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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 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 20 participants.

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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).

Interventions

  • DRUG Placebo
  • DRUG Albiglutide 50 mg
  • DRUG CCK (Kinevac)

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2015-06-11
Est. Completion 2015-10-13
Phase Phase 4

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT02496221

The ClinicalTrials.gov registry entry for NCT02496221 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT02496221 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.