NCT00482638

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started May 2004

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

May 12, 2004

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2004

Completed
2.6 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

November 14, 2019

Status Verified

November 1, 2019

Enrollment Period

6 months

First QC Date

June 1, 2007

Last Update Submit

November 13, 2019

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
  • 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

You may not qualify if:

  • 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

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
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

May 12, 2004

Primary Completion

October 29, 2004

Study Completion

October 29, 2004

Last Updated

November 14, 2019

Record last verified: 2019-11