NCT00482196

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P50-P75 for phase_2 obesity

Timeline
Completed

Started Jul 2005

Shorter than P25 for phase_2 obesity

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2007

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

8 months

First QC Date

June 1, 2007

Last Update Submit

April 27, 2015

Conditions

Obesity

Interventions

MK0493DRUG

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is between 21 and 65 years of age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 19741604RESULT

MeSH Terms

Conditions

Obesity

Interventions

N-1-(2-(1-(tert-butyl-4-(2,4-difluorophenyl)pyrrolidin-3-yl)-5-chlorophenyl)ethyl)acetamide

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2007

First Posted

June 5, 2007

Study Start

July 1, 2005

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

April 28, 2015

Record last verified: 2015-04