Overview

An Investigational Drug Study to Assess Weight Loss in Obese and Overweight Patients (0364-037)(TERMINATED)

Status:
Terminated

Trial end date:
2008-12-01

Target enrollment:
0

Participant gender:
All

Summary

A 1 year worldwide study in obese and overweight patients to assess the safety and effect on body weight of an investigational weight loss drug.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Merck Sharp & Dohme Corp.

Treatments:

N-(3-(4-chlorophenyl)-2-(3-cyanophenyl)-1-methylpropyl)-2-methyl-2-((5-(trifluoromethyl)pyridin-2-yl)oxy)propanamide

Criteria

Inclusion Criteria:

- Male or female, 18 years of age or older, with Body Mass Index (BMI) between 30 kg/m2
and 43 kg/m2, inclusive (BMI between 27 kg/m2 and 43 kg/m2, inclusive, for those with
obesity-related comorbidities). Obesity-related comorbidities associated with a BMI of
27 kg/m2 or higher include hypertension, dyslipidemia or sleep apnea

- Stable weight (+/-3 kg) for at least 3 months prior to study start

Exclusion Criteria:

- History of diabetes mellitis, major psychiatric disorder, significant cardiovascular
disease, stroke, TIA, neurological disorder, non-febrile seizures

- Screening systolic blood pressure > 160 mm Hg or diastolic blood pressure > 100 mm Hg