Overseen BySteven R Smith, MD
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Translational Research Institute for Metabolism and Diabetes, Florida
No Placebo Group
Approved in 4 jurisdictions
Trial Summary
What is the purpose of this trial?To further understand the tolerability of glucagon.
Eligibility Criteria
Adults aged 18-55 with a BMI between 27 and 40, non-diabetic, in good health without significant medical conditions. Participants must not have had weight fluctuations or surgery recently, avoid alcohol, caffeine, strenuous activity before visits, and if female and able to bear children, use birth control.Inclusion Criteria
Subject is willing to avoid strenuous physical activity for 72 hours prior to the inpatient study visit
I am using or willing to use birth control during the study.
Stable body weight for 3 months (self-reported loss/gain <5%)
+6 more
Exclusion Criteria
I have a serious heart condition.
I have anemia.
I have a metabolic, endocrine, or other similar disorder.
+16 more
Participant Groups
The trial is testing the tolerability of glucagon infusions in obese individuals. It aims to understand how well these participants can tolerate this hormone treatment which could potentially influence body weight regulation.
1Treatment groups
Experimental Treatment
Group I: Glucagon InfusionExperimental Treatment1 Intervention
Glucagon infusion in escalating manner at 12.5, 25, 37.5 and 50 ng/kg/min (each step for 60 min). At 30 and 60 mins of each infusion rate, we will administer a previously established questionnaire to assess overall nausea intensity.
Glucagon is already approved in European Union, United States, Canada, Japan for the following indications:
πͺπΊ Approved in European Union as GlucaGen for:
- Hypoglycemia
- Diagnostic aid
πΊπΈ Approved in United States as Glucagon for:
- Severe hypoglycemia
- Diagnostic aid
π¨π¦ Approved in Canada as Glucagon Novo Nordisk for:
- Hypoglycemia
- Diagnostic aid
π―π΅ Approved in Japan as Glucagon Lilly for:
- Hypoglycemia
- Diagnostic aid
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Translational Research Institute for Metabolism and DiabetesOrlando, FL
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Who Is Running the Clinical Trial?
Translational Research Institute for Metabolism and Diabetes, FloridaLead Sponsor
AdventHealth Translational Research InstituteLead Sponsor