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NCT03048578 · ClinicalTrials.gov registry record · Phase 4
Clinical Efficacy and Safety of Using 3.0mg Liraglutide to Treat Weight Regain After Roux-en-Y Gastric Bypass Surgery
A Phase 4 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 132
- Enrollment target
NCT03048578 is a Phase 4 study that has completed, run by NYU Langone Health. The registered enrollment target is 132 participants.
The verdict
NCT03048578, a Phase 4 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 132 participants
- Enrollment target
Study Summary
This is a randomized, double-blinded, placebo-controlled trial of liraglutide versus placebo over a follow-up period of 12 months in patients at least 18 months following Roux-en-Y gastric bypass (RYGB) who are experiencing weight regain. This study will assess the efficacy of liraglutide in improving cardiometabolic risk profile (as indicated by serum lipids, HbA1c, and waist circumference) and quality of life (as assessed by PHQ-9 (Patient Health Questionnaire), versus placebo in patients at least 18 months following RYGB who are experiencing weight regain as well as the safety of liraglutide in this patient population.
Interventions
- DRUG Placebo
- DRUG Saxenda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2017-05-22 |
| Est. Completion | 2021-03-02 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03048578
The ClinicalTrials.gov registry entry for NCT03048578 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03048578 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03048578 about?
NCT03048578 is a clinical study titled "Clinical Efficacy and Safety of Using 3.0mg Liraglutide to Treat Weight Regain After Roux-en-Y Gastric Bypass Surgery". This is a randomized, double-blinded, placebo-controlled trial of liraglutide versus placebo over a follow-up period of 12 months in patients at least 18 months following Roux-en-Y gastric bypass (RYGB) who are experiencing weight regain. This study will assess the efficacy of liraglutide in improvi...
What is the current status of trial NCT03048578?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 132 participants. The study started on 2017-05-22. Estimated completion is 2021-03-02.
What interventions are being tested in trial NCT03048578?
The interventions under investigation include: Placebo (DRUG), Saxenda (DRUG).
Who is sponsoring clinical trial NCT03048578?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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