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
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Republic of Korea
Kangbuk Samsung Medical Center
RECRUITING
Seoul
Yonsei University Health System, Severance Hospital
RECRUITING
Seoul
The Catholic University of Korea, St. Vincent's Hospital
RECRUITING
Suwon
Contact Information
Primary
Jaeheon Kang, Professor
jenny.kim@mdnf.co.kr
+82)2-6959-9927
Backup
Sujeong Shin, Professor
Time Frame
Start Date: 2025-07-29
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 75
Treatments
Placebo_comparator: 1 stage Control Group_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.
Experimental: 1 stage Treatment Group 1_KDS2010 120mg
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.
Placebo_comparator: 2 stage Control Group_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.
Experimental: 2 stage Treatment Group 1_KDS2010 120mg
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.
Experimental: 2 stage Treatment Group 2_KDS2010 180mg
Administer orally three tablets once daily for 12 weeks (three tablets of KDS2010 60mg). This group will receive the higher dose of the investigational drug to evaluate its safety and efficacy.
Related Therapeutic Areas
Sponsors
Leads: NeuroBiogen Co., Ltd

This content was sourced from clinicaltrials.gov

Similar Clinical Trials