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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.

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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

FieldValue
Enrollment Target 486 participants
Start Date 2010-04
Est. Completion 2011-02
Phase Phase 2

Sponsor

Shionogi

54 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.