A Randomized Clinical Trial to Study Ketogenesis and Glucose-Dependent Insulin Secretion Methodologies in Healthy Male Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 12
- Primary Endpoint
- Ambient plasma glucose concentration during the GGI
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Male
- Accepts 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
Arms & Interventions
Treatment sequence 1
OXM 3.0 pmol/kg/min - OXM 0.6 pmol/kg/min - Placebo
Intervention: Oxyntomodulin (OXM) (Drug)
Treatment sequence 2
OXM 0.6 pmol/kg/min - Placebo - OXM 3.0 pmol/kg/min
Intervention: Oxyntomodulin (OXM) (Drug)
Treatment sequence 3
Placebo - OXM 3.0 pmol/kg/min - OXM 0.6 pmol/kg/min
Intervention: Oxyntomodulin (OXM) (Drug)
Treatment sequence 4
OXM 3.0 pmol/kg/min - Placebo - OXM 0.6 pmol/kg/min
Intervention: Oxyntomodulin (OXM) (Drug)
Treatment sequence 5
Placebo - OXM 0.6 pmol/kg/min - OXM 3.0 pmol/kg/min
Intervention: Oxyntomodulin (OXM) (Drug)
Treatment sequence 6
OXM 0.6 pmol/kg/min - OXM 3.0 pmol/kg/min - Placebo
Intervention: Oxyntomodulin (OXM) (Drug)
Outcomes
Primary Outcomes
Ambient plasma glucose concentration during the GGI
Time Frame: Last 160 minutes of OXM/placebo infusion
plasma βOHB + AcAc concentrations
Time Frame: First 300 minutes of OXM/placebo infusion
Secondary Outcomes
No secondary outcomes reported