Effects of Exenatide on Hypothalamic Obesity

• Status: Completed
• Trial end date: 2019-03-15
• Target enrollment: 0
• Participant gender: All

Summary

The primary aim of this study is to evaluate the effect of Exenatide on weight status (change in body mass index) of children treated for craniopharyngioma that have developed hypothalamic obesity at Children's Hospitals and Clinics of Minnesota. We hypothesize that Exenatide given to hypothalamic obese children for 6 months will reduce their body mass index significantly from baseline.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospitals and Clinics of Minnesota
• Collaborator: Amylin Pharmaceuticals, LLC.
• Treatments: Exenatide

Criteria

Inclusion Criteria:

• >/=6 months post surgical or radiation or chemotherapy treatment for 1° craniopharyngiomas or other suprasellar tumors

• 10-21 years old

• Age-and sex-adjusted BMI >/=95%

• Parent sign consent and patient sign assent

Exclusion Criteria:

• < 6 months post surgical or radiation or chemotherapy treatment for 1° craniopharyngiomas or other suprasellar tumors

• Pregnant or breastfeeding, or those women who plan to get pregnant

• Renal impairment

• Gastroparesis

• Pancreatitis

• Diabetes

• <1 month post initiation of Metformin treatment

• Prescription or over-the-counter weight loss medications within 3 months of screening

• Are actively participating in, or have participated in a formal weight loss program within the last 3 months

• Have had bariatric surgery