Phase IIb One Year Efficacy and Safety Study of S-2367 in Obese Subjects With Initial 6-Week Low Calorie Diet

ClinicalTrials.gov ID: NCT00748605

Public ClinicalTrials.gov record NCT00748605. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 28, 2026, 6:10 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Double-Blind, Multi-Center, Randomized, Parallel-Group, Yearlong Study to Assess the Efficacy and Safety of 0 or 1600 mg/Day of S-2367 Administered Orally Once Daily With an Initial 6-Week Low Calorie Diet in Obese Males and Females

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID: NCT00748605
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Shionogi; Industry
Enrollment: 842 participants

Conditions and interventions

Conditions

Obesity

Interventions

Drug · Other

Eligibility (public fields only)

Age range: 18 Years to 65 Years
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jun 2007 (Type not available)
Primary completion: Nov 2008 (Actual)
Completion: Jan 2009 (Actual)
Last update posted: May 11, 2018

2007 – 2009

United States locations

U.S. sites: 40
U.S. states: 26
U.S. cities: 40

Facility	City	State	ZIP	Site status
Not listed	Birmingham	Alabama	35209	—
Not listed	Huntsville	Alabama	35801	—
Not listed	Phoenix	Arizona	85014	—
Not listed	Fountain Valley	California	92708	—
Not listed	San Diego	California	92108	—
Not listed	San Francisco	California	94102	—
Not listed	Waterbury	Connecticut	06708	—
Not listed	Jacksonville	Florida	32259	—
Not listed	Ocala	Florida	34471	—
Not listed	Orlando	Florida	32809	—
Not listed	South Miami	Florida	33143	—
Not listed	Atlanta	Georgia	30338	—
Not listed	Augusta	Georgia	30904	—
Not listed	Boise	Idaho	83704	—
Not listed	Chicago	Illinois	60610	—
Not listed	Gurnee	Illinois	60031	—
Not listed	Wichita	Kansas	67207	—
Not listed	Lexington	Kentucky	40509	—
Not listed	Boston	Massachusetts	02135	—
Not listed	South Dartmouth	Massachusetts	02747	—
Not listed	Brooklyn Center	Minnesota	55430	—
Not listed	Kansas City	Missouri	64114	—
Not listed	St Louis	Missouri	63141	—
Not listed	Lincoln	Nebraska	68510	—
Not listed	Las Vegas	Nevada	89146	—
Not listed	Edison	New Jersey	08817	—
Not listed	Endwell	New York	13760	—
Not listed	Burlington	North Carolina	27215	—
Not listed	Winston-Salem	North Carolina	27103	—
Not listed	Cincinnati	Ohio	45219	—
Not listed	Columbus	Ohio	43212	—
Not listed	Yukon	Oklahoma	73099	—
Not listed	Bensalem	Pennsylvania	19020	—
Not listed	Mt. Pleasant	South Carolina	29464	—
Not listed	Nashville	Tennessee	37203	—
Not listed	Fort Worth	Texas	76135	—
Not listed	New Braunfels	Texas	78130	—
Not listed	San Antonio	Texas	78229	—
Not listed	West Jordan	Utah	84088	—
Not listed	Wauwatosa	Wisconsin	53226	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00748605, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 11, 2018 · Synced Oct 28, 2026

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The complete public registry record, listed eligibility criteria, and available contact information for NCT00748605 live on ClinicalTrials.gov.

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