Phase 2a Study of KDS2010 to Assess Safety and Effectiveness in Overweight or Obese Adults

What this Trial Is About

Researchers are evaluating the safety, effectiveness, and pharmacokinetics of KDS2010, a new reversible monoamine oxidase-B MAO-B inhibitor, in adults who are overweight or obese. This Phase 2a, randomized, double-blind, placebo-controlled, dose-finding study is conducted in Korea and aims to find the appropriate dose of KDS2010 to reduce weight and improve related health markers. The study includes three stages with different doses of KDS2010 120 mg, 180 mg, and 240 mg administered orally once daily for 12 weeks. Each stage randomizes participants to receive either KDS2010 or a matching placebo in a 21 ratio. Before treatment, participants undergo a 2-week run-in period focused on lifestyle modifications including diet and exercise. After treatment, a 1-week safety follow-up is conducted by phone. Participants will visit the study sites at Weeks 4, 8, and 12 for assessments, with a telephone visit at Week 2 and a phone safety follow-up at Week 13. Researchers will measure changes in body weight, waist circumference, BMI, blood pressure, quality of life, body fat via DEXA scan, lipid and glycemic profiles, and liver fat. Safety monitoring includes adverse event tracking, lab tests, vital signs, ECGs, and psychological assessments. Pharmacokinetics of KDS2010 will also be evaluated. The total participation lasts about 17 weeks.

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