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NCT02664441 · ClinicalTrials.gov registry record · Phase 3
Energy Balance & Weight Loss in Craniopharyngioma-related or Other Hypothalamic Tumors in Hypothalamic Obesity
A Phase 3 study, sponsored by Seattle Children's Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 42
- Enrollment target
NCT02664441 is a Phase 3 study that has completed, run by Seattle Children's Hospital. The registered enrollment target is 42 participants.
The verdict
NCT02664441, a Phase 3 study, has completed, sponsored by Seattle Children's Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 42 participants
- Enrollment target
Study 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).
Interventions
- DRUG placebo
- DRUG Exenatide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2016-03 |
| Est. Completion | 2020-07-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02664441
The ClinicalTrials.gov registry entry for NCT02664441 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seattle Children's Hospital, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT02664441 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02664441 about?
NCT02664441 is a clinical study titled "Energy Balance & Weight Loss in Craniopharyngioma-related or Other Hypothalamic Tumors in Hypothalamic Obesity". 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. Fol...
What is the current status of trial NCT02664441?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 42 participants. The study started on 2016-03. Estimated completion is 2020-07-31.
What interventions are being tested in trial NCT02664441?
The interventions under investigation include: placebo (DRUG), Exenatide (DRUG).
Who is sponsoring clinical trial NCT02664441?
This trial is sponsored by Seattle Children's Hospital, which has 168 total clinical trials registered on ClinicalTrials.gov.
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