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NCT02496221 · ClinicalTrials.gov registry record · Phase 4
A Study Evaluating the Effect of Albiglutide on Gallbladder Emptying in Healthy Subjects
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
NCT02496221: Completed Phase 4 study, sponsored by GlaxoSmithKline.
NCT02496221 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02496221, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
Study Summary
Albiglutide, a novel analogue of glucagon-like peptide-1 (GLP-1), has been developed and approved for the treatment of type 2 diabetes mellitus. The primary objective of this study is to assess if a single dose of albiglutide can affect cholecystokinin-induced gallbladder emptying. To make this assessment, each study participant will receive a dose of albiglutide and a dose of placebo followed by cholecystokinin (CCK) infusion and ultrasound measurement of the gallbladder. The study will be comprised of two periods and 20 subjects. The screening visit will occur within 42 days of the start of Treatment Period 1. The Treatment Periods will be separated by a washout period of a minimum of 42 days. Subjects will return for a follow-up visit after 28 days following the last dose of albiglutide or placebo. The total duration of a subject's participation from Screening to Follow-up will be approximately 17.5 weeks. This study is a post marketing commitment to the United States Food and Drug Administration (USFDA).
Primary Outcome
Gallbladder ejection fraction (EF) is defined as the reduction in gallbladder volume at any time point from Baseline divided by baseline gallbladder volume and multiplied by 100. Baseline gallbladder volume is the average of the 3 gallbladder volume measurements prior to CCK infusion on Day 4, for each treatment period. Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes \[min\] relative to start of albiglutide/placebo injection) and Day 4 (\[prior to CCK infusion\] -15, -10,
Interventions
- DRUG Placebo
- DRUG Albiglutide 50 mg
- DRUG CCK (Kinevac)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2015-06-11 |
| Est. Completion | 2015-10-13 |
| Phase | Phase 4 |
What the finished NCT02496221 record still lists
NCT02496221 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02496221 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02496221 about?
NCT02496221 is a clinical study titled "A Study Evaluating the Effect of Albiglutide on Gallbladder Emptying in Healthy Subjects". Albiglutide, a novel analogue of glucagon-like peptide-1 (GLP-1), has been developed and approved for the treatment of type 2 diabetes mellitus. The primary objective of this study is to assess if a single dose of albiglutide can affect cholecystokinin-induced gallbladder emptying. To make this asse...
What is the current status of trial NCT02496221?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2015-06-11. Estimated completion is 2015-10-13.
What interventions are being tested in trial NCT02496221?
The interventions under investigation include: Placebo (DRUG), Albiglutide 50 mg (DRUG), CCK (Kinevac) (DRUG).
Who is sponsoring clinical trial NCT02496221?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02496221's enrollment target sits among peer trials
20 1753rd of 2000 higher than 167 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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