← Trials/Trial dossier/NCT02802514
TerminatedPhase 4Results posted
A Study Comparing the Effect of Albiglutide With Exenatide on Regional Brain Activity Related to Nausea in Healthy Subjects
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
Lead sponsor
Assets
Albiglutide / Exenatide
Listed sites
1
Recruiting sites
—
Enrollment
5
actual
Study population
Healthy volunteers
Key I/E criterion
•Healthy volunteers
Primary endpoints
•Blood Oxygen Level Dependent (BOLD) Signal by Functional Magnetic Resonance•Regional Cerebral Blood Flow (rCBF) by Functional MRI (fMRI)-Arterial Spin•Glutamate Concentration in Nausea-associated Brain Regions by Magnetic
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
NCT IDNCT02802514
Org study ID201840
Timeline
Milestones
Study first posted2016-06-16estimated
Study start2016-09-20actual
Primary completion2017-08-10actual
Study completion2017-09-07actual
Results first posted2020-08-24actual
Last update posted2020-10-30actual
Assets
Investigational agents
Study populations
Who this study enrolls
Healthy volunteers
Eligibility
Who can enroll
Minimum age18 Years
Maximum age50 Years
SexAll
Healthy volunteersAccepted
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
•Motion Sickness Susceptibility Questionnaire (MSSQ) Screening score >60 and mock fMRI nausea rating >=2
•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
•stimulate or inhibit CNS (e.g., modafinil, dexamphetamine, methylphenidate, bromopheniramine, chlorpheniramine, clemastine, diphenhydramine, hyrdoxyzine)
•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
Endpoints (22)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Safety / tolerability / PK
7
Other (unclassified)
5
Cardiometabolic biomarkers
4
Patient-reported / QoL
4
Glycemic / diabetes
1
Other clinical outcomes
1
Glycemic / diabetes
1 endpointSecondary/protocol endpoint
Number of Participants With Abnormal Glycemic Parameters
Time frame:Up to Week 11
threshold achievement, improvement
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Albiglutide 50 mg | 0 | — |
| Exenatide 10 µg | 0 | — |
Cardiometabolic biomarkers
4 endpointsSecondary/protocol endpoint
Heart Rate Variability Using Autonomic Response Measures by MRI
Time frame:Up to Week 11
descriptive
Secondary/protocol endpoint
Number of Participants With Abnormal Heart Rate for Session 2
Time frame: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
Heart rate, change
threshold achievement, improvement
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Off-therapy MRI ArmDay 1, Pre MRI, high, n=0, 0, 2, 0 | 0 | — |
| Day 1, Pre MRI, low, n=0, 0, 2, 0 | 0 | — |
| Day 1, Post MRI 0.5 hr, high, n=0, 0, 2, 0 | 0 | — |
| Day 1, Post MRI 0.5 hr, low, n=0, 0, 2, 0 | 0 | — |
| Albiglutide 50 mgDay 4, -2 hr pre-MRI, high, n=1, 1,0, 0 | 0 | — |
| Day 4, -2 hr pre-MRI, low, n=1, 1, 0, 0 | 0 | — |
| Day 4, Post MRI 0.5 hr, high, n=1, 1, 0, 0 | 0 | — |
| Day 4, 0.5 hr Post MRI, low, n=1, 1, 0, 0 | 0 | — |
| Day 4, 1 hr Post MRI, high, n=1, 1, 0, 0 | 0 | — |
| Day 4, 1 hr Post MRI, low, n=1, 1, 0, 0 | 0 | — |
| Day 8, -2 hr pre-MRI, high, n=1, 1, 0, 0 | 0 | — |
| Day 8, -2 hr pre-MRI, low, n=1, 1, 0, 0 | 0 | — |
| Day 8, 0.5 hr Post MRI, high, n=1, 1, 0, 0 | 0 | — |
| Day 8, 0.5 hr Post MRI, low, n=1, 1, 0, 0 | 0 | — |
| Exenatide 10 µgDay 4, -2 hr pre-MRI, high, n=1, 1,0, 0 | 0 | — |
| Day 4, -2 hr pre-MRI, low, n=1, 1, 0, 0 | 0 | — |
| Day 4, Post MRI 0.5 hr, high, n=1, 1, 0, 0 | 0 | — |
| Day 4, 0.5 hr Post MRI, low, n=1, 1, 0, 0 | 0 | — |
| Day 4, 1 hr Post MRI, high, n=1, 1, 0, 0 | 0 | — |
| Day 4, 1 hr Post MRI, low, n=1, 1, 0, 0 | 0 | — |
| Day 8, -2 hr pre-MRI, high, n=1, 1, 0, 0 | 0 | — |
| Day 8, -2 hr pre-MRI, low, n=1, 1, 0, 0 | 0 | — |
| Day 8, 0.5 hr Post MRI, high, n=1, 1, 0, 0 | 0 | — |
| Day 8, 0.5 hr Post MRI, low, n=1, 1, 0, 0 | 0 | — |
| Day 8, 1 hr Post MRI, high, n=0, 1, 0, 0 | 0 | — |
| Day 8, 1 hr Post MRI, low, n=0, 1, 0, 0 | 0 | — |
| Off-therapy VisitDay 5, high, n=0, 0, 0, 2 | 0 | — |
| Day 5, low, n=0, 0, 0, 2 | 0 | — |
Secondary/protocol endpoint
Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Session 1
Time frame: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
threshold achievement, improvement
componentsSystolic BP, change, Diastolic BP, change
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Off-therapy MRI ArmSBP, Day 1, Pre-MRI, high, n=0, 0, 2, 0 | 0 | — |
| SBP, Day 1, Pre-MRI, low, n=0, 0, 2, 0 | 0 | — |
| SBP, Day 1, 0.5 hr post MRI, high, n=0, 0, 2, 0 | 0 | — |
| SBP, Day 1,0.5 hr post MRI , low, n=0, 0, 2, 0 | 0 | — |
| DBP, Day 1, Pre MRI, high,n= 0,0, 2, 0 | 0 | — |
| DBP, Day 1, Pre MRI, low,n= 0, 0, 2, 0 | 0 | — |
| DBP, Day 1,0.5 hr post MRI, high,n= 0, 0, 2, 0 | 0 | — |
| DBP, Day 1,0.5 hr post MRI, low,n= 0, 0, 2, 0 | 0 | — |
| Albiglutide 50 mgSBP, Day 4,-2 hr pre-MRI, high, n=1,1, 0, 0 | 0 | — |
| SBP, Day 4,-2 hr pre-MRI, low, n=1,1, 0, 0 | 0 | — |
| SBP, Day 4,0.5 hr post MRI , high, n=1,1, 0, 0 | 0 | — |
| SBP, Day 4,0.5 hr post MRI, low, n=1,1, 0, 0 | 0 | — |
| SBP, Day 4,1 hr post MRI , high, n=1,1, 0, 0 | 0 | — |
| SBP, Day 4,1 hr post MRI , low, n=1,1, 0, 0 | 0 | — |
| SBP, Day 8,0.5 hr Post MRI, high, n=1,1, 0, 0 | 0 | — |
| SBP, Day 8,0.5 hr Post MRI, low, n=1,1, 0, 0 | 0 | — |
| DBP, Day 4,-2 hr pre-MRI, high, n=1,1, 0, 0 | 0 | — |
| DBP, Day 4,-2 hr pre-MRI, low, n=1,1, 0, 0 | 0 | — |
| DBP, Day 4,0.5 hr Post MRI, high,n= 1,1, 0, 0 | 0 | — |
| DBP, Day 4,0.5 hr Post MRI, low,n= 1,1, 0, 0 | 0 | — |
| DBP, Day 4,1 hr post MRI, high,n= 1,1, 0, 0 | 0 | — |
| DBP, Day 4,1 hr post MRI , low,n= 1,1, 0, 0 | 0 | — |
| DBP, Day 8, 0.5 hr post MRI ,high, n=1,1,0, 0 | 0 | — |
| DBP, Day 8, 0.5 hr post MRI, low, n= 1,1, 0, 0 | 0 | — |
| Exenatide 10 µgSBP, Day 4,-2 hr pre-MRI, high, n=1,1, 0, 0 | 0 | — |
| SBP, Day 4,-2 hr pre-MRI, low, n=1,1, 0, 0 | 0 | — |
| SBP, Day 4,0.5 hr post MRI , high, n=1,1, 0, 0 | 0 | — |
| SBP, Day 4,0.5 hr post MRI, low, n=1,1, 0, 0 | 0 | — |
| SBP, Day 4,1 hr post MRI , high, n=1,1, 0, 0 | 0 | — |
| SBP, Day 4,1 hr post MRI , low, n=1,1, 0, 0 | 0 | — |
| SBP, Day 8,0.5 hr Post MRI, high, n=1,1, 0, 0 | 0 | — |
| SBP, Day 8,0.5 hr Post MRI, low, n=1,1, 0, 0 | 0 | — |
| SBP, Day 8,1 hr Post MRI, high, n= 0,1, 0, 0 | 0 | — |
| SBP, Day 8,1 hr post MRI , low, n= 0,1, 0, 0 | 0 | — |
| DBP, Day 4,-2 hr pre-MRI, high, n=1,1, 0, 0 | 0 | — |
| DBP, Day 4,-2 hr pre-MRI, low, n=1,1, 0, 0 | 0 | — |
| DBP, Day 4,0.5 hr Post MRI, high,n= 1,1, 0, 0 | 0 | — |
| DBP, Day 4,0.5 hr Post MRI, low,n= 1,1, 0, 0 | 0 | — |
| DBP, Day 4,1 hr post MRI, high,n= 1,1, 0, 0 | 0 | — |
| DBP, Day 4,1 hr post MRI , low,n= 1,1, 0, 0 | 0 | — |
| DBP, Day 8, 0.5 hr post MRI ,high, n=1,1,0, 0 | 0 | — |
| DBP, Day 8, 0.5 hr post MRI, low, n= 1,1, 0, 0 | 0 | — |
| DBP, Day 8, 1 hr post MRI, high, n=0,1, 0, 0 | 0 | — |
| DBP, Day 8, 1 hr post MRI, low, n=0,1, 0, 0 | 0 | — |
| Off-therapy VisitSBP, Day 5, high, n=0, 0, 0, 2 | 0 | — |
| SBP, Day 5, low, n=0, 0, 0, 2 | 0 | — |
| DBP, Day 5, high, n= 0,0,0,2 | 0 | — |
| DBP, Day 5, low, n= 0,0,0,2 | 0 | — |
Secondary/protocol endpoint
Number of Participants With Abnormal SBP and DBP for Session 2
Time frame: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
threshold achievement, improvement
componentsSystolic BP, change, Diastolic BP, change
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Off-therapy MRISBP, Day 1, Pre-MRI, high, n=0, 0, 2, 0 | 0 | — |
| SBP, Day 1, Pre-MRI, low, n=0, 0, 2, 0 | 0 | — |
| SBP, Day 1, 0.5 hr post MRI, high, n=0, 0, 2, 0 | 0 | — |
| SBP, Day 1,0.5 hr post MRI , low, n=0, 0, 2, 0 | 0 | — |
| DBP, Day 1, Pre MRI, high,n= 0, 0, 2, 0 | 0 | — |
| DBP, Day 1, Pre MRI, low,n= 0, 0, 2, 0 | 0 | — |
| DBP, Day 1,0.5 hr post MRI, high,n= 0, 0, 2, 0 | 1 | — |
| DBP, Day 1,0.5 hr post MRI, low,n= 0, 0, 2, 0 | 0 | — |
| Albiglutide 50 mgSBP, Day 4,-2 hr pre-MRI, high, n=1,1, 0, 0 | 0 | — |
| SBP, Day 4,-2 hr pre-MRI, low, n=1,1, 0, 0 | 0 | — |
| SBP, Day 4,0.5 hr post MRI , high, n=1,1, 0, 0 | 0 | — |
| SBP, Day 4,0.5 hr post MRI, low, n=1,1, 0, 0 | 0 | — |
| SBP, Day 4,1 hr post MRI , high, n=1,1, 0, 0 | 0 | — |
| SBP, Day 4,1 hr post MRI , low, n=1,1, 0, 0 | 0 | — |
| SBP, Day 8,0.5 hr Post MRI, high, n=1,1, 0, 0 | 0 | — |
| SBP, Day 8,0.5 hr Post MRI, low, n=1,1, 0, 0 | 0 | — |
| DBP, Day 4,-2 hr pre-MRI, high, n=1,1, 0, 0 | 0 | — |
| DBP, Day 4,-2 hr pre-MRI, low, n=1,1, 0, 0 | 0 | — |
| DBP, Day 4,0.5 hr Post MRI, high,n= 1,1, 0, 0 | 0 | — |
| DBP, Day 4,0.5 hr Post MRI, low,n= 1,1, 0, 0 | 0 | — |
| DBP, Day 4,1 hr post MRI, high,n= 1,1, 0, 0 | 0 | — |
| DBP, Day 4,1 hr post MRI , low,n= 1,1, 0, 0 | 0 | — |
| DBP, Day 8, 0.5 hr post MRI ,high, n=1,1,0, 0 | 0 | — |
| DBP, Day 8, 0.5 hr post MRI, low, n= 1,1, 0, 0 | 0 | — |
| Exenatide 10 µgSBP, Day 4,-2 hr pre-MRI, high, n=1,1, 0, 0 | 0 | — |
| SBP, Day 4,-2 hr pre-MRI, low, n=1,1, 0, 0 | 0 | — |
| SBP, Day 4,0.5 hr post MRI , high, n=1,1, 0, 0 | 0 | — |
| SBP, Day 4,0.5 hr post MRI, low, n=1,1, 0, 0 | 0 | — |
| SBP, Day 4,1 hr post MRI , high, n=1,1, 0, 0 | 0 | — |
| SBP, Day 4,1 hr post MRI , low, n=1,1, 0, 0 | 0 | — |
| SBP, Day 8,0.5 hr Post MRI, high, n=1,1, 0, 0 | 0 | — |
| SBP, Day 8,0.5 hr Post MRI, low, n=1,1, 0, 0 | 0 | — |
| SBP, Day 8,1 hr Post MRI, high, n= 0,1, 0, 0 | 0 | — |
| SBP, Day 8,1 hr post MRI , low, n= 0,1, 0, 0 | 0 | — |
| DBP, Day 4,-2 hr pre-MRI, high, n=1,1, 0, 0 | 0 | — |
| DBP, Day 4,-2 hr pre-MRI, low, n=1,1, 0, 0 | 0 | — |
| DBP, Day 4,0.5 hr Post MRI, high,n= 1,1, 0, 0 | 0 | — |
| DBP, Day 4,0.5 hr Post MRI, low,n= 1,1, 0, 0 | 0 | — |
| DBP, Day 4,1 hr post MRI, high,n= 1,1, 0, 0 | 0 | — |
| DBP, Day 4,1 hr post MRI , low,n= 1,1, 0, 0 | 0 | — |
| DBP, Day 8, 0.5 hr post MRI ,high, n=1,1,0, 0 | 0 | — |
| DBP, Day 8, 0.5 hr post MRI, low, n= 1,1, 0, 0 | 0 | — |
| DBP, Day 8, 1 hr post MRI, high, n=0,1, 0, 0 | 0 | — |
| DBP, Day 8, 1 hr post MRI, low, n=0,1, 0, 0 | 0 | — |
| Off-therapy VisitSBP, Day 5, high, n=0, 0, 0, 2 | 0 | — |
| SBP, Day 5, low, n=0, 0, 0, 2 | 0 | — |
| DBP, Day 5, high, n= 0,0,0,2 | 0 | — |
| DBP, Day 5, low, n= 0,0,0,2 | 0 | — |
Patient-reported / QoL
4 endpointsSecondary/protocol endpoint
Gastrointestinal (GI) Visual Analogue Scale (VAS) for Assessment of Nausea for Session 1
Time frame: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)
PGI, change
descriptive, improvement
Posted result
| Group | Value (mean), Scores on scale | 95% CI |
|---|---|---|
| Off-therapy MRIHunger, Day1, pre-MRI,n=0,0,2 | 29.0 | — |
| Hunger, Day1, 0.5 hour post-MRI,n=0,0,2 | 55.0 | — |
| Stomach fullness, Day1, pre-MRI,n=0,0,2 | 9.0 | — |
| Stomach fullness, Day1, 0.5 hour post-MRI,n=0,0,2 | 0.5 | — |
| Nausea, Day1, pre- MRI,n=0,0,2 | 1.0 | — |
| Nausea, Day1,0.5 hour post-MRI,n=0,0,2 | 19.0 | — |
| Bloating, Day1, pre-MRI,n=0,0,2 | 1.5 | — |
| Bloating, Day1, 0.5 hour post-MRI,n=0,0,2 | 1.0 | — |
| Abdominal pain, Day1, pre-MRI,n=0,0,2 | 2.0 | — |
| Abdominal pain, Day1,0.5 hour post-MRI,n=0,0,2 | 1.5 | — |
| Albiglutide 50 mgHunger, Day4, pre-MRI,n=1,1,0 | 65.0 | — |
| Hunger, Day4, 0.5 hour post-MRI,n=1,1,0 | 66.0 | — |
| Hunger, Day8, pre-MRI,n=1,1,0 | 1.0 | — |
| Hunger, Day8, 0.5 hour post-MRI,n=1,1,0 | 31.0 | — |
| Stomach fullness, Day4,pre-MRI,n=1,1,0 | 3.0 | — |
| Stomach fullness, Day4, 0.5 hour post-MRI,n=1,1,0 | 6.0 | — |
| Stomach fullness, Day8, pre-MRI,n=1,1,0 | 0.0 | — |
| Stomach fullness, Day8, 0.5 hour post- MRI,n=1,1,0 | 0.0 | — |
| Nausea, Day4, pre-MRI,n=1,1,0 | 3.0 | — |
| Nausea, Day4, 0.5 hour post-MRI,n=1,1,0 | 24.0 | — |
| Nausea, Day8, pre-MRI,n=1,1,0 | 0.0 | — |
| Nausea, Day8,0.5 hour post-MRI,n=1,1,0 | 0.0 | — |
| Bloating, Day4, pre-MRI,n=1,1,0 | 2.0 | — |
| Bloating, Day4, 0.5 hour post-MRI,n=1,1,0 | 4.0 | — |
| Bloating, Day8, pre-MRI,n=1,1,0 | 0.0 | — |
| Bloating, Day8, 0.5 hour post-MRI,n=1,1,0 | 0.0 | — |
| Abdominal pain, Day4, pre-MRI,n=1,1,0 | 3.0 | — |
| Abdominal pain, Day4, 0.5 hour post-MRI,n=1,1,0 | 5.0 | — |
| Abdominal pain, Day8, pre-MRI,n=1,1,0 | 0.0 | — |
| Abdominal pain, Day8, 0.5 hour post-MRI,n=1,1,0 | 0.0 | — |
| Exenatide 10 µgHunger, Day4, pre-MRI,n=1,1,0 | 40.0 | — |
| Hunger, Day4, 0.5 hour post-MRI,n=1,1,0 | 50.0 | — |
| Hunger, Day8, pre-MRI,n=1,1,0 | 25.0 | — |
| Hunger, Day8, 0.5 hour post-MRI,n=1,1,0 | 26.0 | — |
| Stomach fullness, Day4,pre-MRI,n=1,1,0 | 1.0 | — |
| Stomach fullness, Day4, 0.5 hour post-MRI,n=1,1,0 | 2.0 | — |
| Stomach fullness, Day8, pre-MRI,n=1,1,0 | 1.0 | — |
| Stomach fullness, Day8, 0.5 hour post- MRI,n=1,1,0 | 1.0 | — |
| Nausea, Day4, pre-MRI,n=1,1,0 | 1.0 | — |
| Nausea, Day4, 0.5 hour post-MRI,n=1,1,0 | 1.0 | — |
| Nausea, Day8, pre-MRI,n=1,1,0 | 0.0 | — |
| Nausea, Day8,0.5 hour post-MRI,n=1,1,0 | 1.0 | — |
| Bloating, Day4, pre-MRI,n=1,1,0 | 3.0 | — |
| Bloating, Day4, 0.5 hour post-MRI,n=1,1,0 | 1.0 | — |
| Bloating, Day8, pre-MRI,n=1,1,0 | 0.0 | — |
| Bloating, Day8, 0.5 hour post-MRI,n=1,1,0 | 1.0 | — |
| Abdominal pain, Day4, pre-MRI,n=1,1,0 | 0.0 | — |
| Abdominal pain, Day4, 0.5 hour post-MRI,n=1,1,0 | 1.0 | — |
| Abdominal pain, Day8, pre-MRI,n=1,1,0 | 1.0 | — |
| Abdominal pain, Day8, 0.5 hour post-MRI,n=1,1,0 | 1.0 | — |
Secondary/protocol endpoint
GI VAS for Assessment of Nausea for Session 2
Time frame: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)
PGI, change
descriptive, improvement
Posted result
| Group | Value (mean), Scores on scale | 95% CI |
|---|---|---|
| Off-therapy MRIHunger, Day1, pre-MRI,n=0,0,2 | 54.5 | — |
| Hunger, Day1,0.5 hour post-MRI,n=0,0,2 | 67.5 | — |
| Stomach fullness, Day1, pre-MRI,n=0,0,2 | 11.5 | — |
| Stomach fullness, Day1, 0.5 hour post-MRI,n=0,0,2 | 7.0 | — |
| Nausea, Day1, pre-MRI,n=0,0,2 | 23.5 | — |
| Nausea, Day1, 0.5 hour post-MRI,n=0,0,2 | 17.5 | — |
| Bloating, Day1, pre-MRI,n=0, 0, 2 | 6.0 | — |
| Bloating, Day1, 0.5 hour post-MRI,n=0,0,2 | 4.0 | — |
| Abdominal pain, Day1, pre-MRI,n=0,0,2 | 7.5 | — |
| Abdominal pain, Day1, 0.5 hour post-MRI,n=0,0,2 | 4.0 | — |
| Albiglutide 50 mgHunger, Day4, pre-MRI,n=1,1,0 | 2.0 | — |
| Hunger, Day4,0.5 hour post-MRI,n=1,1,0 | 57.0 | — |
| Hunger, Day8, pre-MRI,n=1,1,0 | 38.0 | — |
| Hunger, Day8, 0.5 hour post-MRI,n=1,1,0 | 53.0 | — |
| Stomach fullness, Day4, pre-MRI,n=1,1,0 | 2.0 | — |
| Stomach fullness, Day4,0.5 hour post-MRI,n=1,1,0 | 1.0 | — |
| Stomach fullness, Day8, pre-MRI,n=1,1,0 | 11.0 | — |
| Stomach fullness, Day8,0.5 hour post-MRI,n=1,1,0 | 3.0 | — |
| Nausea, Day4, pre-MRI,n=1,1,0 | 1.0 | — |
| Nausea, Day4,0.5 hour post-MRI,n=1,1,0 | 0.0 | — |
| Nausea, Day8, pre-MRI,n=1,1,0 | 2.0 | — |
| Nausea, Day8, 0.5 hour post-MRI,n=1,1,0 | 2.0 | — |
| Bloating, Day4, pre-MRI,n=1,1,0 | 2.0 | — |
| Bloating, Day4,0.5 hour post-MRI,n=1,1,0 | 1.0 | — |
| Bloating, Day8, pre-MRI,n=1,1,0 | 1.0 | — |
| Bloating, Day8, 0.5 hour post-MRI,n=1,1,0 | 2.0 | — |
| Abdominal pain, Day4, pre-MRI,n=1,1,0 | 1.0 | — |
| Abdominal pain, Day4, 0.5 hour post-MRI,n=1,1,0 | 1.0 | — |
| Abdominal pain, Day8, pre-MRI,n=1,1,0 | 1.0 | — |
| Abdominal pain, Day8, 0.5 hour post-MRI,n=1,1,0 | 2.0 | — |
| Exenatide 10 µgHunger, Day4, pre-MRI,n=1,1,0 | 53.0 | — |
| Hunger, Day4,0.5 hour post-MRI,n=1,1,0 | 66.0 | — |
| Hunger, Day8, pre-MRI,n=1,1,0 | 77.0 | — |
| Hunger, Day8, 0.5 hour post-MRI,n=1,1,0 | 73.0 | — |
| Stomach fullness, Day4, pre-MRI,n=1,1,0 | 0.0 | — |
| Stomach fullness, Day4,0.5 hour post-MRI,n=1,1,0 | 0.0 | — |
| Stomach fullness, Day8, pre-MRI,n=1,1,0 | 10.0 | — |
| Stomach fullness, Day8,0.5 hour post-MRI,n=1,1,0 | 13.0 | — |
| Nausea, Day4, pre-MRI,n=1,1,0 | 0.0 | — |
| Nausea, Day4,0.5 hour post-MRI,n=1,1,0 | 0.0 | — |
| Nausea, Day8, pre-MRI,n=1,1,0 | 48.0 | — |
| Nausea, Day8, 0.5 hour post-MRI,n=1,1,0 | 38.0 | — |
| Bloating, Day4, pre-MRI,n=1,1,0 | 0.0 | — |
| Bloating, Day4,0.5 hour post-MRI,n=1,1,0 | 0.0 | — |
| Bloating, Day8, pre-MRI,n=1,1,0 | 6.0 | — |
| Bloating, Day8, 0.5 hour post-MRI,n=1,1,0 | 6.0 | — |
| Abdominal pain, Day4, pre-MRI,n=1,1,0 | 0.0 | — |
| Abdominal pain, Day4, 0.5 hour post-MRI,n=1,1,0 | 0.0 | — |
| Abdominal pain, Day8, pre-MRI,n=1,1,0 | 7.0 | — |
| Abdominal pain, Day8, 0.5 hour post-MRI,n=1,1,0 | 6.0 | — |
Secondary/protocol endpoint/low confidence
Motion Sickness Assessment Questionnaire (MSAQ) for Assessment of Nausea for Session 1
Time frame:Day 1 0.5 hour post-MRI; Day 4 0.5 hour post-MRI; and Day 8 0.5 hour post-MRI
PGI, change
descriptive, improvement
Posted result
| Group | Value (mean), Scores on scale | 95% CI |
|---|---|---|
| Off-therapy MRIC, Felt faint like, Day1,0.5 hr,Post MRI,n=0,0,2 | 4.0 | — |
| C, Felt lightheaded, Day1,0.5 hr,Post MRI,n=0,0,2 | 5.5 | — |
| C, Felt disoriented, Day1,0.5 hr,Post MRI,n=0,0,2 | 4.5 | — |
| C, Felt dizzy, Day1,0.5 hr,Post MRI,n=0,0,2 | 8.0 | — |
| C, Felt spinning, Day1,0.5 hr,Post MRI,n=0,0,2 | 5.5 | — |
| GI, stomach sick, Day1,0.5hr,Post MRI,n=0,0,2 | 5.0 | — |
| GI, felt queasy, Day1,0.5hr,Post MRI,n=0,0,2 | 6.5 | — |
| GI, nauseated, Day1, 0.5hr,Post MRI,n=0,0,2 | 6.5 | — |
| GI, may vomit, Day1,0.5hr,Post MRI,n=0,0,2 | 6.5 | — |
| P, sweaty, Day1,0.5hr,Post MRI,n=0,0,2 | 4.5 | — |
| P, clammy/cold sweat,Day1,0.5hr,Post MRI,n=0,0,2 | 4.5 | — |
| P, hot/warm, Day1,0.5hr,Post MRI,n=0, 0, 2 | 2.5 | — |
| SR,annoyed/irritated,Day1,0.5hr,Post MRI,n=0,0,2 | 5.0 | — |
| SR, drowsy, Day1,0.5hr,Post MRI,n=0,0,2 | 1.0 | — |
| SR, tired/fatigued, Day1,0.5hr,Post MRI,n=0,0,2 | 1.5 | — |
| SR, uneasy, Day1,0.5hr,Post MRI,n=0,0,2 | 8.0 | — |
| Albiglutide 50 mgC, Felt faint like, Day4,0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| C, Felt faint like, Day8, 0.5 hr,Post MRI,n=1,1,0 | 2.0 | — |
| C, Felt lightheaded, Day4,0.5 hr,Post MRI,n=1,1,0 | 2.0 | — |
| C, Felt lightheaded, Day8, 0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| C, Felt disoriented, Day4, 0.5 hr,Post MRI,n=1,1,0 | 3.0 | — |
| C, Felt disoriented, Day8, 0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| C, Felt dizzy, Day4,0.5 hr,Post MRI,n=1,1,0 | 2.0 | — |
| C, Felt dizzy, Day8,0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| C, Felt spinning, Day4,0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| C, Felt spinning, Day8, 0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| GI, stomach sick, Day4,0.5hr,Post MRI,n=1,1,0 | 1.0 | — |
| GI, stomach sick, Day8,0.5hr,Post MRI,n=1,1,0 | 1.0 | — |
| GI, felt queasy, Day4,0.5hr,Post MRI,n=1,1,0 | 4.0 | — |
| GI, felt queasy, Day8,0.5hr,Post MRI,n=1,1,0 | 1.0 | — |
| GI, nauseated, Day4,0.5hr,Post MRI,n=1,1,0 | 3.0 | — |
| GI, nauseated, Day8,0.5hr,Post MRI,n=1,1,0 | 1.0 | — |
| GI, may vomit, Day4,0.5hr,Post MRI,n=1,1,0 | 1.0 | — |
| GI, may vomit, Day8,0.5hr,Post MRI,n=1,1,0 | 1.0 | — |
| P, sweaty, Day4,0.5 hr,Post MRI,n=1,1,0 | 2.0 | — |
| P, sweaty, Day8, 0.5 hr,Post MRI,n=1,1,0 | 2.0 | — |
| P,clammy/cold sweat,Day4,0.5 hr,Post MRI,n=1,1,0 | 3.0 | — |
| P, clammy/cold sweat,Day8,0.5 hr,Post MRI,n=1,1,0 | 2.0 | — |
| P, hot/warm, Day4,0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| P, hot/warm, Day8, 0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| SR,annoyed/irritated,Day4,0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| SR,annoyed/irritated,Day8, 0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| SR, drowsy, Day4, 0.5 hr,Post MRI,n=1,1,0 | 5.0 | — |
| SR, drowsy, Day8, 0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| SR, tired/fatigued, Day4,0.5 hr,Post MRI,n=1,1,0 | 4.0 | — |
| SR, tired/fatigued, Day8,0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| SR, uneasy, Day4, 0.5 hr,Post MRI,n=1,1,0 | 2.0 | — |
| SR, uneasy, Day8,0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| Exenatide 10 µgC, Felt faint like, Day4,0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| C, Felt faint like, Day8, 0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| C, Felt lightheaded, Day4,0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| C, Felt lightheaded, Day8, 0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| C, Felt disoriented, Day4, 0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| C, Felt disoriented, Day8, 0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| C, Felt dizzy, Day4,0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| C, Felt dizzy, Day8,0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| C, Felt spinning, Day4,0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| C, Felt spinning, Day8, 0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| GI, stomach sick, Day4,0.5hr,Post MRI,n=1,1,0 | 1.0 | — |
| GI, stomach sick, Day8,0.5hr,Post MRI,n=1,1,0 | 1.0 | — |
| GI, felt queasy, Day4,0.5hr,Post MRI,n=1,1,0 | 1.0 | — |
| GI, felt queasy, Day8,0.5hr,Post MRI,n=1,1,0 | 1.0 | — |
| GI, nauseated, Day4,0.5hr,Post MRI,n=1,1,0 | 1.0 | — |
| GI, nauseated, Day8,0.5hr,Post MRI,n=1,1,0 | 1.0 | — |
| GI, may vomit, Day4,0.5hr,Post MRI,n=1,1,0 | 1.0 | — |
| GI, may vomit, Day8,0.5hr,Post MRI,n=1,1,0 | 1.0 | — |
| P, sweaty, Day4,0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| P, sweaty, Day8, 0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| P,clammy/cold sweat,Day4,0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| P, clammy/cold sweat,Day8,0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| P, hot/warm, Day4,0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| P, hot/warm, Day8, 0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| SR,annoyed/irritated,Day4,0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| SR,annoyed/irritated,Day8, 0.5 hr,Post MRI,n=1,1,0 | 2.0 | — |
| SR, drowsy, Day4, 0.5 hr,Post MRI,n=1,1,0 | 2.0 | — |
| SR, drowsy, Day8, 0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| SR, tired/fatigued, Day4,0.5 hr,Post MRI,n=1,1,0 | 2.0 | — |
| SR, tired/fatigued, Day8,0.5 hr,Post MRI,n=1,1,0 | 2.0 | — |
| SR, uneasy, Day4, 0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| SR, uneasy, Day8,0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
Secondary/protocol endpoint
MSAQ for Assessment of Nausea for Session 2
Time frame:Day 1 0.5 hour post-MRI; Day 4 0.5 hour post-MRI; and Day 8 0.5 hour post-MRI
descriptive
Posted result
| Group | Value (mean), Scores on scale | 95% CI |
|---|---|---|
| Off-therapy MRIC, Felt faint like, Day1,0.5 hr Post MRI ,n=0,0,2 | 3.0 | — |
| C, Felt lightheaded, Day1,0.5 hr Post MRI,n=0,0,2 | 2.0 | — |
| C, Felt disoriented, Day1,0.5 hr, Post MRI,n=0,0,2 | 2.0 | — |
| C, Felt dizzy, Day1, 0.5 hr,Post MRI,n=0,0,2 | 2.0 | — |
| C, Felt spinning, Day1,0.5 hr,Post MRI,n=0,0,2 | 4.0 | — |
| GI, stomach sick, Day1,0.5hr,Post MRI, n=0,0,2 | 5.0 | — |
| GI, felt queasy, Day1, 0.5hr post-MRI,n=0,0,2 | 4.5 | — |
| GI, nauseated, Day1,0.5hr,Post MRI,n=0,0,2 | 6.0 | — |
| GI, may vomit, Day1,0.5hr,Post MRI,n=0,0,2 | 2.0 | — |
| P, sweaty, Day1,0.5 hr,Post MRI,n=0,0,2 | 1.5 | — |
| P,clammy/cold sweat,Day1,0.5hr,post-MRI,n=0,0,2 | 2.0 | — |
| P, hot/warm, Day1,0.5 hr, Post-MRI,n=0,0,2 | 1.0 | — |
| SR,annoyed/irritated,Day1,0.5hr, Post-MRI,n=0,0,2 | 1.5 | — |
| SR, drowsy, Day1, 0.5 hr,Post-MRI,n=0,0,2 | 4.0 | — |
| SR, tired/fatigued, Day1,0.5 hr,Post MRI,n=0,0,2 | 4.5 | — |
| SR, uneasy, Day1, 0.5 hr,Post-MRI,n=0,0,2 | 4.0 | — |
| Albiglutide 50 mgC, Felt faint like, Day4,0.5 hr Post MRI ,n=1,1,0 | 1.0 | — |
| C, Felt faint like, Day8,0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| C, Felt lightheaded, Day4, 0.5 hr Post MRI,n=1,1,0 | 1.0 | — |
| C, Felt lightheaded, Day8, 0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| C, Felt disoriented, Day4,0.5 hr Post MRI,n=1,1,0 | 1.0 | — |
| C, Felt disoriented, Day8,0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| C, Felt dizzy, Day4,0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| C, Felt dizzy, Day8,0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| C, Felt spinning, Day4,0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| C, Felt spinning, Day8,0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| GI, stomach sick, Day4, 0.5hr post-MRI,n=1,1,0 | 1.0 | — |
| GI, stomach sick, Day8,0.5hr,Post MRI,n=1,1,0 | 1.0 | — |
| GI, felt queasy, Day4,0.5hr,Post MRI,n=1,1,0 | 1.0 | — |
| GI, felt queasy, Day8, 0.5h,Post MRI,n=1,1,0 | 1.0 | — |
| GI, nauseated, Day4,0.5hr,Post MRI,n=1,1,0 | 1.0 | — |
| GI, nauseated, Day8,0.5hr,Post MRI, n=1,1,0 | 1.0 | — |
| GI, may vomit, Day4,0.5hr,Post MRI,n=1,1,0 | 1.0 | — |
| GI, may vomit, Day8,0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| P, sweaty, Day4, 0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| P, sweaty, Day8,0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| P, clammy/cold sweat, Day4,0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| P,clammy/cold sweat,Day8,0.5hr,Post-MRI,n=1,1,0 | 1.0 | — |
| P, hot/warm, Day4, 0.5 hr,Post-MRI,n=1,1,0 | 1.0 | — |
| P, hot/warm,Day8, 0.5 hr Post-MRI,n=1,1,0 | 1.0 | — |
| SR,annoyed/irritated,Day4,0.5hr,Post-MRI,n=1,1,0 | 1.0 | — |
| SR,annoyed/irritated,Day8,0.5hr,Post MRI,n=1,1,0 | 1.0 | — |
| SR, drowsy, Day4, 0.5 hr,Post-MRI,n=1,1,0 | 5.0 | — |
| SR, drowsy, Day8, 0.5 hr, Post-MRI,n=1,1,0 | 1.0 | — |
| SR, tired/fatigued, Day4,0.5 hr,Post MRI,n=1,1,0 | 4.0 | — |
| SR, tired/fatigued, Day8,0.5 hr,Post MRI,n=1,1,0 | 3.0 | — |
| SR, uneasy, Day4, 0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| SR, uneasy, Day8, 0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| Exenatide 10 µgC, Felt faint like, Day4,0.5 hr Post MRI ,n=1,1,0 | 2.0 | — |
| C, Felt faint like, Day8,0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| C, Felt lightheaded, Day4, 0.5 hr Post MRI,n=1,1,0 | 2.0 | — |
| C, Felt lightheaded, Day8, 0.5 hr,Post MRI,n=1,1,0 | 2.0 | — |
| C, Felt disoriented, Day4,0.5 hr Post MRI,n=1,1,0 | 1.0 | — |
| C, Felt disoriented, Day8,0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| C, Felt dizzy, Day4,0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| C, Felt dizzy, Day8,0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| C, Felt spinning, Day4,0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| C, Felt spinning, Day8,0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| GI, stomach sick, Day4, 0.5hr post-MRI,n=1,1,0 | 1.0 | — |
| GI, stomach sick, Day8,0.5hr,Post MRI,n=1,1,0 | 1.0 | — |
| GI, felt queasy, Day4,0.5hr,Post MRI,n=1,1,0 | 1.0 | — |
| GI, felt queasy, Day8, 0.5h,Post MRI,n=1,1,0 | 2.0 | — |
| GI, nauseated, Day4,0.5hr,Post MRI,n=1,1,0 | 1.0 | — |
| GI, nauseated, Day8,0.5hr,Post MRI, n=1,1,0 | 3.0 | — |
| GI, may vomit, Day4,0.5hr,Post MRI,n=1,1,0 | 1.0 | — |
| GI, may vomit, Day8,0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| P, sweaty, Day4, 0.5 hr,Post MRI,n=1,1,0 | 3.0 | — |
| P, sweaty, Day8,0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| P, clammy/cold sweat, Day4,0.5 hr,Post MRI,n=1,1,0 | 3.0 | — |
| P,clammy/cold sweat,Day8,0.5hr,Post-MRI,n=1,1,0 | 1.0 | — |
| P, hot/warm, Day4, 0.5 hr,Post-MRI,n=1,1,0 | 1.0 | — |
| P, hot/warm,Day8, 0.5 hr Post-MRI,n=1,1,0 | 1.0 | — |
| SR,annoyed/irritated,Day4,0.5hr,Post-MRI,n=1,1,0 | 1.0 | — |
| SR,annoyed/irritated,Day8,0.5hr,Post MRI,n=1,1,0 | 1.0 | — |
| SR, drowsy, Day4, 0.5 hr,Post-MRI,n=1,1,0 | 1.0 | — |
| SR, drowsy, Day8, 0.5 hr, Post-MRI,n=1,1,0 | 5.0 | — |
| SR, tired/fatigued, Day4,0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| SR, tired/fatigued, Day8,0.5 hr,Post MRI,n=1,1,0 | 3.0 | — |
| SR, uneasy, Day4, 0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
| SR, uneasy, Day8, 0.5 hr,Post MRI,n=1,1,0 | 1.0 | — |
Safety / tolerability / PK
7 endpointsSecondary/protocol endpoint
Number of Participants With Abnormal Electrocardiogram (ECG) Intervals Using Autonomic Response Measures by MRI
Time frame:Up to Week 11
threshold achievement, event
Secondary/protocol endpoint
Number of Participants With Abnormal Heart Rate for Session 1
Time frame: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
threshold achievement, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Off-therapy MRI ArmDay 1, Pre MRI, high, n=0, 0, 2, 0 | 0 | — |
| Day 1, Pre MRI, low, n=0, 0, 2, 0 | 0 | — |
| Day 1, Post MRI 0.5 hr, high, n=0, 0, 2, 0 | 0 | — |
| Day 1, Post MRI 0.5 hr, low, n=0, 0, 2, 0 | 0 | — |
| Albiglutide 50 mgDay 4, -2 hr pre-MRI, high, n=1, 1, 0, 0 | 0 | — |
| Day 4, -2 hr pre-MRI, low, n=1, 1, 0, 0 | 0 | — |
| Day 4, Post MRI 0.5 hr, high, n=1, 1, 0, 0 | 0 | — |
| Day 4, 0.5 hr Post MRI, low, n=1, 1, 0, 0 | 0 | — |
| Day 4, 1 hr Post MRI, high, n=1, 1, 0, 0 | 0 | — |
| Day 4, 1 hr Post MRI, low, n=1, 1, 0, 0 | 0 | — |
| Day 8, -2 hr pre-MRI, high, n=1, 1, 0, 0 | 0 | — |
| Day 8, -2 hr pre-MRI, low, n=1, 1, 0, 0 | 0 | — |
| Day 8, 0.5 hr Post MRI, high, n=1, 1, 0, 0 | 0 | — |
| Day 8, 0.5 hr Post MRI, low, n=1, 1, 0, 0 | 0 | — |
| Exenatide 10 µgDay 4, -2 hr pre-MRI, high, n=1, 1, 0, 0 | 0 | — |
| Day 4, -2 hr pre-MRI, low, n=1, 1, 0, 0 | 0 | — |
| Day 4, Post MRI 0.5 hr, high, n=1, 1, 0, 0 | 0 | — |
| Day 4, 0.5 hr Post MRI, low, n=1, 1, 0, 0 | 0 | — |
| Day 4, 1 hr Post MRI, high, n=1, 1, 0, 0 | 0 | — |
| Day 4, 1 hr Post MRI, low, n=1, 1, 0, 0 | 0 | — |
| Day 8, -2 hr pre-MRI, high, n=1, 1, 0, 0 | 0 | — |
| Day 8, -2 hr pre-MRI, low, n=1, 1, 0, 0 | 0 | — |
| Day 8, 0.5 hr Post MRI, high, n=1, 1, 0, 0 | 0 | — |
| Day 8, 0.5 hr Post MRI, low, n=1, 1, 0, 0 | 0 | — |
| Day 8, 1 hr Post MRI, high, n=0, 1, 0, 0 | 0 | — |
| Day 8, 1 hr Post MRI, low, n=0, 1, 0, 0 | 0 | — |
| Off-therapy VisitDay 5, high, n=0, 0, 0, 2 | 0 | — |
| Day 5, low, n=0, 0, 0, 2 | 0 | — |
Secondary/protocol endpoint
Number of Participants With Abnormal Clinical Chemistry Parameters
Time frame:Up to Week 11
threshold achievement, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Albiglutide 50 mg | 0 | — |
| Exenatide 10 µg | 0 | — |
Secondary/protocol endpoint
Number of Participants With Abnormal Hematology Parameters
Time frame:Up to Week 11
threshold achievement, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Albiglutide 50 mg | 0 | — |
| Exenatide 10 µg | 0 | — |
Secondary/protocol endpoint
Number of Participants With Abnormal Urinalysis
Time frame:Up to Week 11
threshold achievement, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Albiglutide 50 mg | 0 | — |
| Exenatide 10 µg | 0 | — |
Secondary/protocol endpoint
Number of Participants With Non-serious Adverse Events (AE) With Incidence > = 2 % and Serious AEs (SAE)
Time frame:Up to Week 13
Serious AEs (any)
threshold achievement, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Albiglutide 50 mgNon-serious AEs | 1 | — |
| SAE | 0 | — |
| Exenatide 10 µgNon-serious AEs | 0 | — |
| SAE | 0 | — |
| Albiglutide Matching PlaceboNon-serious AEs | 0 | — |
| SAE | 0 | — |
| Exenatide Matching PlaceboNon-serious AEs | 0 | — |
| SAE | 0 | — |
Secondary/protocol endpoint
Nausea Ratings Scale to Rate Nausea Sensation Using Autonomic Response Measures by MRI
Time frame:Up to Week 11
Nausea
descriptive
Other clinical outcomes
1 endpointSecondary/protocol endpoint/low confidence
Number of Participants With Skin Conductance Level Using Autonomic Response Measures by MRI
Time frame:Up to Week 11
descriptive
Other (unclassified)
5 endpointsPrimary/protocol endpoint/low confidence
Blood Oxygen Level Dependent (BOLD) Signal by Functional Magnetic Resonance Imaging (fMRI) Visual Nauseogenic Task
Time frame:Up to Week 11
descriptive
Primary/protocol endpoint/low confidence
Regional Cerebral Blood Flow (rCBF) by Functional MRI (fMRI)-Arterial Spin Labeling (ASL)
Time frame:Up to Week 11
descriptive
Primary/protocol endpoint/low confidence
Glutamate Concentration in Nausea-associated Brain Regions by Magnetic Resonance Spectroscopy (MRS)
Time frame:Up to Week 11
ratio, descriptive
Primary/protocol endpoint/low confidence
Gama-aminobutyric Acid (GABA) Concentration in Nausea-associated Brain Regions by MRS
Time frame:Up to Week 11
ratio, descriptive
Secondary/protocol endpoint/low confidence
Number of Participants With Abnormal Respiratory Rate Using Autonomic Response Measures by MRI
Time frame:Up to Week 11
threshold achievement, descriptive
Provenance
Sources
Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.