Obesity
Conditions
Keywords
Ketogenesis, Glucose-Dependent Insulin Secretion, Graded Glucose Infusion, Oxyntomodulin
Brief summary
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.
Interventions
DRUGOxyntomodulin (OXM)
Single infusion of OXM 3.0 pmol/kg/min by IV
DRUGComparator: Oxyntomodulin (OXM)
Single infusion of OXM 0.6 pmol/kg/min by IV
DRUGComparator: Placebo [ hemaccel-containing saline]
Single Placebo infusion of hemaccel-containing saline by IV
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ambient plasma glucose concentration during the GGI | Last 160 minutes of OXM/placebo infusion |
| plasma βOHB + AcAc concentrations | First 300 minutes of OXM/placebo infusion |
Outcome results
None listed