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Phase IIb One Year Efficacy and Safety Study of S-2367 in Obese Subjects With Reduced Calorie Diet

NCT00747929 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 724

Last updated 2018-05-11

No results posted yet for this study

Summary

1. To evaluate the effect of S-2367 on body weight when administered following a 6-week placebo lead-in period and then a 54-week 800 kilocalorie deficit reduced calorie diet compared to placebo in healthy obese male and female subjects
2. To evaluate the safety and tolerability of S-2367 during 54 weeks of drug exposure
3. To evaluate the steady-state/trough pharmacokinetics of S-2367

Conditions

Interventions

DRUG

S-2367 Placebo

four placebo tablets (total dose = 0 mg/day S-2367) administered orally once-a-day with morning meal while on a reduced calorie diet for a total of 54 weeks,

DRUG

S-2367 800 mg

two 400 mg S-2367 tablets (total dose = 800 mg/day S-2367) administered orally once-a-day with morning meal while on a reduced calorie diet for a total of 54 weeks

DRUG

S-2367 1600 mg

four 400 mg S-2367 tablets (total dose = 1600 mg/day S-2367) administered orally once-a-day with morning meal while on a reduced calorie diet for total of 54 weeks,

OTHER

Reduced Calorie Diet

A diet with restricted calorie content

Sponsors & Collaborators

  • Shionogi

    lead INDUSTRY

Principal Investigators

  • Shionogi Clinical Trials Administrator Clinical Support Help Line · Shionogi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-11-30
Completion
2009-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00747929 on ClinicalTrials.gov