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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 is a Phase 2 study that has completed, run by Shionogi. The registered enrollment target is 486 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01126970
The ClinicalTrials.gov registry entry for NCT01126970 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 486 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shionogi, which has 54 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Reduced Calorie Diet is the first listed.
NCT01126970 reports 0 study locations.
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.
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