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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Energy Balance & Weight Loss in Craniopharyngioma-related or Other Hypothalamic Tumors in Hypothalamic Obesity

Short name ECHO

NCTNCT02664441 (opens ClinicalTrials.gov in a new tab)Other idR01DK104936-01A1
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
42 participants (actual)
Sponsor
Seattle Children's Hospital · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
Mar 2016
Primary completion
16 Mar 2020
Completion
31 Jul 2020
First posted
27 Jan 2016 (estimated)
Last update posted
5 May 2022
Conditions
Hypothalamic Obesity

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201620172018201920202021
  1. Ph 3

    ECHO

    NCT02664441

    Mar 2016 to 31 Jul 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • ExenatideDrug
  • placeboDrug

Arms2

  • Active comparator

    Exenatide once weekly extended-release

    Injections of glucagon-like peptide (GLP)-1 agonist exenatide once weekly extended-release (Bydureon®) for 36 weeks in randomized intervention followed by 18 weeks open label exenatide once weekly extended-release.

  • Placebo comparator

    Matching placebo

    Weekly injections of placebo for 36 weeks followed by 18 weeks open label exenatide once weekly extended-release.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percent Change of Body Mass Index (BMI) as Calculated by the Formula: Body Weight in kg Divided by Height in Meters².

    Time frame · From baseline to 36 weeks

    Registry description

    Percent change of body mass index (BMI), as calculated by the formula: body weight in kg divided by height in meters², between baseline and the end of the 36-week randomized drug treatment phase.

Secondary outcomes(10)

  1. Changes in Body Composition as Assessed by Body Fat Mass Using Dual Energy X-ray Absorptiometry (DEXA)

    Time frame · At baseline and 36 weeks

    Registry description

    Body composition change between baseline and the end of the 36-week randomized drug treatment phase assessed by dual energy x-ray absorptiometry (DEXA) and expressed as the change in adipose tissue mass.

  2. Changes in Fat and Total Calorie Intake Assessed by Free Buffet Meal Analysis.

    Time frame · From baseline to 36 weeks

    Registry description

    Changes in fat and total calorie intake during free buffet meals assessed at baseline and after 36-weeks of study drug treatment. The buffet meal is an objective measure of satiety as it assesses food intake and choice after a caloric preload. A standardized test meal preload provided 20% of estimated daily caloric requirements,based on the Schofield-HW equation. The purpose of the test meal is to ensure that study participants are in an equally fed state. Ninety minutes later, an ad libitum buffet meal was served consisting of a wide variety of food items and more than the child's estimated daily calorie requirements will be offered (5,000 kcal). Children had access to the buffet for 30 min, after which calorie intake and composition of consumed foods was measured by weighing back uneaten food.

  3. Changes in Fasting Glucose

    Time frame · From baseline to 36 weeks

    Registry description

    Change in fasting blood glucose between baseline and the end of the 36-week randomized drug treatment phase.

  4. Changes in HDL Cholesterol and Triglycerides Assessed by Fasting Lipids

    Time frame · From baseline to 36 weeks

    Registry description

    Change in fasting HDL cholesterol and triglycerides between baseline and the end of the 36-week randomized drug treatment phase.

  5. Changes in Inflammation Assessed by C-reactive Protein (CRP)

    Time frame · From baseline to 36 weeks

    Registry description

    Change in C-reactive protein (CRP) between baseline and the end of the 36-week randomized drug treatment phase.

  6. Changes of Insulin Resistance Assessed by Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

    Time frame · From baseline to 36 weeks

    Registry description

    Changes of insulin resistance estimated by the homeostasis model assessment of insulin resistance (HOMA-IR) using the formula HOMA-IR = insulin \[mU/l\] x glucose \[mmol/l\]) / 22.5 where both insulin and glucose values are obtained from a fasting blood sample.

  7. Changes of Circulating Leptin Levels

    Time frame · From baseline to 36 weeks

    Registry description

    Change in circulating leptin between baseline and the end of the 36-week randomized drug treatment phase.

  8. Changes of Energy Expenditure Assessed by Doubly Labeled Water Analysis

    Time frame · Baseline and 36 weeks

    Registry description

    Total energy expenditure in the free-living environment was measured using doubly labeled water which estimates carbon dioxide production by measuring the elimination of the tracers deuterium (²H) and oxygen-18 (¹⁸O) from the body. These measures are used to determine the average daily rate of carbon dioxide production which is then used to calculate total energy expenditure using an equation from Weir and an assumed food quotient (0.85).

  9. Changes of Energy Intake Assessed by Automated Self-Administered 24-Hour Dietary Recall (ASA24-Kids)

    Time frame · Baseline and 36 weeks

    Registry description

    Self-reported daily energy intake was assessed by Automated Self-Administered 24-Hour Dietary Recall (ASA24-Kids, http://appliedresearch.cancer.gov/tools/instruments/asa24/), a web-based diet assessment tool that allows 24-hour diet recall using branded food items.

  10. Changes in Glucose 120 Minutes Following an Oral Glucose Tolerance Test

    Time frame · From baseline to 36 weeks

    Registry description

    Change in blood glucose measures 120 minutes post-glucose bolus during an oral glucose tolerance test between baseline and the end of the 36-week randomized drug treatment phase.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· From baseline to 36 weeks

Percent Change of Body Mass Index (BMI) as Calculated by the Formula: Body Weight in kg Divided by Height in Meters².

GroupValue (percent change from baseline)Spread
Exenatide Once Weekly Extended-release1.70.8
Matching Placebo3.50.9
Secondary and other outcome results(7)
Secondary outcomeMean· At baseline and 36 weeks

Changes in Body Composition as Assessed by Body Fat Mass Using Dual Energy X-ray Absorptiometry (DEXA)

GroupValue (kilograms)Spread
Exenatide Once Weekly Extended-release1.50.9
Matching Placebo4.61.0
Secondary outcomeMean· From baseline to 36 weeks

Changes in Fat and Total Calorie Intake Assessed by Free Buffet Meal Analysis.

GroupValue (grams)Spread
Exenatide Once Weekly Extended-release-9.56.3
Matching Placebo14.57.7
Secondary outcomeMean· From baseline to 36 weeks

Changes in Fasting Glucose

GroupValue (mg/dL)Spread
Exenatide Once Weekly Extended-release7.46.0
Matching Placebo3.73.5
Secondary outcomeMean· From baseline to 36 weeks

Changes in HDL Cholesterol and Triglycerides Assessed by Fasting Lipids

GroupValue (mg/dL)Spread
Exenatide Once Weekly Extended-release0.72.1
Matching Placebo0.62.8
Secondary outcomeMean· From baseline to 36 weeks

Changes in Inflammation Assessed by C-reactive Protein (CRP)

GroupValue (mg/dL)Spread
Exenatide Once Weekly Extended-release0.000.07
Matching Placebo0.180.27
Secondary outcomeMean· From baseline to 36 weeks

Changes of Insulin Resistance Assessed by Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

GroupValue (HOMA-IR score)Spread
Exenatide Once Weekly Extended-release3.51.7
Matching Placebo2.22.4
Secondary outcomeMean· From baseline to 36 weeks

Changes of Circulating Leptin Levels

GroupValue (ng/mL)Spread
Exenatide Once Weekly Extended-release1.46.3
Matching Placebo11.89.4

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Double-Blind Exenatide Once Weekly Extended-releaseInjections of glucagon-like peptide (GLP)-1 agonist exenatide once weekly extended-release (Bydureon®) for 36 weeks in randomized intervention Exenatide: Weekly injections of active drug.0 / 232 / 2321 / 23
Double-Blind PlaceboWeekly injections of placebo for 36 weeks in randomized intervention placebo: Weekly placebo injections0 / 181 / 1815 / 18
Open Label Exenatide Once Weekly Extended-release18 weeks open label exenatide once weekly extended-release (Bydureon®) arm. Exenatide: Weekly injections of active drug.1 / 354 / 3517 / 35

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 10 Years up to 25 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Age 10-25 years at time of enrollment * Diagnosis of hypothalamic obesity with age- and sex adjusted BMI ≥ 95% or BMI ≥30 kg/m² if over 18 y * History of craniopharyngioma or another tumor located in the hypothalamic area * Hypothalamic lesion documented by neuroradiology * ≥ 6 months post-surgical or radiation treatment * Weight stable or increasing over 3 months prior to screening visit * Stable hormone replacement for at least 3 months prior to screening visit Exclusion Criteria: * Renal impairment (GFR\<60 ml/min/1.73m² using the Schwarz formula) * History of gastroparesis; pancreatitis or gallstones (unless status post cholecystectomy) * Family history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma metabolic disorders * Any insulin-treated diabetes mellitus, poorly controlled type 2 diabetes (HbA1c ≥ 10%), or any other chronic serious medical conditions such as cardiovascular disease, malignancy or hematologic disorder, complicated syndromic disorder, or psychiatric disorders (schizophrenia, major depression, history of suicide attempts) * Calcitonin \>50 mg/L at screening * Initiation of weight loss medications within 3 months of screening visit * Previous donation of blood \>10% of estimated blood volume within 3 months prior study * Current warfarin use * Current use of any other GLP1 receptor agonist * Untreated thyroid disorder or adrenal insufficiency * History of bariatric surgery or planned bariatric surgery until end of study * Pregnancy, lactation or expectation to conceive during study period * Subject unlikely to adhere to study procedures in opinion of investigator * Subject with contraindication to neuroimaging by MRI

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