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Completed

NCT Number: NCT00479492

Study To Determine The Effects And Safety Of A Weight Loss Compound On Overweight, Otherwise Healthy, Volunteers

The purpose of this study is to determine whether CP-866,087 is effective in the weight loss of overweight patients.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Orlando, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body Mass Index (BMI) 30 to 40 kg/m2 and total body weight of >110 lbs.
  • Otherwise healthy

Exclusion criteria

  • Women must be of non-childbearing potential.
  • Significant current or history of medical illness.

Treatment and study plan

CP-866,087

Drug

1 mg of CP-866,087, administered QD for 84 days

Placebo

Drug

placebo administered QD for 84 days

Primary outcomes

  1. Measure the effect of weight loss over 12 weeks in overweight otherwise healthy patients. Measurements will include body weight and waist circumference. Measurements will occur at Day 1, 7, 14, 28, 42, 56, 70, 84 and 94.

    Time frame: 94 days

Secondary outcomes

  1. To characterize the effect of 4 weeks of dosing of 3 different doses of CP-866,087 on 24-hour urinary cortisol levels. Measured at Day 1 and Day 29

    Time frame: 29 days

  2. Exploratory biomarkers measured at Day 1, 14, 28, 56, and 84.

    Time frame: 84 days

  3. Waist circumference measured at Day 1, 7, 14, 28, 42, 56, 70, 84, 94.

    Time frame: 94 days

  4. To explore changes in pharmacodynamics (PD) markers of efficacy resulting from multiple PO doses of CP-866,087, including waist circumference, and serum lipids and exploratory biomarkers.

    Time frame: 94 days

  5. Serum Lipids measured at Day 1, 7, 14, 28, 56, 84 and 94.

    Time frame: 94 days

  6. To explore the effects of chronic, 12-week dosing with CP-866,087 on neuroendocrine endpoints, including testosterone, TSH, T4, and IGF1. Measured at Day 1, 28, 84 and 94.

    Time frame: 94 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A 12-Week, Randomized, Subject And Investigator Blind, Placebo-Controlled Trial To Evaluate The Effect Of CP-866,087 On Weight Loss In Obese, Otherwise Healthy Adult Subjects

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 28, 2007
Registry last updated
Oct 1, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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