Energy Balance & Weight Loss in Craniopharyngioma-related or Other Hypothalamic Tumors in Hypothalamic Obesity
Status:
Completed
Trial end date:
2020-07-31
Target enrollment:
Participant gender:
Summary
The proposed multicenter study will test the effect of glucagon-like peptide (GLP)-1 agonist
exenatide once weekly extended-release (ExQW, Bydureon®) on clinical outcomes and metabolic
parameters in a double-blind, placebo-controlled 36 week randomized trial with an 18 week
open label extension. Following baseline testing, 48 patients will be randomly assigned with
equal allocation to ExQW or matching placebo injection for 36 weeks, followed by an 18 week
open label extension during which all patients receive ExQW. Changes of weight status, body
composition, free-living total daily energy expenditure (EE) by doubly labeled water (DLW),
activity by acetimetry, energy intake (questionnaires and food diary), as well as glucose
tolerance and hormonal parameters of energy homeostasis and insulin resistance will be
assessed before treatment and at the end of the placebo-controlled phase (week 36). Activity,
metabolic outcomes, energy intake will be also assessed at study week 18 (mid treatment of
randomized study), as well as week 54 (end of open label treatment).
Phase:
Phase 3
Details
Lead Sponsor:
Seattle Children's Hospital
Collaborators:
Children's Hospitals and Clinics of Minnesota Vanderbilt University