Study of Safety, Tolerability and Efficacy of MK0493 in Obese Patients (0493-008)(COMPLETED)

NCT ID: NCT00482638

Last Updated: 2019-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-12
• Study Completion Date: 2004-10-29

Brief Summary

To assess the effect of MK0493 on body weight, blood pressure, mood, and appetite.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

MK0493

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patient is between 21 and 65 years
• Patient is able to read and understand and complete study questionnaires
• Patient is not pregnant or breast-feeding and does not plan to become pregnant for the duration of the study and post-study follow-up period

Exclusion Criteria

• Patient has a history of significant psychiatric disorder (such as major depression, bipolar disorder, bulimia, or anorexia nervosa
• Patient is HIV positive as determined by medical history
• Patient has undergone surgical treatment for obesity
• Patient plans to consume more than two 8 ounce glasses of grapefruit juice per day during the study
• Patient participated in another clinical study involving an investigational drug) within 3 months prior to Visit 1
• Patient is currently a heavy consumer of alcohol (>2 drinks per day or >14 drinks per week [1 drink is defined as 2 oz hard alcohol, 5 oz wine, 12 oz beer], or uses (including recreational use) any illicit drugs, or has a history of drug or alcohol abuse

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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

2007_571

Identifier Type: -

Identifier Source: secondary_id

0493-008

Identifier Type: -

Identifier Source: org_study_id