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NCT03158805 · ClinicalTrials.gov registry record · Phase 2
Saxenda® in Obese or Overweight Patients With Stable Bipolar Disorder (Investigator Initiated)
A Phase 2 study, sponsored by Lindner Center of HOPE.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT03158805: Completed Phase 2 study, sponsored by Lindner Center of HOPE.
NCT03158805 is a Phase 2 study that has completed, run by Lindner Center of HOPE. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03158805, a Phase 2 study, has completed, sponsored by Lindner Center of HOPE.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
Taken together these data support the hypothesis that liraglutide 3.0 mg sc injection will reduce body weight and improve metabolic variables in obese or overweight patients with BP without worsening psychiatric symptoms. The investigators predict that liraglutide 3.0 mg sc injection will display greater efficacy as compared to placebo in decreasing body weight in patients with BP who are obese or overweight. To prove this hypothesis, investigators will conduct a single-center, randomized, placebo-controlled, double-blind, parallel-group, 2-arm clinical trial of liraglutide 3.0 mg sc injection in 60 obese or overweight outpatients with stable BP. The investigators have chosen BP rather than another SMI because it is the most common SMI (more common than schizophrenia or schizoaffective disorder) and has a particularly strong association with obesity.
Primary Outcome
Percent change in body weight over 40 weeks
Interventions
- OTHER Placebo
- DRUG LIRAGLUTIDE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2017-04-26 |
| Est. Completion | 2023-01-01 |
| Phase | Phase 2 |
What the finished NCT03158805 record still lists
NCT03158805 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03158805 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03158805 about?
NCT03158805 is a clinical study titled "Saxenda® in Obese or Overweight Patients With Stable Bipolar Disorder (Investigator Initiated)". Taken together these data support the hypothesis that liraglutide 3.0 mg sc injection will reduce body weight and improve metabolic variables in obese or overweight patients with BP without worsening psychiatric symptoms. The investigators predict that liraglutide 3.0 mg sc injection will display gr...
What is the current status of trial NCT03158805?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2017-04-26. Estimated completion is 2023-01-01.
What interventions are being tested in trial NCT03158805?
The interventions under investigation include: Placebo (OTHER), LIRAGLUTIDE (DRUG).
Who is sponsoring clinical trial NCT03158805?
This trial is sponsored by Lindner Center of HOPE, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03158805's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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