To Study Different Levels of MK0493 for Safety, Efficacy, and Tolerability in Obese Patients (0493-017)(COMPLETED)

NCT ID: NCT00482196

Last Updated: 2015-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

173 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2006-03-31

Brief Summary

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To study different doses of MK0493 for safety, efficacy and tolerability in obese patients.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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MK0493

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient is between 21 and 65 years of age

Exclusion Criteria

* HIV positive as determined by medical history
* Patient is pregnant, lactating or plans to become pregnant
* Patient has undergone surgical treatment for obesity
* Patient has undergone a surgical procedure within 4 weeks prior to Visit 1 or plans to undergo a surgical procedure during the study
* Patient plans to consume more than 2 glasses of grapefruit juice per day during the study
* Patient has participated in another clinical study (involving an investigational drug) within 3 months prior to restudy screening
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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Krishna R, Gumbiner B, Stevens C, Musser B, Mallick M, Suryawanshi S, Maganti L, Zhu H, Han TH, Scherer L, Simpson B, Cosgrove D, Gottesdiener K, Amatruda J, Rolls BJ, Blundell J, Bray GA, Fujioka K, Heymsfield SB, Wagner JA, Herman GA. Potent and selective agonism of the melanocortin receptor 4 with MK-0493 does not induce weight loss in obese human subjects: energy intake predicts lack of weight loss efficacy. Clin Pharmacol Ther. 2009 Dec;86(6):659-66. doi: 10.1038/clpt.2009.167. Epub 2009 Sep 9.

Reference Type RESULT
PMID: 19741604 (View on PubMed)

Other Identifiers

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2007_577

Identifier Type: -

Identifier Source: secondary_id

0493-017

Identifier Type: -

Identifier Source: org_study_id

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