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

A Double-Blind, Multi-Center, Randomized, Parallel-Group Study to Assess the Efficacy and Safety of 400 mg of Velneperit (S-2367) and 120 mg of Orlistat Administered Individually or Combined Orally Three Times Per Day With a Reduced Calorie Diet (RCD) in Obese Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 486 (actual)
• Sponsor: Shionogi · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Velneperit 400 mg	Velneperit 400 mg q.d.
DRUG	Orlistat 120 mg	Orlistat 120 mg t.i.d
DRUG	Orlistat Placebo	Orlistat Placebo t.i.d.
DRUG	Velneperit Placebo	Velneperit Placebo q.d
OTHER	Reduced Calorie Diet	Reduced calorie diet

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-01-01
• Completion: 2011-02-01
• First posted: 2010-05-20
• Last updated: 2018-05-09

Locations

25 sites across 1 country: United States