A 2-Year Study of an Investigational Drug in Obese Patients (0557-011)

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

NCT00092859

Enrollment

1500

Registered

2004-09-28

Start date

2003-08-31

Completion date

2005-06-30

Last updated

2017-01-02

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 2-year study to assess the safety, tolerability, and efficacy of an investigational drug in obese patients.

Interventions

DRUGMK0557

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Obese men and nonpregnant women at least 18 years of age with a specific body mass index (height and weight ratio) 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. Safety and tolerability for 2 years.	After 1 & 2 years of treatment

Secondary

Measure	Time frame
Durability of weight loss over two years.	Over two years.

Outcome results

None listed

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