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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: Completed Phase 2 study of Obesity, sponsored by GlaxoSmithKline.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical o
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2013-02-10 |
| Est. Completion | 2013-09-12 |
| Phase | Phase 2 |
What the finished NCT01725126 record still lists
NCT01725126 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (94% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Obesity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01725126's enrollment target sits among peer trials
53 700th of 1053 higher than 349 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity 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.
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