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NCT01126970 · ClinicalTrials.gov registry record · Phase 2
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 Phase 2 study, sponsored by Shionogi.
- Completed
- Registry status
- Phase 2
- Development phase
- 486
- Enrollment target
NCT01126970: Completed Phase 2 study, sponsored by Shionogi.
NCT01126970 is a Phase 2 study that has completed, run by Shionogi. The registered enrollment target is 486 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (265% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01126970, a Phase 2 study, has completed, sponsored by Shionogi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 486 participants
- Enrollment target
Study 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.
Primary Outcome
Change in body weight from baseline to 24 weeks
Interventions
- OTHER Reduced Calorie Diet
- DRUG Velneperit 400 mg
- DRUG Orlistat 120 mg
- DRUG Orlistat Placebo
- DRUG Velneperit Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 486 participants |
| Start Date | 2010-04 |
| Est. Completion | 2011-02 |
| Phase | Phase 2 |
What the finished NCT01126970 record still lists
NCT01126970 is an interventional study that assigns participants to a tested intervention. The registered 486 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (265% higher).
The record links to 0 conditions, and to 5 interventions - of which Reduced Calorie Diet is the first listed.
NCT01126970 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01126970 about?
NCT01126970 is a clinical study titled "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". 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) ...
What is the current status of trial NCT01126970?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 486 participants. The study started on 2010-04. Estimated completion is 2011-02.
What interventions are being tested in trial NCT01126970?
The interventions under investigation include: Reduced Calorie Diet (OTHER), Velneperit 400 mg (DRUG), Orlistat 120 mg (DRUG), Orlistat Placebo (DRUG), Velneperit Placebo (DRUG).
Who is sponsoring clinical trial NCT01126970?
This trial is sponsored by Shionogi, which has 54 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01126970's enrollment target sits among peer trials
486 76th of 2000 higher than 1,925 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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