabolic surgery during the study
- Heart failure classified as NYHA class IV
- History of malignant tumors within 5 years prior to screening, except certain skin or thyroid cancers with no recurrence for over 3 years
- Hypersensitivity to MAO inhibitors
- Recent cerebrovascular disease or hospitalization for unstable angina or congestive heart failure
- History of depressive or other psychiatric disorders within 2 years prior to screening
- Use of anti-obesity agents, corticosteroids for 2 or more consecutive weeks, MAO inhibitors, opioid medications, serotonergic drugs, or certain other specified medications within 12 weeks or 2 weeks before baseline
- Abnormal lab test results including HbA1c ≥6.5%, severe liver or kidney impairment, or abnormal thyroid function
- Lifetime history of suicide attempts
- PHQ-9 score of 10 or higher at screening
- Affirmative response to specific suicide risk questions at screening
- Pregnant or breastfeeding women
- Females of childbearing potential and males not using adequate contraception or planning conception during the study
- Participation in another clinical trial with investigational drug or device within 4 weeks prior to screening
- Any condition deemed unsuitable by the investigator such as alcohol or substance abuse
AI-Screening
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Trial Site Locations
Total: 3 locations
1
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea, 16247
Actively Recruiting
2
Kangbuk Samsung Medical Center
Seoul, Seoul, South Korea, 03181
Actively Recruiting
3
Yonsei University Health System, Severance Hospital
Seoul, Seoul, South Korea, 03722
Actively Recruiting
Research Team
J
Jaeheon Kang, Professor
CONTACT
S
Sujeong Shin, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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