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, Shionogi
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT01126970. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01126970
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT01126970
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 486 participants, actual
- Lead sponsor
- Shionogi
- Conditions
- Obesity
- Interventions
- Velneperit 400 mg, Orlistat 120 mg, Orlistat Placebo, Velneperit Placebo, Reduced Calorie Diet
- First posted
- 2010-05-20
- Last updated
- 2018-05-09
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The primary efficacy endpoint was the change from baseline in body weight (kg) over the 168-day (24-week) double-blind treatment period, where baseline body weight was defined as the last measurement prior to randomization | 168 days (24 weeks) | Change in body weight from baseline to 24 weeks |
| Secondary | Efficacy analysis: The proportion of subjects with (a) a 5% decrease in body weight at Visit 7 and Visit 10 and (b) percent change in body weight from baseline to each study visit was summarized by treatment group | change from baseline to each study visit | Percentage of subjects who achieve a 5% decrease in body weight |
| Secondary | Efficacy analysis: The change in waist & hip circumference (cm) from baseline to each study visit was summarized by treatment group | Change from baseline to each study visit | Change in physical measurement from baseline |
| Secondary | Efficacy analysis: The proportion of subjects with a decrease equal to or greater than 1 BMI unit at Visit 7 and Visit 10 was summarized by treatment group | Baseline to Visits 7 and 10 | The proportion of subjects with decreases in BMI of 1 unit |
| Secondary | Safety analysis: (a) Treatment-emergent adverse events and (b) monitoring clinical laboratory evaluations, vital signs, 12-lead electrocardiograms, and physical examinations | Baseline to each visit and to Week 24 | Change from baseline to each visit and to Week 24 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01126970
GET https://conductscience.org/api/trials/v1/NCT01126970/registered