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Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT01126970

Public ClinicalTrials.gov record NCT01126970. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 28, 2026, 11:54 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01126970
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Shionogi
Industry
Enrollment
486 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 2010 (Type not available)
Primary completion
Jan 2011 (Actual)
Completion
Feb 2011 (Actual)
Last update posted
May 9, 2018

2010 – 2011

United States locations

U.S. sites
25
U.S. states
17
U.S. cities
25
Facility City State ZIP Site status
Not listed Santa Rosa California — —
Not listed Waterbury Connecticut — —
Not listed Clearwater Florida — —
Not listed Jacksonville Florida — —
Not listed Ocala Florida — —
Not listed Ponte Vedra Florida — —
Not listed Augusta Georgia — —
Not listed Louisville Kentucky — —
Not listed Boston Massachusetts — —
Not listed Milford Massachusetts — —
Not listed North Dartmouth Massachusetts — —
Not listed St Louis Missouri — —
Not listed Lincoln Nebraska — —
Not listed Albuquerque New Mexico — —
Not listed Manlius New York — —
Not listed Rochester New York — —
Not listed Cary North Carolina — —
Not listed Raleigh North Carolina — —
Not listed Cleveland Ohio — —
Not listed Columbus Ohio — —
Not listed Greenville South Carolina — —
Not listed Nashville Tennessee — —
Not listed New Braunfels Texas — —
Not listed Renton Washington — —
Not listed Wauwatosa Wisconsin — —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01126970, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 9, 2018 · Synced Oct 28, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01126970 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →