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

NCT00748605 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 842

Last updated 2018-05-11

No results posted yet for this 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

Conditions

Interventions

DRUG

S-2367 Placebo

Four placebo tablets (total dose = 0 mg/day S-2367) administered orally once daily with AM (ante meridiem) meal while on both LCD (low calorie diet for 6 weeks) and RCD (reduced calorie diet for 54 weeks) for a total of 60 weeks

DRUG

S-2367 1600 mg q.d. 54 Weeks

Four 400 mg S- 2367 tablets (total dose = 1600 mg/day S-2367) administered orally once daily with AM meal while on RCD for a total of 54 weeks

DRUG

S-2367 1600 mg q.d. 60 weeks

Four 400 mg S- 2367 tablets (total dose = 1600 mg/day S-2367) administered orally once daily with AM meal while on both LCD and RCD for a total of 60 weeks

OTHER

LCD (low calorie diet)

A low calorie diet was utilized during the first 6 weeks of the study

OTHER

RCD (reduced calorie diet)

A reduced calorie diet was used during the last 54 weeks for the study

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 NCT00748605 on ClinicalTrials.gov