A 1-Year Study of an Investigational Drug in Obese Patients (0557-012)(COMPLETED)

A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of MK0557 in Obese Patients

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092872

Enrollment

359

Registered

2004-09-28

Start date

2003-11-30

Completion date

2005-02-28

Last updated

2015-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Brief summary

This is a 1-year study to assess the safety, tolerability, and efficacy of an investigational drug in obese patients after a very low calorie diet.

Interventions

DRUGMK0557

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Obese men and nonpregnant women between the ages of 18 and 65 years with a body mass index (height to weight ratio) as required by the study.

Exclusion criteria

* Patients with uncontrolled high blood pressure and/or diabetes mellitus (high blood sugar)

Design outcomes

Primary

Measure	Time frame
Body weight after 1 year of treatment.	After 1 year of treatment
Safety and tolerability.	After 1 year of treatment

Secondary

Measure	Time frame
Waist circumference; Blood pressure, body fat mass, biochemical markers (fasting plasma, lipid profile, fasting plasma glucose, leptin, insulin, insulin sensitivity); body weight after 2 years	After 2 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026