← Trials/Trial dossier/NCT02793154
TerminatedPhase 4Results posted
An Exploratory Study on the Effects of Repeat Doses of Albiglutide Compared to Exenatide on Gastric Myoelectrical Activity and Gastric Emptying in Type 2 Diabetes Mellitus Subjects
A Randomized, Open-label, Active-Controlled, Parallel-Group, Exploratory Study on the Effects of Repeated Doses of Albiglutide Compared to Exenatide on Gastric Myoelectrical Activity and Gastric Emptying in Subjects With Type 2 Diabetes Mellitus
Lead sponsor
Assets
Albiglutide / Exenatide
Listed sites
2
Recruiting sites
—
Enrollment
4
actual
Study population
Type 2 diabetes
Key I/E criteria
•BMI 2-35•HbA1c 6.5-9%
Primary endpoints
•Part•EGG dominant freq pct time•Nausea
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 IDNCT02793154
Org study ID204879
Timeline
Milestones
Study first posted2016-06-08estimated
Study start2016-09-26actual
Primary completion2017-03-16actual
Study completion2017-03-16actual
Results first posted2018-05-23actual
Last update posted2020-10-30actual
Assets
Investigational agents
Study populations
Who this study enrolls
Type 2 diabetes
Eligibility
Who can enroll
Minimum age18 Years
Maximum age60 Years
SexAll
Healthy volunteersNot accepted
Inclusion criteria
•Male or female, aged between 18 and 60 years of age at the time of signing the informed consent.
•Type 2 diabetes mellitus diagnosed at least 6 months prior to screening.
•Subjects treated with diet and exercise alone or stable dose of single oral antihyperglycemic medication (OAM) of metformin, sulfonylurea (except chlorpropamide), sodium glucose co-transporter 2-inhibitor, or meglitinide for at least 2 months prior to screening
•Glycated hemoglobin A1C (HbA1c) >6.5% and <=9.0% at screening. If the first HbA1c value does not meet eligibility criterion, the HbA1c may be rechecked once during screening. If the average of these determinations meets the criterion, the subject is eligible.
•Fasting plasma glucose (FPG) <=210 mg/deciliter (dL; central lab) at screening. If the first FPG value does not meet eligibility criterion, the FPG may be rechecked once during screening.
•Patient assessment of upper GI symptom severity index at screening:
Overall score <=20 (if score is >=21 and <=25, subjects can be re-evaluated 2 weeks later) Total score of items 1-9 is <=9 Score from any of single item <=2
•Body mass index (BMI) >20 kilograms (kg)/meter (m)^2 and <35 kg/m^2 and a stable weight (no more than 5% reported change within 3 months prior to screening).
•A female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin [hCG] test for females of reproductive potential [FRP] only), not breastfeeding, and at least one of the following conditions applies:
Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in FRP (eg., combined oral contraceptive pill) from 30 days prior to the first dose of study medication and until after the last dose of study medication and completion of the follow-up visit.
Non-reproductive potential defined as either:
•Pre-menopausal with one of the following: documented tubal ligation; documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; hysterectomy; or documented bilateral oophorectomy, or;
•Postmenopausal defined as 12 months of spontaneous amenorrhea and age appropriate (i.e., >50 years). In questionable cases, a blood sample with simultaneous follicle stimulating hormone >40 milli-International units/milliliters (mL) and estradiol <40 picograms/mL (<140 picomoles/L) is confirmatory, depending on local laboratory ranges. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment
–For the regular use of other medications (does not include protocol excluded medications), subjects must be on a stable dose for at least 4 weeks before screening
–Capable of giving signed informed consent; which includes compliance with the requirements and restrictions listed in the consent form and in this protocol
Exclusion criteria
•Type 1 diabetes mellitus
•Type 2 diabetes mellitus treated with more than one OAM or with chronic use of insulin within 3 months prior to screening
•Hemoglobin <11 grams (g)/dL (<110 g/L) for male subjects and <10 g/dL (<100 g/L) for female subjects at screening
•Fasting triglyceride level >500 mg/dL at screening
•Hemoglobinopathy that may affect proper interpretation of HbA1c
•History of cancer that has not been in full remission for at least 3 years before screening. (A history of squamous cell or basal cell carcinoma of the skin or treated cervical intra-epithelial neoplasia I or II is allowed).
•Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
•History of acute or chronic pancreatitis.
•History or current severe lactose intolerance
•History of thyroid dysfunction or an abnormal (i.e., outside the normal reference range) thyroid function test assessed by thyroid stimulating hormone at screening.
•Alanine aminotransferase (ALT) >2.5x upper limit of normal (ULN).
•Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
•Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).
•Clinical diagnosis of gastroparesis.
•History of significant GI medical conditions such as chronic esophagitis, peptic ulcer diseases, celiac disease, inflammatory bowel disease, unexplained abdominal pain or irritable bowel syndrome and/or history of surgery that in the opinion of the investigator is likely to significantly affect upper GI or pancreatic function (e.g., gastric bypass, gastric banding, antrectomy, Roux en Y bypass, gastric vagotomy, small bowel resection, or surgeries thought to significantly affect upper GI function).
•History of hypoglycemia unawareness (i.e., the absence of autonomic warning symptoms before the development of neuroglycopenic symptoms such as blurred vision, difficulty speaking, feeling faint, difficulty thinking, and confusion).
•Diabetic complications (e.g., active proliferative retinopathy or severe diabetic neuropathy) or any other clinically significant abnormality (including a psychiatric disorder) that, in the opinion of the investigator, may pose additional risk in administering the investigational product or may influence data interpretation.
•Clinically significant cardiovascular and/or cerebrovascular disease at any time, such as prior myocardial infarction, unstable angina, stroke, transient ischemic attack or documented heart failure, before screening.
•Estimated glomerular filtration rate (eGFR) <=75 mL/min/1.73 m^2 (calculated using the MDRD formula) at screening.
•Lung diseases associated with pulmonary dysfunction (e.g. chronic obstructive pulmonary disease).
•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 should be excluded unless 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
•Unable to refrain from medications that might modify GMA or GI motility, such as prokinetics (e.g., erythromycin), anti-emetics (e.g., metoclopromide), narcotics (e.g., morphine), anticholinergics (e.g.,domperidone), anti-acids (e.g., proton pump inhibitors, H2 blockers) and laxatives, received within 7 days prior to screening or high likelihood of a requirement during the study.
•Use of oral or systemically injected glucocorticoids within the 3 months prior to randomization or high likelihood of a requirement for prolonged treatment (>1 week) in the 4months following randomization. However, short courses of oral steroids (single dose or multiple doses for up to 7 days) may be permitted provided these cases are discussed with the Medical Monitor. Inhaled, intra-articular, epidural, and topical corticosteroids are allowed
•Known allergy to albiglutide, exenatide or any product components (including yeast and human albumin), any other glucagon-like receptor 1 analogue, or other study treatment excipients OR other contraindications (per the principal investigator) for the use of potential study treatment.
•Intolerance or allergy to any component of GE test meal
•Received any glucagon-like peptide 1 receptor agonist at any time
•Receipt of any investigational drug within the 30 days or 5 half-lives, whichever is longer, before screening, a history of receipt of an investigational antidiabetic drug within the 3 months before randomization.
•Exposure to more than 4 investigational medicinal products within 12 months prior to the first dosing day
Endpoints (46)
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
21
Other (unclassified)
7
Other clinical outcomes
6
Renal / kidney
5
Patient-reported / QoL
4
Glycemic / diabetes
1
MASH / liver
1
Cardiometabolic biomarkers
1
Glycemic / diabetes
1 endpointPrimary/protocol endpoint/low confidence
Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels
Time frame:Day 5
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Posted result
| Group | Value (number), Millimoles per liter | 95% CI |
|---|---|---|
| Part A: Exenatide SC InjectionPar. 1; Glucose | 9.2 | — |
| Par. 1; Calcium | 2.44 | — |
| Par. 1; Magnesium | 0.86 | — |
| Par. 1; Potassium | 5.6 | — |
| Par. 1; Sodium | 139 | — |
| Par. 1; Phosphorus inorganic | 1.5 | — |
| Par. 1; Chloride | 105 | — |
| Par. 1; Urea/BUN | 7.5 | — |
| Par. 2; Glucose | 7.5 | — |
| Par. 2; Calcium | 2.44 | — |
| Par. 2; Magnesium | 0.9 | — |
| Par. 2; Potassium | 5.1 | — |
| Par. 2; Sodium | 139 | — |
| Par. 2; Phosphorus inorganic | 1.25 | — |
| Par. 2; Chloride | 105 | — |
| Par. 2; Urea/BUN | 6.5 | — |
| Par. 3; Glucose | 9.1 | — |
| Par. 3; Calcium | 2.38 | — |
| Par. 3; Magnesium | 0.8 | — |
| Par. 3; Potassium | 4.2 | — |
| Par. 3; Sodium | 140 | — |
| Par. 3; Phosphorus inorganic | 1.2 | — |
| Par. 3; Chloride | 103 | — |
| Par. 3; Urea/BUN | 7 | — |
| Par. 4; Glucose | 7.9 | — |
| Par. 4; Calcium | 2.4 | — |
| Par. 4; Magnesium | 0.8 | — |
| Par. 4; Potassium | 4.3 | — |
| Par. 4; Sodium | 138 | — |
| Par. 4; Phosphorus inorganic | 1.15 | — |
| Par. 4; Chloride | 101 | — |
| Par. 4; Urea/BUN | 4.5 | — |
MASH / liver
1 endpointPrimary/protocol endpoint
Part A: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) Levels at Indicated Time Points
Time frame:Day 5
descriptive
Posted result
| Group | Value (number), International unit per liter | 95% CI |
|---|---|---|
| Part A: Exenatide SC InjectionPar. 1; ALT | 21 | — |
| Par. 1; AST | 20 | — |
| Par. 1; GGT | 46 | — |
| Par. 2; ALT | 25 | — |
| Par. 2; AST | 18 | — |
| Par. 2; GGT | 76 | — |
| Par. 3; ALT | 11 | — |
| Par. 3; AST | 12 | — |
| Par. 3; GGT | 19 | — |
| Par. 4; ALT | 17 | — |
| Par. 4; AST | 20 | — |
| Par. 4; GGT | 30 | — |
Renal / kidney
5 endpointsPrimary/protocol endpoint/low confidence
Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points
Time frame:Day 5
descriptive
Posted result
| Group | Value (number), Micromoles per liter | 95% CI |
|---|---|---|
| Part A: Exenatide SC InjectionPar. 1; Creatinine | 67.2 | — |
| Par. 1; Direct Bilirubin | 2 | — |
| Par. 1; Total Bilirubin | 10 | — |
| Par. 1; Indirect Bilirubin | 8 | — |
| Par. 2; Creatinine | 105.2 | — |
| Par. 2; Direct Bilirubin | 2 | — |
| Par. 2; Total Bilirubin | 6 | — |
| Par. 2; Indirect Bilirubin | 4 | — |
| Par. 3; Creatinine | 76.9 | — |
| Par. 3; Direct Bilirubin | 4 | — |
| Par. 3; Total Bilirubin | 16 | — |
| Par. 3; Indirect Bilirubin | 12 | — |
| Par. 4; Creatinine | 83.1 | — |
| Par. 4; Direct Bilirubin | 2 | — |
| Par. 4; Total Bilirubin | 6 | — |
| Par. 4; Indirect Bilirubin | 4 | — |
Primary/protocol endpoint
Part A: Estimated Glomerular Filtration Rate at Indicated Time Points
Time frame:Day 5
eGFR, change
change from baseline, improvement
Posted result
| Group | Value (number), Milliliter per second per 1.73 meter ^2 | 95% CI |
|---|---|---|
| Part A: Exenatide SC InjectionPart. 1 | 1.3026 | — |
| Part. 2 | 1.2859 | — |
| Part. 3 | 1.5197 | — |
| Part. 4 | 1.6533 | — |
Primary/protocol endpoint
Part A: Albumin Level in Urine at Indicated Time Points
Time frame:Day 5
descriptive
Posted result
| Group | Value (number), Milligrams per liter | 95% CI |
|---|---|---|
| Part A: Exenatide SC InjectionPar. 1 | 35 | — |
| Par. 2 | 35 | — |
| Par. 3 | 5 | — |
| Par. 4 | 5 | — |
Primary/protocol endpoint
Part A: Concentration of Creatinine in Urine at Indicated Time Points
Time frame:Day 5
concentration, descriptive
Posted result
| Group | Value (number), Micromoles per liter | 95% CI |
|---|---|---|
| Part A: Exenatide SC InjectionPar. 1 | 12450 | — |
| Par. 2 | 16240 | — |
| Par. 3 | 13300 | — |
| Par. 4 | 22020 | — |
Primary/protocol endpoint
Part A: Presence RBC and WBC in Urine Assessed by Microscopy
Time frame:Day 5
descriptive
Posted result
| Group | Value (number), High Power field | 95% CI |
|---|---|---|
| Part A: Exenatide SC InjectionPar.1; RBC | 1 | — |
| Par. 1; WBC | 1 | — |
| Par. 2; RBC | NA | — |
| Par. 2; WBC | NA | — |
| Par. 3; RBC | NA | — |
| Part. 3; WBC | NA | — |
| Part 4; RBC | NA | — |
| Part. 4; WBC | NA | — |
Cardiometabolic biomarkers
1 endpointPrimary/protocol endpoint
Part A: Assessment of Heart Rate (HR) as a Measure of Safety
Time frame:Up to 12 days
Heart rate, change
change from baseline, descriptive
Posted result
| Group | Value (number), Beats per minute | 95% CI |
|---|---|---|
| Part A: Exenatide SC InjectionPar. 1; Day -1 | 69 | — |
| Par. 1; Day 1 | 65 | — |
| Par. 1; Day 4 | 66 | — |
| Par. 1; Day 5 | 84 | — |
| Par. 1; Follow-up | 68 | — |
| Par. 2; Day -1 | 57 | — |
| Par. 2; Day 1 | 64 | — |
| Par. 2; Day 4 | 62 | — |
| Par. 2; Day 5 | 82 | — |
| Par. 2; Follow-up | 58 | — |
| Par. 3; Day -1 | 72 | — |
| Par. 3; Day 1 | 74 | — |
| Par. 3; Day 4 | 78 | — |
| Par. 3; Day 5 | 82 | — |
| Par. 3; Follow-up | 78 | — |
| Par. 4; Day -1 | 78 | — |
| Par. 4; Day 1 | 89 | — |
| Par. 4; Day 4 | 77 | — |
| Par. 4; Day 5 | 82 | — |
| Par. 4; Follow-up | 72 | — |
Patient-reported / QoL
4 endpointsPrimary/protocol endpoint
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Time frame:Up to Day 5
descriptive, improvement
Posted result
| Group | Value (number), Scores on GCSI-DD scale | 95% CI |
|---|---|---|
| Part A: Exenatide SC InjectionPar. 1; Day-1; Epi of vomiting | 0 | — |
| Par. 1; Day 1; Epi of vomiting | 0 | — |
| Par. 1; Day 4; Epi of vomiting | 0 | — |
| Par. 1; Day 5; Epi of vomiting | 0 | — |
| Par. 1; Day -1; Epi of retching | 0 | — |
| Par. 1; Day 1; Epi of retching | 0 | — |
| Par. 1; Day 4; Epi of retching | 0 | — |
| Par. 1; Day 5; Epi of retching | 0 | — |
| Par 1; Day -1; Nausea | 0 | — |
| Par 1; Day 1; Nausea | 0 | — |
| Par 1; Day 4; Nausea | 2 | — |
| Par 1; Day 5; Nausea | 1 | — |
| Par 1; Day -1; Excessively full after meals | 2 | — |
| Par 1; Day 1; Excessively full after meals | 2 | — |
| Par 1; Day 4; Excessively full after meals | 5 | — |
| Par 1; Day 5; Excessively full after meals | 2 | — |
| Par 1; Day -1; Bloating | 0 | — |
| Par 1; Day 1; Bloating | 0 | — |
| Par 1; Day 4; Bloating | 0 | — |
| Par 1; Day 5; Bloating | 5 | — |
| Par 1; Day -1; Unable to finish normal-sized meal | 2 | — |
| Par 1; Day 1; Unable to finish normal-sized meal | 2 | — |
| Par 1; Day 4; Unable to finish normal-sized meal | 5 | — |
| Par 1; Day 5; Unable to finish normal-sized meal | 2 | — |
| Par 1; Day -1; Retching | 0 | — |
| Par 1; Day 1; Retching | 0 | — |
| Par 1; Day 4; Retching | 2 | — |
| Par 1; Day 5; Retching | 1 | — |
| Par 1; Day -1; Vomiting | 0 | — |
| Par 1; Day 1; Vomiting | 0 | — |
| Par 1; Day 4; Vomiting | 0 | — |
| Par 1; Day 5; Vomiting | 0 | — |
| Par 1; Day -1; Stomach or belly visibly larger | 0 | — |
| Par 1; Day 1; Stomach or belly visibly larger | 0 | — |
| Par 1; Day 4; Stomach or belly visibly larger | 0 | — |
| Par 1; Day 5; Stomach or belly visibly larger | 0 | — |
| Par 1; Day -1; Stomach fullness | 2 | — |
| Par 1; Day 1; Stomach fullness | 2 | — |
| Par 1; Day 4; Stomach fullness | 5 | — |
| Par 1; Day 5; Stomach fullness | 5 | — |
| Par 1; Day -1; Loss of appetite | 2 | — |
| Par 1; Day 1; Loss of appetite | 2 | — |
| Par 1; Day 4; Loss of appetite | 0 | — |
| Par 1; Day 5; Loss of appetite | 2 | — |
| Par 1; Day -1; Upper abdominal pain | 0 | — |
| Par 1; Day 1; Upper abdominal pain | 0 | — |
| Par 1; Day 4; Upper abdominal pain | 0 | — |
| Par 1; Day 5; Upper abdominal pain | 3 | — |
| Par 1; Day -1; Upper abdominal discomfort | 0 | — |
| Par 1; Day 1; Upper abdominal discomfort | 0 | — |
| Par 1; Day 4; Upper abdominal discomfort | 0 | — |
| Par 1; Day 5; Upper abdominal discomfort | 3 | — |
| Par 1; Day -1; Overall severity of gastroparesis | 0 | — |
| Par 1; Day 1; Overall severity of gastroparesis | 0 | — |
| Par 1; Day 4; Overall severity of gastroparesis | 0 | — |
| Par 1; Day 5; Overall severity of gastroparesis | 4 | — |
| Par. 2; Day -1; Epi of vomiting | 0 | — |
| Par. 2; Day 1; Epi of vomiting | 0 | — |
| Par. 2; Day 4; Epi of vomiting | 0 | — |
| Par. 2; Day 5; Epi of vomiting | 0 | — |
| Par. 2; Day -1; Epi of retching | 0 | — |
| Par. 2; Day 1; Epi of retching | 0 | — |
| Par. 2; Day 4; Epi of retching | 0 | — |
| Par. 2; Day 5; Epi of retching | 0 | — |
| Par. 2; Day -1; Nausea | 0 | — |
| Par. 2 Day 1; Nausea | 0 | — |
| Par. 2; Day 4; Nausea | 0 | — |
| Par. 2; Day 5; Nausea | 0 | — |
| Par. 2; Day -1; Excessively full after meals | 0 | — |
| Par. 2; Day 1; Excessively full after meals | 0 | — |
| Par. 2; Day 4; Excessively full after meals | 0 | — |
| Par. 2; Day 5; Excessively full after meals | 0 | — |
| Par. 2; Day -1; Bloating | 0 | — |
| Par. 2; Day 1; Bloating | 0 | — |
| Par. 2; Day 4; Bloating | 0 | — |
| Par. 2; Day 5; Bloating | 0 | — |
| Par. 2; Day -1; Unable to finish normal-sized meal | 0 | — |
| Par. 2; Day 1; Unable to finish normal-sized meal | 0 | — |
| Par. 2; Day 4; Unable to finish normal-sized meal | 0 | — |
| Par. 2; Day 5; Unable to finish normal-sized meal | 0 | — |
| Par. 2; Day -1; Retching | 0 | — |
| Par. 2; Day 1; Retching | 0 | — |
| Par. 2; Day 4; Retching | 0 | — |
| Par. 2; Day 5; Retching | 0 | — |
| Par. 2; Day -1; Vomiting | 0 | — |
| Par. 2; Day 1; Vomiting | 0 | — |
| Par. 2; Day 4; Vomiting | 0 | — |
| Par. 2; Day 5; Vomiting | 0 | — |
| Par. 2; Day -1; Stomach or belly visibly larger | 0 | — |
| Par. 2; Day 1; Stomach or belly visibly larger | 0 | — |
| Par. 2; Day 4; Stomach or belly visibly larger | 0 | — |
| Par. 2; Day 5; Stomach or belly visibly larger | 0 | — |
| Par. 2; Day -1; Stomach fullness | 0 | — |
| Par. 2; Day 1; Stomach fullness | 0 | — |
| Par. 2; Day 4; Stomach fullness | 1 | — |
| Par. 2; Day 5; Stomach fullness | 0 | — |
| Par. 2; Day -1; Loss of appetite | 0 | — |
| Par. 2; Day 1; Loss of appetite | 0 | — |
| Par. 2; Day 4; Loss of appetite | 0 | — |
| Par. 2; Day 5; Loss of appetite | 0 | — |
| Par. 2; Day -1; Upper abdominal pain | 0 | — |
| Par. 2; Day 1; Upper abdominal pain | 0 | — |
| Par. 2; Day 4; Upper abdominal pain | 0 | — |
| Par. 2; Day 5; Upper abdominal pain | 0 | — |
| Par. 2; Day -1; Upper abdominal discomfort | 0 | — |
| Par. 2; Day 1; Upper abdominal discomfort | 0 | — |
| Par. 2; Day 4; Upper abdominal discomfort | 0 | — |
| Par. 2; Day 5; Upper abdominal discomfort | 0 | — |
| Par. 2; Day -1; Overall severity of gastroparesis | 0 | — |
| Par. 2; Day 1; Overall severity of gastroparesis | 0 | — |
| Par. 2; Day 4; Overall severity of gastroparesis | 0 | — |
| Par. 2; Day 5; Overall severity of gastroparesis | 0 | — |
| Par. 3; Day -1; Epi of vomiting | 0 | — |
| Par. 3; Day 1; Epi of vomiting | 0 | — |
| Par. 3; Day 4; Epi of vomiting | 0 | — |
| Par. 3; Day 5; Epi of vomiting | 0 | — |
| Par. 3; Day -1; Epi of retching | 0 | — |
| Par. 3; Day 1; Epi of retching | 0 | — |
| Par. 3; Day 4; Epi of retching | 0 | — |
| Par. 3; Day 5; Epi of retching | 0 | — |
| Par. 3; Day -1; Nausea | 0 | — |
| Par. 3; Day 1; Nausea | 0 | — |
| Par. 3; Day 4; Nausea | 0 | — |
| Par. 3; Day 5; Nausea | 0 | — |
| Par. 3; Day -1; Excessively full after meals | 0 | — |
| Par. 3; Day 1; Excessively full after meals | 0 | — |
| Par. 3; Day 4; Excessively full after meals | 0 | — |
| Par. 3; Day 5; Excessively full after meals | 0 | — |
| Par. 3; Day -1; Bloating | 0 | — |
| Par. 3; Day 1; Bloating | 0 | — |
| Par. 3; Day 4; Bloating | 0 | — |
| Par. 3; Day 5; Bloating | 0 | — |
| Par. 3; Day -1; Unable to finish normal-sized meal | 0 | — |
| Par. 3; Day 1; Unable to finish normal-sized meal | 0 | — |
| Par. 3; Day 4; Unable to finish normal-sized meal | 0 | — |
| Par. 3; Day 5; Unable to finish normal-sized meal | 0 | — |
| Par. 3; Day -1; Retching | 0 | — |
| Par. 3; Day 1; Retching | 0 | — |
| Par. 3; Day 4; Retching | 0 | — |
| Par. 3; Day 5; Retching | 0 | — |
| Par. 3; Day -1; Vomiting | 0 | — |
| Par. 3; Day 1; Vomiting | 0 | — |
| Par. 3; Day 4; Vomiting | 0 | — |
| Par. 3; Day 5; Vomiting | 0 | — |
| Par. 3; Day -1; Stomach or belly visibly larger | 0 | — |
| Par. 3; Day 1; Stomach or belly visibly larger | 0 | — |
| Par. 3; Day 4; Stomach or belly visibly larger | 0 | — |
| Par. 3; Day 5; Stomach or belly visibly larger | 0 | — |
| Par. 3; Day -1; Stomach fullness | 0 | — |
| Par. 3; Day 1; Stomach fullness | 0 | — |
| Par. 3; Day 4; Stomach fullness | 0 | — |
| Par. 3; Day 5; Stomach fullness | 0 | — |
| Par. 3; Day -1; Loss of appetite | 0 | — |
| Par. 3; Day 1; Loss of appetite | 0 | — |
| Par. 3; Day 4; Loss of appetite | 0 | — |
| Par. 3; Day 5; Loss of appetite | 0 | — |
| Par. 3; Day -1; Upper abdominal pain | 0 | — |
| Par. 3; Day 1; Upper abdominal pain | 0 | — |
| Par. 3; Day 4; Upper abdominal pain | 0 | — |
| Par. 3; Day 5; Upper abdominal pain | 0 | — |
| Par. 3; Day -1; Upper abdominal discomfort | 0 | — |
| Par. 3; Day 1; Upper abdominal discomfort | 0 | — |
| Par. 3; Day 4; Upper abdominal discomfort | 0 | — |
| Par. 3; Day 5; Upper abdominal discomfort | 0 | — |
| Par. 3; Day -1; Overall severity of gastroparesis | 0 | — |
| Par. 3; Day 1; Overall severity of gastroparesis | 0 | — |
| Par. 3; Day 4; Overall severity of gastroparesis | 0 | — |
| Par. 3; Day 5; Overall severity of gastroparesis | 0 | — |
| Par. 4; Day -1; Epi of vomiting | 0 | — |
| Par. 4; Day 1; Epi of vomiting | 0 | — |
| Par. 4; Day 4; Epi of vomiting | 0 | — |
| Par. 4; Day 5; Epi of vomiting | 0 | — |
| Par. 4; Day -1; Epi of retching | 0 | — |
| Par. 4; Day 1; Epi of retching | 0 | — |
| Par. 4; Day 4; Epi of retching | 0 | — |
| Par. 4; Day 5; Epi of retching | 0 | — |
| Par. 4; Day -1; Nausea | 0 | — |
| Par. 4; Day 1; Nausea | 0 | — |
| Par. 4; Day 4; Nausea | 0 | — |
| Par. 4; Day 5; Nausea | 0 | — |
| Par. 4; Day -1; Excessively full after meals | 0 | — |
| Par. 4; Day 1; Excessively full after meals | 1 | — |
| Par. 4; Day 4; Excessively full after meals | 1 | — |
| Par. 4; Day 5; Excessively full after meals | 0 | — |
| Par. 4; Day -1; Bloating | 0 | — |
| Par. 4; Day 1; Bloating | 1 | — |
| Par. 4; Day 4; Bloating | 0 | — |
| Par. 4; Day 5; Bloating | 0 | — |
| Par.4; Day -1; Unable to finish normal-sized meal | 0 | — |
| Par.4; Day 1; Unable to finish normal-sized meal | 0 | — |
| Par.4; Day 4; Unable to finish normal-sized meal | 0 | — |
| Par.4; Day 5; Unable to finish normal-sized meal | 0 | — |
| Par. 4; Day -1; Retching | 0 | — |
| Par. 4; Day 1; Retching | 0 | — |
| Par. 4; Day 4; Retching | 0 | — |
| Par. 4; Day 5; Retching | 0 | — |
| Par. 4; Day -1; Vomiting | 0 | — |
| Par. 4; Day 1; Vomiting | 0 | — |
| Par. 4; Day 4; Vomiting | 0 | — |
| Par. 4; Day 5; Vomiting | 0 | — |
| Par. 4; Day -1; Stomach or belly visibly larger | 0 | — |
| Par. 4; Day 1; Stomach or belly visibly larger | 0 | — |
| Par. 4; Day 4; Stomach or belly visibly larger | 0 | — |
| Par. 4; Day 5; Stomach or belly visibly larger | 0 | — |
| Par. 4; Day -1; Stomach fullness | 0 | — |
| Par. 4; Day 1; Stomach fullness | 1 | — |
| Par. 4; Day 4; Stomach fullness | 1 | — |
| Par. 4; Day 5; Stomach fullness | 0 | — |
| Par. 4; Day -1; Loss of appetite | 0 | — |
| Par. 4; Day 1; Loss of appetite | 0 | — |
| Par. 4; Day 4; Loss of appetite | 0 | — |
| Par. 4; Day 5; Loss of appetite | 0 | — |
| Par. 4; Day -1; Upper abdominal pain | 0 | — |
| Par. 4; Day 1; Upper abdominal pain | 0 | — |
| Par. 4; Day 4; Upper abdominal pain | 0 | — |
| Par. 4; Day 5; Upper abdominal pain | 0 | — |
| Par. 4; Day -1; Upper abdominal discomfort | 0 | — |
| Par. 4; Day 1; Upper abdominal discomfort | 0 | — |
| Par. 4; Day 4; Upper abdominal discomfort | 0 | — |
| Par. 4; Day 5; Upper abdominal discomfort | 0 | — |
| Par. 4; Day -1; Overall severity of gastroparesis | 0 | — |
| Par. 4; Day 1; Overall severity of gastroparesis | 1 | — |
| Par. 4; Day 4; Overall severity of gastroparesis | 1 | — |
| Par. 4; Day 5; Overall severity of gastroparesis | 0 | — |
Primary/protocol endpoint
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Time frame:Day 4
descriptive
componentsstomach fullness VAS, hunger/satiety VAS, bloating VAS, abdominal pain VAS
Posted result
| Group | Value (number), Scores on VAS scale | 95% CI |
|---|---|---|
| Part A: Exenatide SC InjectionPar. 1; Day 4; Pre-WL; Stomach fullness | 3 | — |
| Par. 1; Day 4; 10 minutes Post-WL;Stomach fullness | 43 | — |
| Par. 1; Stomach fullness;Day 4; 20 minutes Post-WL | 50 | — |
| Par. 1; Day 4; 30 minutes Post-WL;Stomach fullness | 9 | — |
| Par. 2; Day 4; Pre-WL;Stomach fullness | 11 | — |
| Par. 2; Day 4; 10 minutes Post-WL;Stomach fullness | 94 | — |
| Par. 2; Day 4; 20 minutes Post-WL;Stomach fullness | 92 | — |
| Par. 2; Day 4; 30 minutes Post-WL;Stomach fullness | 85 | — |
| Par. 3; Day 4; Pre-WL; Stomach fullness | 10 | — |
| Par. 3; Day 4; 10 minutes Post-WL;Stomach fullness | 89 | — |
| Par. 3; Day 4; 20 minutes Post-WL;Stomach fullness | 82 | — |
| Par. 3; Day 4; 30 minutes Post-WL;Stomach fullness | 75 | — |
| Par. 4; Day 4; Pre-WL;Stomach fullness | 28 | — |
| Par. 4; Day 4; 10 minutes Post-WL;Stomach fullness | 34 | — |
| Par. 4; Day 4; 20 minutes Post-WL;Stomach fullness | 38 | — |
| Par. 4; Day 4; 30 minutes Post-WL;Stomach fullness | 35 | — |
| Par. 1; Day 4; Pre-WL; Bloating | 4 | — |
| Par. 1; Day 4; 10 minutes Post-WL;Bloating | 27 | — |
| Par. 1; Day 4; 20 minutes Post-WL;Bloating | 46 | — |
| Par. 1; Day 4; 30 minutes Post-WL; Bloating | 45 | — |
| Par. 2; Day 4; Pre-WL;Bloating | 3 | — |
| Par. 2; Day 4; 10 minutes Post-WL;Bloating | 5 | — |
| Par. 2; Day 4; 20 minutes Post-WL;Bloating | 6 | — |
| Par. 2; Day 4; 30 minutes Post-WL;Bloating | 26 | — |
| Par. 3; Bloating; Day 4; Pre-WL;Bloating | 1 | — |
| Par. 3; Day 4; 10 minutes Post-WL;Bloating | 0 | — |
| Par. 3; Day 4; 20 minutes Post-WL;Bloating | 0 | — |
| Par. 3; Day 4; 30 minutes Post-WL;Bloating | 1 | — |
| Par. 4; Day 4; Pre-WL; Bloating | 3 | — |
| Par. 4; Day 4; 10 minutes Post-WL;Bloating | 22 | — |
| Par. 4; Day 4; 20 minutes Post-WL; Bloating | 42 | — |
| Par. 4; Bloating; Day 4; 30 minutes Post-WL | 35 | — |
| Par. 1; Day 4; Pre-WL; Abdominal pain | 3 | — |
| Par. 1; Day 4; 10 minutes Post-WL; Abdominal pain | 4 | — |
| Par. 1; Day 4; 20 minutes Post-WL; Abdominal pain | 3 | — |
| Par. 1; Day 4; 30 minutes Post-WL;Abdominal pain | 3 | — |
| Par. 2; Day 4; Pre-WL; Abdominal pain | 4 | — |
| Par. 2; Day 4; 10 minutes Post-WL; Abdominal pain | 4 | — |
| Par. 2; Day 4; 20 minutes Post-WL; Abdominal pain | 7 | — |
| Par. 2; Day 4; 30 minutes Post-WL;Abdominal pain | 6 | — |
| Par. 3; Day 4; Pre-WL; Abdominal pain | 0 | — |
| Par. 3;Day 4; 10 minutes Post-WL; Abdominal pain | 0 | — |
| Par. 3; Day 4; 20 minutes Post-WL; Abdominal pain | 0 | — |
| Par. 3; Day 4; 30 minutes Post-WL; Abdominal pain | 0 | — |
| Par. 4; Day 4; Pre-WL; Abdominal pain | 4 | — |
| Par. 4; Day 4; 10 minutes Post-WL;Abdominal pain | 4 | — |
| Par. 4; Day 4; 20 minutes Post-WL; Abdominal pain | 5 | — |
| Par. 4; Day 4; 30 minutes Post-WL; Abdominal pain | 5 | — |
| Par. 1; Day 4; Pre-WL; Hunger | 88 | — |
| Par. 1; Day 4; 10 minutes Post-WL; Hunger | 79 | — |
| Par. 1; Day 4; 20 minutes Post-WL;Hunger | 85 | — |
| Par. 1;Day 4; 30 minutes Post-WL;Hunger | 84 | — |
| Par. 2; Day 4; Pre-WL;Hunger | 32 | — |
| Par. 2; Day 4; 10 minutes Post-WL; Hunger | 16 | — |
| Par. 2; Day 4; 20 minutes Post-WL; Hunger | 19 | — |
| Par. 2; Day 4; 30 minutes Post-WL; Hunger | 27 | — |
| Par. 3; Day 4; Pre-WL; Hunger | 21 | — |
| Par. 3; Day 4; 10 minutes Post-WL; Hunger | 3 | — |
| Par. 3; Day 4; 20 minutes Post-WL; Hunger | 6 | — |
| Par. 3; Day 4; 30 minutes Post-WL;Hunger | 17 | — |
| Par. 4; Day 4; Pre-WL;Hunger | 19 | — |
| Par. 4; Day 4; 10 minutes Post-WL; Hunger | 16 | — |
| Par. 4; Day 4; 20 minutes Post-WL; Hunger | 29 | — |
| Par. 4; Day 4; 30 minutes Post-WL;Hunger | 37 | — |
Secondary/protocol endpoint
Part B: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Time frame:Up to 8 weeks
change from baseline, improvement
Secondary/protocol endpoint
Part B: Assessment of GCSI-DD Score
Time frame:Up to 8 weeks
descriptive, improvement
Safety / tolerability / PK
21 endpointsPrimary/protocol endpoint
Part A: Number of Par. With Shifts in Gastric Rhythm Status
Time frame:Up to 12 days
categorical status, descriptive
Primary/protocol endpoint
Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score
Time frame:Day 4
Nausea
descriptive
Posted result
| Group | Value (number), Scores on a scale | 95% CI |
|---|---|---|
| Part A: Exenatide SC InjectionPar. 1; Day 4; Pre-WL | 4 | — |
| Par. 1; Day 4; 10 minutes Post-WL | 2 | — |
| Par. 1; Day 4; 20 minutes Post-WL | 4 | — |
| Par. 1; Day 4; 30 minutes Post-WL | 3 | — |
| Par. 2; Day 4; Pre-WL | 3 | — |
| Par. 2; Day 4; 10 minutes Post-WL | 4 | — |
| Par. 2; Day 4; 20 minutes Post-WL | 4 | — |
| Par. 2; Day 4; 30 minutes Post-WL | 24 | — |
| Par. 3; Day 4; Pre-WL | 1 | — |
| Par. 3; Day 4; 10 minutes Post-WL | 0 | — |
| Par. 3; Day 4; 20 minutes Post-WL | 0 | — |
| Par. 3; Day 4; 30 minutes Post-WL | 0 | — |
| Par. 4; Day 4; Pre-WL | 4 | — |
| Par. 4; Day 4; 10 minutes Post-WL | 5 | — |
| Par. 4; Day 4; 20 minutes Post-WL | 3 | — |
| Par. 4; Day 4; 30 minutes Post-WL | 4 | — |
Primary/protocol endpoint
Part A: The Volume of Water Ingested During EGG
Time frame:Up to Day 4
egg wlt volume ingested
descriptive
Posted result
| Group | Value (number), Milliliter | 95% CI |
|---|---|---|
| Part A: Exenatide SC InjectionPar. 1; Day 1 | 430 | — |
| Par. 1; Day 4 | 360 | — |
| Par. 2; Day 1 | 2160 | — |
| Par. 2; Day 4 | 1980 | — |
| Par. 3; Day 1 | 900 | — |
| Par. 3; Day 4 | 1080 | — |
| Par. 4; Day 1 | 1000 | — |
| Par. 4; Day 4 | 1000 | — |
Primary/protocol endpoint
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Time frame:Up to 12 days
descriptive
Posted result
| Group | Value (number), Millimeter of mercury | 95% CI |
|---|---|---|
| Part A: Exenatide SC InjectionPar. 1; Day -1; SBP | 126 | — |
| Par. 1; Day 1; SBP | 121 | — |
| Par. 1; Day 4; SBP | 124 | — |
| Par. 1; Day 5; SBP | 112 | — |
| Par. 1; Follow-up; SBP | 125 | — |
| Par. 1; Day -1; DBP | 71 | — |
| Par. 1; Day 1; DBP | 61 | — |
| Par. 1; Day 4; DBP | 69 | — |
| Par. 1; Day 5; DBP | 67 | — |
| Par. 1; Follow-up; DBP | 72 | — |
| Par. 2; Day -1; SBP | 105 | — |
| Par. 2; Day 1; SBP | 109 | — |
| Par. 2; Day 4; SBP | 119 | — |
| Par. 2; Day 5; SBP | 121 | — |
| Par. 2; Follow-up; SBP | 124 | — |
| Par. 2; Day -1; DBP | 61 | — |
| Par. 2; Day 1; DBP | 68 | — |
| Par. 2; Day 4; DBP | 71 | — |
| Par. 2; Day 5; DBP | 68 | — |
| Par. 2; Follow-up; DBP | 75 | — |
| Par. 3; Day -1; SBP | 131 | — |
| Par. 3; Day 1; SBP | 131 | — |
| Par. 3; Day 4; SBP | 132 | — |
| Par. 3; Day 5; SBP | 112 | — |
| Par. 3; Follow-up; SBP | 126 | — |
| Par. 3; Day -1; DBP | 86 | — |
| Par. 3; Day 1; DBP | 82 | — |
| Par. 3; Day 4; DBP | 87 | — |
| Par. 3; Day 5; DBP | 76 | — |
| Par. 3; Follow-up; DBP | 87 | — |
| Par. 4; Day -1; SBP | 138 | — |
| Par. 4; Day 1; SBP | 139 | — |
| Par. 4; Day 4; SBP | 127 | — |
| Par. 4; Day 5; SBP | 123 | — |
| Par. 4; Follow-up; SBP | 160 | — |
| Par. 4; Day -1; DBP | 83 | — |
| Par. 4; Day 1; DBP | 90 | — |
| Par. 4; Day 4; DBP | 83 | — |
| Par. 4; Day 5; DBP | 81 | — |
| Par. 4; Follow-up; DBP | 86 | — |
Primary/protocol endpoint
Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points
Time frame:Day 5
descriptive
Posted result
| Group | Value (number), Giga unit per liter | 95% CI |
|---|---|---|
| Part A: Exenatide SC InjectionPar.1; Basophils | 0.02 | — |
| Par.1; Eosinophils | 0.11 | — |
| Par.1; Lymphocytes | 1.57 | — |
| Par.1; Monocytes | 0.35 | — |
| Par.1; Platelet count | 268 | — |
| Par.1; Total Neutrophils | 6.33 | — |
| Par.1; WBC | 8.4 | — |
| Par.2; Basophils | 0.02 | — |
| Par.2; Eosinophils | 0.04 | — |
| Par.2; Lymphocytes | 1.39 | — |
| Par.2; Monocytes | 0.25 | — |
| Par.2; Platelet count | 217 | — |
| Par.2; Total Neutrophils | 2.54 | — |
| Par.2; WBC | 4.2 | — |
| Par.3; Basophils | 0.03 | — |
| Par.3; Eosinophils | 0.21 | — |
| Par.3; Lymphocytes | 1.77 | — |
| Par.3; Monocytes | 0.58 | — |
| Par.3; Platelet count | 202 | — |
| Par.3; Total Neutrophils | 5.09 | — |
| Par.3; WBC | 7.7 | — |
| Par.4; Basophils | 0.04 | — |
| Par.4; Eosinophils | 0.23 | — |
| Par.4; Lymphocytes | 3.06 | — |
| Par.4; Monocytes | 0.89 | — |
| Par.4; Platelet count | 230 | — |
| Par.4; Total Neutrophils | 1.2 | — |
| Par.4; WBC | 5.4 | — |
Primary/protocol endpoint
Part A: Red Blood Cell (RBC) Count at Indicated Time Points
Time frame:Day 5
RBC count
descriptive
LOINC 789-8
Posted result
| Group | Value (number), Tetra unit per liter | 95% CI |
|---|---|---|
| Part A: Exenatide SC InjectionPar. 1 | 4.7 | — |
| Par. 2 | 4.8 | — |
| Par. 3 | 5 | — |
| Par. 4 | 4.9 | — |
Primary/protocol endpoint
Part A: Hemoglobin Level at Indicated Time Points
Time frame:Day 5
descriptive
LOINC 718-7
Posted result
| Group | Value (number), Grams per liter | 95% CI |
|---|---|---|
| Part A: Exenatide SC InjectionPar. 1 | 125 | — |
| Par. 2 | 133 | — |
| Par. 3 | 149 | — |
| Par. 4 | 156 | — |
Primary/protocol endpoint
Part A: Hematocrit Level at Indicated Time Points
Time frame:Day 5
descriptive
Posted result
| Group | Value (number), Proportion of RBC in blood | 95% CI |
|---|---|---|
| Part A: Exenatide SC InjectionPar. 1 | 0.399 | — |
| Par. 2 | 0.426 | — |
| Par. 3 | 0.466 | — |
| Par. 4 | 0.462 | — |
Primary/protocol endpoint
Part A: Total Protein, Albumin Levels at Indicated Time Points
Time frame:Day 5
change from baseline, descriptive
Posted result
| Group | Value (number), Grams per liter | 95% CI |
|---|---|---|
| Part A: Exenatide SC InjectionPar. 1; Total Protein | 77 | — |
| Par. 1; Albumin levels | 43 | — |
| Par. 2; Total Protein | 75 | — |
| Par. 2; Albumin levels | 46 | — |
| Par. 3; Total Protein | 71 | — |
| Par. 3; Albumin levels | 44 | — |
| Par. 4; Total Protein | 74 | — |
| Par. 4; Albumin levels | 46 | — |
Primary/protocol endpoint
Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points
Time frame:Day 5
descriptive
Posted result
| Group | Value (number), Participants | 95% CI |
|---|---|---|
| Part A: Exenatide SC InjectionPar. 1; Ketones; Negative | 1 | — |
| Par 1; Occult blood; Trace | 1 | — |
| Par 1; Glucose | NA | — |
| Par 1; Nitrates | NA | — |
| Par 1; Leukocyte esterase | NA | — |
| Par. 2; Ketones; Negative | 1 | — |
| Par. 2; Occult blood; Negative | 1 | — |
| Par. 2; Glucose | NA | — |
| Par 2; Nitrates | NA | — |
| Par 2; Leukocyte esterase | NA | — |
| Par. 3; Ketones; Negative | 1 | — |
| Par. 3; Occult blood; Negative | 1 | — |
| Par. 3; Glucose | NA | — |
| Par 3; Nitrates | NA | — |
| Par 3; Leukocyte esterase | NA | — |
| Par. 4; Ketones; Negative | 1 | — |
| Par. 4; Occult blood; Negative | 1 | — |
| Par. 4; Glucose | NA | — |
| Par 4; Nitrates | NA | — |
| Par 4; Leukocyte esterase | NA | — |
Primary/protocol endpoint
Part A: Specific Gravity of Urine at Indicated Time Points
Time frame:Day 5
urine specific gravity
descriptive
Posted result
| Group | Value (number), Kilograms per meter^3 | 95% CI |
|---|---|---|
| Part A: Exenatide SC InjectionPar. 1 | 1.021 | — |
| Par. 2 | 1.019 | — |
| Par. 3 | 1.023 | — |
| Par. 4 | 1.027 | — |
Primary/protocol endpoint
Part A: Potential of Hydrogen (pH) of Urine at Indicated Time Points
Time frame:Day 5
descriptive
Posted result
| Group | Value (number), Points on a scale | 95% CI |
|---|---|---|
| Part A: Exenatide SC InjectionPar. 1 | 5 | — |
| Par. 2 | 5.5 | — |
| Par. 3 | 6 | — |
| Par. 4 | 5 | — |
Primary/protocol endpoint
Part A: Number of Par. With Adverse Events (AEs) and Serious AEs (SAEs)
Time frame:Up to 12 days
Treatment-emergent AEs (any)
event count, event
componentsTreatment-emergent AEs (any), Serious AEs (any)
Posted result
| Group | Value (number), Participants | 95% CI |
|---|---|---|
| Part A: Exenatide SC InjectionAny AE | 1 | — |
| Any SAE | 0 | — |
Primary/protocol endpoint
Part A: Number of Par. With Nausea AEs Presenting Outside the Timing of the WLT and GCSI-DD
Time frame:Up to 12 days
Nausea
event count, event
Posted result
| Group | Value (number), Participants | 95% CI |
|---|---|---|
| Part A: Exenatide SC Injection | 0 | — |
Primary/protocol endpoint
Part B: Assessment of Nausea by VAS Score
Time frame:Up to 8 weeks
Nausea
descriptive
Secondary/protocol endpoint
Part B: Number of Par. With Abnormal Values for Vital Signs
Time frame:Up to 12 weeks
event count, event
Secondary/protocol endpoint
Part B: Number of Par. With Abnormal Values for Hematology Parameters
Time frame:Up to 8 weeks
event count, event
Secondary/protocol endpoint
Part B: Number of Par. With Abnormal Values for Clinical Chemistry Parameters
Time frame:Up to 8 weeks
descriptive
Secondary/protocol endpoint
Part B: Number of Par. With Abnormal Values for Urinalysis
Time frame:Up to 8 weeks
descriptive
Secondary/protocol endpoint
Part B: Number of Par. With AEs and SAEs
Time frame:Up to 12 weeks
Serious AEs (any)
event count, event
Secondary/protocol endpoint
Part B: Number of Par. With Nausea AEs Presenting Outside the Timing of the WLT and GCSI-DD
Time frame:Up to 12 weeks
Nausea
event count, event
Other clinical outcomes
6 endpointsPrimary/protocol endpoint/low confidence
Part A: Distribution of Average Power by Frequency Region
Time frame:Up to Day 4
descriptive
Posted result
| Group | Value (number), Percentage of power | 95% CI |
|---|---|---|
| Part A: Exenatide SC InjectionPar. 1; Day 1; Pre-WL; Bradygastria | 56.15 | — |
| Par. 1; Day 1; Pre-WL; Normal | 23.49 | — |
| Par. 1; Day 1; Pre-WL; Tachygastria | 17 | — |
| Par. 1; Day 1; Pre-WL; Duodenal | 3.35 | — |
| Par. 1; Day 1; 10 minutes Post-WL; Bradygastria | 93.97 | — |
| Par. 1; Day 1; 10 minutes Post-WL; Normal | 2.9 | — |
| Par. 1; Day 1; 10 minutes Post-WL; Tachygastria | 2.4 | — |
| Par. 1; Day 1; 10 minutes Post-WL; Duodenal | 0.73 | — |
| Par. 1; Day 1; 20 minutes Post-WL; Bradygastria | 57.13 | — |
| Par. 1; Day 1; 20 minutes Post-WL; Normal | 23.29 | — |
| Par. 1; Day 1; 20 minutes Post-WL; Tachygastria | 13.17 | — |
| Par. 1; Day 1; 20 minutes Post-WL; Duodenal | 6.41 | — |
| Par. 1; Day 1; 30 minutes Post-WL; Bradygastria | 43.44 | — |
| Par. 1; Day 1; 30 minutes Post-WL; Normal | 36.16 | — |
| Par. 1; Day 1; 30 minutes Post-WL; Tachygastria | 17.78 | — |
| Par. 1; Day 1; 30 minutes Post-WL; Duodenal | 2.62 | — |
| Par. 1; Day 4; Pre-WL; Bradygastria | 71.94 | — |
| Par. 1; Day 4; Pre-WL; Normal | 13 | — |
| Par. 1; Day 4; Pre-WL; Tachygastria | 9.51 | — |
| Par. 1; Day 4; Pre-WL; Duodenal | 5.55 | — |
| Par. 1; Day 4; 10 minutes Post-WL; Bradygastria | 43.99 | — |
| Par. 1; Day 4; 10 minutes Post-WL; Normal | 12.94 | — |
| Par. 1; Day 4; 10 minutes Post-WL; Tachygastria | 28.33 | — |
| Par. 1; Day 4; 10 minutes Post-WL; Duodenal | 14.74 | — |
| Par. 1; Day 4; 20 minutes Post-WL; Bradygastria | 73.87 | — |
| Par. 1; Day 4; 20 minutes Post-WL; Normal | 10.97 | — |
| Par. 1; Day 4; 20 minutes Post-WL; Tachygastria | 8.77 | — |
| Par. 1; Day 4; 20 minutes Post-WL; Duodenal | 6.39 | — |
| Par. 1; Day 4; 30 minutes Post-WL; Bradygastria | 48.87 | — |
| Par. 1; Day 4; 30 minutes Post-WL; Normal | 16.66 | — |
| Par. 1; Day 4; 30 minutes Post-WL; Tachygastria | 23.16 | — |
| Par. 1; Day 4; 30 minutes Post-WL; Duodenal | 11.31 | — |
| Par. 2; Day 1; Pre-WL; Bradygastria | 67.44 | — |
| Par. 2; Day 1; Pre-WL; Normal | 10.67 | — |
| Par. 2; Day 1; Pre-WL; Tachygastria | 17.2 | — |
| Par. 2; Day 1; Pre-WL; Duodenal | 4.68 | — |
| Par. 2; Day 1; 10 minutes Post-WL; Bradygastria | 94.05 | — |
| Par. 2; Day 1; 10 minutes Post-WL; Normal | 2.46 | — |
| Par. 2; Day 1; 10 minutes Post-WL; Tachygastria | 2.83 | — |
| Par. 2; Day 1; 10 minutes Post-WL; Duodenal | 0.67 | — |
| Par. 2; Day 1; 20 minutes Post-WL; Bradygastria | 85.64 | — |
| Par. 2; Day 1; 20 minutes Post-WL; Normal | 11.72 | — |
| Par. 2; Day 1; 20 minutes Post-WL; Tachygastria | 2.43 | — |
| Par. 2; Day 1; 20 minutes Post-WL; Duodenal | 0.22 | — |
| Par. 2; Day 1; 30 minutes Post-WL; Bradygastria | 77.34 | — |
| Par. 2; Day 1; 30 minutes Post-WL; Normal | 15.57 | — |
| Par. 2; Day 1; 30 minutes Post-WL; Tachygastria | 6.23 | — |
| Par. 2; Day 1; 30 minutes Post-WL; Duodenal | 0.86 | — |
| Par. 2; Day 4; Pre-WL; Bradygastria | 43.32 | — |
| Par. 2; Day 4; Pre-WL; Normal | 23.82 | — |
| Par. 2; Day 4; Pre-WL; Tachygastria | 18.71 | — |
| Par. 2; Day 4; Pre-WL; Duodenal | 14.14 | — |
| Par. 2; Day 4; 10 minutes Post-WL; Bradygastria | 84.23 | — |
| Par. 2; Day 4; 10 minutes Post-WL; Normal | 7.93 | — |
| Par. 2; Day 4; 10 minutes Post-WL; Tachygastria | 6.81 | — |
| Par. 2; Day 4; 10 minutes Post-WL; Duodenal | 1.02 | — |
| Par. 2; Day 4; 20 minutes Post-WL; Bradygastria | 66.32 | — |
| Par. 2; Day 4; 20 minutes Post-WL; Normal | 19.43 | — |
| Par. 2; Day 4; 20 minutes Post-WL; Tachygastria | 11.7 | — |
| Par. 2; Day 4; 20 minutes Post-WL; Duodenal | 2.55 | — |
| Par. 2; Day 4; 30 minutes Post-WL; Bradygastria | 73.05 | — |
| Par. 2; Day 4; 30 minutes Post-WL; Normal | 19.64 | — |
| Par. 2; Day 4; 30 minutes Post-WL; Tachygastria | 6.47 | — |
| Par. 2; Day 4; 30 minutes Post-WL; Duodenal | 0.84 | — |
| Par. 3; Day 1; Pre-WL; Bradygastria | 59.66 | — |
| Par. 3; Day 1; Pre-WL; Normal | 9.05 | — |
| Par. 3; Day 1; Pre-WL; Tachygastria | 22.39 | — |
| Par. 3; Day 1; Pre-WL; Duodenal | 8.91 | — |
| Par. 3; Day 1; 10 minutes Post-WL; Bradygastria | 32.73 | — |
| Par. 3; Day 1; 10 minutes Post-WL; Normal | 11.03 | — |
| Par. 3; Day 1; 10 minutes Post-WL; Tachygastria | 48.77 | — |
| Par. 3; Day 1; 10 minutes Post-WL; Duodenal | 7.47 | — |
| Par. 3; Day 1; 20 minutes Post-WL; Bradygastria | 29.94 | — |
| Par. 3; Day 1; 20 minutes Post-WL; Normal | 22.84 | — |
| Par. 3; Day 1; 20 minutes Post-WL; Tachygastria | 39.72 | — |
| Par. 3; Day 1; 20 minutes Post-WL; Duodenal | 7.5 | — |
| Par. 3; Day 1; 30 minutes Post-WL; Bradygastria | 16.32 | — |
| Par. 3; Day 1; 30 minutes Post-WL; Normal | 22.48 | — |
| Par. 3; Day 1; 30 minutes Post-WL; Tachygastria | 54.77 | — |
| Par. 3; Day 1; 30 minutes Post-WL; Duodenal | 6.43 | — |
| Par. 3; Day 4; Pre-WL; Bradygastria | 52.85 | — |
| Par. 3; Day 4; Pre-WL; Normal | 16.64 | — |
| Par. 3; Day 4; Pre-WL; Tachygastria | 13.21 | — |
| Par. 3; Day 4; Pre-WL; Duodenal | 17.29 | — |
| Par. 3; Day 4; 10 minutes Post-WL; Bradygastria | 64.27 | — |
| Par. 3; Day 4; 10 minutes Post-WL; Normal | 10.37 | — |
| Par. 3; Day 4; 10 minutes Post-WL; Tachygastria | 13.26 | — |
| Par. 3; Day 4; 10 minutes Post-WL; Duodenal | 12.1 | — |
| Par. 3; Day 4; 20 minutes Post-WL; Bradygastria | 71.66 | — |
| Par. 3; Day 4; 20 minutes Post-WL; Normal | 11.11 | — |
| Par. 3; Day 4; 20 minutes Post-WL; Tachygastria | 9.52 | — |
| Par. 3; Day 4; 20 minutes Post-WL; Duodenal | 7.72 | — |
| Par. 3; Day 4; 30 minutes Post-WL; Bradygastria | 53.97 | — |
| Par. 3; Day 4; 30 minutes Post-WL; Normal | 8.61 | — |
| Par. 3; Day 4; 30 minutes Post-WL; Tachygastria | 16.12 | — |
| Par. 3; Day 4; 30 minutes Post-WL; Duodenal | 21.3 | — |
| Par. 4; Day 1; Pre-WL; Bradygastria | 82.47 | — |
| Par. 4; Day 1; Pre-WL; Normal | 6.66 | — |
| Par. 4; Day 1; Pre-WL; Tachygastria | 7.86 | — |
| Par. 4; Day 1; Pre-WL; Duodenal | 3.01 | — |
| Par. 4; Day 1; 10 minutes Post-WL; Bradygastria | 81.89 | — |
| Par. 4; Day 1; 10 minutes Post-WL; Normal | 5.6 | — |
| Par. 4; Day 1; 10 minutes Post-WL; Tachygastria | 11.63 | — |
| Par. 4; Day 1; 10 minutes Post-WL; Duodenal | 0.88 | — |
| Par. 4; Day 1; 20 minutes Post-WL; Bradygastria | 62.96 | — |
| Par. 4; Day 1; 20 minutes Post-WL; Normal | 12.84 | — |
| Par. 4; Day 1; 20 minutes Post-WL; Tachygastria | 17.04 | — |
| Par. 4; Day 1; 20 minutes Post-WL; Duodenal | 7.17 | — |
| Par. 4; Day 1; 30 minutes Post-WL; Bradygastria | 73.64 | — |
| Par. 4; Day 1; 30 minutes Post-WL; Normal | 12.7 | — |
| Par. 4; Day 1; 30 minutes Post-WL; Tachygastria | 11.1 | — |
| Par. 4; Day 1; 30 minutes Post-WL; Duodenal | 2.56 | — |
| Par. 4; Day 4; Pre-WL; Bradygastria | 54.98 | — |
| Par. 4; Day 4; Pre-WL; Normal | 17.6 | — |
| Par. 4; Day 4; Pre-WL; Tachygastria | 22.97 | — |
| Par. 4; Day 4; Pre-WL; Duodenal | 4.45 | — |
| Par. 4; Day 4; 10 minutes Post-WL; Bradygastria | 83.7 | — |
| Par. 4; Day 4; 10 minutes Post-WL; Normal | 4.2 | — |
| Par. 4; Day 4; 10 minutes Post-WL; Tachygastria | 10.69 | — |
| Par. 4; Day 4; 10 minutes Post-WL; Duodenal | 1.4 | — |
| Par. 4; Day 4; 20 minutes Post-WL; Bradygastria | 82.96 | — |
| Par. 4; Day 4; 20 minutes Post-WL; Normal | 5.92 | — |
| Par. 4; Day 4; 20 minutes Post-WL; Tachygastria | 10.1 | — |
| Par. 4; Day 4; 20 minutes Post-WL; Duodenal | 1.02 | — |
| Par. 4; Day 4; 30 minutes Post-WL; Bradygastria | 39.01 | — |
| Par. 4; Day 4; 30 minutes Post-WL; Normal | 42.61 | — |
| Par. 4; Day 4; 30 minutes Post-WL; Tachygastria | 16.77 | — |
| Par. 4; Day 4; 30 minutes Post-WL; Duodenal | 1.62 | — |
Primary/protocol endpoint
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Time frame:Up to Day 4
ratio, descriptive
Posted result
| Group | Value (number), Ratio | 95% CI |
|---|---|---|
| Part A: Exenatide SC InjectionPar. 1; Day 1; 10 minutes Post-WL; Bradygastria | 0 | — |
| Par. 1; Day 1; 10 minutes Post-WL; Normal | 0 | — |
| Par. 1; Day 1; 10 minutes Post-WL; Tachygastria | 0 | — |
| Par. 1; Day 1; 10 minutes Post-WL; Duodenal | 0 | — |
| Par. 1; Day 1; 20 minutes Post-WL; Bradygastria | 0 | — |
| Par. 1; Day 1; 20 minutes Post-WL; Normal | 0 | — |
| Par. 1; Day 1; 20 minutes Post-WL; Tachygastria | 0 | — |
| Par. 1; Day 1; 20 minutes Post-WL; Duodenal | 0 | — |
| Par. 1; Day 1; 30 minutes Post-WL; Bradygastria | 0 | — |
| Par. 1; Day 1; 30 minutes Post-WL; Normal | 0 | — |
| Par. 1; Day 1; 30 minutes Post-WL; Tachygastria | 0 | — |
| Par. 1; Day 1; 30 minutes Post-WL; Duodenal | 0 | — |
| Par. 1; Day 4; 10 minutes Post-WL; Bradygastria | 0 | — |
| Par. 1; Day 4; 10 minutes Post-WL; Normal | 0 | — |
| Par. 1; Day 4; 10 minutes Post-WL; Tachygastria | 0 | — |
| Par. 1; Day 4; 10 minutes Post-WL; Duodenal | 0 | — |
| Par. 1; Day 4; 20 minutes Post-WL; Bradygastria | 0 | — |
| Par. 1; Day 4; 20 minutes Post-WL; Normal | 0 | — |
| Par. 1; Day 4; 20 minutes Post-WL; Tachygastria | 0 | — |
| Par. 1; Day 4; 20 minutes Post-WL; Duodenal | 0 | — |
| Par. 1; Day 4; 30 minutes Post-WL; Bradygastria | 0 | — |
| Par. 1; Day 4; 30 minutes Post-WL; Normal | 0 | — |
| Par. 1; Day 4; 30 minutes Post-WL; Tachygastria | 0 | — |
| Par. 1; Day 4; 30 minutes Post-WL; Duodenal | 0 | — |
| Par. 2; Day 1; 10 minutes Post-WL; Bradygastria | 0.01 | — |
| Par. 2; Day 1; 10 minutes Post-WL; Normal | 0 | — |
| Par. 2; Day 1; 10 minutes Post-WL; Tachygastria | 0 | — |
| Par. 2; Day 1; 10 minutes Post-WL; Duodenal | 0 | — |
| Par. 2; Day 1; 20 minutes Post-WL; Bradygastria | 0.04 | — |
| Par. 2; Day 1; 20 minutes Post-WL; Normal | 0.04 | — |
| Par. 2; Day 1; 20 minutes Post-WL; Tachygastria | 0 | — |
| Par. 2; Day 1; 20 minutes Post-WL; Duodenal | 0 | — |
| Par. 2; Day 1; 30 minutes Post-WL; Bradygastria | 0.01 | — |
| Par. 2; Day 1; 30 minutes Post-WL; Normal | 0.02 | — |
| Par. 2; Day 1; 30 minutes Post-WL; Tachygastria | 0 | — |
| Par. 2; Day 1; 30 minutes Post-WL; Duodenal | 0 | — |
| Par. 2; Day 4; 10 minutes Post-WL; Bradygastria | 0.03 | — |
| Par. 2; Day 4; 10 minutes Post-WL; Normal | 0 | — |
| Par. 2; Day 4; 10 minutes Post-WL; Tachygastria | 0 | — |
| Par. 2; Day 4; 10 minutes Post-WL; Duodenal | 0 | — |
| Par. 2; Day 4; 20 minutes Post-WL; Bradygastria | 0.03 | — |
| Par. 2; Day 4; 20 minutes Post-WL; Normal | 0.02 | — |
| Par. 2; Day 4; 20 minutes Post-WL; Tachygastria | 0.01 | — |
| Par. 2; Day 4; 20 minutes Post-WL; Duodenal | 0 | — |
| Par. 2; Day 4; 30 minutes Post-WL; Bradygastria | 0.22 | — |
| Par. 2; Day 4; 30 minutes Post-WL; Normal | 0.11 | — |
| Par. 2; Day 4; 30 minutes Post-WL; Tachygastria | 0.05 | — |
| Par. 2; Day 4; 30 minutes Post-WL; Duodenal | 0.01 | — |
| Par. 3; Day 1; 10 minutes Post-WL; Bradygastria | 0.13 | — |
| Par. 3; Day 1; 10 minutes Post-WL; Normal | 0.29 | — |
| Par. 3; Day 1; 10 minutes Post-WL; Tachygastria | 0.52 | — |
| Par. 3; Day 1; 10 minutes Post-WL; Duodenal | 0.2 | — |
| Par. 3; Day 1; 20 minutes Post-WL; Bradygastria | 0.2 | — |
| Par. 3; Day 1; 20 minutes Post-WL; Normal | 0.99 | — |
| Par. 3; Day 1; 20 minutes Post-WL; Tachygastria | 0.7 | — |
| Par. 3; Day 1; 20 minutes Post-WL; Duodenal | 0.33 | — |
| Par. 3; Day 1; 30 minutes Post-WL; Bradygastria | 0.15 | — |
| Par. 3; Day 1; 30 minutes Post-WL; Normal | 1.38 | — |
| Par. 3; Day 1; 30 minutes Post-WL; Tachygastria | 1.36 | — |
| Par. 3; Day 1; 30 minutes Post-WL; Duodenal | 0.4 | — |
| Par. 3; Day 4; 10 minutes Post-WL; Bradygastria | 0.16 | — |
| Par. 3; Day 4; 10 minutes Post-WL; Normal | 0.08 | — |
| Par. 3; Day 4; 10 minutes Post-WL; Tachygastria | 0.13 | — |
| Par. 3; Day 4; 10 minutes Post-WL; Duodenal | 0.09 | — |
| Par. 3; Day 4; 20 minutes Post-WL; Bradygastria | 0.2 | — |
| Par. 3; Day 4; 20 minutes Post-WL; Normal | 0.1 | — |
| Par. 3; Day 4; 20 minutes Post-WL; Tachygastria | 0.11 | — |
| Par. 3; Day 4; 20 minutes Post-WL; Duodenal | 0.07 | — |
| Par. 3; Day 4; 30 minutes Post-WL; Bradygastria | 0.16 | — |
| Par. 3; Day 4; 30 minutes Post-WL; Normal | 0.08 | — |
| Par. 3; Day 4; 30 minutes Post-WL; Tachygastria | 0.19 | — |
| Par. 3; Day 4; 30 minutes Post-WL; Duodenal | 0.19 | — |
| Par. 4; Day 1; 10 minutes Post-WL; Bradygastria | 2.6 | — |
| Par. 4; Day 1; 10 minutes Post-WL; Normal | 2.21 | — |
| Par. 4; Day 1; 10 minutes Post-WL; Tachygastria | 3.88 | — |
| Par. 4; Day 1; 10 minutes Post-WL; Duodenal | 0.76 | — |
| Par. 4; Day 1; 20 minutes Post-WL; Bradygastria | 0.89 | — |
| Par. 4; Day 1; 20 minutes Post-WL; Normal | 2.24 | — |
| Par. 4; Day 1; 20 minutes Post-WL; Tachygastria | 2.52 | — |
| Par. 4; Day 1; 20 minutes Post-WL; Duodenal | 2.76 | — |
| Par. 4; Day 1; 30 minutes Post-WL; Bradygastria | 1.54 | — |
| Par. 4; Day 1; 30 minutes Post-WL; Normal | 3.29 | — |
| Par. 4; Day 1; 30 minutes Post-WL; Tachygastria | 2.44 | — |
| Par. 4; Day 1; 30 minutes Post-WL; Duodenal | 1.47 | — |
| Par. 4; Day 4; 10 minutes Post-WL; Bradygastria | 4.7 | — |
| Par. 4; Day 4; 10 minutes Post-WL; Normal | 0.74 | — |
| Par. 4; Day 4; 10 minutes Post-WL; Tachygastria | 1.44 | — |
| Par. 4; Day 4; 10 minutes Post-WL; Duodenal | 0.97 | — |
| Par. 4; Day 4; 20 minutes Post-WL; Bradygastria | 10.24 | — |
| Par. 4; Day 4; 20 minutes Post-WL; Normal | 2.28 | — |
| Par. 4; Day 4; 20 minutes Post-WL; Tachygastria | 2.98 | — |
| Par. 4; Day 4; 20 minutes Post-WL; Duodenal | 1.55 | — |
| Par. 4; Day 4; 30 minutes Post-WL; Bradygastria | 3.4 | — |
| Par. 4; Day 4; 30 minutes Post-WL; Normal | 11.6 | — |
| Par. 4; Day 4; 30 minutes Post-WL; Tachygastria | 3.5 | — |
| Par. 4; Day 4; 30 minutes Post-WL; Duodenal | 1.74 | — |
Primary/protocol endpoint
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Time frame:Up to Day 4
EGG dominant freq pct time
descriptive
Posted result
| Group | Value (number), Percentage of time | 95% CI |
|---|---|---|
| Part A: Exenatide SC InjectionPar. 1; Day 1; Pre-WL; Bradygastria | 80 | — |
| Par. 1; Day 1; Pre-WL; Normal | 20 | — |
| Par. 1; Day 1; Pre-WL; Tachygastria | 0 | — |
| Par. 1; Day 1; Pre-WL; Duodenal | 0 | — |
| Par. 1; Day 1; 10 minutes Post-WL; Bradygastria | 100 | — |
| Par. 1; Day 1; 10 minutes Post-WL; Normal | 0 | — |
| Par. 1; Day 1; 10 minutes Post-WL; Tachygastria | 0 | — |
| Par. 1; Day 1; 10 minutes Post-WL; Duodenal | 0 | — |
| Par. 1; Day 1; 20 minutes Post-WL; Bradygastria | 100 | — |
| Par. 1; Day 1; 20 minutes Post-WL; Normal | 0 | — |
| Par. 1; Day 1; 20 minutes Post-WL; Tachygastria | 0 | — |
| Par. 1; Day 1; 20 minutes Post-WL; Duodenal | 0 | — |
| Par. 1; Day 1; 30 minutes Post-WL; Bradygastria | 50 | — |
| Par. 1; Day 1; 30 minutes Post-WL; Normal | 50 | — |
| Par. 1; Day 1; 30 minutes Post-WL; Tachygastria | 0 | — |
| Par. 1; Day 1; 30 minutes Post-WL; Duodenal | 0 | — |
| Par. 1; Day 4; Pre-WL; Bradygastria | 100 | — |
| Par. 1; Day 4; Pre-WL; Normal | 0 | — |
| Par. 1; Day 4; Pre-WL; Tachygastria | 0 | — |
| Par. 1; Day 4; Pre-WL; Duodenal | 0 | — |
| Par. 1; Day 4; 10 minutes Post-WL; Bradygastria | 100 | — |
| Par. 1; Day 4; 10 minutes Post-WL; Normal | 0 | — |
| Par. 1; Day 4; 10 minutes Post-WL; Tachygastria | 0 | — |
| Par. 1; Day 4; 10 minutes Post-WL; Duodenal | 0 | — |
| Par. 1; Day 4; 20 minutes Post-WL; Bradygastria | 100 | — |
| Par. 1; Day 4; 20 minutes Post-WL; Normal | 0 | — |
| Par. 1; Day 4; 20 minutes Post-WL; Tachygastria | 0 | — |
| Par. 1; Day 4; 20 minutes Post-WL; Duodenal | 0 | — |
| Par. 1; Day 4; 30 minutes Post-WL; Bradygastria | 50 | — |
| Par. 1; Day 4; 30 minutes Post-WL; Normal | 50 | — |
| Par. 1; Day 4; 30 minutes Post-WL; Tachygastria | 0 | — |
| Par. 1; Day 4; 30 minutes Post-WL; Duodenal | 0 | — |
| Par. 2; Day 1; Pre-WL; Bradygastria | 100 | — |
| Par. 2; Day 1; Pre-WL; Normal | 0 | — |
| Par. 2; Day 1; Pre-WL; Tachygastria | 0 | — |
| Par. 2; Day 1; Pre-WL; Duodenal | 0 | — |
| Par. 2; Day 1; 10 minutes Post-WL; Bradygastria | 100 | — |
| Par. 2; Day 1; 10 minutes Post-WL; Normal | 0 | — |
| Par. 2; Day 1; 10 minutes Post-WL; Tachygastria | 0 | — |
| Par. 2; Day 1; 10 minutes Post-WL; Duodenal | 0 | — |
| Par. 2; Day 1; 20 minutes Post-WL; Bradygastria | 100 | — |
| Par. 2; Day 1; 20 minutes Post-WL; Normal | 0 | — |
| Par. 2; Day 1; 20 minutes Post-WL; Tachygastria | 0 | — |
| Par. 2; Day 1; 20 minutes Post-WL; Duodenal | 0 | — |
| Par. 2; Day 1; 30 minutes Post-WL; Bradygastria | 100 | — |
| Par. 2; Day 1; 30 minutes Post-WL; Normal | 0 | — |
| Par. 2; Day 1; 30 minutes Post-WL; Tachygastria | 0 | — |
| Par. 2; Day 1; 30 minutes Post-WL; Duodenal | 0 | — |
| Par. 2; Day 4; Pre-WL; Bradygastria | 100 | — |
| Par. 2; Day 4; Pre-WL; Normal | 0 | — |
| Par. 2; Day 4; Pre-WL; Tachygastria | 0 | — |
| Par. 2; Day 4; Pre-WL; Duodenal | 0 | — |
| Par. 2; Day 4; 10 minutes Post-WL; Bradygastria | 100 | — |
| Par. 2; Day 4; 10 minutes Post-WL; Normal | 0 | — |
| Par. 2; Day 4; 10 minutes Post-WL; Tachygastria | 0 | — |
| Par. 2; Day 4; 10 minutes Post-WL; Duodenal | 0 | — |
| Par. 2; Day 4; 20 minutes Post-WL; Bradygastria | 100 | — |
| Par. 2; Day 4; 20 minutes Post-WL; Normal | 0 | — |
| Par. 2; Day 4; 20 minutes Post-WL; Tachygastria | 0 | — |
| Par. 2; Day 4; 20 minutes Post-WL; Duodenal | 0 | — |
| Par. 2; Day 4; 30 minutes Post-WL; Bradygastria | 50 | — |
| Par. 2; Day 4; 30 minutes Post-WL; Normal | 50 | — |
| Par. 2; Day 4; 30 minutes Post-WL; Tachygastria | 0 | — |
| Par. 2; Day 4; 30 minutes Post-WL; Duodenal | 0 | — |
| Par. 3; Day 1; Pre-WL; Bradygastria | 100 | — |
| Par. 3; Day 1; Pre-WL; Normal | 0 | — |
| Par. 3; Day 1; Pre-WL; Tachygastria | 0 | — |
| Par. 3; Day 1; Pre-WL; Duodenal | 0 | — |
| Par. 3; Day 1; 10 minutes Post-WL; Bradygastria | 100 | — |
| Par. 3; Day 1; 10 minutes Post-WL; Normal | 0 | — |
| Par. 3; Day 1; 10 minutes Post-WL; Tachygastria | 0 | — |
| Par. 3; Day 1; 10 minutes Post-WL; Duodenal | 0 | — |
| Par. 3; Day 1; 20 minutes Post-WL; Bradygastria | 0 | — |
| Par. 3; Day 1; 20 minutes Post-WL; Normal | 100 | — |
| Par. 3; Day 1; 20 minutes Post-WL; Tachygastria | 0 | — |
| Par. 3; Day 1; 20 minutes Post-WL; Duodenal | 0 | — |
| Par. 3; Day 1; 30 minutes Post-WL; Bradygastria | 0 | — |
| Par. 3; Day 1; 30 minutes Post-WL; Normal | 50 | — |
| Par. 3; Day 1; 30 minutes Post-WL; Tachygastria | 50 | — |
| Par. 3; Day 1; 30 minutes Post-WL; Duodenal | 0 | — |
| Par. 3; Day 4; Pre-WL; Bradygastria | 100 | — |
| Par. 3; Day 4; Pre-WL; Normal | 0 | — |
| Par. 3; Day 4; Pre-WL; Tachygastria | 0 | — |
| Par. 3; Day 4; Pre-WL; Duodenal | 0 | — |
| Par. 3; Day 4; 10 minutes Post-WL; Bradygastria | 100 | — |
| Par. 3; Day 4; 10 minutes Post-WL; Normal | 0 | — |
| Par. 3; Day 4; 10 minutes Post-WL; Tachygastria | 0 | — |
| Par. 3; Day 4; 10 minutes Post-WL; Duodenal | 0 | — |
| Par. 3; Day 4; 20 minutes Post-WL; Bradygastria | 100 | — |
| Par. 3; Day 4; 20 minutes Post-WL; Normal | 0 | — |
| Par. 3; Day 4; 20 minutes Post-WL; Tachygastria | 0 | — |
| Par. 3; Day 4; 20 minutes Post-WL; Duodenal | 0 | — |
| Par. 3; Day 4; 30 minutes Post-WL; Bradygastria | 100 | — |
| Par. 3; Day 4; 30 minutes Post-WL; Normal | 0 | — |
| Par. 3; Day 4; 30 minutes Post-WL; Tachygastria | 0 | — |
| Par. 3; Day 4; 30 minutes Post-WL; Duodenal | 0 | — |
| Par. 4; Day 1; Pre-WL; Bradygastria | 100 | — |
| Par. 4; Day 1; Pre-WL; Normal | 0 | — |
| Par. 4; Day 1; Pre-WL; Tachygastria | 0 | — |
| Par. 4; Day 1; Pre-WL; Duodenal | 0 | — |
| Par. 4; Day 1; 10 minutes Post-WL; Bradygastria | 100 | — |
| Par. 4; Day 1; 10 minutes Post-WL; Normal | 0 | — |
| Par. 4; Day 1; 10 minutes Post-WL; Tachygastria | 0 | — |
| Par. 4; Day 1; 10 minutes Post-WL; Duodenal | 0 | — |
| Par. 4; Day 1; 20 minutes Post-WL; Bradygastria | 100 | — |
| Par. 4; Day 1; 20 minutes Post-WL; Normal | 0 | — |
| Par. 4; Day 1; 20 minutes Post-WL; Tachygastria | 0 | — |
| Par. 4; Day 1; 20 minutes Post-WL; Duodenal | 0 | — |
| Par. 4; Day 1; 30 minutes Post-WL; Bradygastria | 100 | — |
| Par. 4; Day 1; 30 minutes Post-WL; Normal | 0 | — |
| Par. 4; Day 1; 30 minutes Post-WL; Tachygastria | 0 | — |
| Par. 4; Day 1; 30 minutes Post-WL; Duodenal | 0 | — |
| Par. 4; Day 4; Pre-WL; Bradygastria | 100 | — |
| Par. 4; Day 4; Pre-WL; Normal | 0 | — |
| Par. 4; Day 4; Pre-WL; Tachygastria | 0 | — |
| Par. 4; Day 4; Pre-WL; Duodenal | 0 | — |
| Par. 4; Day 4; 10 minutes Post-WL; Bradygastria | 100 | — |
| Par. 4; Day 4; 10 minutes Post-WL; Normal | 0 | — |
| Par. 4; Day 4; 10 minutes Post-WL; Tachygastria | 0 | — |
| Par. 4; Day 4; 10 minutes Post-WL; Duodenal | 0 | — |
| Par. 4; Day 4; 20 minutes Post-WL; Bradygastria | 100 | — |
| Par. 4; Day 4; 20 minutes Post-WL; Normal | 0 | — |
| Par. 4; Day 4; 20 minutes Post-WL; Tachygastria | 0 | — |
| Par. 4; Day 4; 20 minutes Post-WL; Duodenal | 0 | — |
| Par. 4; Day 4; 30 minutes Post-WL; Bradygastria | 0 | — |
| Par. 4; Day 4; 30 minutes Post-WL; Normal | 80 | — |
| Par. 4; Day 4; 30 minutes Post-WL; Tachygastria | 20 | — |
| Par. 4; Day 4; 30 minutes Post-WL; Duodenal | 0 | — |
Primary/protocol endpoint
Part A: Average Dominant Frequency
Time frame:Up to Day 4
descriptive
Posted result
| Group | Value (number), Cycles per minute | 95% CI |
|---|---|---|
| Part A: Exenatide SC InjectionPar. 1; Day 1; Pre-WL; Bradygastria | 1.5 | — |
| Par. 1; Day 1; 10 minutes Post-WL; Bradygastria | 0.75 | — |
| Par. 1; Day 1; 20 minutes Post-WL; Bradygastria | 1.25 | — |
| Par. 1; Day 1; 30 minutes Post-WL; Bradygastria | 2.19 | — |
| Par. 1; Day 4; Pre-WL; Bradygastria | 1.05 | — |
| Par. 1; Day 4; 10 minutes Post-WL; Bradygastria | 0.96 | — |
| Par. 1; Day 4; 20 minutes Post-WL; Bradygastria | 1.25 | — |
| Par. 1; Day 4; 30 minutes Post-WL; Bradygastria | 2.38 | — |
| Par. 2; Day 1; Pre-WL; Bradygastria | 1 | — |
| Par. 2; Day 1; 10 minutes Post-WL; Bradygastria | 1 | — |
| Par. 2; Day 1; 20 minutes Post-WL; Bradygastria | 1.5 | — |
| Par. 2; Day 1; 30 minutes Post-WL; Bradygastria | 1.75 | — |
| Par. 2; Day 4; Pre-WL; Bradygastria | 0.75 | — |
| Par. 2; Day 4; 10 minutes Post-WL; Bradygastria | 1.38 | — |
| Par. 2; Day 4; 20 minutes Post-WL; Bradygastria | 1 | — |
| Par. 2; Day 4; 30 minutes Post-WL; Bradygastria | 2.42 | — |
| Par. 3; Day 1; Pre-WL; Bradygastria | 0.96 | — |
| Par. 3; Day 1; 10 minutes Post-WL; Bradygastria | 1.83 | — |
| Par. 3; Day 1; 20 minutes Post-WL; Normal | 3 | — |
| Par. 3; Day 1; 30 minutes Post-WL; Tachygastria | 4.13 | — |
| Par. 3; Day 4; Pre-WL; Bradygastria | 1.2 | — |
| Par. 3; Day 4; 10 minutes Post-WL; Bradygastria | 1.5 | — |
| Par. 3; Day 4; 20 minutes Post-WL; Bradygastria | 0.94 | — |
| Par. 3; Day 4; 30 minutes Post-WL; Bradygastria | 1.5 | — |
| Par. 4; Day 1; Pre-WL; Bradygastria | 0.86 | — |
| Par. 4; Day 1; 10 minutes Post-WL; Bradygastria | 1.88 | — |
| Par. 4; Day 1; 20 minutes Post-WL; Bradygastria | 1.7 | — |
| Par. 4; Day 1; 30 minutes Post-WL; Bradygastria | 1.19 | — |
| Par. 4; Day 4; Pre-WL; Bradygastria | 1.2 | — |
| Par. 4; Day 4; 10 minutes Post-WL; Bradygastria | 0.94 | — |
| Par. 4; Day 4; 20 minutes Post-WL; Bradygastria | 1.29 | — |
| Par. 4; Day 4; 30 minutes Post-WL; Normal | 2.9 | — |
Primary/protocol endpoint
Part A: Time to Half-gastric Emptying
Time frame:Up to Day 5
GE T1 2
descriptive
Posted result
| Group | Value (number), Minutes | 95% CI |
|---|---|---|
| Part A: Exenatide SC InjectionPar. 1; Day -1 | 87.2 | — |
| Par. 1; Day 5 | 226.5 | — |
| Par. 2; Day -1 | 73.0 | — |
| Par. 2; Day 5 | 75.5 | — |
| Par. 3; Day -1 | 57.6 | — |
| Par. 3; Day 5 | 174.0 | — |
| Par. 4; Day -1 | 52.9 | — |
| Par. 4; Day 5 | 103.8 | — |
Primary/protocol endpoint
Part A: Rate of [13]C Dose Excreted in Breath
Time frame:Day 5
descriptive
Posted result
| Group | Value (number), kPCD per minute | 95% CI |
|---|---|---|
| Part A: Exenatide SC InjectionPar. 1; Day 5; Pre-Meal | 0 | — |
| Par. 1; Day 5; 45 Minutes Post-Meal | 1.8 | — |
| Par. 1; Day 5; 90 Minutes Post-Meal | 3.3 | — |
| Par. 1; Day 5; 120 Minutes Post-Meal | 3.1 | — |
| Par. 1; Day 5; 150 Minutes Post-Meal | 3.3 | — |
| Par. 1; Day 5; 180 Minutes Post-Meal | 7.4 | — |
| Par. 1; Day 5; 240 Minutes Post-Meal | 21.1 | — |
| Par. 2; Day 5; Pre-Meal | 0 | — |
| Par. 2; Day 5; 45 Minutes Post-Meal | 22.2 | — |
| Par. 2; Day 5; 90 Minutes Post-Meal | 42.5 | — |
| Par. 2; Day 5; 120 Minutes Post-Meal | 66.5 | — |
| Par. 2; Day 5; 150 Minutes Post-Meal | 82.3 | — |
| Par. 2; Day 5; 180 Minutes Post-Meal | 84.7 | — |
| Par. 2; Day 5; 240 Minutes Post-Meal | 75.8 | — |
| Par. 3; Day 5; Pre-Meal | 0 | — |
| Par. 3; Day 5; 45 Minutes Post-Meal | 1 | — |
| Par. 3; Day 5; 90 Minutes Post-Meal | 2.3 | — |
| Par. 3; Day 5; 120 Minutes Post-Meal | 6.5 | — |
| Par. 3; Day 5; 150 Minutes Post-Meal | 16.4 | — |
| Par. 3; Day 5; 180 Minutes Post-Meal | 28.2 | — |
| Par. 3; Day 5; 240 Minutes Post-Meal | 56.3 | — |
| Par. 4; Day 5; Pre-Meal | 0 | — |
| Par. 4; Day 5; 45 Minutes Post-Meal | 11.3 | — |
| Par. 4; Day 5; 90 Minutes Post-Meal | 27.8 | — |
| Par. 4; Day 5; 120 Minutes Post-Meal | 39.6 | — |
| Par. 4; Day 5; 150 Minutes Post-Meal | 51.1 | — |
| Par. 4; Day 5; 180 Minutes Post-Meal | 59.8 | — |
| Par. 4; Day 5; 240 Minutes Post-Meal | 61.6 | — |
Other (unclassified)
7 endpointsPrimary/protocol endpoint/low confidence
Part A: Number Par. by Gastric Rhythm Status
Time frame:Up to 12 days
descriptive
Primary/protocol endpoint/low confidence
Part B: Distribution of Average Power by Frequency Region
Time frame:Up to 8 weeks
descriptive
Primary/protocol endpoint/low confidence
Part B: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Time frame:Up to 8 weeks
ratio, descriptive
Primary/protocol endpoint/low confidence
Part B: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Time frame:Up to 8 weeks
descriptive
Secondary/protocol endpoint/low confidence
Part B: Time to Half-gastric Emptying
Time frame:Up to 8 weeks
time to event, descriptive
Secondary/protocol endpoint/low confidence
Part B: Rate of [13]C Dose Excreted in Breath
Time frame:Up to 8 weeks
descriptive
Secondary/protocol endpoint/low confidence
Part B: The Volume of Water Ingested During EGG
Time frame:Up to 8 weeks
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.