Trial · NCT03480022

Liraglutide 3mg (Saxenda) on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With PCOS

NCT03480022, Phase 3, Completed, Woman's; results first posted 2021-06-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Liraglutide 3mg (Saxenda) on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With PCOS. Trials, record NCT03480022. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03480022

On this page

Trial

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

Title: Liraglutide 3mg (Saxenda) on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With PCOS
NCT number: NCT03480022
Status: Completed
Phases: Phase 3
Enrollment: 88 participants, actual
Lead sponsor: Woman's
Conditions: Pre Diabetes, Polycystic Ovary Syndrome, Obesity Android
Interventions: Liraglutide Pen Injector [Saxenda], Placebo Liraglutide Pen Injector
First posted: 2018-03-27
Last updated: 2021-06-07
Results first posted: 2021-06-07

Source ClinicalTrials.gov

Registered outcomes29

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

List	Outcome	Time frame	Description
Primary	Absolute Body Weight (BW)	32 weeks of treatment	Treatment impact on change in body weight after 32 weeks of treatment.
Primary	Free Androgen Index (FAI)	32 weeks of treatment	Drug treatment effect on free androgen levels as calculated as FAI= total testosterone (T) concentrations divided by sex hormone binding globulin (SHBG) levels. A higher score indicates a worse outcome (more androgenic).
Secondary	Body Mass Index (BMI)	32 weeks of treatment	Treatment effect in reducing body mass
Secondary	Change in Percent Body Weight	Change from baseline (time 0) to study end (32 weeks)	Treatment effect on reducing body weight expressed as percent body weight loss from baseline
Secondary	5% Weight Loss From Baseline	32 weeks of treatment	Frequency of patients achieving 5% weight loss from baseline with treatment
Secondary	10% Body Weight Loss From Baseline	32 weeks of treatment	Frequency of patients with at least 10% reduction in body weight from baseline
Secondary	Abdominal Adiposity (Waist Circumference [WC]	32 weeks of treatment	Treatment effect on loss of WC (abdominal adiposity) with drug treatment
Secondary	Waist-to-Hip Ratio	32 weeks of treatment	Change in central adiposity with treatment as measured by WHR. A reduction in ratio indicates a decrease in truncal fat.
Secondary	Waist-to Height Ratio [WHtR])	32 weeks of treatment	Treatment effect on loss of central adiposity as determined by WHt ratio. The lower the ratio indicates less abdominal adiposity.
Secondary	Total Fat Mass Evaluated by DEXA	32 weeks of treatment	Treatment effect on reduction of fat mass (kg)

1 to 10 of 29Source ClinicalTrials.gov

See all 29 registered outcomes

Outcomes29

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Absolute Body Weight (BW)	32 weeks of treatment	kilogram	MEAN
PRIMARY	Free Androgen Index (FAI)	32 weeks of treatment	index score	MEAN
SECONDARY	Body Mass Index (BMI)	32 weeks of treatment	kilogram/meter squared	MEAN
SECONDARY	Change in Percent Body Weight	Change from baseline (time 0) to study end (32 weeks)	percentage loss in body weight	MEAN
SECONDARY	5% Weight Loss From Baseline	32 weeks of treatment	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	10% Body Weight Loss From Baseline	32 weeks of treatment	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Abdominal Adiposity (Waist Circumference [WC]	32 weeks of treatment	centimeters	MEAN
SECONDARY	Waist-to-Hip Ratio	32 weeks of treatment	ratio	MEAN
SECONDARY	Waist-to Height Ratio [WHtR])	32 weeks of treatment	ratio	MEAN
SECONDARY	Total Fat Mass Evaluated by DEXA	32 weeks of treatment	kilogram	MEAN

1 to 10 of 29Source ClinicalTrials.gov

See all 29 outcomes

Results by group58

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

Outcome	Group	Value	Spread	Units
Absolute Body Weight (BW)	Liraglutide Pen Injector (Saxenda)	104.7	Standard Error 2.9	kilogram
Absolute Body Weight (BW)	Placebo Liraglutide Pen Injector	117.9	Standard Error 5	kilogram
Free Androgen Index (FAI)	Liraglutide Pen Injector (Saxenda)	5.98	Standard Error 0.6	index score
Free Androgen Index (FAI)	Placebo Liraglutide Pen Injector	6.4	Standard Error .75	index score
Body Mass Index (BMI)	Liraglutide Pen Injector (Saxenda)	39.1	Standard Error 1.1	kilogram/meter squared
Body Mass Index (BMI)	Placebo Liraglutide Pen Injector	43.4	Standard Error 1.8	kilogram/meter squared
Change in Percent Body Weight	Liraglutide Pen Injector (Saxenda)	5.7	Standard Error 0.75	percentage loss in body weight
Change in Percent Body Weight	Placebo Liraglutide Pen Injector	1.4	Standard Error 1.09	percentage loss in body weight
5% Weight Loss From Baseline	Liraglutide Pen Injector (Saxenda)	25		Participants
5% Weight Loss From Baseline	Placebo Liraglutide Pen Injector	5		Participants

1 to 10 of 58Source ClinicalTrials.gov

See all 58 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Liraglutide Pen Injector (Saxenda)	55
Overall Study	STARTED	Placebo Liraglutide Pen Injector	27
Overall Study	COMPLETED	Liraglutide Pen Injector (Saxenda)	44
Overall Study	COMPLETED	Placebo Liraglutide Pen Injector	23
Overall Study	NOT COMPLETED	Liraglutide Pen Injector (Saxenda)	11
Overall Study	NOT COMPLETED	Placebo Liraglutide Pen Injector	4

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
other	Nausea	Gastrointestinal disorders	Liraglutide Pen Injector (Saxenda)	14	55
other	Nausea	Gastrointestinal disorders	Placebo Liraglutide Pen Injector	3	27
other	Pregnancy	Pregnancy, puerperium and perinatal conditions	Liraglutide Pen Injector (Saxenda)	2	55
other	Pregnancy	Pregnancy, puerperium and perinatal conditions	Placebo Liraglutide Pen Injector	0	27
other	Vomiting	Gastrointestinal disorders	Liraglutide Pen Injector (Saxenda)	5	55
other	Vomiting	Gastrointestinal disorders	Placebo Liraglutide Pen Injector	0	27
other	Diarrhea	Gastrointestinal disorders	Liraglutide Pen Injector (Saxenda)	4	55
other	Diarrhea	Gastrointestinal disorders	Placebo Liraglutide Pen Injector	0	27
other	Constipation	Gastrointestinal disorders	Liraglutide Pen Injector (Saxenda)	3	55
other	Constipation	Gastrointestinal disorders	Placebo Liraglutide Pen Injector	1	27

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	Liraglutide Pen Injector (Saxenda)	0	55
Total, all-cause mortality	Placebo Liraglutide Pen Injector	0	27
Total, other adverse events	Liraglutide Pen Injector (Saxenda)	40	55
Total, other adverse events	Placebo Liraglutide Pen Injector	8	27
Total, serious adverse events	Liraglutide Pen Injector (Saxenda)	0	55
Total, serious adverse events	Placebo Liraglutide Pen Injector	0	27

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35710599	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 comparisons4

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

Comparison	Source
Liraglutide Pen Injector (Saxenda) vs Placebo Liraglutide Pen Injector: 5% Weight Loss From Baseline	Trial comparisons
Liraglutide Pen Injector (Saxenda) vs Placebo Liraglutide Pen Injector: 10% Body Weight Loss From Baseline	Trial comparisons
Liraglutide Pen Injector (Saxenda) vs Placebo Liraglutide Pen Injector: deaths from any cause	Trial comparisons
Liraglutide Pen Injector (Saxenda) vs Placebo Liraglutide Pen Injector: 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/NCT03480022

GET https://conductscience.org/api/trials/v1/NCT03480022/registered?page=2

API reference For AI assistants