GLPwatch
Energy Balance & Weight Loss in Craniopharyngioma-related or Other Hypothalamic Tumors in Hypothalamic Obesity
NCT02664441 · Completed
Last updated 2026-05-28This clinical trial tests whether a weight loss program helps people with hypothalamic obesity, such as those with craniopharyngioma or other hypothalamic tumors, reduce their body mass index (BMI).
What this study is testing ClinicalTrials.gov NCT02664441 ↗
Description as written by the study sponsor.
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).
Treatments tested
- Exenatide also known as Bydureon® Drug
Weekly injections of active drug.
- placebo Drug
Weekly placebo injections
| Main thing measured | Percent Change of Body Mass Index (BMI) as Calculated by the Formula: Body Weight in kg Divided by Height in Meters². |
|---|---|
| Sponsor | Seattle Children's Hospital |
| Conditions studied | Hypothalamic Obesity |
| GLP-1 drugs | — |
Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT02664441 ↗