NCT00092872

Brief Summary

This is a 1-year study to assess the safety, tolerability, and efficacy of an investigational drug in obese patients after a very low calorie diet.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
359

participants targeted

Target at P50-P75 for phase_3 obesity

Timeline
Completed

Started Nov 2003

Shorter than P25 for phase_3 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

November 1, 2003

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2004

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 28, 2004

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
Last Updated

January 30, 2015

Status Verified

January 1, 2015

Enrollment Period

1.3 years

First QC Date

September 23, 2004

Last Update Submit

January 29, 2015

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

  • Body weight after 1 year of treatment.

    After 1 year of treatment

  • Safety and tolerability.

    After 1 year of treatment

Secondary Outcomes (1)

  • Waist circumference; Blood pressure, body fat mass, biochemical markers (fasting plasma, lipid profile, fasting plasma glucose, leptin, insulin, insulin sensitivity); body weight after 2 years

    After 2 years

Interventions

MK0557DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Obese men and nonpregnant women between the ages of 18 and 65 years with a body mass index (height to weight ratio) as required by the study.

You may not qualify if:

  • Patients with uncontrolled high blood pressure and/or diabetes mellitus (high blood sugar)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Erondu N, Gantz I, Musser B, Suryawanshi S, Mallick M, Addy C, Cote J, Bray G, Fujioka K, Bays H, Hollander P, Sanabria-Bohorquez SM, Eng W, Langstrom B, Hargreaves RJ, Burns HD, Kanatani A, Fukami T, MacNeil DJ, Gottesdiener KM, Amatruda JM, Kaufman KD, Heymsfield SB. Neuropeptide Y5 receptor antagonism does not induce clinically meaningful weight loss in overweight and obese adults. Cell Metab. 2006 Oct;4(4):275-82. doi: 10.1016/j.cmet.2006.08.002.

    PMID: 17011500RESULT

MeSH Terms

Conditions

Obesity

Interventions

spiro(cyclohexane-1,3'(1'H)-furo(3,4-C)pyridine)-4-carboxamide, N-(1-(2-fluorophenyl)-1h-pyrazol-3-yl)-1'-oxo-, trans-

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 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2004

First Posted

September 28, 2004

Study Start

November 1, 2003

Primary Completion

February 1, 2005

Study Completion

February 1, 2005

Last Updated

January 30, 2015

Record last verified: 2015-01