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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: Completed Phase 4 study, sponsored by NYU Langone Health.

NCT03048578 is a Phase 4 study that has completed, run by NYU Langone Health. The registered enrollment target is 132 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

CMH is a test used in the analysis of stratified or matched categorical data. It allows testing of the association between a binary predictor or treatment and a binary outcome such as case or control status while taking into account the stratification

Interventions

  • DRUG Placebo
  • DRUG Saxenda

Trial Details

FieldValue
Enrollment Target 132 participants
Start Date 2017-05-22
Est. Completion 2021-03-02
Phase Phase 4
NYU Langone Health

1,164 total trials

What the finished NCT03048578 record still lists

NCT03048578 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03048578 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT03048578's enrollment target sits among peer trials

132 610th of 2000 higher than 1,382 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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Source: ClinicalTrials.gov NCT03048578, the US trial registry maintained by the National Library of Medicine. NCT03048578 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.