Study to Evaluate the Efficacy and Safety of KDS2010 in Overweight or Obese Patients

NCT07009171 | Recruiting Phase 2 DMC

• 2 other identifiers: NB_KDS_OBP2_23KCT0010560
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Overweight; Obesity; Obese Patients

Keywords

Obese Patients; Overweight; KDS2010; Obesity; MAO-B inhibitor

Outcome Measures

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).

  Baseline to Week 12

Secondary Outcomes (11)

• Proportion of Subjects with ≥5%, ≥10%, ≥15%, and ≥20% weight loss from baseline (%)

  Baseline to Week 12

• Change from baseline in Waist Circumference

  Screening(Week -4 to -2), Run-in(Week -2), Baseline(Week 0), Week 4, 8, 12

• Change from baseline in Body Mass Index (BMI)

  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

  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

  Baseline(Week 0), Week 12

Other Outcomes (17)

• Number of subjects with treatment-related Adverse Events (AEs)

  Conducted from screening (Week -4 to -2) through Treatment (Week 0 to 12) and Follow-up (Week 13)

• Change from baseline in laboratory test results

  Screening(Week -4 to -2), Baseline(Week 0), Week 4, 8, 12, 13

• Change from baseline in pulse rate

  Screening(Week -4 to -2), Run-in(Week -2), Baseline(Week 0), Week 4, 8, 12, 13

Study Arms (5)

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.

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.

Drug: KDS2010

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.

Drug: Placebo

2 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.

Drug: KDS2010

2 stage Treatment Group 2_KDS2010 180mg

EXPERIMENTAL

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.

Drug: KDS2010

Interventions

KDS2010 DRUG

KDS2010 will be administered orally once daily, three tablets per day, for 12 weeks. Dosage will be either 120 mg or 180 mg depending on the assigned group.

1 stage Treatment Group 1_KDS2010 120mg; 2 stage Treatment Group 1_KDS2010 120mg; 2 stage Treatment Group 2_KDS2010 180mg

Placebo DRUG

Placebo matching the investigational product in appearance but containing no active ingredient, administered orally once daily, three tablets per day, for 12 weeks.

1 stage Control Group_Placebo; 2 stage Control Group_Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• NeuroBiogen Co., Ltd: lead

Study Sites (3)

The Catholic University of Korea, St. Vincent's Hospital

Suwon, Gyeonggi-do, 16247, South Korea

RECRUITING

Kangbuk Samsung Medical Center

Seoul, Seoul, 03181, South Korea

RECRUITING

Yonsei University Health System, Severance Hospital

Seoul, Seoul, 03722, South Korea

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sangwook Kim, Chief Executive Officer

  NeuroBiogen Co., Ltd

  STUDY DIRECTOR

Central Study Contacts

Jaeheon Kang, Professor

CONTACT

+82)2-6959-9927; jenny.kim@mdnf.co.kr

Sujeong Shin, Professor

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A double-blind design is used to ensure scientific validity. Subjects and investigators are unaware of treatment allocation, with identical appearance between the drug and placebo. Randomization numbers are used for subject identification, and group assignments are disclosed only after the end of treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blind, Placebo-Controlled, Dose-Finding, Phase 2a Clinical Trial

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: June 6, 2025
• Study Start: July 29, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)