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Completed

NCT Number: NCT01055340

A Study That Will Evaluate Ketogenesis and Glucose-Dependent Insulin Secretion Methodologies in Healthy Male Subjects (MK-0000-159)(COMPLETED)

This study will test the hypotheses that a single dose of oxyntomodulin (OXM) will be neutral or better than placebo in lowering ambient glucose levels during a graded glucose infusion (GGI) and that a single dose of OXM will lead to a statistically significant increase in the sum of the plasma βOHB + AcAc levels compared to placebo.

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subject is judged to be in good health based on medical history, physical examination, and laboratory safety tests
  • Subject has a Body Mass Index of ≥27 kg/m^2 and ≤35 kg/m^2 and weighs ≥70 kg at the prestudy (screening) visit
  • Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months
  • Subject is willing to avoid strenuous physical activity (weight lifting, running, bicycling, etc.) for the duration of the study

Exclusion criteria

  • Subject is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit
  • Subject has a history of stroke, chronic seizures, or major neurological disorder
  • Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
  • Subject has irritable bowel disease, or recurrent occurrences of nausea, vomiting, diarrhea, or abdominal pain
  • Subject has a history of hypertension requiring treatment
  • Subject has a history of cancer
  • Subject has history of diabetes, or family history of diabetes mellitus
  • Subject has a history of hypersensitivity to OXM or hemaccel

Treatment and study plan

Oxyntomodulin (OXM)

Drug

Single infusion of OXM 3.0 pmol/kg/min by IV

Comparator: Oxyntomodulin (OXM)

Drug

Single infusion of OXM 0.6 pmol/kg/min by IV

Comparator: Placebo [ hemaccel-containing saline]

Drug

Single Placebo infusion of hemaccel-containing saline by IV

Primary outcomes

  1. Ambient plasma glucose concentration during the GGI

    Time frame: Last 160 minutes of OXM/placebo infusion

  2. plasma βOHB + AcAc concentrations

    Time frame: First 300 minutes of OXM/placebo infusion

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Randomized Clinical Trial to Study Ketogenesis and Glucose-Dependent Insulin Secretion Methodologies in Healthy Male Subjects

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 25, 2010
Registry last updated
May 29, 2015

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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