CompletedPhase 4Results posted

A Study Evaluating the Effect of Albiglutide on Gallbladder Emptying in Healthy Subjects

A Randomized, Double-blind, Single-dose, Placebo Controlled, 2-way Cross-over Study Evaluating Effect of Albiglutide on Cholecystokinin-induced Gallbladder Emptying in Fasting Healthy Subjects

Lead sponsor

GlaxoSmithKline

Asset

Albiglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Healthy volunteers

Eligibility highlights

•BMI 2-30•Healthy volunteers

Primary endpoints

•Maximum Absolute Value of Gallbladder Ejection Fraction (Emax GEF) During•Area Under the Effect Curve for Gallbladder Ejection Fraction (AUEC GEF)•TEMAXEF

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02496221

Org study ID201834

Timeline

Milestones

Study start2015-06-11actual

Study first posted2015-07-14estimated

Primary completion2015-10-13actual

Study completion2015-10-13actual

Results first posted2016-07-21estimated

Last update posted2018-04-05actual

Assets

Investigational agents

Albiglutide

Who this study enrolls

Healthy volunteers

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Between 18 and 65 years of age

•Healthy

•Have venous access sufficient to allow for intravenous (IV) infusion and blood sampling as per protocol

•Subject's body mass index (BMI) is >=18 kilogram (kg)/meter(m)^2 and <=30 kg/m^2

•Male or

•Female: if she is not pregnant (as confirmed by a test at screening and at other timepoints), not lactating, and at least one of the following conditions applies:

a)cannot bear children OR

b)agrees to follow contraception requirements defined in the protocol

•Capable of giving signed informed consent

Exclusion criteria

•Alanine aminotransferase (ALT) >1.5x Upper 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 milliseconds (msec)

•Systolic blood pressure is >=140 millimetre (mm) mercury (Hg) at Screening

•Diastolic blood pressure is >=90 mm Hg at Screening

•Heart rate is >100 beats/min at Screening

•Fasting triglyceride level >300 milligram/decilitre at Screening

•History of cholecystitis or other gallbladder disease

•History of gallstones, biliary motility dysfunction, or any condition rendering the subject unsuitable for ultrasonography assessments

•Prior cholecystectomy or any other gallbladder or biliary ducts procedure, prior ileal or gastric surgery, or any other medical procedure that precluded gallbladder emptying

•History of significant cardiovascular or pulmonary dysfunction prior to screening

•History of thyroid dysfunction

•History of intestinal obstruction, ileus, lap-band, gastrointestinal surgery or any other procedures that in the opinion of the investigator could influence gastric emptying (e.g., gastrectomy, gastric bypass)

•History of acute or chronic pancreatitis

•History of abdominal pain of unknown cause

•History of severe gastrointestinal disease, including gastroparesis, inflammatory bowel disease, Crohn's disease, or irritable bowel syndrome

•Personal or family history of multiple endocrine neoplasia type 2

•Personal or family history of medullary carcinoma of the thyroid

•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

•Current or past use of medications that may have significantly affected gastrointestinal and/or gallbladder motility or pancreatic or hepatobiliary systems

•History of regular alcohol consumption within 6 months of the study

•Urinary cotinine levels indicative of smoking or history of regular use of tobacco- or nicotine-containing products within 3 months prior to screening

•Subject has a history of significant weight loss or is currently attempting weight loss

•History of sensitivity or contraindication to any of the study medications or components thereof or a history of drug or other allergy

•Subject has previously received any GLP-1 mimetic compound (e.g., exenatide, liraglutide, lixisenatide, dulaglutide)

•A biliary pathology as assessed by ultrasound

•An abnormal (i.e., outside the normal reference range) thyroid function test assessed by thyroid stimulating hormone at screening

•An abnormal amylase or lipase test at screening

•A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result

•A positive pre-study drug/alcohol screen

•A positive test for Human immunodeficiency virus (HIV) antibody

•A screening ultrasound which demonstrates inadequate imaging of gallbladder, main pancreatic duct, or common duct

•Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 56-day period

•The subject participated in a clinical trial and received an investigational product within 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 chemical entities within 12 months prior to the first dosing day

Endpoints (15)

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

Other clinical outcomes

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Time frame:Day -1, Baseline Day 1(Pre-dose), Day 2, Day 3, and 15 minutes (-15 min) prior to dosing and 80 min post dosing on Day 4 in each treatment period and Follow-up (assessed up to a total of approximately 12 weeks)

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Mean · Millimeters of mercury (mmHg)	95% CI
PlaceboSBP, Period 1, Day 2, n=10, 10	2.5	-
SBP, Period 1, Day 3, n=10, 10	4.2	-
SBP, Period 1, Day 4 (-15 min), n=10, 10	4.8	-
SBP, Period 1, Day 4 (80 min), n=10, 10	2.2	-
SBP, Period 2, Day 2, n=8, 10	2.1	-
SBP, Period 2, Day 3, n=8, 10	-2.5	-
SBP, Period 2, Day 4 (-15 min), n=8, 10	4.5	-
SBP, Period 2, Day 4 (80 min), n=8, 9	8.9	-
DBP, Period 1, Day 2, n=10, 10	2.9	-
DBP, Period 1, Day 3, n=10, 10	1.7	-
DBP, Period 1, Day 4 (-15 min), n=10, 10	6.3	-
DBP, Period 1, Day 4 (80 min), n=10, 10	2.2	-
DBP, Period 2, Day 2, n=8, 10	-2.1	-
DBP, Period 2, Day 3, n=8, 10	-3.4	-
DBP, Period 2, Day 4 (-15 min), n=8, 10	3.3	-
DBP, Period 2, Day 4 (80 min), n=8, 9	6.4	-
Albiglutide 50 mgSBP, Period 1, Day 2, n=10, 10	2.5	-
SBP, Period 1, Day 3, n=10, 10	4.3	-
SBP, Period 1, Day 4 (-15 min), n=10, 10	0.4	-
SBP, Period 1, Day 4 (80 min), n=10, 10	9.4	-
SBP, Period 2, Day 2, n=8, 10	0.0	-
SBP, Period 2, Day 3, n=8, 10	-0.4	-
SBP, Period 2, Day 4 (-15 min), n=8, 10	0.8	-
SBP, Period 2, Day 4 (80 min), n=8, 9	4.7	-
DBP, Period 1, Day 2, n=10, 10	-0.4	-
DBP, Period 1, Day 3, n=10, 10	3.2	-
DBP, Period 1, Day 4 (-15 min), n=10, 10	5.2	-
DBP, Period 1, Day 4 (80 min), n=10, 10	9.5	-
DBP, Period 2, Day 2, n=8, 10	-4.3	-
DBP, Period 2, Day 3, n=8, 10	-3.0	-
DBP, Period 2, Day 4 (-15 min), n=8, 10	0.0	-
DBP, Period 2, Day 4 (80 min), n=8, 9	0.4	-

Secondary/protocol endpoint

Change From Baseline in Heart Rate

Time frame:Day -1, Baseline Day 1(Pre-dose), Day 2, Day 3, and 15 minutes (-15 min) prior to dosing and 80 min post dosing on Day 4 in each treatment period and Follow-up (a total of approximately 12 weeks)

Heart rate, change

change from baseline, improvement

Posted result

Group	Mean · Beats per minute (bpm)	95% CI
PlaceboPeriod 1, Day 2, n=10, 10	2.4	-
Period 1, Day 3, n=10, 10	4.7	-
Period 1, Day 4 (-15 min), n=10, 10	3.8	-
Period 1, Day 4 (80 min), n=10, 10	1.4	-
Period 2, Day 2, n=8, 10	2.5	-
Period 2, Day 3, n=8, 10	3.4	-
Period 2, Day 4 (-15 min), n=8, 10	1.0	-
Period 2, Day 4 (80 min), n=8, 9	1.8	-
Albiglutide 50 mgPeriod 1, Day 2, n=10, 10	4.3	-
Period 1, Day 3, n=10, 10	7.9	-
Period 1, Day 4 (-15 min), n=10, 10	8.5	-
Period 1, Day 4 (80 min), n=10, 10	9.4	-
Period 2, Day 2, n=8, 10	4.2	-
Period 2, Day 3, n=8, 10	9.4	-
Period 2, Day 4 (-15 min), n=8, 10	6.3	-
Period 2, Day 4 (80 min), n=8, 9	6.3	-

Safety / tolerability / PK

8 endpoints

Primary/protocol endpoint

Maximum Absolute Value of Gallbladder Ejection Fraction (Emax GEF) During Cholecystokinin (CCK) Infusion, as a Measure of Maximum Effect

Time frame:Day 4 in each treatment period

descriptive

Posted result

Group	Least-squares mean · Percent of gallbladder EF	95% CI
Placebo	47.4352	-
Albiglutide 50 mg	38.4331	-

Mean difference (final values)-9.002195% CI-20.5781 - 2.5739p0.1229Mixed Models Analysis

Primary/protocol endpoint

Time at Which the Maximum Effect (Emax GEF) Occurred (TEMAXEF) During the CCK Infusion

Time frame:Day 4 in each treatment period

TEMAXEF

descriptive

Posted result

Group	Mean · Minutes	95% CI
Placebo	37.64706	-
Albiglutide 50 mg	32.94118	-

Primary/protocol endpoint

Maximum Absolute Change From Baseline in Value of Gallbladder Volume (Emax VL) During CCK Infusion, as a Measure of Maximum Effect

Time frame:Day 4 in each treatment period

Gallbladder event

change from baseline, descriptive

Posted result

Group	Mean · Millilitre (mL)	95% CI
Placebo	8.8385	-
Albiglutide 50 mg	8.4637	-

Mean difference (final values)-0.374895% CI-3.4109 - 2.6614p0.7961Mixed Models Analysis

Primary/protocol endpoint

Maximum Change From Baseline in Common Bile Duct Diameter During CCK Infusion

Time frame:Day 4 in each treatment period

change from baseline, descriptive

Posted result

Group	Mean · Centimetre (cm)	95% CI
Placebo	0.08814	-
Albiglutide 50 mg	0.07358	-

Mean difference (final values)-0.0145695% CI-0.030666 - 0.001554p0.0733Mixed Models Analysis

Secondary/protocol endpoint

Number of Participants With Clinical Chemistry and Hematology Abnormalities of Potential Clinical Importance

Time frame:Day -1 in each treatment period and Follow-up (at approximately Week 12)

threshold achievement, event

Posted result

Group	Number · Participants	95% CI
Albiglutide 50 mg and PlaceboClinical Chemistry, Albiglutide Period 1, n=10	1	-
Clinical Chemistry, Placebo Period 2, n=8	2	-
Clinical Chemistry, Follow-up, n=17	1	-
Hematology, Albiglutide Period 1, n=10	1	-
Hematology, Albiglutide Period 2, n=10	1	-

Secondary/protocol endpoint

Change From Baseline in Electrocardiogram (ECG) Parameters

Time frame:Baseline (Day -1) and Day 4 in each treatment period, and at Follow-up (at approximately Week 12)

change from baseline, descriptive

Posted result

Group	Mean · Milliseconds (msec)	95% CI
PlaceboPR	2.1	-
QRS	-1.8	-
QT	-5.0	-
QTcF	-7.7	-
Albiglutide 50 mgPR	2.2	-
QRS	-0.7	-
QT	-19.9	-
QTcF	-7.0	-

Secondary/protocol endpoint

Part A: Number of Participants With at Least One Non-serious Adverse Event (AE), Serious Adverse Event (SAE), or Drug-related Adverse Event

Time frame:From Day -1 in treatment period 1 and up to Follow-up Visit (a total of approximately 12 weeks)

Treatment-emergent AEs (any)

threshold achievement, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Posted result

Group	Number · Participants	95% CI
PlaceboAny AE	8	-
Any SAE	0	-
Any Drug-Related AE	5	-
Albiglutide 50 mgAny AE	9	-
Any SAE	0	-
Any Drug-Related AE	6	-

Secondary/protocol endpoint

Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick

Time frame:Day -1 and Follow-up (assessed up to a total of approximately 12 weeks)

descriptive

Posted result

Group	Number · Participants	95% CI
PlaceboUrine Glucose Normal; Day -1; n=18, 20, 0	18	-
Urine Glucose Normal; Follow-up; n=0, 0, 19	NA	-
Urine Ketones Negative; Day -1; n=18, 20, 0	18	-
Urine Ketones Trace; Day -1; n=18, 20, 0	0	-
Urine Ketones Negative; Follow-up; n=0, 0, 19	NA	-
Urine Nitrite Negative; Day -1; n=18, 20, 0	18	-
Urine Nitrite Negative; Follow-up; n=0, 0, 19	NA	-
Urine Protein Negative; Day -1; n=17, 20, 0	17	-
Urine Protein Negative; Follow-up; n=0, 0, 18	NA	-
Albiglutide 50 mgUrine Glucose Normal; Day -1; n=18, 20, 0	20	-
Urine Glucose Normal; Follow-up; n=0, 0, 19	NA	-
Urine Ketones Negative; Day -1; n=18, 20, 0	19	-
Urine Ketones Trace; Day -1; n=18, 20, 0	1	-
Urine Ketones Negative; Follow-up; n=0, 0, 19	NA	-
Urine Nitrite Negative; Day -1; n=18, 20, 0	20	-
Urine Nitrite Negative; Follow-up; n=0, 0, 19	NA	-
Urine Protein Negative; Day -1; n=17, 20, 0	20	-
Urine Protein Negative; Follow-up; n=0, 0, 18	NA	-
Albiglutide 50 mg and PlaceboUrine Glucose Normal; Day -1; n=18, 20, 0	NA	-
Urine Glucose Normal; Follow-up; n=0, 0, 19	19	-
Urine Ketones Negative; Day -1; n=18, 20, 0	NA	-
Urine Ketones Trace; Day -1; n=18, 20, 0	NA	-
Urine Ketones Negative; Follow-up; n=0, 0, 19	19	-
Urine Nitrite Negative; Day -1; n=18, 20, 0	NA	-
Urine Nitrite Negative; Follow-up; n=0, 0, 19	19	-
Urine Protein Negative; Day -1; n=17, 20, 0	NA	-
Urine Protein Negative; Follow-up; n=0, 0, 18	18	-

Other clinical outcomes

5 endpoints

Primary/protocol endpoint

Area Under the Effect Curve for Gallbladder Ejection Fraction (AUEC GEF)

Time frame:Day 4 in each treatment period

descriptive

Posted result

Group	Mean · %*min	95% CI
Placebo	1004.2510	-
Albiglutide 50 mg	458.2926	-

Mean difference (final values)-545.958595% CI-1260.00 - 168.0858p0.1291Mixed Models Analysis

Primary/protocol endpoint/low confidence

Maximum Gallbladder Ejection Fraction Value During CCK Infusion

Time frame:Day 1 and Day 4 in each treatment period

descriptive

Posted result

Group	Mean · Percentage	95% CI
Placebo	44.5989	-
Albiglutide 50 mg	28.2997	-

Mean difference (final values)-16.299295% CI-31.0762 - -1.5223p0.0317Mixed Models Analysis

Primary/protocol endpoint

Area Under the Effect Curve for Gallbladder Volume (AUEC VL)

Time frame:Day 4 in each treatment period

descriptive

Posted result

Group	Mean · mL*min	95% CI
Placebo	610.5642	-
Albiglutide 50 mg	863.1741	-

Mean difference (final values)252.609995% CI29.5081 - 475.7117p0.0291Mixed Models Analysis

Primary/protocol endpoint

Time at Which the Maximum Effect (Emax VL) Occurred (TEmax VL) During the CCK Infusion

Time frame:Day 4 in each treatment period

descriptive

Posted result

Group	Mean · Minutes	95% CI
Placebo	37.64706	-
Albiglutide 50 mg	32.94118	-

Primary/protocol endpoint

Maximum Change From Baseline in Main Pancreatic Duct Diameter During CCK Infusion

Time frame:Day 4 in each treatment period

change from baseline, descriptive

Posted result

Group	Mean · Centimetre (CM)	95% CI
Placebo	0.04359	-
Albiglutide 50 mg	0.04511	-

Mean difference (final values)0.00152695% CI-0.045665 - 0.048717p0.9424Mixed Models Analysis

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Effect of Albiglutide on Cholecystokinin-Induced Gallbladder Emptying in Healthy Individuals: A Randomized Crossover Study.
Journal of clinical pharmacology2017 Oct (month)PMID28543352doi:10.1002/jcph.940via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.