Saxenda® in Obese or Overweight Patients With Stable Bipolar Disorder (Investigator Initiated)

NCT03158805 · Completed

Last updated 2026-05-28

This clinical trial tested the medication Saxenda® in adults with bipolar disorder who are also overweight or obese to see how it affects their body weight.

Status Completed The study has finished.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 60 people

Who can join Ages 18–65 · all sexes

Timeline Started 2017-04 · est. completion 2023-01

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT03158805 ↗

Description as written by the study sponsor.

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.

Treatments tested

LIRAGLUTIDE also known as Saxenda Drug

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

Placebo injection

Main thing measured	Percent Change in Body Weight
Sponsor	Lindner Center of HOPE
Conditions studied	Bipolar Disorder, Obesity
GLP-1 drugs	liraglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT03158805 ↗