CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
LIRAGLUTIDE +1 moredrug
Likely dose
LIRAGLUTIDE 3 Mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03158805
NCT03158805Phase 2Completed

A Randomized, Placebo-Controlled Study of Liraglutide 3mg Daily (Saxenda®) in Obese or Overweight Patients With Stable Bipolar Disorder

Lindner Center of HOPE·interventional·Posted May 18, 2017·Updated Mar 12, 2025

In Brief

A Phase 2 clinical trial evaluating LIRAGLUTIDE and Placebo for Bipolar Disorder and Obesity. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMay 18, 2017
Enrollment StartApr 26, 2017
Primary CompletionOct 11, 2022
Study CompletionJan 1, 2023
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 9.1 years ago

Interventions

LIRAGLUTIDEdrug

3 Mg/0.5 mL (18 Mg/3 mL) SUB-Q PEN INJECTOR (ML)

Placeboother

Placebo injection