Trial Outcomes & Findings for A Study Comparing the Effect of Albiglutide With Exenatide on Regional Brain Activity Related to Nausea in Healthy Subjects (NCT NCT02802514)

Last Updated: 2020-10-30

Results Overview

BOLD signal fMRI Visual Nauseogenic Task data were to be collected at indicated time-points. The seed-to-voxel driven approach included a priori seed Regions of interest (ROIs) placed in brain areas subserving nausea-related processing included regions like interoceptive/sensory (insula, Dorsal anterior cingulate cortex \[dACC\]), emotional/affective (amygdala, Pregenual anterior cingulate cortex \[pgACC\]), and cognitive/evaluative (dorsolateral prefrontal cortex \[dlPFC\]/ Occipitofrontal Circumference \[OFC\]) brain areas, primary visual (V1) and extrastriate cortices. The primary endpoints of this exploratory study involved combining data from Part A and Part B. The purpose of Part A was decision making for Part B. Placebo was used to enable albiglutide and exenatide to be dosed at different times relative to MRI due to differences in Tmax, while preserving single-blind (similar to double dummy), hence data was to be reported in albiglutide, exenatide and off-therapy arms only.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

5 participants

Primary outcome timeframe

Up to Week 11

Results posted on

2020-10-30

Participant Flow

This crossover study conducted in adult healthy volunteers who were susceptible to motion sickness to explore regional brain activity and connectivity associated with treatment using magnetic resonance imaging (MRI). Participants were randomized to receive single dose of 50milligram (mg) albiglutide and 10microgram (µg) exenatide along with placebo

A total of 10 participants were screened, of which 6 were screen-failures and 4 were randomized. Participants from United States site were part of the study. This was a 2-part study; however, study was terminated early due to portfolio strategic reason and only Part A was completed.

Participant milestones

Participant milestones
Measure	Session 1 Off-therapy MRI+Albiglutide Followed by Session 2 Participants underwent off-therapy MRI on Day 1 then received albiglutide 50 mg on Day 5 followed by exenatide matching placebo on Day 8 during Session 1. Post-dose MRI was conducted following exenatide placebo on Day 8 in session 1. There was a wash-out period of 6-9 weeks between the two sessions. In Session 2 participants received albiglutide matching placebo on Day 1 followed by 10 µg of exenatide on Day 4. Post-dose MRI was conducted following exenatide dose on Day 4 in session 2. Placebo was used to enable albiglutide and exenatide to be dosed at different times relative to MRI due to differences in Tmax, while preserving single-blind. Hence, post-exenatide placebo MRI served as the post-albiglutide MRI in this study, to preserve the study blinding and to allow albiglutide sufficient time to reach Tmax.	Session 1 Off-therapy MRI+Exenatide Followed by Session 2 Participants underwent off-therapy MRI on Day 1 then received albiglutide matching placebo on Day 5 followed by 10 µg of exenatide on Day 8 during Session 1. Post-dose MRI was conducted following exenatide dose on Day 8 in session 1. There was a wash-out period of 6-9 weeks between the two sessions. In Session 2 participants received albiglutide 50 mg on Day 1 followed by exenatide matching placebo on Day 4. Post-dose MRI was conducted following exenatide matching placebo dose on Day 4 in session 2. Placebo was used to enable albiglutide and exenatide to be dosed at different times relative to MRI due to differences in Tmax, while preserving single-blind. Hence, post-exenatide placebo MRI served as the post-albiglutide MRI in this study, to preserve the study blinding and to allow albiglutide sufficient time to reach Tmax.	Session1 Albiglutide Followed by Session2Off-therapy+Exenatide Participants received albiglutide 50 mg on Day 1 followed by exenatide matching placebo on Day 4 during Session 1. Post-dose MRI was conducted following exenatide placebo on Day 4 in session 1. There was a wash-out period of 6-9 weeks between the two sessions. In Session 2 participants underwent off-therapy MRI on Day 1 then received albiglutide matching placebo on Day 5 followed by 10 µg of exenatide on Day 8. Post-dose MRI was conducted following exenatide dose on Day 8 in session 2. Placebo was used to enable albiglutide and exenatide to be dosed at different times relative to MRI due to differences in Tmax, while preserving single-blind. Hence, post-exenatide placebo MRI served as the post-albiglutide MRI in this study, to preserve the study blinding and to allow albiglutide sufficient time to reach Tmax.	Session 1 Exenatide Followed by Session2 Off-therapy+Exenatide Participants received albiglutide matching placebo on Day 1 followed by 10 µg of exenatide on Day 4 during Session 1. Post-dose MRI was conducted following exenatide dose on Day 4 in session 1. There was a wash-out period of 6-9 weeks between the two sessions. In Session 2 participants underwent off-therapy MRI on Day 1 then received albiglutide 50 mg on Day 5 followed by exenatide matching placebo on Day 8. Post-dose MRI was conducted following exenatide matching placebo dose on Day 8 in session 2. Placebo was used to enable albiglutide and exenatide to be dosed at different times relative to MRI due to differences in Tmax, while preserving single-blind. Hence, post-exenatide placebo MRI served as the post-albiglutide MRI in this study, to preserve the study blinding and to allow albiglutide sufficient time to reach Tmax.
Session 1 (up to Day 8) STARTED	1	1	1	1
Session 1 (up to Day 8) COMPLETED	1	1	1	1
Session 1 (up to Day 8) NOT COMPLETED	0	0	0	0
Wash Out Period (up to Week 9) STARTED	1	1	1	1
Wash Out Period (up to Week 9) COMPLETED	1	1	1	1
Wash Out Period (up to Week 9) NOT COMPLETED	0	0	0	0
Session 2 (Up to Day 8) STARTED	1	1	1	1
Session 2 (Up to Day 8) COMPLETED	1	1	1	1
Session 2 (Up to Day 8) NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study Comparing the Effect of Albiglutide With Exenatide on Regional Brain Activity Related to Nausea in Healthy Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=4 Participants Participants received albiglutide 50 mg or exenatide 10 µg along with matching placebo post off-therapy MRI in a cross-over manner in Session 1 and 2. There was a wash-out period of 6-9 weeks between the two sessions.
Age, Continuous	28.8 Years STANDARD_DEVIATION 7.41 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Mixed Race	1 Participants n=5 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	1 Participants n=5 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Week 11

Population: All randomized Population (included participants who were randomized to receive study treatment, regardless of whether they took randomized study treatment). Imaging data were analyzed in Part A for only one participant who experienced nausea out of four study participants, and that, as a consequence, data cannot be summarized for Part A.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to Week 11

Population: All randomized Population. Imaging data were analyzed in Part A for only one participant who experienced nausea out of four study participants, and that, as a consequence, data cannot be summarized for Part A.

Pseudo-Continuous Arterial spin labeling (pCASL) data were planned to be analyzed to assess rCBF within the brain during using functional MRI scans. Quality control of imaging data were planned to be performed by visual inspection with adequate data denoted by mean rCBF values over the gray matter within a previously defined normal range (i.e., 40-60 millimeter \[mm\]/100 gram \[g\] tissue/ minute \[min\]). In addition, all data were planned to undergo motion and physiological noise correction. Placebo was used to enable albiglutide and exenatide to be dosed at different times relative to MRI due to differences in Tmax, while preserving single-blind (similar to double dummy), hence data was reported in albiglutide, exenatide and off-therapy arms only.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to Week 11

Glutamine/Glutamate (Glx) was planned to be analyzed using proton-density weighted magnetic resonance spectroscopy (1H-MRS). 1H-MRS analysis assessed regional differences in Glx concentrations, normalized as a ratio with creatine. MRS quantification of metabolites of interest were based on frequency domain analysis using a Linear Combination of Model spectra (LCModel). Cramer-Rao lower bounds (CRLBs), as reported from the LCModel analysis, were planned to be used to assess the reliability of the major metabolites and adequate Signal to noise ratio (SNR). CRLBs values less than 40% were further planned to be analyzed. Metabolite maps for each participant, and each session were planned to be calculated. Placebo was used to enable albiglutide and exenatide to be dosed at different times relative to MRI due to differences in Tmax, while preserving single-blind (similar to double dummy), hence data was reported in albiglutide, exenatide and off-therapy arms only.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to Week 11

GABA concentrations was planned to be analyzed using proton-density weighted 1H-MRS. 1H-MRS analysis assessed regional differences GABA concentrations, normalized as a ratio with creatine. MRS quantification of metabolites of interest were based on frequency domain analysis using a LC Model. CRLBs, as reported from the LC Model analysis, were planned to be used to assess the reliability of the major metabolites and adequate SNR. CRLBs values less than 40% were further planned to be analyzed. Metabolite maps for each participant, and each session were planned to be calculated. Placebo was used to enable albiglutide and exenatide to be dosed at different times relative to MRI due to differences in Tmax, while preserving single-blind (similar to double dummy), hence data was reported in albiglutide, exenatide and off-therapy arms only.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Week 11

Population: Safety Population. Imaging data were analyzed in Part A for only one participant who experienced nausea out of four study participants, and that, as a consequence, data cannot be summarized for Part A.

Heart rate variability was to be evaluated using autonomic response measure. All peripheral autonomic physiological signals were planned to be collected at 400 Hz using Chart Data Acquisition Software (ADInstruments) on a laptop equipped with a 16-channel Powerlab DAQ System (ADInstruments). Heart rate variability was to be reported as recorded by chart data acquisition software. Placebo was planned to be used to enable albiglutide and exenatide to be dosed at different times relative to MRI due to differences in Tmax, while preserving single-blind (similar to double dummy), hence data was reported in albiglutide, exenatide and off-therapy arms only.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Week 11

ECGs intervals were to be evaluated for the participant during the scanning session using autonomic response measures. ECG signal were planned to be collected with an MRI-compatible participant Monitoring system (Biopac 150, Biopac Systems Inc.) through MRI-compatible electrodes (VerMed, Bellows Falls) placed on the chest. Placebo was planned to be used to enable albiglutide and exenatide to be dosed at different times relative to MRI due to differences in Tmax, while preserving single-blind (similar to double dummy), hence data was reported in albiglutide, exenatide and off-therapy arms only.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Week 11

Number of participants with abnormal respiratory rate are reported during imaging session was to be evaluated using autonomic response measures. All peripheral autonomic physiological signals were planned to be collected at 400 Hz using Chart Data Acquisition Software (ADInstruments) on a laptop equipped with a 16-channel Powerlab DAQ System (ADInstruments). Placebo was planned to be used to enable albiglutide and exenatide to be dosed at different times relative to MRI due to differences in Tmax, while preserving single-blind (similar to double dummy), hence data was reported in albiglutide, exenatide and off-therapy arms only.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Week 11

Skin conductance level was to planned to be evaluated with MRI-compatible bipolar Silver (Ag)/Silver chloride (AgCl) finger electrodes placed on the palmar aspect of the second and fourth fingers of the non-dominant (left) hand, prior to the MRI session. All peripheral autonomic physiological signals were planned to be collected at 400 Hz using Chart Data Acquisition Software (ADInstruments) on a laptop equipped with a 16-channel Powerlab DAQ System (ADInstruments). Placebo was planned to be used to enable albiglutide and exenatide to be dosed at different times relative to MRI due to differences in Tmax, while preserving single-blind (similar to double dummy), hence data was reported in albiglutide, exenatide and off-therapy arms only.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1: pre-MRI, 0.5 hour post-MRI; Day 4: -2 hours pre-MRI, 0.5 and 1 hour post MRI; Day 5; Day 8: -2 hour pre-MRI, 0.5 and 1 hour post-MRI

Population: Safety Population. Only participants present at specific time points were analyzed. Placebo was planned to be used to enable albiglutide and exenatide to be dosed at different times relative to MRI due to differences in Tmax, for preserving single-blind (like double dummy), hence data was reported in albiglutide, exenatide and off-therapy arms only

Data of participants with abnormal heart rate (measured during site visits by sphygmomanometer) were reported. Participants with low and high heart rate has been presented. Potential clinical concern value for heart rate is \< 50 beats per minute to \> 120 beats per minute. Safety Population comprised of all participants who received at least one dose of the study treatment.

Outcome measures

Outcome measures
Measure	Albiglutide 50 mg n=2 Participants Participants received albiglutide 50 mg on Day 5 and exenatide placebo on Day 8 or albiglutide 50 mg on Day 1 and exenatide placebo on Day 4 during session 1 or 2 as per randomization. The timing of the albiglutide dose and post-dose MRI were based on the Tmax of albiglutide. Hence, the Day 4 and Day 8 post dose MRI served as the post-albiglutide dose MRI in this study and the exenatide placebo served to preserve the study blinding.	Exenatide 10 µg n=2 Participants Participants received albiglutide matching placebo on Day 5 and exenatide 10 μg on Day 8 or albiglutide matching placebo on Day 1 and exenatide 10 μg on Day 4 during session 1 or 2 as per randomization schedule. The timing of the exenatide dose and post-dose MRI were based on the Tmax of exentatide. Hence, the Day 4 and Day 8 post dose MRI served as the post exenatide dose MRI and the albiglutide matching placebo served to preserve the study blind.	Off-therapy MRI n=2 Participants Participants underwent off-therapy MRI. Off-therapy scans served as natural history scan with a 6-9 week washout period between the dosing scans.	Off-therapy Visit n=2 Participants Participants had out-patient visit on Day 5 for assessment of vital signs. They did not undergo MRI on off-therapy visit on Day 5.
Number of Participants With Abnormal Heart Rate for Session 1 Day 1, Pre MRI, high, n=0, 0, 2, 0	—	—	0 Participants	—
Number of Participants With Abnormal Heart Rate for Session 1 Day 1, Pre MRI, low, n=0, 0, 2, 0	—	—	0 Participants	—
Number of Participants With Abnormal Heart Rate for Session 1 Day 1, Post MRI 0.5 hr, high, n=0, 0, 2, 0	—	—	0 Participants	—
Number of Participants With Abnormal Heart Rate for Session 1 Day 1, Post MRI 0.5 hr, low, n=0, 0, 2, 0	—	—	0 Participants	—
Number of Participants With Abnormal Heart Rate for Session 1 Day 4, -2 hr pre-MRI, high, n=1, 1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal Heart Rate for Session 1 Day 4, -2 hr pre-MRI, low, n=1, 1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal Heart Rate for Session 1 Day 4, Post MRI 0.5 hr, high, n=1, 1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal Heart Rate for Session 1 Day 4, 0.5 hr Post MRI, low, n=1, 1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal Heart Rate for Session 1 Day 4, 1 hr Post MRI, high, n=1, 1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal Heart Rate for Session 1 Day 4, 1 hr Post MRI, low, n=1, 1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal Heart Rate for Session 1 Day 5, high, n=0, 0, 0, 2	—	—	—	0 Participants
Number of Participants With Abnormal Heart Rate for Session 1 Day 5, low, n=0, 0, 0, 2	—	—	—	0 Participants
Number of Participants With Abnormal Heart Rate for Session 1 Day 8, -2 hr pre-MRI, high, n=1, 1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal Heart Rate for Session 1 Day 8, -2 hr pre-MRI, low, n=1, 1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal Heart Rate for Session 1 Day 8, 0.5 hr Post MRI, high, n=1, 1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal Heart Rate for Session 1 Day 8, 0.5 hr Post MRI, low, n=1, 1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal Heart Rate for Session 1 Day 8, 1 hr Post MRI, high, n=0, 1, 0, 0	—	0 Participants	—	—
Number of Participants With Abnormal Heart Rate for Session 1 Day 8, 1 hr Post MRI, low, n=0, 1, 0, 0	—	0 Participants	—	—

SECONDARY outcome

Timeframe: Day 1: pre-MRI, 0.5 hour post-MRI; Day 4: -2 hours pre-MRI, 0.5 and 1 hour post MRI; Day 5; Day 8: -2 hour pre-MRI, 0.5 and 1 hour post-MRI

Outcome measures

Outcome measures
Measure	Albiglutide 50 mg n=2 Participants Participants received albiglutide 50 mg on Day 5 and exenatide placebo on Day 8 or albiglutide 50 mg on Day 1 and exenatide placebo on Day 4 during session 1 or 2 as per randomization. The timing of the albiglutide dose and post-dose MRI were based on the Tmax of albiglutide. Hence, the Day 4 and Day 8 post dose MRI served as the post-albiglutide dose MRI in this study and the exenatide placebo served to preserve the study blinding.	Exenatide 10 µg n=2 Participants Participants received albiglutide matching placebo on Day 5 and exenatide 10 μg on Day 8 or albiglutide matching placebo on Day 1 and exenatide 10 μg on Day 4 during session 1 or 2 as per randomization schedule. The timing of the exenatide dose and post-dose MRI were based on the Tmax of exentatide. Hence, the Day 4 and Day 8 post dose MRI served as the post exenatide dose MRI and the albiglutide matching placebo served to preserve the study blind.	Off-therapy MRI n=2 Participants Participants underwent off-therapy MRI. Off-therapy scans served as natural history scan with a 6-9 week washout period between the dosing scans.	Off-therapy Visit n=2 Participants Participants had out-patient visit on Day 5 for assessment of vital signs. They did not undergo MRI on off-therapy visit on Day 5.
Number of Participants With Abnormal Heart Rate for Session 2 Day 1, Pre MRI, high, n=0, 0, 2, 0	—	—	0 Participants	—
Number of Participants With Abnormal Heart Rate for Session 2 Day 1, Pre MRI, low, n=0, 0, 2, 0	—	—	0 Participants	—
Number of Participants With Abnormal Heart Rate for Session 2 Day 1, Post MRI 0.5 hr, high, n=0, 0, 2, 0	—	—	0 Participants	—
Number of Participants With Abnormal Heart Rate for Session 2 Day 1, Post MRI 0.5 hr, low, n=0, 0, 2, 0	—	—	0 Participants	—
Number of Participants With Abnormal Heart Rate for Session 2 Day 4, -2 hr pre-MRI, high, n=1, 1,0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal Heart Rate for Session 2 Day 4, -2 hr pre-MRI, low, n=1, 1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal Heart Rate for Session 2 Day 4, Post MRI 0.5 hr, high, n=1, 1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal Heart Rate for Session 2 Day 4, 0.5 hr Post MRI, low, n=1, 1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal Heart Rate for Session 2 Day 4, 1 hr Post MRI, high, n=1, 1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal Heart Rate for Session 2 Day 4, 1 hr Post MRI, low, n=1, 1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal Heart Rate for Session 2 Day 5, high, n=0, 0, 0, 2	—	—	—	0 Participants
Number of Participants With Abnormal Heart Rate for Session 2 Day 5, low, n=0, 0, 0, 2	—	—	—	0 Participants
Number of Participants With Abnormal Heart Rate for Session 2 Day 8, -2 hr pre-MRI, high, n=1, 1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal Heart Rate for Session 2 Day 8, -2 hr pre-MRI, low, n=1, 1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal Heart Rate for Session 2 Day 8, 0.5 hr Post MRI, high, n=1, 1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal Heart Rate for Session 2 Day 8, 0.5 hr Post MRI, low, n=1, 1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal Heart Rate for Session 2 Day 8, 1 hr Post MRI, high, n=0, 1, 0, 0	—	0 Participants	—	—
Number of Participants With Abnormal Heart Rate for Session 2 Day 8, 1 hr Post MRI, low, n=0, 1, 0, 0	—	0 Participants	—	—

SECONDARY outcome

Timeframe: Day 1: pre-MRI, 0.5 hour post-MRI; Day 4: -2 hours pre-MRI, 0.5 and 1 hour post MRI; Day 5; Day 8: 0.5 and 1 hour post-MRI

SBP and DBP were measured in supine position after 5 minutes rest. Data for Session 1 and 2 and for Pre and Post MRI has been presented. Potential clinical concern value for SBP is \<100 millimeters of mercury (mmHg) and \>170 mmHg. Potential clinical concern value for DBP is \<50 mmHg and \>110 mmHg.

Outcome measures

Outcome measures
Measure	Albiglutide 50 mg n=2 Participants Participants received albiglutide 50 mg on Day 5 and exenatide placebo on Day 8 or albiglutide 50 mg on Day 1 and exenatide placebo on Day 4 during session 1 or 2 as per randomization. The timing of the albiglutide dose and post-dose MRI were based on the Tmax of albiglutide. Hence, the Day 4 and Day 8 post dose MRI served as the post-albiglutide dose MRI in this study and the exenatide placebo served to preserve the study blinding.	Exenatide 10 µg n=2 Participants Participants received albiglutide matching placebo on Day 5 and exenatide 10 μg on Day 8 or albiglutide matching placebo on Day 1 and exenatide 10 μg on Day 4 during session 1 or 2 as per randomization schedule. The timing of the exenatide dose and post-dose MRI were based on the Tmax of exentatide. Hence, the Day 4 and Day 8 post dose MRI served as the post exenatide dose MRI and the albiglutide matching placebo served to preserve the study blind.	Off-therapy MRI n=2 Participants Participants underwent off-therapy MRI. Off-therapy scans served as natural history scan with a 6-9 week washout period between the dosing scans.	Off-therapy Visit n=2 Participants Participants had out-patient visit on Day 5 for assessment of vital signs. They did not undergo MRI on off-therapy visit on Day 5.
Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Session 1 SBP, Day 1, Pre-MRI, high, n=0, 0, 2, 0	—	—	0 Participants	—
Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Session 1 SBP, Day 1, Pre-MRI, low, n=0, 0, 2, 0	—	—	0 Participants	—
Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Session 1 SBP, Day 1, 0.5 hr post MRI, high, n=0, 0, 2, 0	—	—	0 Participants	—
Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Session 1 SBP, Day 1,0.5 hr post MRI , low, n=0, 0, 2, 0	—	—	0 Participants	—
Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Session 1 SBP, Day 4,-2 hr pre-MRI, high, n=1,1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Session 1 SBP, Day 4,-2 hr pre-MRI, low, n=1,1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Session 1 SBP, Day 4,0.5 hr post MRI , high, n=1,1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Session 1 SBP, Day 4,0.5 hr post MRI, low, n=1,1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Session 1 SBP, Day 4,1 hr post MRI , high, n=1,1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Session 1 SBP, Day 4,1 hr post MRI , low, n=1,1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Session 1 SBP, Day 5, high, n=0, 0, 0, 2	—	—	—	0 Participants
Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Session 1 SBP, Day 5, low, n=0, 0, 0, 2	—	—	—	0 Participants
Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Session 1 SBP, Day 8,0.5 hr Post MRI, high, n=1,1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Session 1 SBP, Day 8,0.5 hr Post MRI, low, n=1,1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Session 1 SBP, Day 8,1 hr Post MRI, high, n= 0,1, 0, 0	—	0 Participants	—	—
Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Session 1 SBP, Day 8,1 hr post MRI , low, n= 0,1, 0, 0	—	0 Participants	—	—
Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Session 1 DBP, Day 1, Pre MRI, high,n= 0,0, 2, 0	—	—	0 Participants	—
Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Session 1 DBP, Day 1, Pre MRI, low,n= 0, 0, 2, 0	—	—	0 Participants	—
Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Session 1 DBP, Day 1,0.5 hr post MRI, high,n= 0, 0, 2, 0	—	—	0 Participants	—
Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Session 1 DBP, Day 1,0.5 hr post MRI, low,n= 0, 0, 2, 0	—	—	0 Participants	—
Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Session 1 DBP, Day 4,-2 hr pre-MRI, high, n=1,1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Session 1 DBP, Day 4,-2 hr pre-MRI, low, n=1,1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Session 1 DBP, Day 4,0.5 hr Post MRI, high,n= 1,1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Session 1 DBP, Day 4,0.5 hr Post MRI, low,n= 1,1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Session 1 DBP, Day 4,1 hr post MRI, high,n= 1,1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Session 1 DBP, Day 4,1 hr post MRI , low,n= 1,1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Session 1 DBP, Day 5, high, n= 0,0,0,2	—	—	—	0 Participants
Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Session 1 DBP, Day 5, low, n= 0,0,0,2	—	—	—	0 Participants
Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Session 1 DBP, Day 8, 0.5 hr post MRI ,high, n=1,1,0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Session 1 DBP, Day 8, 0.5 hr post MRI, low, n= 1,1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Session 1 DBP, Day 8, 1 hr post MRI, high, n=0,1, 0, 0	—	0 Participants	—	—
Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Session 1 DBP, Day 8, 1 hr post MRI, low, n=0,1, 0, 0	—	0 Participants	—	—

SECONDARY outcome

Timeframe: Day 1: pre-MRI, 0.5 hour post-MRI; Day 4: -2 hours pre-MRI, 0.5 and 1 hour post MRI; Day 5; Day 8: 0.5 and 1 hour post-MRI

Outcome measures

Outcome measures
Measure	Albiglutide 50 mg n=2 Participants Participants received albiglutide 50 mg on Day 5 and exenatide placebo on Day 8 or albiglutide 50 mg on Day 1 and exenatide placebo on Day 4 during session 1 or 2 as per randomization. The timing of the albiglutide dose and post-dose MRI were based on the Tmax of albiglutide. Hence, the Day 4 and Day 8 post dose MRI served as the post-albiglutide dose MRI in this study and the exenatide placebo served to preserve the study blinding.	Exenatide 10 µg n=2 Participants Participants received albiglutide matching placebo on Day 5 and exenatide 10 μg on Day 8 or albiglutide matching placebo on Day 1 and exenatide 10 μg on Day 4 during session 1 or 2 as per randomization schedule. The timing of the exenatide dose and post-dose MRI were based on the Tmax of exentatide. Hence, the Day 4 and Day 8 post dose MRI served as the post exenatide dose MRI and the albiglutide matching placebo served to preserve the study blind.	Off-therapy MRI n=2 Participants Participants underwent off-therapy MRI. Off-therapy scans served as natural history scan with a 6-9 week washout period between the dosing scans.	Off-therapy Visit n=2 Participants Participants had out-patient visit on Day 5 for assessment of vital signs. They did not undergo MRI on off-therapy visit on Day 5.
Number of Participants With Abnormal SBP and DBP for Session 2 DBP, Day 4,1 hr post MRI, high,n= 1,1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal SBP and DBP for Session 2 DBP, Day 4,1 hr post MRI , low,n= 1,1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal SBP and DBP for Session 2 DBP, Day 5, high, n= 0,0,0,2	—	—	—	0 Participants
Number of Participants With Abnormal SBP and DBP for Session 2 DBP, Day 5, low, n= 0,0,0,2	—	—	—	0 Participants
Number of Participants With Abnormal SBP and DBP for Session 2 DBP, Day 8, 0.5 hr post MRI ,high, n=1,1,0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal SBP and DBP for Session 2 DBP, Day 8, 0.5 hr post MRI, low, n= 1,1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal SBP and DBP for Session 2 DBP, Day 8, 1 hr post MRI, high, n=0,1, 0, 0	—	0 Participants	—	—
Number of Participants With Abnormal SBP and DBP for Session 2 DBP, Day 8, 1 hr post MRI, low, n=0,1, 0, 0	—	0 Participants	—	—
Number of Participants With Abnormal SBP and DBP for Session 2 SBP, Day 1, Pre-MRI, high, n=0, 0, 2, 0	—	—	0 Participants	—
Number of Participants With Abnormal SBP and DBP for Session 2 SBP, Day 1, Pre-MRI, low, n=0, 0, 2, 0	—	—	0 Participants	—
Number of Participants With Abnormal SBP and DBP for Session 2 SBP, Day 1, 0.5 hr post MRI, high, n=0, 0, 2, 0	—	—	0 Participants	—
Number of Participants With Abnormal SBP and DBP for Session 2 SBP, Day 1,0.5 hr post MRI , low, n=0, 0, 2, 0	—	—	0 Participants	—
Number of Participants With Abnormal SBP and DBP for Session 2 SBP, Day 4,-2 hr pre-MRI, high, n=1,1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal SBP and DBP for Session 2 SBP, Day 4,-2 hr pre-MRI, low, n=1,1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal SBP and DBP for Session 2 SBP, Day 4,0.5 hr post MRI , high, n=1,1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal SBP and DBP for Session 2 SBP, Day 4,0.5 hr post MRI, low, n=1,1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal SBP and DBP for Session 2 SBP, Day 4,1 hr post MRI , high, n=1,1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal SBP and DBP for Session 2 SBP, Day 4,1 hr post MRI , low, n=1,1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal SBP and DBP for Session 2 SBP, Day 5, high, n=0, 0, 0, 2	—	—	—	0 Participants
Number of Participants With Abnormal SBP and DBP for Session 2 SBP, Day 5, low, n=0, 0, 0, 2	—	—	—	0 Participants
Number of Participants With Abnormal SBP and DBP for Session 2 SBP, Day 8,0.5 hr Post MRI, high, n=1,1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal SBP and DBP for Session 2 SBP, Day 8,0.5 hr Post MRI, low, n=1,1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal SBP and DBP for Session 2 SBP, Day 8,1 hr Post MRI, high, n= 0,1, 0, 0	—	0 Participants	—	—
Number of Participants With Abnormal SBP and DBP for Session 2 SBP, Day 8,1 hr post MRI , low, n= 0,1, 0, 0	—	0 Participants	—	—
Number of Participants With Abnormal SBP and DBP for Session 2 DBP, Day 1, Pre MRI, high,n= 0, 0, 2, 0	—	—	0 Participants	—
Number of Participants With Abnormal SBP and DBP for Session 2 DBP, Day 1, Pre MRI, low,n= 0, 0, 2, 0	—	—	0 Participants	—
Number of Participants With Abnormal SBP and DBP for Session 2 DBP, Day 1,0.5 hr post MRI, high,n= 0, 0, 2, 0	—	—	1 Participants	—
Number of Participants With Abnormal SBP and DBP for Session 2 DBP, Day 1,0.5 hr post MRI, low,n= 0, 0, 2, 0	—	—	0 Participants	—
Number of Participants With Abnormal SBP and DBP for Session 2 DBP, Day 4,-2 hr pre-MRI, high, n=1,1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal SBP and DBP for Session 2 DBP, Day 4,-2 hr pre-MRI, low, n=1,1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal SBP and DBP for Session 2 DBP, Day 4,0.5 hr Post MRI, high,n= 1,1, 0, 0	0 Participants	0 Participants	—	—
Number of Participants With Abnormal SBP and DBP for Session 2 DBP, Day 4,0.5 hr Post MRI, low,n= 1,1, 0, 0	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Up to Week 11

Population: Safety Population. The data was reported in cumulative format as placebo was included to maintain the single blind only; similar to double dummy.

Clinical chemistry parameters included assessment of blood urea nitrogen (BUN), creatinine, epidermal growth factor receptor (eGRF), potassium, sodium, calcium, Aspartate transaminase (AST), Alanine transaminase (AST), Alkaline phosphatase, total and direct bilirubin, total protein and albumin.

Outcome measures

Outcome measures
Measure	Albiglutide 50 mg n=4 Participants Participants received albiglutide 50 mg on Day 5 and exenatide placebo on Day 8 or albiglutide 50 mg on Day 1 and exenatide placebo on Day 4 during session 1 or 2 as per randomization. The timing of the albiglutide dose and post-dose MRI were based on the Tmax of albiglutide. Hence, the Day 4 and Day 8 post dose MRI served as the post-albiglutide dose MRI in this study and the exenatide placebo served to preserve the study blinding.	Exenatide 10 µg n=4 Participants Participants received albiglutide matching placebo on Day 5 and exenatide 10 μg on Day 8 or albiglutide matching placebo on Day 1 and exenatide 10 μg on Day 4 during session 1 or 2 as per randomization schedule. The timing of the exenatide dose and post-dose MRI were based on the Tmax of exentatide. Hence, the Day 4 and Day 8 post dose MRI served as the post exenatide dose MRI and the albiglutide matching placebo served to preserve the study blind.	Off-therapy MRI Participants underwent off-therapy MRI. Off-therapy scans served as natural history scan with a 6-9 week washout period between the dosing scans.	Off-therapy Visit Participants had out-patient visit on Day 5 for assessment of vital signs. They did not undergo MRI on off-therapy visit on Day 5.
Number of Participants With Abnormal Clinical Chemistry Parameters	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Up to Week 11

Population: Safety Population. The data was reported in cumulative format as placebo was included to maintain the single blind only; similar to double dummy.

Hematology parameters included assessment of platelet count, red blood cell (RBC) count, hemoglobin, hemotocrit, RBC indices including mean corpuscular volume and mean corpuscular hemoglobin (MCH), and White blood cells (WBC) count with differential count including, neutrophils, lymphocytes, monocytes, eosinophils and basophils.

Outcome measures

Outcome measures
Measure	Albiglutide 50 mg n=4 Participants Participants received albiglutide 50 mg on Day 5 and exenatide placebo on Day 8 or albiglutide 50 mg on Day 1 and exenatide placebo on Day 4 during session 1 or 2 as per randomization. The timing of the albiglutide dose and post-dose MRI were based on the Tmax of albiglutide. Hence, the Day 4 and Day 8 post dose MRI served as the post-albiglutide dose MRI in this study and the exenatide placebo served to preserve the study blinding.	Exenatide 10 µg n=4 Participants Participants received albiglutide matching placebo on Day 5 and exenatide 10 μg on Day 8 or albiglutide matching placebo on Day 1 and exenatide 10 μg on Day 4 during session 1 or 2 as per randomization schedule. The timing of the exenatide dose and post-dose MRI were based on the Tmax of exentatide. Hence, the Day 4 and Day 8 post dose MRI served as the post exenatide dose MRI and the albiglutide matching placebo served to preserve the study blind.	Off-therapy MRI Participants underwent off-therapy MRI. Off-therapy scans served as natural history scan with a 6-9 week washout period between the dosing scans.	Off-therapy Visit Participants had out-patient visit on Day 5 for assessment of vital signs. They did not undergo MRI on off-therapy visit on Day 5.
Number of Participants With Abnormal Hematology Parameters	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Up to Week 11

Population: Safety Population. The data was reported in cumulative format as placebo was included to maintain the single blind only; similar to double dummy.

Urinalysis parameters included assessment of specific gravity, microscopic analysis, and potential of hydrogen (pH), glucose, protein, blood and ketones by dipstick method.

Outcome measures

Outcome measures
Measure	Albiglutide 50 mg n=4 Participants Participants received albiglutide 50 mg on Day 5 and exenatide placebo on Day 8 or albiglutide 50 mg on Day 1 and exenatide placebo on Day 4 during session 1 or 2 as per randomization. The timing of the albiglutide dose and post-dose MRI were based on the Tmax of albiglutide. Hence, the Day 4 and Day 8 post dose MRI served as the post-albiglutide dose MRI in this study and the exenatide placebo served to preserve the study blinding.	Exenatide 10 µg n=4 Participants Participants received albiglutide matching placebo on Day 5 and exenatide 10 μg on Day 8 or albiglutide matching placebo on Day 1 and exenatide 10 μg on Day 4 during session 1 or 2 as per randomization schedule. The timing of the exenatide dose and post-dose MRI were based on the Tmax of exentatide. Hence, the Day 4 and Day 8 post dose MRI served as the post exenatide dose MRI and the albiglutide matching placebo served to preserve the study blind.	Off-therapy MRI Participants underwent off-therapy MRI. Off-therapy scans served as natural history scan with a 6-9 week washout period between the dosing scans.	Off-therapy Visit Participants had out-patient visit on Day 5 for assessment of vital signs. They did not undergo MRI on off-therapy visit on Day 5.
Number of Participants With Abnormal Urinalysis	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Up to Week 11

Population: Safety Population.The data was reported in cumulative format as placebo was included to maintain the single blind only; similar to double dummy.

Glycemic parameters included assessment of capillary blood glucose and fasting plasma glucose.

Outcome measures

Outcome measures
Measure	Albiglutide 50 mg n=4 Participants Participants received albiglutide 50 mg on Day 5 and exenatide placebo on Day 8 or albiglutide 50 mg on Day 1 and exenatide placebo on Day 4 during session 1 or 2 as per randomization. The timing of the albiglutide dose and post-dose MRI were based on the Tmax of albiglutide. Hence, the Day 4 and Day 8 post dose MRI served as the post-albiglutide dose MRI in this study and the exenatide placebo served to preserve the study blinding.	Exenatide 10 µg n=4 Participants Participants received albiglutide matching placebo on Day 5 and exenatide 10 μg on Day 8 or albiglutide matching placebo on Day 1 and exenatide 10 μg on Day 4 during session 1 or 2 as per randomization schedule. The timing of the exenatide dose and post-dose MRI were based on the Tmax of exentatide. Hence, the Day 4 and Day 8 post dose MRI served as the post exenatide dose MRI and the albiglutide matching placebo served to preserve the study blind.	Off-therapy MRI Participants underwent off-therapy MRI. Off-therapy scans served as natural history scan with a 6-9 week washout period between the dosing scans.	Off-therapy Visit Participants had out-patient visit on Day 5 for assessment of vital signs. They did not undergo MRI on off-therapy visit on Day 5.
Number of Participants With Abnormal Glycemic Parameters	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Up to Week 13

Population: Safety Population.

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment were categorized as SAE. Data of participants with non-serious AEs ( with incidence \>= 2%) and SAEs has been presented. Placebo was included to maintain the single blind only; similar to double dummy.

Outcome measures

Outcome measures
Measure	Albiglutide 50 mg n=4 Participants Participants received albiglutide 50 mg on Day 5 and exenatide placebo on Day 8 or albiglutide 50 mg on Day 1 and exenatide placebo on Day 4 during session 1 or 2 as per randomization. The timing of the albiglutide dose and post-dose MRI were based on the Tmax of albiglutide. Hence, the Day 4 and Day 8 post dose MRI served as the post-albiglutide dose MRI in this study and the exenatide placebo served to preserve the study blinding.	Exenatide 10 µg n=4 Participants Participants received albiglutide matching placebo on Day 5 and exenatide 10 μg on Day 8 or albiglutide matching placebo on Day 1 and exenatide 10 μg on Day 4 during session 1 or 2 as per randomization schedule. The timing of the exenatide dose and post-dose MRI were based on the Tmax of exentatide. Hence, the Day 4 and Day 8 post dose MRI served as the post exenatide dose MRI and the albiglutide matching placebo served to preserve the study blind.	Off-therapy MRI n=4 Participants Participants underwent off-therapy MRI. Off-therapy scans served as natural history scan with a 6-9 week washout period between the dosing scans.	Off-therapy Visit n=4 Participants Participants had out-patient visit on Day 5 for assessment of vital signs. They did not undergo MRI on off-therapy visit on Day 5.
Number of Participants With Non-serious Adverse Events (AE) With Incidence > = 2 % and Serious AEs (SAE) Non-serious AEs	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Non-serious Adverse Events (AE) With Incidence > = 2 % and Serious AEs (SAE) SAE	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 11

Nausea ratings were planned to be collected during motion sickness provocation using a 0-4 numerical rating scale (NRS), where 1 is rated as minimal nausea experienced and 4 as severe nausea was experienced. Participants were asked to press buttons on a MRI compatible button-box to rate nausea from 0 to 4. Placebo was planned to be used to enable albiglutide and exenatide to be dosed at different times relative to MRI due to differences in Tmax, while preserving single-blind (similar to double dummy), hence data was reported in albiglutide, exenatide and off-therapy arms only.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 (Pre-MRI and 0.5 hour post-MRI); Day 4 (Pre-MRI and 0.5 hour post-MRI); and Day 8 (Pre-MRI and 0.5 hour post-MRI)

Participant completed VAS to record their perception of stomach fullness, hunger, nausea, bloating and abdominal pain. The VAS was represented by lines, 100 millimeter in length, anchored with words describing the most negative rating on the left and the most positive rating on the right. Scores ranged from 0 mm to 100 mm. Scores of 0 mm are worst (most negative rating on the left) and scores of 100 mm are best (most positive rating on the right). NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.

Outcome measures

SECONDARY outcome

Timeframe: Day 1 (Pre-MRI and 0.5 hour post-MRI); Day 4 (Pre-MRI and 0.5 hour post-MRI); and Day 8 (Pre-MRI and 0.5 hour post-MRI)

Outcome measures

SECONDARY outcome

Timeframe: Day 1 0.5 hour post-MRI; Day 4 0.5 hour post-MRI; and Day 8 0.5 hour post-MRI

Participant completed MSAQ to quantify the severity of different dimensions of nausea induced by motion sickness. There were total 16 items: 4 related to gastro-intestinal (GI), 5 related to central (C), 3 related to peripheral (P) and 4 related to sopite-related (SR). All items were scored individually on a scale of 1-9 where 1 means 'not at all severe' and 9 means 'severe', with higher score indicates more severity. Individual 16 items with their scores are presented. NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.

Outcome measures

SECONDARY outcome

Timeframe: Day 1 0.5 hour post-MRI; Day 4 0.5 hour post-MRI; and Day 8 0.5 hour post-MRI

Outcome measures

Adverse Events

Albiglutide 50 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Exenatide 10 µg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Albiglutide Matching Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Exenatide Matching Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Albiglutide 50 mg n=4 participants at risk Participants received albiglutide 50 mg on Day 5 and exenatide placebo on Day 8 or albiglutide 50 mg on Day 1 and exenatide placebo on Day 4 during session 1 or 2 as per randomization. The timing of the albiglutide dose and post-dose MRI were based on the Tmax of albiglutide. Hence, the Day 4 and Day 8 post dose MRI served as the post-albiglutide dose MRI in this study and the exenatide placebo served to preserve the study blinding.	Exenatide 10 µg n=4 participants at risk Participants received albiglutide matching placebo on Day 5 and exenatide 10 μg on Day 8 or albiglutide matching placebo on Day 1 and exenatide 10 μg on Day 4 during session 1 or 2 as per randomization schedule. The timing of the exenatide dose and post-dose MRI were based on the Tmax of exentatide. Hence, the Day 4 and Day 8 post dose MRI served as the post exenatide dose MRI and the albiglutide matching placebo served to preserve the study blind.	Albiglutide Matching Placebo n=4 participants at risk Participants in Session 1 received albiglutide matching placebo on Day 1 and during Session 2 participants received albiglutide matching placebo on Day 5. There was a wash-out period of 6-9 weeks between the two sessions.	Exenatide Matching Placebo n=4 participants at risk Participants in Session 1 received exenatide matching placebo on Day 4 and during Session 2 participants received exenatide matching placebo on Day 8. There was a wash-out period of 6-9 weeks between the two sessions.
Gastrointestinal disorders Nausea	25.0% 1/4 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment up to Week 13. SAEs and Non-serious AEs for participants of Safety Population were reported. AEs data was reported per Intervention.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment up to Week 13. SAEs and Non-serious AEs for participants of Safety Population were reported. AEs data was reported per Intervention.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment up to Week 13. SAEs and Non-serious AEs for participants of Safety Population were reported. AEs data was reported per Intervention.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment up to Week 13. SAEs and Non-serious AEs for participants of Safety Population were reported. AEs data was reported per Intervention.
Infections and infestations Nasopharyngitis	25.0% 1/4 • Number of events 1 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment up to Week 13. SAEs and Non-serious AEs for participants of Safety Population were reported. AEs data was reported per Intervention.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment up to Week 13. SAEs and Non-serious AEs for participants of Safety Population were reported. AEs data was reported per Intervention.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment up to Week 13. SAEs and Non-serious AEs for participants of Safety Population were reported. AEs data was reported per Intervention.	0.00% 0/4 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment up to Week 13. SAEs and Non-serious AEs for participants of Safety Population were reported. AEs data was reported per Intervention.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	Albiglutide 50 mg n=2 Participants Participants received albiglutide 50 mg on Day 5 and exenatide placebo on Day 8 or albiglutide 50 mg on Day 1 and exenatide placebo on Day 4 during session 1 or 2 as per randomization. The timing of the albiglutide dose and post-dose MRI were based on the Tmax of albiglutide. Hence, the Day 4 and Day 8 post dose MRI served as the post-albiglutide dose MRI in this study and the exenatide placebo served to preserve the study blinding.	Exenatide 10 µg n=2 Participants Participants received albiglutide matching placebo on Day 5 and exenatide 10 μg on Day 8 or albiglutide matching placebo on Day 1 and exenatide 10 μg on Day 4 during session 1 or 2 as per randomization schedule. The timing of the exenatide dose and post-dose MRI were based on the Tmax of exentatide. Hence, the Day 4 and Day 8 post dose MRI served as the post exenatide dose MRI and the albiglutide matching placebo served to preserve the study blind.	Off-therapy MRI n=2 Participants Participants underwent off-therapy MRI. Off-therapy scans served as natural history scan with a 6-9 week washout period between the dosing scans.	Off-therapy Visit Participants had out-patient visit on Day 5 for assessment of vital signs. They did not undergo MRI on off-therapy visit on Day 5.
Gastrointestinal (GI) Visual Analogue Scale (VAS) for Assessment of Nausea for Session 1 Stomach fullness, Day1, pre-MRI,n=0,0,2	—	—	9.0 Scores on scale Standard Deviation 9.90	—
Gastrointestinal (GI) Visual Analogue Scale (VAS) for Assessment of Nausea for Session 1 Hunger, Day4, pre-MRI,n=1,1,0	65.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	40.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Gastrointestinal (GI) Visual Analogue Scale (VAS) for Assessment of Nausea for Session 1 Hunger, Day4, 0.5 hour post-MRI,n=1,1,0	66.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	50.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Gastrointestinal (GI) Visual Analogue Scale (VAS) for Assessment of Nausea for Session 1 Hunger, Day8, pre-MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	25.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Gastrointestinal (GI) Visual Analogue Scale (VAS) for Assessment of Nausea for Session 1 Hunger, Day8, 0.5 hour post-MRI,n=1,1,0	31.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	26.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Gastrointestinal (GI) Visual Analogue Scale (VAS) for Assessment of Nausea for Session 1 Stomach fullness, Day1, 0.5 hour post-MRI,n=0,0,2	—	—	0.5 Scores on scale Standard Deviation 0.71	—
Gastrointestinal (GI) Visual Analogue Scale (VAS) for Assessment of Nausea for Session 1 Stomach fullness, Day4,pre-MRI,n=1,1,0	3.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Gastrointestinal (GI) Visual Analogue Scale (VAS) for Assessment of Nausea for Session 1 Stomach fullness, Day4, 0.5 hour post-MRI,n=1,1,0	6.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	2.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Gastrointestinal (GI) Visual Analogue Scale (VAS) for Assessment of Nausea for Session 1 Stomach fullness, Day8, pre-MRI,n=1,1,0	0.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Gastrointestinal (GI) Visual Analogue Scale (VAS) for Assessment of Nausea for Session 1 Stomach fullness, Day8, 0.5 hour post- MRI,n=1,1,0	0.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Gastrointestinal (GI) Visual Analogue Scale (VAS) for Assessment of Nausea for Session 1 Nausea, Day1, pre- MRI,n=0,0,2	—	—	1.0 Scores on scale Standard Deviation 1.41	—
Gastrointestinal (GI) Visual Analogue Scale (VAS) for Assessment of Nausea for Session 1 Nausea, Day1,0.5 hour post-MRI,n=0,0,2	—	—	19.0 Scores on scale Standard Deviation 25.46	—
Gastrointestinal (GI) Visual Analogue Scale (VAS) for Assessment of Nausea for Session 1 Nausea, Day4, pre-MRI,n=1,1,0	3.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Gastrointestinal (GI) Visual Analogue Scale (VAS) for Assessment of Nausea for Session 1 Nausea, Day4, 0.5 hour post-MRI,n=1,1,0	24.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Gastrointestinal (GI) Visual Analogue Scale (VAS) for Assessment of Nausea for Session 1 Nausea, Day8, pre-MRI,n=1,1,0	0.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	0.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Gastrointestinal (GI) Visual Analogue Scale (VAS) for Assessment of Nausea for Session 1 Nausea, Day8,0.5 hour post-MRI,n=1,1,0	0.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Gastrointestinal (GI) Visual Analogue Scale (VAS) for Assessment of Nausea for Session 1 Bloating, Day1, pre-MRI,n=0,0,2	—	—	1.5 Scores on scale Standard Deviation 0.71	—
Gastrointestinal (GI) Visual Analogue Scale (VAS) for Assessment of Nausea for Session 1 Bloating, Day1, 0.5 hour post-MRI,n=0,0,2	—	—	1.0 Scores on scale Standard Deviation 1.41	—
Gastrointestinal (GI) Visual Analogue Scale (VAS) for Assessment of Nausea for Session 1 Bloating, Day4, pre-MRI,n=1,1,0	2.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	3.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Gastrointestinal (GI) Visual Analogue Scale (VAS) for Assessment of Nausea for Session 1 Bloating, Day4, 0.5 hour post-MRI,n=1,1,0	4.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Gastrointestinal (GI) Visual Analogue Scale (VAS) for Assessment of Nausea for Session 1 Bloating, Day8, pre-MRI,n=1,1,0	0.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	0.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Gastrointestinal (GI) Visual Analogue Scale (VAS) for Assessment of Nausea for Session 1 Bloating, Day8, 0.5 hour post-MRI,n=1,1,0	0.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Gastrointestinal (GI) Visual Analogue Scale (VAS) for Assessment of Nausea for Session 1 Abdominal pain, Day1, pre-MRI,n=0,0,2	—	—	2.0 Scores on scale Standard Deviation 1.41	—
Gastrointestinal (GI) Visual Analogue Scale (VAS) for Assessment of Nausea for Session 1 Abdominal pain, Day1,0.5 hour post-MRI,n=0,0,2	—	—	1.5 Scores on scale Standard Deviation 2.12	—
Gastrointestinal (GI) Visual Analogue Scale (VAS) for Assessment of Nausea for Session 1 Abdominal pain, Day4, pre-MRI,n=1,1,0	3.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	0.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Gastrointestinal (GI) Visual Analogue Scale (VAS) for Assessment of Nausea for Session 1 Abdominal pain, Day4, 0.5 hour post-MRI,n=1,1,0	5.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Gastrointestinal (GI) Visual Analogue Scale (VAS) for Assessment of Nausea for Session 1 Abdominal pain, Day8, pre-MRI,n=1,1,0	0.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Gastrointestinal (GI) Visual Analogue Scale (VAS) for Assessment of Nausea for Session 1 Abdominal pain, Day8, 0.5 hour post-MRI,n=1,1,0	0.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Gastrointestinal (GI) Visual Analogue Scale (VAS) for Assessment of Nausea for Session 1 Hunger, Day1, pre-MRI,n=0,0,2	—	—	29.0 Scores on scale Standard Deviation 41.01	—
Gastrointestinal (GI) Visual Analogue Scale (VAS) for Assessment of Nausea for Session 1 Hunger, Day1, 0.5 hour post-MRI,n=0,0,2	—	—	55.0 Scores on scale Standard Deviation 21.21	—

Measure	Albiglutide 50 mg n=2 Participants Participants received albiglutide 50 mg on Day 5 and exenatide placebo on Day 8 or albiglutide 50 mg on Day 1 and exenatide placebo on Day 4 during session 1 or 2 as per randomization. The timing of the albiglutide dose and post-dose MRI were based on the Tmax of albiglutide. Hence, the Day 4 and Day 8 post dose MRI served as the post-albiglutide dose MRI in this study and the exenatide placebo served to preserve the study blinding.	Exenatide 10 µg n=2 Participants Participants received albiglutide matching placebo on Day 5 and exenatide 10 μg on Day 8 or albiglutide matching placebo on Day 1 and exenatide 10 μg on Day 4 during session 1 or 2 as per randomization schedule. The timing of the exenatide dose and post-dose MRI were based on the Tmax of exentatide. Hence, the Day 4 and Day 8 post dose MRI served as the post exenatide dose MRI and the albiglutide matching placebo served to preserve the study blind.	Off-therapy MRI n=2 Participants Participants underwent off-therapy MRI. Off-therapy scans served as natural history scan with a 6-9 week washout period between the dosing scans.	Off-therapy Visit Participants had out-patient visit on Day 5 for assessment of vital signs. They did not undergo MRI on off-therapy visit on Day 5.
GI VAS for Assessment of Nausea for Session 2 Nausea, Day4, pre-MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	0.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
GI VAS for Assessment of Nausea for Session 2 Nausea, Day4,0.5 hour post-MRI,n=1,1,0	0.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	0.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
GI VAS for Assessment of Nausea for Session 2 Nausea, Day8, pre-MRI,n=1,1,0	2.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	48.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
GI VAS for Assessment of Nausea for Session 2 Nausea, Day8, 0.5 hour post-MRI,n=1,1,0	2.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	38.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
GI VAS for Assessment of Nausea for Session 2 Bloating, Day1, pre-MRI,n=0, 0, 2	—	—	6.0 Scores on scale Standard Deviation 7.07	—
GI VAS for Assessment of Nausea for Session 2 Bloating, Day1, 0.5 hour post-MRI,n=0,0,2	—	—	4.0 Scores on scale Standard Deviation 4.24	—
GI VAS for Assessment of Nausea for Session 2 Bloating, Day4, pre-MRI,n=1,1,0	2.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	0.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
GI VAS for Assessment of Nausea for Session 2 Bloating, Day4,0.5 hour post-MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	0.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
GI VAS for Assessment of Nausea for Session 2 Hunger, Day1, pre-MRI,n=0,0,2	—	—	54.5 Scores on scale Standard Deviation 33.23	—
GI VAS for Assessment of Nausea for Session 2 Hunger, Day1,0.5 hour post-MRI,n=0,0,2	—	—	67.5 Scores on scale Standard Deviation 23.33	—
GI VAS for Assessment of Nausea for Session 2 Hunger, Day4, pre-MRI,n=1,1,0	2.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	53.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
GI VAS for Assessment of Nausea for Session 2 Hunger, Day4,0.5 hour post-MRI,n=1,1,0	57.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	66.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
GI VAS for Assessment of Nausea for Session 2 Hunger, Day8, pre-MRI,n=1,1,0	38.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	77.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
GI VAS for Assessment of Nausea for Session 2 Hunger, Day8, 0.5 hour post-MRI,n=1,1,0	53.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	73.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
GI VAS for Assessment of Nausea for Session 2 Stomach fullness, Day1, pre-MRI,n=0,0,2	—	—	11.5 Scores on scale Standard Deviation 4.95	—
GI VAS for Assessment of Nausea for Session 2 Stomach fullness, Day1, 0.5 hour post-MRI,n=0,0,2	—	—	7.0 Scores on scale Standard Deviation 7.07	—
GI VAS for Assessment of Nausea for Session 2 Bloating, Day8, pre-MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	6.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
GI VAS for Assessment of Nausea for Session 2 Bloating, Day8, 0.5 hour post-MRI,n=1,1,0	2.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	6.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
GI VAS for Assessment of Nausea for Session 2 Abdominal pain, Day1, pre-MRI,n=0,0,2	—	—	7.5 Scores on scale Standard Deviation 9.19	—
GI VAS for Assessment of Nausea for Session 2 Abdominal pain, Day1, 0.5 hour post-MRI,n=0,0,2	—	—	4.0 Scores on scale Standard Deviation 4.24	—
GI VAS for Assessment of Nausea for Session 2 Abdominal pain, Day4, pre-MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	0.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
GI VAS for Assessment of Nausea for Session 2 Abdominal pain, Day4, 0.5 hour post-MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	0.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
GI VAS for Assessment of Nausea for Session 2 Abdominal pain, Day8, pre-MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	7.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
GI VAS for Assessment of Nausea for Session 2 Abdominal pain, Day8, 0.5 hour post-MRI,n=1,1,0	2.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	6.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
GI VAS for Assessment of Nausea for Session 2 Stomach fullness, Day4, pre-MRI,n=1,1,0	2.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	0.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
GI VAS for Assessment of Nausea for Session 2 Stomach fullness, Day4,0.5 hour post-MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	0.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
GI VAS for Assessment of Nausea for Session 2 Stomach fullness, Day8, pre-MRI,n=1,1,0	11.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	10.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
GI VAS for Assessment of Nausea for Session 2 Stomach fullness, Day8,0.5 hour post-MRI,n=1,1,0	3.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	13.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
GI VAS for Assessment of Nausea for Session 2 Nausea, Day1, pre-MRI,n=0,0,2	—	—	23.5 Scores on scale Standard Deviation 31.82	—
GI VAS for Assessment of Nausea for Session 2 Nausea, Day1, 0.5 hour post-MRI,n=0,0,2	—	—	17.5 Scores on scale Standard Deviation 14.85	—

Measure	Albiglutide 50 mg n=2 Participants Participants received albiglutide 50 mg on Day 5 and exenatide placebo on Day 8 or albiglutide 50 mg on Day 1 and exenatide placebo on Day 4 during session 1 or 2 as per randomization. The timing of the albiglutide dose and post-dose MRI were based on the Tmax of albiglutide. Hence, the Day 4 and Day 8 post dose MRI served as the post-albiglutide dose MRI in this study and the exenatide placebo served to preserve the study blinding.	Exenatide 10 µg n=2 Participants Participants received albiglutide matching placebo on Day 5 and exenatide 10 μg on Day 8 or albiglutide matching placebo on Day 1 and exenatide 10 μg on Day 4 during session 1 or 2 as per randomization schedule. The timing of the exenatide dose and post-dose MRI were based on the Tmax of exentatide. Hence, the Day 4 and Day 8 post dose MRI served as the post exenatide dose MRI and the albiglutide matching placebo served to preserve the study blind.	Off-therapy MRI n=2 Participants Participants underwent off-therapy MRI. Off-therapy scans served as natural history scan with a 6-9 week washout period between the dosing scans.	Off-therapy Visit Participants had out-patient visit on Day 5 for assessment of vital signs. They did not undergo MRI on off-therapy visit on Day 5.
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 P, sweaty, Day4,0.5 hr,Post MRI,n=1,1,0	2.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 SR, drowsy, Day8, 0.5 hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 C, Felt lightheaded, Day8, 0.5 hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 C, Felt disoriented, Day1,0.5 hr,Post MRI,n=0,0,2	—	—	4.5 Scores on scale Standard Deviation 2.12	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 C, Felt disoriented, Day4, 0.5 hr,Post MRI,n=1,1,0	3.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 C, Felt dizzy, Day4,0.5 hr,Post MRI,n=1,1,0	2.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 C, Felt dizzy, Day8,0.5 hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 C, Felt disoriented, Day8, 0.5 hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 C, Felt dizzy, Day1,0.5 hr,Post MRI,n=0,0,2	—	—	8.0 Scores on scale Standard Deviation 1.41	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 C, Felt spinning, Day1,0.5 hr,Post MRI,n=0,0,2	—	—	5.5 Scores on scale Standard Deviation 4.95	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 C, Felt spinning, Day4,0.5 hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 C, Felt spinning, Day8, 0.5 hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 GI, stomach sick, Day1,0.5hr,Post MRI,n=0,0,2	—	—	5.0 Scores on scale Standard Deviation 4.24	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 C, Felt faint like, Day1,0.5 hr,Post MRI,n=0,0,2	—	—	4.0 Scores on scale Standard Deviation 4.24	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 C, Felt faint like, Day4,0.5 hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 C, Felt faint like, Day8, 0.5 hr,Post MRI,n=1,1,0	2.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 C, Felt lightheaded, Day1,0.5 hr,Post MRI,n=0,0,2	—	—	5.5 Scores on scale Standard Deviation 3.54	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 C, Felt lightheaded, Day4,0.5 hr,Post MRI,n=1,1,0	2.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 P, hot/warm, Day8, 0.5 hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 SR,annoyed/irritated,Day1,0.5hr,Post MRI,n=0,0,2	—	—	5.0 Scores on scale Standard Deviation 4.24	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 SR,annoyed/irritated,Day4,0.5 hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 SR,annoyed/irritated,Day8, 0.5 hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	2.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 SR, drowsy, Day1,0.5hr,Post MRI,n=0,0,2	—	—	1.0 Scores on scale Standard Deviation 0.00	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 SR, drowsy, Day4, 0.5 hr,Post MRI,n=1,1,0	5.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	2.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 GI, stomach sick, Day4,0.5hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 GI, stomach sick, Day8,0.5hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 GI, felt queasy, Day1,0.5hr,Post MRI,n=0,0,2	—	—	6.5 Scores on scale Standard Deviation 2.12	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 GI, felt queasy, Day4,0.5hr,Post MRI,n=1,1,0	4.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 GI, felt queasy, Day8,0.5hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 GI, nauseated, Day1, 0.5hr,Post MRI,n=0,0,2	—	—	6.5 Scores on scale Standard Deviation 2.12	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 GI, nauseated, Day4,0.5hr,Post MRI,n=1,1,0	3.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 GI, nauseated, Day8,0.5hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 GI, may vomit, Day1,0.5hr,Post MRI,n=0,0,2	—	—	6.5 Scores on scale Standard Deviation 2.12	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 GI, may vomit, Day4,0.5hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 GI, may vomit, Day8,0.5hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 P, sweaty, Day1,0.5hr,Post MRI,n=0,0,2	—	—	4.5 Scores on scale Standard Deviation 4.95	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 P, sweaty, Day8, 0.5 hr,Post MRI,n=1,1,0	2.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 SR, tired/fatigued, Day1,0.5hr,Post MRI,n=0,0,2	—	—	1.5 Scores on scale Standard Deviation 0.71	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 SR, tired/fatigued, Day4,0.5 hr,Post MRI,n=1,1,0	4.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	2.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 P, clammy/cold sweat,Day1,0.5hr,Post MRI,n=0,0,2	—	—	4.5 Scores on scale Standard Deviation 4.95	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 P,clammy/cold sweat,Day4,0.5 hr,Post MRI,n=1,1,0	3.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 SR, tired/fatigued, Day8,0.5 hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	2.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 P, clammy/cold sweat,Day8,0.5 hr,Post MRI,n=1,1,0	2.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 P, hot/warm, Day1,0.5hr,Post MRI,n=0, 0, 2	—	—	2.5 Scores on scale Standard Deviation 2.12	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 P, hot/warm, Day4,0.5 hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 SR, uneasy, Day1,0.5hr,Post MRI,n=0,0,2	—	—	8.0 Scores on scale Standard Deviation 0.00	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 SR, uneasy, Day4, 0.5 hr,Post MRI,n=1,1,0	2.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1 SR, uneasy, Day8,0.5 hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—

Measure	Albiglutide 50 mg n=2 Participants Participants received albiglutide 50 mg on Day 5 and exenatide placebo on Day 8 or albiglutide 50 mg on Day 1 and exenatide placebo on Day 4 during session 1 or 2 as per randomization. The timing of the albiglutide dose and post-dose MRI were based on the Tmax of albiglutide. Hence, the Day 4 and Day 8 post dose MRI served as the post-albiglutide dose MRI in this study and the exenatide placebo served to preserve the study blinding.	Exenatide 10 µg n=2 Participants Participants received albiglutide matching placebo on Day 5 and exenatide 10 μg on Day 8 or albiglutide matching placebo on Day 1 and exenatide 10 μg on Day 4 during session 1 or 2 as per randomization schedule. The timing of the exenatide dose and post-dose MRI were based on the Tmax of exentatide. Hence, the Day 4 and Day 8 post dose MRI served as the post exenatide dose MRI and the albiglutide matching placebo served to preserve the study blind.	Off-therapy MRI n=2 Participants Participants underwent off-therapy MRI. Off-therapy scans served as natural history scan with a 6-9 week washout period between the dosing scans.	Off-therapy Visit Participants had out-patient visit on Day 5 for assessment of vital signs. They did not undergo MRI on off-therapy visit on Day 5.
MSAQ for Assessment of Nausea for Session 2 SR,annoyed/irritated,Day1,0.5hr, Post-MRI,n=0,0,2	—	—	1.5 Scores on scale Standard Deviation 0.71	—
MSAQ for Assessment of Nausea for Session 2 P, sweaty, Day1,0.5 hr,Post MRI,n=0,0,2	—	—	1.5 Scores on scale Standard Deviation 0.71	—
MSAQ for Assessment of Nausea for Session 2 SR, tired/fatigued, Day1,0.5 hr,Post MRI,n=0,0,2	—	—	4.5 Scores on scale Standard Deviation 3.54	—
MSAQ for Assessment of Nausea for Session 2 SR, tired/fatigued, Day4,0.5 hr,Post MRI,n=1,1,0	4.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
MSAQ for Assessment of Nausea for Session 2 SR, tired/fatigued, Day8,0.5 hr,Post MRI,n=1,1,0	3.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	3.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
MSAQ for Assessment of Nausea for Session 2 SR, uneasy, Day1, 0.5 hr,Post-MRI,n=0,0,2	—	—	4.0 Scores on scale Standard Deviation 2.83	—
MSAQ for Assessment of Nausea for Session 2 SR, uneasy, Day4, 0.5 hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
MSAQ for Assessment of Nausea for Session 2 SR, uneasy, Day8, 0.5 hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
MSAQ for Assessment of Nausea for Session 2 C, Felt spinning, Day4,0.5 hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
MSAQ for Assessment of Nausea for Session 2 C, Felt spinning, Day8,0.5 hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
MSAQ for Assessment of Nausea for Session 2 GI, stomach sick, Day1,0.5hr,Post MRI, n=0,0,2	—	—	5.0 Scores on scale Standard Deviation 0.00	—
MSAQ for Assessment of Nausea for Session 2 GI, stomach sick, Day4, 0.5hr post-MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
MSAQ for Assessment of Nausea for Session 2 GI, stomach sick, Day8,0.5hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
MSAQ for Assessment of Nausea for Session 2 GI, felt queasy, Day1, 0.5hr post-MRI,n=0,0,2	—	—	4.5 Scores on scale Standard Deviation 2.12	—
MSAQ for Assessment of Nausea for Session 2 GI, felt queasy, Day4,0.5hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
MSAQ for Assessment of Nausea for Session 2 GI, felt queasy, Day8, 0.5h,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	2.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
MSAQ for Assessment of Nausea for Session 2 GI, nauseated, Day1,0.5hr,Post MRI,n=0,0,2	—	—	6.0 Scores on scale Standard Deviation 1.41	—
MSAQ for Assessment of Nausea for Session 2 GI, nauseated, Day4,0.5hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
MSAQ for Assessment of Nausea for Session 2 GI, nauseated, Day8,0.5hr,Post MRI, n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	3.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
MSAQ for Assessment of Nausea for Session 2 GI, may vomit, Day1,0.5hr,Post MRI,n=0,0,2	—	—	2.0 Scores on scale Standard Deviation 0.00	—
MSAQ for Assessment of Nausea for Session 2 GI, may vomit, Day4,0.5hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
MSAQ for Assessment of Nausea for Session 2 GI, may vomit, Day8,0.5 hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
MSAQ for Assessment of Nausea for Session 2 P, sweaty, Day4, 0.5 hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	3.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
MSAQ for Assessment of Nausea for Session 2 P, sweaty, Day8,0.5 hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
MSAQ for Assessment of Nausea for Session 2 P,clammy/cold sweat,Day1,0.5hr,post-MRI,n=0,0,2	—	—	2.0 Scores on scale Standard Deviation 1.41	—
MSAQ for Assessment of Nausea for Session 2 P, clammy/cold sweat, Day4,0.5 hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	3.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
MSAQ for Assessment of Nausea for Session 2 P,clammy/cold sweat,Day8,0.5hr,Post-MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
MSAQ for Assessment of Nausea for Session 2 P, hot/warm, Day1,0.5 hr, Post-MRI,n=0,0,2	—	—	1.0 Scores on scale Standard Deviation 0.00	—
MSAQ for Assessment of Nausea for Session 2 P, hot/warm, Day4, 0.5 hr,Post-MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
MSAQ for Assessment of Nausea for Session 2 P, hot/warm,Day8, 0.5 hr Post-MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
MSAQ for Assessment of Nausea for Session 2 SR,annoyed/irritated,Day4,0.5hr,Post-MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
MSAQ for Assessment of Nausea for Session 2 SR,annoyed/irritated,Day8,0.5hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
MSAQ for Assessment of Nausea for Session 2 SR, drowsy, Day1, 0.5 hr,Post-MRI,n=0,0,2	—	—	4.0 Scores on scale Standard Deviation 1.41	—
MSAQ for Assessment of Nausea for Session 2 SR, drowsy, Day4, 0.5 hr,Post-MRI,n=1,1,0	5.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
MSAQ for Assessment of Nausea for Session 2 SR, drowsy, Day8, 0.5 hr, Post-MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	5.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
MSAQ for Assessment of Nausea for Session 2 C, Felt faint like, Day1,0.5 hr Post MRI ,n=0,0,2	—	—	3.0 Scores on scale Standard Deviation 2.83	—
MSAQ for Assessment of Nausea for Session 2 C, Felt faint like, Day4,0.5 hr Post MRI ,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	2.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
MSAQ for Assessment of Nausea for Session 2 C, Felt faint like, Day8,0.5 hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
MSAQ for Assessment of Nausea for Session 2 C, Felt lightheaded, Day1,0.5 hr Post MRI,n=0,0,2	—	—	2.0 Scores on scale Standard Deviation 0.00	—
MSAQ for Assessment of Nausea for Session 2 C, Felt lightheaded, Day4, 0.5 hr Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	2.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
MSAQ for Assessment of Nausea for Session 2 C, Felt lightheaded, Day8, 0.5 hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	2.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
MSAQ for Assessment of Nausea for Session 2 C, Felt disoriented, Day1,0.5 hr, Post MRI,n=0,0,2	—	—	2.0 Scores on scale Standard Deviation 1.41	—
MSAQ for Assessment of Nausea for Session 2 C, Felt disoriented, Day4,0.5 hr Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
MSAQ for Assessment of Nausea for Session 2 C, Felt disoriented, Day8,0.5 hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
MSAQ for Assessment of Nausea for Session 2 C, Felt dizzy, Day1, 0.5 hr,Post MRI,n=0,0,2	—	—	2.0 Scores on scale Standard Deviation 0.00	—
MSAQ for Assessment of Nausea for Session 2 C, Felt dizzy, Day4,0.5 hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
MSAQ for Assessment of Nausea for Session 2 C, Felt dizzy, Day8,0.5 hr,Post MRI,n=1,1,0	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	1.0 Scores on scale Standard Deviation NA NA indicates that data were not available as standard deviation could not be calculated due to low number of participants.	—	—
MSAQ for Assessment of Nausea for Session 2 C, Felt spinning, Day1,0.5 hr,Post MRI,n=0,0,2	—	—	4.0 Scores on scale Standard Deviation 4.24	—