A Study Comparing the Effect of Albiglutide With Exenatid... | NCT02802514 | Trialant
NCT02802514
Sponsor
GlaxoSmithKline
Status
Terminated
Last Update Posted
Oct 30, 2020Actual
Enrollment
5Actual
Phase
Phase 4
Conditions
Diabetes Mellitus
Interventions
Albiglutide 50mg
Albiglutide matching placebo
Exenatide 10microgram
Exenatide placebo (saline)
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT02802514
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
201840
Secondary IDs
Not provided
Brief Title
A Study Comparing the Effect of Albiglutide With Exenatide on Regional Brain Activity Related to Nausea in Healthy Subjects
Official Title
An Exploratory Randomized, 2-Part, Single-blind, 2-Period Crossover Study Comparing the Effect of Albiglutide With Exenatide on Regional Brain Activity Related to Nausea in Healthy Volunteers
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Oct 2020
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 20, 2016Actual
Primary Completion Date
Aug 10, 2017Actual
Completion Date
Sep 7, 2017Actual
First Submitted Date
Jun 2, 2016
First Submission Date that Met QC Criteria
Jun 13, 2016
First Posted Date
Jun 16, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 30, 2018
Results First Submitted that Met QC Criteria
Jul 30, 2020
Results First Posted Date
Aug 24, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 8, 2020
Last Update Posted Date
Oct 30, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Name
Class
The General Hospital Corporation d/b/a Massachusetts General Hospital
UNKNOWN
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The drug effects will be studied after a single dose of 50 milligram (mg) albiglutide and a single dose of 10 microgram exenatide, to gain insight into the central mechanisms of nausea associated with Glucagon-like peptide-1 receptor (GLP-1R) agonists. This study will explore the potential differences at the expected time of maximum concentration (Cmax) between a long-acting (albiglutide) and short-acting (exenatide) GLP-1R agonist in brain activation of healthy volunteers assessed by magnetic resonance imaging (MRI). This is a phase IV, 2-part, 2-period crossover (session), single dose, randomized, single blind (blinded to both the subject and the imaging evaluators analysing the MRI data), placebo- and active-controlled study in adult healthy volunteers who are susceptible to motion sickness. Part A and Part B are the same in design, both consisting of a screening stage, a dosing/assessment stage, and a follow-up visit. Data from Part A will inform progression, methods, and analysis plan for Part B. Each sequence includes three scanning visits: albiglutide plus scan, exenatide plus scan and an off-therapy -natural history scan with a 6-9 week washout period between the dosing scans. A total of 24 to 28 subjects will be randomized in the study (Part A and Part B). The cross over design is divided into 2 sessions and schedule is as follow, on Day 1 (either Session 1 (S1) or Session 2 (S2) per, if randomized) subject will under go an off-therapy MRI scan, on Day 5 subject will receive a single dose of 50 mg albiglutide or albiglutide placebo, and Day 8 subject will receive a single dose of 10 microgram exenatide or saline placebo followed by a post-dose MRI scan. At each session subject will receive only one active drug (albiglutide or exenatide).
Detailed Description
Not provided
Conditions Module
Conditions
Diabetes Mellitus
Keywords
Gastrointestinal
Glucagon like peptide
Nausea
Magnetic resonance imaging
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 4
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
5Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
With Off therapy MRI in S1:Albiglutide-S1 & Exenatide-S2
Experimental
In session 1, eligible subject will undergo off-therapy MRI scan Subject will receive single dose each of 50 mg albiglutide on Day 5 and exenatide placebo on Day 8 followed by a post-dose MRI. In session 2, subject will receive single dose each of albiglutide placebo on Day 1 (Week 9) and 10 microgram exenatide on Day 4 followed by a post-dose MRI scan. There will be 6-9 week washout period between Session 1 and Session 2
Drug: Albiglutide 50mg
Drug: Albiglutide matching placebo
Drug: Exenatide 10microgram
Drug: Exenatide placebo (saline)
Without Off therapy MRI in S1:Albiglutide-S1 & Exenatide-S2
Experimental
In session 1, eligible subject will receive single dose each of 50 mg albiglutide on Day 1 and exenatide placebo on Day 4 followed by a post-dose MRI scan. In session 2, Day 1 (Week 9) subject will undergo off-therapy MRI scan. Subject will receive single dose each of albiglutide placebo on Day 5 and 10 microgram of exenatide on Day 8 followed by a post-dose MRI scan. There will be 6-9 week washout period between Session 1 and Session 2
Drug: Albiglutide 50mg
Drug: Albiglutide matching placebo
Drug: Exenatide 10microgram
Drug: Exenatide placebo (saline)
With Off therapy MRI in S1:Exenatide-S1 & Albiglutide-S2
Experimental
In session 1, Day 1 subject will undergo off-therapy MRI scan Subject will receive single dose each of albiglutide placebo on Day 5 and 10 microgram of exenatide on Day 8 followed by a post-dose MRI scan In session 2, eligible subject will receive single dose each of 50 mg albiglutide on Day 1 (Week 9) and exenatide placebo Day 4 followed by a post-dose MRI scan. There will be 6-9 week washout period between Session 1 and Session 2
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Albiglutide 50mg
Drug
It is provided as a single use fixed dose disposable pen injector (0.5 mL) system for SC delivery. A 50 mg pen contains 67 mg lyophilized albiglutide and 0.65 mL diluents. It will be injected subcutaneously (SC) in the upper arm.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Blood Oxygen Level Dependent (BOLD) Signal by Functional Magnetic Resonance Imaging (fMRI) Visual Nauseogenic Task
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.
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.
Up to Week 11
Glutamate Concentration in Nausea-associated Brain Regions by Magnetic Resonance Spectroscopy (MRS)
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.
Secondary Outcomes
Measure
Description
Time Frame
Heart Rate Variability Using Autonomic Response Measures by MRI
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Between 18 and 50 years of age inclusive, at the time of signing the informed consent.
Healthy as determined by the Investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
Pure right-handed based on Edinburgh Handedness Inventory
A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the Investigator (in consultation with the Medical Monitor, if necessary) decides and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures or ability to interpret study results.
Subject's body mass index (BMI) is >=19 (kilogram per square meter)kg/m^2 and =<30 kg/m^2
Male OR
Female: eligible to participate if she is not pregnant (as confirmed by a negative human chorionic gonadotrophin (hCG) test at screening and at other timepoints), not lactating, and at least one of the following conditions applies: a. Non-reproductive potential defined as pre-menopausal females who are having documented tubal ligation or Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion or hysterectomy or documented Bilateral Oophorectomy OR Postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause to confirm (refer to laboratory reference ranges for confirmatory levels)]. b. Reproductive potential and agrees to follow one of the options listed for avoiding pregnancy in females of reproductive potential (FRP) requirements from 30 days prior to the first dose of study medication and for the duration of study including the completion of the follow-up visit. The options are, Contraceptive subdermal implant or Intrauterine device or intrauterine system or Combined estrogen and progestogen oral contraceptive or Injectable progestogen or Contraceptive vaginal ring or Percutaneous contraceptive patches or Male partner sterilization with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject. The documentation on male sterility can come from the site personnel's: review of subject's medical records, medical examination and/or semen analysis, or medical history interview provided by her or her partner.
Capable of giving signed informed consent which includes compliance with the requirements and restrictions.
Exclusion Criteria:
Severe nausea (with or without vomiting) in the last three months or any event of unexplained nausea (with or without vomiting) as reported by the subject in the last 14 days before screening.
History of vestibular or balance disorders as determined by the Investigator.
History of smoking cigarettes or using tobacco products or any nicotine-containing products (including nicotine patches) within 3 months of screening.
Use of eyeglasses during functional MRI (fMRI). Subjects requiring visual correction to participate in visual task that cannot be corrected with contact lenses.
Alanine amino transferase (ALT) >1.5xupper limit of normal (ULN)
Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
Current or chronic history of liver disease, or known hepatic or biliary abnormalities
QT interval corrected for heart rate according to Fridericia's formula (QTcF) >450 msec
Systolic blood pressure is >=140 millimeter of Mercury (mm Hg) at Screening; repeat blood pressures should be taken if the subject's systolic blood pressure is >=140 mm Hg and if the results are consistently >=140 mm Hg, then the subject will be excluded and advised to consult a physician
Diastolic blood pressure is >=90 mm Hg at Screening; repeat blood pressures should be taken if the subject's diastolic blood pressure is >=90 mm Hg and if the results are consistently >=90 mm Hg, then the subject should be excluded and advised to consult a physician
Mean resting heart rate is >100 beats/minutes (mins) out of 3 consecutive measures taken 10 mins apart at Screening
History of intestinal obstruction, ileus, gastrointestinal surgery or any other medical condition or procedure (e.g., gastrectomy, gastric bypass, lap-band) that may impair gastrointestinal motility
History of significant cardiovascular or pulmonary dysfunction prior to screening
History of acute or chronic pancreatitis
History of severe gastrointestinal disease, including gastroparesis, inflammatory bowel disease, Crohn's disease, or irritable bowel syndrome
History of any significant psychiatric illness (e.g., schizophrenia, bipolar affective disorder, bulimia or anorexia nervosa) that in the opinion of the Investigator would interfere with participation in the study.
History and/or evidence of any other Central Nervous System (CNS) disorder that in the opinion of the Investigator would interfere with participation in the study (e.g., epilepsy, brain tumour, brain surgery).
History of clinically significant CNS trauma (e.g. traumatic brain injury, cerebral contusion, spinal cord compression) or seizures.
Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
Received within 7 days prior to screening or unable to refrain from taking for the duration of each part of study, medications that might; modify gastric myoelectical activity or gastrointestinal motility as prokinetic (e.g., erythromycin), anti-emetic agents (e.g., metoclopromide), narcotic analgesics (e.g., morphine), anticholinergic drugs (e.g., domperidone), anti-acid (e.g., pump inhibitors, H2 blockers) and laxative agents or
History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 g of alcohol: 12 ounces (360 milliliter [mL]) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
Is unwilling to abstain from alcohol for 24 hours before dosing and before each MRI scanning visit
Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 3 months prior to screening.
Subject has a history of significant weight loss (>5% reported change within 3 months prior to screening) or is currently attempting weight loss
History of hypersensitivity to albiglutide, exenatide, or any product components
Personal or family history of multiple endocrine neoplasia type 2, or medullary carcinoma of the thyroid
Subject has any known condition(s) that may be contraindicated or interfere with the completion of MRI scanning such as implants (e.g., pacemaker, cochlear), a medical or electronic device (e.g., metallic joint prostheses, metal pins, screws, plates, stents or surgical staples), or claustrophobia.
An abnormal (i.e., outside the normal reference range) thyroid function test assessed by thyroid stimulating hormone and Free T4 at screening.
An abnormal amylase or lipase test at screening
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening or at screening
A positive pre-study drug/alcohol screen
A positive test for human immunodeficiency virus (HIV) antibody
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 56-day period
Subject has previously received any Glucagon-like peptide-1 receptor (GLP-1R) agonist at any time (e.g., albiglutide, exenatide, liraglutide, lixisenatide, dulaglutide)
Subject has previously received dipeptidyl peptidase 4 (DPP-IV) inhibitor (sitagliptin, saxagliptin, linagliptin, alogliptin) within 30 days from screening
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Exposure to more than 4 new investigational products within 12 months prior to the first dosing day
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
50 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
GSK Clinical Trials
GlaxoSmithKline
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
GSK Investigational Site
Boston
Massachusetts
02114
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
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.
Recruitment Details
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
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
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.
Periods
Title
Milestones
Reasons Not Completed
Session 1 (up to Day 8)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
2
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Nov 28, 2016
Mar 26, 2018
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Single
Masking Description
Not provided
Who Masked
Participant
Drug: Albiglutide 50mg
Drug: Albiglutide matching placebo
Drug: Exenatide 10microgram
Drug: Exenatide placebo (saline)
Without Off therapy MRI in S1: Exenatide-S1 & Albiglutide-S2
Experimental
In session 1, subject will receive single dose each of albiglutide placebo on Day 1 and 10 microgram exenatide on Day 4 followed by a post-dose MRI scan. In session 2, subject will undergo off-therapy MRI scan on Day 1 (Week 9). Subject will receive single dose each of 50 mg albiglutide on Day 5 and exenatide placebo on Day 8 followed by a post-dose MRI scan.. There will be 6-9 week washout period between Session 1 and Session 2
Drug: Albiglutide 50mg
Drug: Albiglutide matching placebo
Drug: Exenatide 10microgram
Drug: Exenatide placebo (saline)
With Off therapy MRI in S1:Albiglutide-S1 & Exenatide-S2
With Off therapy MRI in S1:Exenatide-S1 & Albiglutide-S2
Without Off therapy MRI in S1: Exenatide-S1 & Albiglutide-S2
Without Off therapy MRI in S1:Albiglutide-S1 & Exenatide-S2
Albiglutide matching placebo
Drug
It is provided as a single use fixed dose disposable pen injector (0.5 mL) system for SC delivery. It will be injected subcutaneously (SC) in the upper arm
With Off therapy MRI in S1:Albiglutide-S1 & Exenatide-S2
With Off therapy MRI in S1:Exenatide-S1 & Albiglutide-S2
Without Off therapy MRI in S1: Exenatide-S1 & Albiglutide-S2
Without Off therapy MRI in S1:Albiglutide-S1 & Exenatide-S2
Exenatide 10microgram
Drug
It is provided as a sterile solution containing 250 microgram/mL exenatide. One dose of 10 microgram is equivalent to 0.04 ml. It will be injected subcutaneously (SC) in the upper arm
With Off therapy MRI in S1:Albiglutide-S1 & Exenatide-S2
With Off therapy MRI in S1:Exenatide-S1 & Albiglutide-S2
Without Off therapy MRI in S1: Exenatide-S1 & Albiglutide-S2
Without Off therapy MRI in S1:Albiglutide-S1 & Exenatide-S2
Exenatide placebo (saline)
Drug
It is provided as a sterile saline. It will be injected subcutaneously (SC) in the upper arm
With Off therapy MRI in S1:Albiglutide-S1 & Exenatide-S2
With Off therapy MRI in S1:Exenatide-S1 & Albiglutide-S2
Without Off therapy MRI in S1: Exenatide-S1 & Albiglutide-S2
Without Off therapy MRI in S1:Albiglutide-S1 & Exenatide-S2
Up to Week 11
Gama-aminobutyric Acid (GABA) Concentration in Nausea-associated Brain Regions by MRS
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.
Up to Week 11
Up to Week 11
Number of Participants With Abnormal Electrocardiogram (ECG) Intervals Using Autonomic Response Measures by MRI
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.
Up to Week 11
Number of Participants With Abnormal Respiratory Rate Using Autonomic Response Measures by MRI
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.
Up to Week 11
Number of Participants With Skin Conductance Level Using Autonomic Response Measures by MRI
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.
Up to Week 11
Number of Participants With Abnormal Heart Rate for Session 1
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.
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
Number of Participants With Abnormal Heart Rate for Session 2
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.
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
Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Session 1
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.
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
Number of Participants With Abnormal SBP and DBP for Session 2
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.
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
Number of Participants With Abnormal Clinical Chemistry Parameters
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.
Up to Week 11
Number of Participants With Abnormal Hematology Parameters
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.
Up to Week 11
Number of Participants With Abnormal Urinalysis
Urinalysis parameters included assessment of specific gravity, microscopic analysis, and potential of hydrogen (pH), glucose, protein, blood and ketones by dipstick method.
Up to Week 11
Number of Participants With Abnormal Glycemic Parameters
Glycemic parameters included assessment of capillary blood glucose and fasting plasma glucose.
Up to Week 11
Number of Participants With Non-serious Adverse Events (AE) With Incidence > = 2 % and Serious AEs (SAE)
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.
Up to Week 13
Nausea Ratings Scale to Rate Nausea Sensation Using Autonomic Response Measures by MRI
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.
Up to Week 11
Gastrointestinal (GI) Visual Analogue Scale (VAS) for Assessment of Nausea for Session 1
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.
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)
GI VAS for Assessment of Nausea for Session 2
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.
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)
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1
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.
Day 1 0.5 hour post-MRI; Day 4 0.5 hour post-MRI; and Day 8 0.5 hour post-MRI
MSAQ for Assessment of Nausea for Session 2
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.
Day 1 0.5 hour post-MRI; Day 4 0.5 hour post-MRI; and Day 8 0.5 hour post-MRI
FG001
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.
FG002
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.
FG003
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.
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
COMPLETED
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Wash Out Period (up to Week 9)
Type
Comment
Milestone Data
STARTED
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
COMPLETED
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Session 2 (Up to Day 8)
Type
Comment
Milestone Data
STARTED
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
COMPLETED
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Safety Population: Comprised of all participants who received at least one dose of the study treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
All 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.
Denominators
Units
Counts
Participants
BG0004
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00028.8± 7.41
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
Male
BG0000
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Asian - Mixed Race
BG0001
White - Arabic/North African Heritage
BG000
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Blood Oxygen Level Dependent (BOLD) Signal by Functional Magnetic Resonance Imaging (fMRI) Visual Nauseogenic Task
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.
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.
Posted
Up to Week 11
ID
Title
Description
OG000
Albiglutide 50 mg
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.
OG001
Exenatide 10 µg
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.
OG002
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.
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.
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.
Posted
Up to Week 11
ID
Title
Description
OG000
Albiglutide 50 mg
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.
OG001
Exenatide 10 µg
Primary
Glutamate Concentration in Nausea-associated Brain Regions by Magnetic Resonance Spectroscopy (MRS)
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.
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.
Posted
Up to Week 11
ID
Title
Description
OG000
Albiglutide 50 mg
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.
Primary
Gama-aminobutyric Acid (GABA) Concentration in Nausea-associated Brain Regions by MRS
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.
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.
Posted
Up to Week 11
ID
Title
Description
OG000
Albiglutide 50 mg
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.
Secondary
Heart Rate Variability Using Autonomic Response Measures by MRI
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.
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.
Posted
Up to Week 11
ID
Title
Description
OG000
Albiglutide 50 mg
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.
OG001
Exenatide 10 µg
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.
Secondary
Number of Participants With Abnormal Electrocardiogram (ECG) Intervals Using Autonomic Response Measures by MRI
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.
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.
Posted
Up to Week 11
ID
Title
Description
OG000
Albiglutide 50 mg
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.
OG001
Exenatide 10 µg
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.
Secondary
Number of Participants With Abnormal Respiratory Rate Using Autonomic Response Measures by MRI
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.
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.
Posted
Up to Week 11
ID
Title
Description
OG000
Albiglutide 50 mg
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.
OG001
Exenatide 10 µg
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.
Secondary
Number of Participants With Skin Conductance Level Using Autonomic Response Measures by MRI
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.
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.
Posted
Up to Week 11
ID
Title
Description
OG000
Albiglutide 50 mg
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.
OG001
Exenatide 10 µg
Secondary
Number of Participants With Abnormal Heart Rate for Session 1
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.
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
Posted
Count of Participants
Participants
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
ID
Title
Description
OG000
Albiglutide 50 mg
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.
OG001
Exenatide 10 µg
Secondary
Number of Participants With Abnormal Heart Rate for Session 2
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. 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
Posted
Count of Participants
Participants
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
ID
Title
Description
OG000
Albiglutide 50 mg
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.
OG001
Exenatide 10 µg
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.
Secondary
Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Session 1
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.
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
Posted
Count of Participants
Participants
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
ID
Title
Description
OG000
Albiglutide 50 mg
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.
OG001
Exenatide 10 µg
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.
Secondary
Number of Participants With Abnormal SBP and DBP for Session 2
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.
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
Posted
Count of Participants
Participants
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
ID
Title
Description
OG000
Albiglutide 50 mg
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.
OG001
Exenatide 10 µg
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.
Secondary
Number of Participants With Abnormal Clinical Chemistry Parameters
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.
Safety Population. The data was reported in cumulative format as placebo was included to maintain the single blind only; similar to double dummy.
Posted
Count of Participants
Participants
Up to Week 11
ID
Title
Description
OG000
Albiglutide 50 mg
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.
OG001
Exenatide 10 µg
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.
Secondary
Number of Participants With Abnormal Hematology Parameters
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.
Safety Population. The data was reported in cumulative format as placebo was included to maintain the single blind only; similar to double dummy.
Posted
Count of Participants
Participants
Up to Week 11
ID
Title
Description
OG000
Albiglutide 50 mg
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.
OG001
Exenatide 10 µg
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.
Secondary
Number of Participants With Abnormal Urinalysis
Urinalysis parameters included assessment of specific gravity, microscopic analysis, and potential of hydrogen (pH), glucose, protein, blood and ketones by dipstick method.
Safety Population. The data was reported in cumulative format as placebo was included to maintain the single blind only; similar to double dummy.
Posted
Count of Participants
Participants
Up to Week 11
ID
Title
Description
OG000
Albiglutide 50 mg
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.
OG001
Exenatide 10 µg
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.
Secondary
Number of Participants With Abnormal Glycemic Parameters
Glycemic parameters included assessment of capillary blood glucose and fasting plasma glucose.
Safety Population.The data was reported in cumulative format as placebo was included to maintain the single blind only; similar to double dummy.
Posted
Count of Participants
Participants
Up to Week 11
ID
Title
Description
OG000
Albiglutide 50 mg
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.
OG001
Exenatide 10 µg
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.
Secondary
Number of Participants With Non-serious Adverse Events (AE) With Incidence > = 2 % and Serious AEs (SAE)
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.
Safety Population.
Posted
Count of Participants
Participants
Up to Week 13
ID
Title
Description
OG000
Albiglutide 50 mg
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.
OG001
Exenatide 10 µg
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.
Secondary
Nausea Ratings Scale to Rate Nausea Sensation Using Autonomic Response Measures by MRI
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.
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.
Posted
Up to Week 11
ID
Title
Description
OG000
Albiglutide 50 mg
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.
OG001
Exenatide 10 µg
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.
Secondary
Gastrointestinal (GI) Visual Analogue Scale (VAS) for Assessment of Nausea for Session 1
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.
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
Posted
Mean
Standard Deviation
Scores on scale
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)
ID
Title
Description
OG000
Albiglutide 50 mg
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.
Secondary
GI VAS for Assessment of Nausea for Session 2
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.
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
Posted
Mean
Standard Deviation
Scores on scale
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)
ID
Title
Description
OG000
Albiglutide 50 mg
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.
Secondary
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1
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.
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
Posted
Mean
Standard Deviation
Scores on scale
Day 1 0.5 hour post-MRI; Day 4 0.5 hour post-MRI; and Day 8 0.5 hour post-MRI
ID
Title
Description
OG000
Albiglutide 50 mg
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.
Secondary
MSAQ for Assessment of Nausea for Session 2
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.
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
Posted
Mean
Standard Deviation
Scores on scale
Day 1 0.5 hour post-MRI; Day 4 0.5 hour post-MRI; and Day 8 0.5 hour post-MRI
ID
Title
Description
OG000
Albiglutide 50 mg
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.
OG001
Time Frame
Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment up to Week 13.
Description
SAEs and Non-serious AEs for participants of Safety Population were reported. AEs data was reported per Intervention.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Albiglutide 50 mg
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.
0
4
0
4
1
4
EG001
Exenatide 10 µg
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.
0
4
0
4
0
4
EG002
Albiglutide Matching Placebo
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.
0
4
0
4
0
4
EG003
Exenatide Matching Placebo
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.
0
4
0
4
0
4
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nausea
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected4 at risk
Nasopharyngitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected4 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
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.
OG002
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.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG001
Exenatide 10 µg
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.
OG002
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.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG001
Exenatide 10 µg
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.
OG002
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.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG002
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.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG002
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.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG002
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.
Units
Counts
Participants
OG0000
OG0010
OG0020
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.
OG002
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.
Units
Counts
Participants
OG0000
OG0010
OG0020
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.
OG002
Off-therapy MRI Arm
Participants underwent single off-therapy MRI on Day 1 of session 1 or session 2 as per randomization schedule. Off-therapy scans served as natural history scan with a 6-9 week washout period between the dosing scans. Participants did not undergo MRI on off-therapy visit on Day 5.
OG003
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.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0032
Title
Denominators
Categories
Day 1, Pre MRI, high, n=0, 0, 2, 0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
Title
Measurements
OG0020
Day 1, Pre MRI, low, n=0, 0, 2, 0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
Day 1, Post MRI 0.5 hr, high, n=0, 0, 2, 0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
Day 1, Post MRI 0.5 hr, low, n=0, 0, 2, 0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
Day 4, -2 hr pre-MRI, high, n=1, 1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Day 4, -2 hr pre-MRI, low, n=1, 1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Day 4, Post MRI 0.5 hr, high, n=1, 1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Day 4, 0.5 hr Post MRI, low, n=1, 1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Day 4, 1 hr Post MRI, high, n=1, 1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Day 4, 1 hr Post MRI, low, n=1, 1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Day 5, high, n=0, 0, 0, 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0032
Day 5, low, n=0, 0, 0, 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0032
Day 8, -2 hr pre-MRI, high, n=1, 1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Day 8, -2 hr pre-MRI, low, n=1, 1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Day 8, 0.5 hr Post MRI, high, n=1, 1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Day 8, 0.5 hr Post MRI, low, n=1, 1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Day 8, 1 hr Post MRI, high, n=0, 1, 0, 0
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Day 8, 1 hr Post MRI, low, n=0, 1, 0, 0
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
OG002
Off-therapy MRI Arm
Participants underwent single off-therapy MRI on Day 1 of session 1 or session 2 as per randomization schedule. Off-therapy scans served as natural history scan with a 6-9 week washout period between the dosing scans. Participants did not undergo MRI on off-therapy visit on Day 5.
OG003
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.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0032
Title
Denominators
Categories
Day 1, Pre MRI, high, n=0, 0, 2, 0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
Title
Measurements
OG0020
Day 1, Pre MRI, low, n=0, 0, 2, 0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
Day 1, Post MRI 0.5 hr, high, n=0, 0, 2, 0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
Day 1, Post MRI 0.5 hr, low, n=0, 0, 2, 0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
Day 4, -2 hr pre-MRI, high, n=1, 1,0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Day 4, -2 hr pre-MRI, low, n=1, 1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Day 4, Post MRI 0.5 hr, high, n=1, 1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Day 4, 0.5 hr Post MRI, low, n=1, 1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Day 4, 1 hr Post MRI, high, n=1, 1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Day 4, 1 hr Post MRI, low, n=1, 1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Day 5, high, n=0, 0, 0, 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0032
Day 5, low, n=0, 0, 0, 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0032
Day 8, -2 hr pre-MRI, high, n=1, 1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Day 8, -2 hr pre-MRI, low, n=1, 1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Day 8, 0.5 hr Post MRI, high, n=1, 1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Day 8, 0.5 hr Post MRI, low, n=1, 1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Day 8, 1 hr Post MRI, high, n=0, 1, 0, 0
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Day 8, 1 hr Post MRI, low, n=0, 1, 0, 0
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
OG002
Off-therapy MRI Arm
Participants underwent single off-therapy MRI on Day 1 of session 1 or session 2 as per randomization schedule. Off-therapy scans served as natural history scan with a 6-9 week washout period between the dosing scans. Participants did not undergo MRI on off-therapy visit on Day 5.
OG003
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.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0032
Title
Denominators
Categories
SBP, Day 1, Pre-MRI, high, n=0, 0, 2, 0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
Title
Measurements
OG0020
SBP, Day 1, Pre-MRI, low, n=0, 0, 2, 0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
SBP, Day 1, 0.5 hr post MRI, high, n=0, 0, 2, 0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
SBP, Day 1,0.5 hr post MRI , low, n=0, 0, 2, 0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
SBP, Day 4,-2 hr pre-MRI, high, n=1,1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
SBP, Day 4,-2 hr pre-MRI, low, n=1,1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
SBP, Day 4,0.5 hr post MRI , high, n=1,1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
SBP, Day 4,0.5 hr post MRI, low, n=1,1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
SBP, Day 4,1 hr post MRI , high, n=1,1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
SBP, Day 4,1 hr post MRI , low, n=1,1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
SBP, Day 5, high, n=0, 0, 0, 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0032
SBP, Day 5, low, n=0, 0, 0, 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0032
SBP, Day 8,0.5 hr Post MRI, high, n=1,1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
SBP, Day 8,0.5 hr Post MRI, low, n=1,1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
SBP, Day 8,1 hr Post MRI, high, n= 0,1, 0, 0
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
SBP, Day 8,1 hr post MRI , low, n= 0,1, 0, 0
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
DBP, Day 1, Pre MRI, high,n= 0,0, 2, 0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
DBP, Day 1, Pre MRI, low,n= 0, 0, 2, 0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
DBP, Day 1,0.5 hr post MRI, high,n= 0, 0, 2, 0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
DBP, Day 1,0.5 hr post MRI, low,n= 0, 0, 2, 0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
DBP, Day 4,-2 hr pre-MRI, high, n=1,1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
DBP, Day 4,-2 hr pre-MRI, low, n=1,1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
DBP, Day 4,0.5 hr Post MRI, high,n= 1,1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
DBP, Day 4,0.5 hr Post MRI, low,n= 1,1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
DBP, Day 4,1 hr post MRI, high,n= 1,1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
DBP, Day 4,1 hr post MRI , low,n= 1,1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
DBP, Day 5, high, n= 0,0,0,2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0032
DBP, Day 5, low, n= 0,0,0,2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0032
DBP, Day 8, 0.5 hr post MRI ,high, n=1,1,0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
DBP, Day 8, 0.5 hr post MRI, low, n= 1,1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
DBP, Day 8, 1 hr post MRI, high, n=0,1, 0, 0
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
DBP, Day 8, 1 hr post MRI, low, n=0,1, 0, 0
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
OG002
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.
OG003
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.
Units
Counts
Participants
OG0002
OG0012
OG0022
OG0032
Title
Denominators
Categories
SBP, Day 1, Pre-MRI, high, n=0, 0, 2, 0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
Title
Measurements
OG0020
SBP, Day 1, Pre-MRI, low, n=0, 0, 2, 0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
SBP, Day 1, 0.5 hr post MRI, high, n=0, 0, 2, 0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
SBP, Day 1,0.5 hr post MRI , low, n=0, 0, 2, 0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
SBP, Day 4,-2 hr pre-MRI, high, n=1,1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
SBP, Day 4,-2 hr pre-MRI, low, n=1,1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
SBP, Day 4,0.5 hr post MRI , high, n=1,1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
SBP, Day 4,0.5 hr post MRI, low, n=1,1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
SBP, Day 4,1 hr post MRI , high, n=1,1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
SBP, Day 4,1 hr post MRI , low, n=1,1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
SBP, Day 5, high, n=0, 0, 0, 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0032
SBP, Day 5, low, n=0, 0, 0, 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0032
SBP, Day 8,0.5 hr Post MRI, high, n=1,1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
SBP, Day 8,0.5 hr Post MRI, low, n=1,1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
SBP, Day 8,1 hr Post MRI, high, n= 0,1, 0, 0
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
SBP, Day 8,1 hr post MRI , low, n= 0,1, 0, 0
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
DBP, Day 1, Pre MRI, high,n= 0, 0, 2, 0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
DBP, Day 1, Pre MRI, low,n= 0, 0, 2, 0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
DBP, Day 1,0.5 hr post MRI, high,n= 0, 0, 2, 0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
DBP, Day 1,0.5 hr post MRI, low,n= 0, 0, 2, 0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
DBP, Day 4,-2 hr pre-MRI, high, n=1,1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
DBP, Day 4,-2 hr pre-MRI, low, n=1,1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
DBP, Day 4,0.5 hr Post MRI, high,n= 1,1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
DBP, Day 4,0.5 hr Post MRI, low,n= 1,1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
DBP, Day 4,1 hr post MRI, high,n= 1,1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
DBP, Day 4,1 hr post MRI , low,n= 1,1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
DBP, Day 5, high, n= 0,0,0,2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0032
DBP, Day 5, low, n= 0,0,0,2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0032
DBP, Day 8, 0.5 hr post MRI ,high, n=1,1,0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
DBP, Day 8, 0.5 hr post MRI, low, n= 1,1, 0, 0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
DBP, Day 8, 1 hr post MRI, high, n=0,1, 0, 0
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
DBP, Day 8, 1 hr post MRI, low, n=0,1, 0, 0
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Units
Counts
Participants
OG0004
OG0014
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
Units
Counts
Participants
OG0004
OG0014
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
Units
Counts
Participants
OG0004
OG0014
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
Units
Counts
Participants
OG0004
OG0014
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG002
Albiglutide Matching Placebo
Participants in Session 1 received albiglutide matching placebo on Day 1 or Day 5 and during Session 2 participants received albiglutide matching placebo on Day 5 or Day 1. 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.
OG003
Exenatide Matching Placebo
Participants in Session 1 received exenatide matching placebo on Day 4 or Day 8 and during Session 2 participants received exenatide matching placebo on Day 8 or Day 4. 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.
Units
Counts
Participants
OG0004
OG0014
OG0024
OG0034
Title
Denominators
Categories
Non-serious AEs
Title
Measurements
OG0001
OG0010
OG0020
OG0030
SAE
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
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.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG001
Exenatide 10 µg
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.
OG002
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.
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.
OG002
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.
Units
Counts
Participants
OG0002
OG0012
OG0022
Title
Denominators
Categories
Hunger, Day1, pre-MRI,n=0,0,2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
Title
Measurements
OG00254.5± 33.23
Hunger, Day1,0.5 hour post-MRI,n=0,0,2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
Title
Measurements
OG002
Hunger, Day4, pre-MRI,n=1,1,0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG000
Hunger, Day4,0.5 hour post-MRI,n=1,1,0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG000
Hunger, Day8, pre-MRI,n=1,1,0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG000
Hunger, Day8, 0.5 hour post-MRI,n=1,1,0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG000
Stomach fullness, Day1, pre-MRI,n=0,0,2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
Title
Measurements
OG002
Stomach fullness, Day1, 0.5 hour post-MRI,n=0,0,2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
Title
Measurements
OG002
Stomach fullness, Day4, pre-MRI,n=1,1,0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG000
Stomach fullness, Day4,0.5 hour post-MRI,n=1,1,0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG000
Stomach fullness, Day8, pre-MRI,n=1,1,0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG000
Stomach fullness, Day8,0.5 hour post-MRI,n=1,1,0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG000
Nausea, Day1, pre-MRI,n=0,0,2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
Title
Measurements
OG002
Nausea, Day1, 0.5 hour post-MRI,n=0,0,2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
Title
Measurements
OG002
Nausea, Day4, pre-MRI,n=1,1,0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG000
Nausea, Day4,0.5 hour post-MRI,n=1,1,0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG000
Nausea, Day8, pre-MRI,n=1,1,0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG000
Nausea, Day8, 0.5 hour post-MRI,n=1,1,0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG000
Bloating, Day1, pre-MRI,n=0, 0, 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
Title
Measurements
OG002
Bloating, Day1, 0.5 hour post-MRI,n=0,0,2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
Title
Measurements
OG002
Bloating, Day4, pre-MRI,n=1,1,0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG000
Bloating, Day4,0.5 hour post-MRI,n=1,1,0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG000
Bloating, Day8, pre-MRI,n=1,1,0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG000
Bloating, Day8, 0.5 hour post-MRI,n=1,1,0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG000
Abdominal pain, Day1, pre-MRI,n=0,0,2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
Title
Measurements
OG002
Abdominal pain, Day1, 0.5 hour post-MRI,n=0,0,2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
Title
Measurements
OG002
Abdominal pain, Day4, pre-MRI,n=1,1,0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG000
Abdominal pain, Day4, 0.5 hour post-MRI,n=1,1,0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG000
Abdominal pain, Day8, pre-MRI,n=1,1,0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG000
Abdominal pain, Day8, 0.5 hour post-MRI,n=1,1,0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG000
OG001
Exenatide 10 µg
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.
OG002
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.
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.
OG002
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.
Units
Counts
Participants
OG0002
OG0012
OG0022
Title
Denominators
Categories
C, Felt faint like, Day1,0.5 hr Post MRI ,n=0,0,2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
Title
Measurements
OG0023.0± 2.83
C, Felt faint like, Day4,0.5 hr Post MRI ,n=1,1,0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG000
C, Felt faint like, Day8,0.5 hr,Post MRI,n=1,1,0
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0020
Title
Measurements
OG000
C, Felt lightheaded, Day1,0.5 hr Post MRI,n=0,0,2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
Title
Measurements
OG002
C, Felt lightheaded, Day4, 0.5 hr Post MRI,n=1,1,0