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NCT01725126 · ClinicalTrials.gov registry record · Phase 2

To Investigate the Safety, Tolerability and Pharmacodynamics of GSK2890457 in Healthy Volunteers and Subjects With Type 2 Diabetes

A Phase 2 study of Obesity, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 2
Development phase
53
Enrollment target
3
Study locations

NCT01725126 is a Phase 2 study of Obesity that has completed, run by GlaxoSmithKline. The registered enrollment target is 53 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (94% lower). The trial reports 3 study locations across 3 states.

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The verdict

NCT01725126, a Phase 2 study of Obesity, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 2
Development phase
53 participants
Enrollment target
3
Study locations

Study Summary

This study is the first administration of GSK2890457 in humans. The study will be conducted in 3 parts: - Part A (conducted at a single investigative site) will determine the safety and tolerability of GSK2890457 alone in healthy subjects during six weeks of dosing, as well as evaluating the potential for a pharmacokinetic interaction with metformin. Part A consists of Screening, Treatment (6 weeks) and Follow-up periods. - Part B (conducted at multiple sites) will determine safety, tolerability, and pharmacodynamics (PD) in subjects with Type 2 diabetes (T2D) when co-dosed for six weeks with liraglutide (Victoza). Part B consists of Screening, Run-in (1 week), Stabilization (12 weeks), Treatment (6 weeks) and Follow-up periods. - Part C (conducted at multiple sites) will determine safety, tolerability, and PD in subjects with T2D when co-dosed for 6 weeks with metformin. Part C consists of Screening, Run-in (1 week), Stabilization (12 weeks), Treatment (6 weeks) and Follow-up periods.

Conditions Studied

Obesity

Interventions

  • DRUG Placebo
  • DRUG Metformin
  • DRUG Liraglutide
  • DRUG GSK2890457

Study Locations (3)

California

  • GSK Investigational Site - Chula Vista

Florida

  • GSK Investigational Site - Miami

Kansas

  • GSK Investigational Site - Overland Park

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2013-02-10
Est. Completion 2013-09-12
Phase Phase 2

Sponsor

GlaxoSmithKline

1,345 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01725126

The ClinicalTrials.gov registry entry for NCT01725126 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (94% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Obesity appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.

NCT01725126 reports 3 study locations spanning 3 distinct geographic areas - top geographies include California, Florida, Kansas.

Frequently Asked Questions

What is clinical trial NCT01725126 about?

NCT01725126 is a clinical study titled "To Investigate the Safety, Tolerability and Pharmacodynamics of GSK2890457 in Healthy Volunteers and Subjects With Type 2 Diabetes". This study is the first administration of GSK2890457 in humans. The study will be conducted in 3 parts: - Part A (conducted at a single investigative site) will determine the safety and tolerability of GSK2890457 alone in healthy subjects during six weeks of dosing, as well as evaluating the potenti...

What is the current status of trial NCT01725126?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2013-02-10. Estimated completion is 2013-09-12.

What conditions does trial NCT01725126 study?

This clinical trial studies the following conditions: Obesity.

What interventions are being tested in trial NCT01725126?

The interventions under investigation include: Placebo (DRUG), Metformin (DRUG), Liraglutide (DRUG), GSK2890457 (DRUG).

Who is sponsoring clinical trial NCT01725126?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01725126 being conducted?

This trial has 3 study locations across California, Florida, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.