Actively Recruiting
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
Led by NeuroBiogen Co., Ltd · Updated on 2025-07-30
75
Participants Needed
3
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase 2a multinational clinical trial to evaluate the safety and effectiveness of KDS2010, a new reversible monoamine oxidase-B (MAO-B) inhibitor, in adults who are overweight or obese. The study involves participants from Korea and the United States and aims to assess how well KDS2010 works in reducing body weight, as well as its safety and how the body processes the drug. The study also explores changes in certain biological markers like MAO-B activity and adiponectin levels. The trial includes two stages. After a 2-week run-in period focusing on lifestyle changes, participants are randomly assigned to one of several groups receiving either KDS2010 at doses of 120 mg or 180 mg, or a placebo, all taken orally once daily for 12 weeks. Stage 1 involves a smaller group to test safety and tolerability, followed by Stage 2 with more participants across three groups. Visits for assessments occur at Weeks 2, 4, 8, 12, and a safety follow-up by phone at Week 13. Participants will undergo various evaluations throughout the study, including measurements of body weight, waist circumference, BMI, blood pressure, quality of life questionnaires, body composition scans, and blood tests for lipid and glucose levels. Safety is monitored through adverse event reporting, lab tests, ECGs, and psychological assessments. Pharmacokinetic analyses will track how KDS2010 is absorbed and processed. Each participant's involvement lasts up to 17 weeks, including screening, treatment, and follow-up periods.
CONDITIONS
Brief 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...
- Adult males and females aged 18 years or older (or legal adult age) at consent
- BMI of 30 kg/m2 or higher, or BMI of 27 kg/m2 or higher with at least one weight-related condition: hypertension, dyslipidemia, cardiovascular disease, or obstructive sleep apnea
- Hypertension defined as under treatment or SBP ≥130 mmHg or DBP ≥80 mmHg
- Dyslipidemia defined as under treatment or LDL >160 mg/dL or triglycerides >200 mg/dL or HDL <40 mg/dL
- 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
- Voluntary 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
- Compliance less than 80% or more than 120% during the run-in period
- Obesity due to secondary causes such as neurological, endocrine, genetic, or congenital disorders
- History of type 1 or type 2 diabetes
- Prior bariatric or metabolic surgery or planned surgery during the study
- Heart failure classified as NYHA class IV
- History of malignant tumors within 5 years before screening (with some exceptions)
- Hypersensitivity to MAO inhibitors
- Cerebrovascular disease or hospitalization for unstable angina or heart failure within 12 weeks prior to baseline
- History of depressive or psychiatric disorders within 2 years prior to screening
- Use of anti-obesity agents, corticosteroids (over 2 weeks), MAO inhibitors, opioids, serotonergic drugs, lithium, and certain other medications within specified timeframes before baseline
- Glycated hemoglobin (HbA1c) ≥6.5%
- Severe liver or kidney impairment based on lab tests
- Abnormal thyroid hormone levels
- Lifetime history of suicide attempts or high scores on suicide risk assessments
- Pregnant or breastfeeding women
- Females and males not agreeing to use adequate contraception during the study and 2 weeks after
- Participation in another clinical trial with investigational drug or device within 4 weeks prior to screening
- Other conditions deemed unsuitable by the investigator, such as alcohol or substance abuse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants undergo a 2-week run-in period to confirm eligibility based on adherence to lifestyle modifications including calorie reduction and physical activity.
1 visit (in-person)
Duration - 12 weeks
Participants receive once-daily oral administration of KDS2010 or placebo for 12 weeks to evaluate the efficacy and safety of the investigational drug.
3 in-person visits (Weeks 4, 8, and 12) and 1 telephone visit (Week 2)
Duration - 1 week
Participants are monitored for safety through a 1-week post-treatment follow-up conducted by telephone.
1 telephone visit (Week 13)
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
S
Sujeong Shin, Professor
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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