Hypothalamic ObesityPhase 3ECHONCT02664441
Energy Balance & Weight Loss in Craniopharyngioma-related or Other Hypothalamic Tumors in Hypothalamic Obesity
A Phase 3 study testing Exenatide in people with Hypothalamic Obesity, run by Seattle Children's Hospital at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 25 years
- Conditions the study is for
- Hypothalamic Obesity
- What is being tested?
- Exenatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2016to 31 Jul 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Children's Hospitals adn Clinics of Minnesota
Minneapolis, Minnesota, 55404
Vanderbilt University School of Medicine
Nashville, Tennessee, 37235
Seattle Childrens
Seattle, Washington, 98105
About this study
Official title: Glucagon-Like Peptide-1 Agonist Effects on Energy Balance 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. 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).
Read the detailed description
Excessive weight gain and its cardiometabolic sequela are frequent complications of hypothalamic tumors, a condition known as hypothalamic obesity (HO). Most tumors in this region are craniopharyngiomas (CP),1 which constitute 5-9% of childhood brain tumors. Patients with CP typically become obese and have more features of the metabolic syndrome compared to matched controls. Overall, a 3-19-fold higher cardiovascular mortality had been reported, and a recent nationwide population-based study in Sweden demonstrated increased rates for cerebral infarction (7-fold), death due to cerebrovascular diseases (5-fold), and type 2 diabetes mellitus (6-fold) in CP patients in comparison to the general population. Thus, early and effective management of obesity is vital for this population, which is more resistant to treatment than uncomplicated obesity. Recognized risk factors for severe obesity include large hypothalamic tumors or lesions affecting several medial and posterior hypothalamic nuclei that impact satiety signaling pathways. Structural damage in these nuclei often lead to uncontrolled appetite, rapid weight gain, central insulin and leptin resistance, decreased sympathetic activity, low energy expenditure (EE), and increased energy storage in adipose tissue. Recently, the investigators developed a semi-quantitative assessment of hypothalamic damage on brain magnetic resonance imaging (MRI) to predict the risk for HO development in CP.
Previous results of treating HO with a glucagon-like-peptide-1 receptor agonist (GLP1RA) in rats and humans provide promising proof-of-principle data to support this current randomized clinical trial. The primary hypothesis of this study is that drugs causing weight loss via intact hindbrain signaling pathways offer a desperately needed option for treatment of HO, even in very obese HO subjects with severe hypothalamic damage. Induction of weight loss by GLP1RAs is believed to be related to multiple mechanisms involving the gastrointestinal tract, vagus nerve, and the brain leading to increased satiety. Peripheral administration of GLP-1 or GLP1RA reduces blood glucose and energy intake in humans and rodents, and long-term treatment results in loss of body weight. Critically, the investigators do not know whether GLP1RA treatment affects EE and activity, or whether the site and size of brain lesions affect responses to GLP1RA treatment.
The investigators' previous clinical studies of the GLP1RA exenatide in obese adolescents and adults have generated the critical safety and efficacy data needed to design a clinical trial. In a pilot study conducted at Children's Hospitals and Clinics of MN, pretreatment hyperphagia was associated with BMI reduction. Using these data, the investigators have designed a prospective, multicenter trial that will examine the effects of GLP1RA on BMI, cardiovascular disease (CVD) risk factors, energy homeostasis and other factors in subjects with HO secondary to CP.
- Conditions
- Hypothalamic Obesity
- Being tested
- Exenatide, placebo
- Keywords
- Obesity, Drug intervention, Children, Adolescents, Young adults, Hypothalamic lesion, Change of weight status, Food intake, Energy expenditure, Hormonal changes, Glucagon-like peptide-1 agonist, Bydureon, Weight Loss, Energy balance
- Medical subject headings
- Sexual Infantilism, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExenatideDrug
Also called Bydureon®
Weekly injections of active drug.
placeboDrug
Weekly placebo injections
| Study group | Role | What they receive |
|---|---|---|
| Exenatide once weekly extended-release | Active comparator | 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. Receives: Drug: Exenatide |
| Matching placebo | Placebo comparator | Weekly injections of placebo for 36 weeks followed by 18 weeks open label exenatide once weekly extended-release. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change of Body Mass Index (BMI) as Calculated by the Formula: Body Weight in kg Divided by Height in Meters².
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.
Measured: From baseline to 36 weeks
Secondary outcomes (10)
Changes in Body Composition as Assessed by Body Fat Mass Using Dual Energy X-ray Absorptiometry (DEXA)
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.
Measured: At baseline and 36 weeks
Changes in Fat and Total Calorie Intake Assessed by Free Buffet Meal Analysis.
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.
Measured: From baseline to 36 weeks
Changes in Fasting Glucose
Change in fasting blood glucose between baseline and the end of the 36-week randomized drug treatment phase.
Measured: From baseline to 36 weeks
Changes in HDL Cholesterol and Triglycerides Assessed by Fasting Lipids
Change in fasting HDL cholesterol and triglycerides between baseline and the end of the 36-week randomized drug treatment phase.
Measured: From baseline to 36 weeks
Changes in Inflammation Assessed by C-reactive Protein (CRP)
Change in C-reactive protein (CRP) between baseline and the end of the 36-week randomized drug treatment phase.
Measured: From baseline to 36 weeks
Changes of Insulin Resistance Assessed by Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
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.
Measured: From baseline to 36 weeks
Changes of Circulating Leptin Levels
Change in circulating leptin between baseline and the end of the 36-week randomized drug treatment phase.
Measured: From baseline to 36 weeks
Changes of Energy Expenditure Assessed by Doubly Labeled Water Analysis
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).
Measured: Baseline and 36 weeks
Changes of Energy Intake Assessed by Automated Self-Administered 24-Hour Dietary Recall (ASA24-Kids)
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.
Measured: Baseline and 36 weeks
Changes in Glucose 120 Minutes Following an Oral Glucose Tolerance Test
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.
Measured: From baseline to 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startMar 2016
- Primary completion16 Mar 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hypothalamic ObesityStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospitals and Clinics of Minnesota, Vanderbilt University
- Responsible party
- Principal investigator, Christian L Roth, MD, Seattle Children's Hospital
- Investigators
- Christian Roth, MD, Principal investigator, Seattle Childrens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02664441
- Sponsor's protocol ID
- R01DK104936-01A1
- Acronym
- ECHO
- Status last verified
- May 2022
- First submitted
- 4 Jan 2016
- Last updated
- 5 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucagon-Like Peptide-1 Agonist Effects on Energy Balance in Hypothalamic Obesity
- ClinicalTrials.gov ID
- NCT02664441
- Acronym / sponsor ID
- ECHO / R01DK104936-01A1
- Conditions
- Hypothalamic Obesity
- Keywords
- Obesity, Drug intervention, Children, Adolescents, Young adults, Hypothalamic lesion, Change of weight status, Food intake
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- Children's Hospitals and Clinics of Minnesota, Vanderbilt University
- Study start
- Mar 2016
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 27 Jan 2016 (estimated)
- Results
- Posted 5 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Excessive weight gain and its cardiometabolic sequela are frequent complications of hypothalamic tumors, a condition known as hypothalamic obesity (HO). Most tumors in this region are craniopharyngiomas (CP),1 which constitute 5-9% of childhood brain tumors. Patients with CP typically become obese and have more features of the metabolic syndrome compared to matched controls. Overall, a 3-19-fold higher cardiovascular mortality had been reported, and a recent nationwide population-based study in Sweden demonstrated increased rates for cerebral infarction (7-fold), death due to cerebrovascular diseases (5-fold), and type 2 diabetes mellitus (6-fold) in CP patients in comparison to the general population. Thus, early and effective management of obesity is vital for this population, which is more resistant to treatment than uncomplicated obesity. Recognized risk factors for severe obesity include large hypothalamic tumors or lesions affecting several medial and posterior hypothalamic nuclei that impact satiety signaling pathways. Structural damage in these nuclei often lead to uncontrolled appetite, rapid weight gain, central insulin and leptin resistance, decreased sympathetic activity, low energy expenditure (EE), and increased energy storage in adipose tissue. Recently, the investigators developed a semi-quantitative assessment of hypothalamic damage on brain magnetic resonance imaging (MRI) to predict the risk for HO development in CP.
Previous results of treating HO with a glucagon-like-peptide-1 receptor agonist (GLP1RA) in rats and humans provide promising proof-of-principle data to support this current randomized clinical trial. The primary hypothesis of this study is that drugs causing weight loss via intact hindbrain signaling pathways offer a desperately needed option for treatment of HO, even in very obese HO subjects with severe hypothalamic damage. Induction of weight loss by GLP1RAs is believed to be related to multiple mechanisms involving the gastrointestinal tract, vagus nerve, and the brain leading to increased satiety. Peripheral administration of GLP-1 or GLP1RA reduces blood glucose and energy intake in humans and rodents, and long-term treatment results in loss of body weight. Critically, the investigators do not know whether GLP1RA treatment affects EE and activity, or whether the site and size of brain lesions affect responses to GLP1RA treatment.
The investigators' previous clinical studies of the GLP1RA exenatide in obese adolescents and adults have generated the critical safety and efficacy data needed to design a clinical trial. In a pilot study conducted at Children's Hospitals and Clinics of MN, pretreatment hyperphagia was associated with BMI reduction. Using these data, the investigators have designed a prospective, multicenter trial that will examine the effects of GLP1RA on BMI, cardiovascular disease (CVD) risk factors, energy homeostasis and other factors in subjects with HO secondary to CP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exenatide once weekly extended-release | Active comparator | Drug: ExenatideInjections 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. |
| Matching placebo | Placebo comparator | Drug: placeboWeekly injections of placebo for 36 weeks followed by 18 weeks open label exenatide once weekly extended-release. |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExenatideAlso: Bydureon®Weekly injections of active drug. | Drug | Exenatide once weekly extended-release |
| placeboWeekly placebo injections | Drug | Matching placebo |
Primary outcome
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
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.
10 secondary outcomes
Changes in Body Composition as Assessed by Body Fat Mass Using Dual Energy X-ray Absorptiometry (DEXA)
Time frame: At baseline and 36 weeks
Changes in Fat and Total Calorie Intake Assessed by Free Buffet Meal Analysis.
Time frame: From baseline to 36 weeks
Changes in Fasting Glucose
Time frame: From baseline to 36 weeks
Changes in HDL Cholesterol and Triglycerides Assessed by Fasting Lipids
Time frame: From baseline to 36 weeks
Changes in Inflammation Assessed by C-reactive Protein (CRP)
Time frame: From baseline to 36 weeks
Changes of Insulin Resistance Assessed by Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: From baseline to 36 weeks
Changes of Circulating Leptin Levels
Time frame: From baseline to 36 weeks
Changes of Energy Expenditure Assessed by Doubly Labeled Water Analysis
Time frame: Baseline and 36 weeks
Changes of Energy Intake Assessed by Automated Self-Administered 24-Hour Dietary Recall (ASA24-Kids)
Time frame: Baseline and 36 weeks
Changes in Glucose 120 Minutes Following an Oral Glucose Tolerance Test
Time frame: From baseline to 36 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Roth, MD principal investigator
Seattle Childrens
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Exenatide in people with Hypothalamic Obesity, run by Seattle Children's Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.