Trial Outcomes & Findings for Weight Loss Study for Patients With Obesity Due to Craniopharyngioma or Other Brain Tumor (NCT NCT01484873)

NCT ID: NCT01484873

Last Updated: 2017-03-03

Results Overview

Change in body weight from baseline to end of study

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 10 participants
• Primary outcome timeframe: baseline, 50 weeks
• Results posted on: 2017-03-03

Participant Flow

University clinics and online advertisements from June, 2012 - March, 2013

Participant milestones

Measure	Exenatide exenatide 10 mcg twice daily
Overall Study STARTED	10
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Exenatide exenatide 10 mcg twice daily
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Weight Loss Study for Patients With Obesity Due to Craniopharyngioma or Other Brain Tumor

Baseline characteristics by cohort

Measure	Exenatide n=10 Participants exenatide 10 mcg twice daily
Age, Categorical <=18 years	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Gender Female	7 Participants n=5 Participants
Gender Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
Weight	137.2 kg STANDARD_DEVIATION 37.6 • n=5 Participants
Resting energy expenditure	2215.0 kcal/day STANDARD_DEVIATION 654.9 • n=5 Participants
Satiety	68.9 mm STANDARD_DEVIATION 15.4 • n=5 Participants
Insulin AUC	13076 120 min*uU/mL STANDARD_DEVIATION 7482 • n=5 Participants
Gastric emptying half life	175.4 minutes STANDARD_DEVIATION 81.0 • n=5 Participants

PRIMARY outcome

Timeframe: baseline, 50 weeks

Population: Patients that completed the study

Change in body weight from baseline to end of study

Outcome measures

Measure	Exenatide n=8 Participants exenatide 10 mcg twice daily
Body Weight (kg)	-1.4 kg Interval -2.2 to 4.9

SECONDARY outcome

Timeframe: baseline, 50 weeks

Population: 8 patients completed the study but one patient did not have REE data available due to technical difficulties

Change in resting energy expenditure from baseline to 50 weeks

Outcome measures

Measure	Exenatide n=7 Participants exenatide 10 mcg twice daily
Resting Energy Expenditure (Kcals Per Day)	-157.7 kcal/day Interval -766.1 to 450.6

SECONDARY outcome

Timeframe: baseline, 50 weeks

Change in visual analogue scales scores from baseline to 50 weeks. Higher score indicates greater satiety (minimum 0, maximum 100).

Outcome measures

Measure	Exenatide n=8 Participants exenatide 10 mcg twice daily
Visual Analogue Scales for Post-meal Satiety	-2.5 mm Interval -19.7 to 14.7

SECONDARY outcome

Timeframe: baseline, 50 weeks

Change in insulin secretion from baseline

Outcome measures

Measure	Exenatide n=8 Participants exenatide 10 mcg twice daily
Insulin Secretion (Area Under the Curve)	-89.3 120 min*uU/mL x Interval -5127.0 to 4948.0

SECONDARY outcome

Timeframe: baseline, 50 weeks

Change in the isotope excretion half life during a gastric emptying test at baseline and at 50 weeks

Outcome measures

Measure	Exenatide n=8 Participants exenatide 10 mcg twice daily
Gastric Emptying Rate (13C-octanoic Acid Isotope Excretion Half Life)	12.9 minutes Interval -38.5 to 64.3

Adverse Events

Exenatide

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Exenatide n=10 participants at risk exenatide 10 mcg twice daily
Gastrointestinal disorders Nausea	70.0% 7/10 • Number of events 7 • 1 year
Gastrointestinal disorders Vomiting	20.0% 2/10 • Number of events 2 • 1 year
Endocrine disorders Hypoglycemia	20.0% 2/10 • Number of events 2 • 1 year
General disorders Fatigue	10.0% 1/10 • Number of events 1 • 1 year
Psychiatric disorders Mood swings	10.0% 1/10 • Number of events 1 • 1 year
Skin and subcutaneous tissue disorders Hives	10.0% 1/10 • Number of events 1 • 1 year
Nervous system disorders Headache	10.0% 1/10 • Number of events 1 • 1 year
Gastrointestinal disorders Gastroenteritis	30.0% 3/10 • Number of events 3 • 1 year
Cardiac disorders Irregular heart beat	10.0% 1/10 • Number of events 1 • 1 year
Ear and labyrinth disorders Acute otitis media	10.0% 1/10 • Number of events 1 • 1 year
Psychiatric disorders Anxiety	10.0% 1/10 • Number of events 1 • 1 year
Musculoskeletal and connective tissue disorders Myalgias	10.0% 1/10 • Number of events 1 • 1 year
Musculoskeletal and connective tissue disorders Joint pain	30.0% 3/10 • Number of events 3 • 1 year
Renal and urinary disorders kidney stones	10.0% 1/10 • Number of events 1 • 1 year
Infections and infestations URI	30.0% 3/10 • Number of events 4 • 1 year
Blood and lymphatic system disorders Nose bleed	10.0% 1/10 • Number of events 1 • 1 year
Skin and subcutaneous tissue disorders Injection site reaction	20.0% 2/10 • Number of events 2 • 1 year
Infections and infestations strep throat	10.0% 1/10 • Number of events 1 • 1 year
Nervous system disorders tingling/numbness	10.0% 1/10 • Number of events 1 • 1 year

Additional Information

Ashley Shoemaker

Vanderbilt University

Phone: 615-343-8116

Email: ashley.h.shoemaker@vanderbilt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place