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

Summary

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.

Conditions

• Overweight
• Obesity
• Obese Patients

Interventions

DRUG

KDS2010

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

DRUG

KDS2010

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

DRUG

KDS2010

KDS2010 will be administered orally once daily, four tablets per day, for 12 weeks. Dosage will be 240mg depending on the assigned group.

DRUG

Placebo

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

DRUG

Placebo

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

DRUG

Placebo

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

Sponsors & Collaborators

• NeuroBiogen Co., Ltd

  lead INDUSTRY

Principal Investigators

• Sangwook Kim, Chief Executive Officer · NeuroBiogen Co., Ltd

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-29

Primary Completion

2027-01-31

Completion

2027-06-30

Countries

• South Korea

Study Locations