drugset / Trial / NCT01126970

Double-Blind, Multi-Center, Randomized Study to Assess the Efficacy and Safety of Velneperit (S-2367) and Orlistat Administered Individually or Combined With a Reduced Calorie Diet (RCD) in Obese Subjects

NCT01126970

Phase 2 Completed 486 enrolled Shionogi
RandomizedParallel-groupQuadruple-blindTreatment

Summary

To evaluate the weight loss effect and safety of 400 mg velneperit and 120 mg orlistat administered individually or combined three times per day for 24 weeks while on a reduced calorie diet (RCD) and also to evaluate the steady-state trough concentrations of velneperit (S-2367), velneperit (S-2367) tert-butyl OH, and velneperit (S-2367) tert-butyl OH-O glucuronide following 400 mg of velneperit (S-2367) three times per day and 120 mg of orlistat, either combined or separate.

Timeline

Start
2010-04
Primary completion
2011-01
Completion
2011-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Orlistat Small molecule 120 mg Oral
Subject Velneperit Small molecule 400 mg Oral

Indications