Trial · NCT03158805

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

NCT03158805, Phase 2, Completed, Lindner Center of HOPE; results first posted 2024-03-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Saxenda® in Obese or Overweight Patients With Stable Bipolar Disorder (Investigator Initiated). Trials, record NCT03158805. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03158805

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Saxenda® in Obese or Overweight Patients With Stable Bipolar Disorder (Investigator Initiated)
NCT number: NCT03158805
Status: Completed
Phases: Phase 2
Enrollment: 60 participants, actual
Lead sponsor: Lindner Center of HOPE
Conditions: Bipolar Disorder, Obesity
Interventions: LIRAGLUTIDE, Placebo
First posted: 2017-05-18
Last updated: 2025-03-12
Results first posted: 2024-03-27
Limitations and caveats: The small sample size may have compromised the study's ability to detect important effects. Premature termination rate was high and treatment duration was relatively short. Only individuals with stable BD were enrolled, and therefore results cannot be generalized to individuals with unstable BD.

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percent Change in Body Weight	40 week	Percent change in body weight over 40 weeks

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent Change in Body Weight	40 week	≥ 5% of baseline body weight	% change	MEAN

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Percent Change in Body Weight	Active Drug		-3.3	Standard Deviation 5.2	% change
Percent Change in Body Weight	Placebo		0.2	Standard Deviation 4.2	% change

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Active Drug	29
Overall Study	STARTED	Placebo	31
Overall Study	COMPLETED	Active Drug	13
Overall Study	COMPLETED	Placebo	8
Overall Study	NOT COMPLETED	Active Drug	16
Overall Study	NOT COMPLETED	Placebo	23

Source ClinicalTrials.gov

Adverse events24

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nausea	Gastrointestinal disorders	Active Drug	19	29	19
other	Nausea	Gastrointestinal disorders	Placebo	14	31	14
other	URI	Respiratory, thoracic and mediastinal disorders	Active Drug	10	29	10
other	URI	Respiratory, thoracic and mediastinal disorders	Placebo	6	31	10
other	Constipation	Gastrointestinal disorders	Active Drug	12	29	12
other	Constipation	Gastrointestinal disorders	Placebo	3	31	3
other	Heartburn	Gastrointestinal disorders	Active Drug	10	29	10
other	Heartburn	Gastrointestinal disorders	Placebo	2	31	2
other	Mood dysregulation	Psychiatric disorders	Active Drug	7	29	7
other	Mood dysregulation	Psychiatric disorders	Placebo	8	31	8

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Active Drug	0	29
Total, all-cause mortality	Placebo	0	31
Total, other adverse events	Active Drug	29	29
Total, other adverse events	Placebo	25	31
Total, serious adverse events	Active Drug	0	29
Total, serious adverse events	Placebo	2	31

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
38227621	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Active Drug vs Placebo: deaths from any cause	Trial comparisons
Active Drug vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03158805

GET https://conductscience.org/api/trials/v1/NCT03158805/events?page=2

API reference For AI assistants