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NCT00748605 · ClinicalTrials.gov registry record · Phase 2
Phase IIb One Year Efficacy and Safety Study of S-2367 in Obese Subjects With Initial 6-Week Low Calorie Diet
A Phase 2 study, sponsored by Shionogi.
- Completed
- Registry status
- Phase 2
- Development phase
- 842
- Enrollment target
NCT00748605 is a Phase 2 study that has completed, run by Shionogi. The registered enrollment target is 842 participants.
The verdict
NCT00748605, a Phase 2 study, has completed, sponsored by Shionogi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 842 participants
- Enrollment target
Study Summary
1. To evaluate the weight loss effect of 1600 mg/day S-2367 administered orally once daily with the morning meal after a 6-week low calorie diet (LCD) of 950 kcal/day with or without S-2367 followed by 54 weeks while on a 800 kcal deficit reduced calorie diet (RCD) compared with placebo in medically stable and otherwise healthy obese male and female subjects 2. To evaluate the safety and tolerability of 1600 mg/day S-2367 administered orally once daily with the morning meal after a 6-week LCD with or without S-2367 followed by 54 weeks on a RCD compared with placebo in medically stable and otherwise healthy obese male and female subjects 3. To evaluate the steady-state/trough pharmacokinetics of 1600 mg/day S-2367 administered orally once daily with the morning meal after a 6-week LCD with or without S-2367 followed by 54 weeks on a RCD in obese male and female subjects 4. To evaluate the weight loss effect of 1600 mg/day S-2367 administered orally once daily with the morning meal during an initial 6-week LCD compared with placebo in medically stable and otherwise healthy obese male and female subjects
Interventions
- DRUG S-2367 Placebo
- DRUG S-2367 1600 mg q.d. 54 Weeks
- DRUG S-2367 1600 mg q.d. 60 weeks
- OTHER LCD (low calorie diet)
- OTHER RCD (reduced calorie diet)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 842 participants |
| Start Date | 2007-06 |
| Est. Completion | 2009-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00748605
The ClinicalTrials.gov registry entry for NCT00748605 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 842 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 S-2367 Placebo is the first listed.
NCT00748605 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00748605 about?
NCT00748605 is a clinical study titled "Phase IIb One Year Efficacy and Safety Study of S-2367 in Obese Subjects With Initial 6-Week Low Calorie Diet". 1. To evaluate the weight loss effect of 1600 mg/day S-2367 administered orally once daily with the morning meal after a 6-week low calorie diet (LCD) of 950 kcal/day with or without S-2367 followed by 54 weeks while on a 800 kcal deficit reduced calorie diet (RCD) compared with placebo in medically...
What is the current status of trial NCT00748605?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 842 participants. The study started on 2007-06. Estimated completion is 2009-01.
What interventions are being tested in trial NCT00748605?
The interventions under investigation include: S-2367 Placebo (DRUG), S-2367 1600 mg q.d. 54 Weeks (DRUG), S-2367 1600 mg q.d. 60 weeks (DRUG), LCD (low calorie diet) (OTHER), RCD (reduced calorie diet) (OTHER).
Who is sponsoring clinical trial NCT00748605?
This trial is sponsored by Shionogi, which has 54 total clinical trials registered on ClinicalTrials.gov.
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