Study to Evaluate the Efficacy and Safety of KDS2010 in Overweight or Obese Patients
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNeuroBiogen Co., Ltd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
KDS2010
DrugKDS2010 will be administered orally once daily, two tablets per day, for 12 weeks. Dosage will be 120 mg depending on the assigned group.
KDS2010
DrugKDS2010 will be administered orally once daily, three tablets per day, for 12 weeks. Dosage will be 180 mg depending on the assigned group
KDS2010
DrugKDS2010 will be administered orally once daily, four tablets per day, for 12 weeks. Dosage will be 240mg depending on the assigned group.
Placebo
DrugPlacebo matching the investigational product in appearance but containing no active ingredient, administered orally once daily, one tablets per day, for 12 weeks.
Placebo
DrugPlacebo matching the investigational product in appearance but containing no active ingredient, administered orally once daily, three tablets per day, for 12 weeks.
Placebo
DrugPlacebo matching the investigational product in appearance but containing no active ingredient, administered orally once daily, four tablets per day, for 12 weeks.
Treatment groups
75 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: 1 stage Control Group_PlaceboPlacebo comparator 1 intervention
Group B: 1 stage Treatment Group 1_KDS2010 120mgExperimental treatment 2 interventions
Group C: 2 stage Control Group_PlaceboPlacebo comparator 1 intervention
Group D: 2 stage Treatment Group 1_KDS2010 180mgExperimental treatment 1 intervention
Group E: 3 stage Control Group_PlaceboPlacebo comparator 1 intervention
Group F: 3 stage Treatment Group 1_KDS2010 240mgExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 12Secondary outcomes
1
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 122
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, 123
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, 124
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, 13Other outcomes
1
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)2
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, 133
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, 134
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, 13Sponsors and contacts
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Source ClinicalTrials.gov