SAXAPCOS

CompletedPhase 3Results posted

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

A Randomized Placebo-controlled Double Blind Trial of Liraglutide 3 mg [Saxenda] on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With Polycystic Ovary Syndrome (PCOS)

Lead sponsor

Woman's

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight, PCOS

Key I/E criteria

•BMI ≥30•Female

Primary endpoints

•Body weight, absolute change (kg)•Androgen, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03480022

Org study IDU1111-1198-4126

Timeline

Milestones

Study first posted2018-03-27actual

Study start2018-09-26actual

Primary completion2021-02-22actual

Study completion2021-05-19actual

Last update posted2021-06-07actual

Results first posted2021-06-07actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Obesity / overweightPCOS

Eligibility

Who can enroll

Minimum age18 Years

Maximum age45 Years

SexFemale

Healthy volunteersNot accepted

Inclusion criteria

•Female gender

•18-45 years of age

•BMI ≥30 kg/m2 or BMI ≥27 kg/m2 with one or more obesity-associated co-morbid conditions (e.g. hypertension, and dyslipidemia)

•PCOS- NIH criteria hyperandrogenism and irregular menstrual cyclicity

•Non-diabetic as determined by a 75 gram oral glucose tolerance test (OGTT) and hemoglobin A1C. Non-diabetic is inclusive of women with impaired fasting glucose (IFG), impaired glucose tolerance (IGT), or both (IFG/IGT). Participants with diabetes will be excluded

•Willing to use effective contraception consistently during therapy which is defined as:

–an intrauterine device, tubal sterilization, or male partner vasectomy, or

–combination of two barrier methods with one being male condom.

•Written consent for participation in the study

Exclusion criteria

•Presence of significant systemic disease, cerebrovascular disease, clinically significant cardiac abnormalities or heart problems including congestive heart failure, unstable angina or acute myocardial infarction, current infectious liver disease, acute stroke or transient ischemic attacks, history of pancreatitis, or diabetes mellitus (Type 1 or 2)

•Any hepatic diseases in the past (infectious liver disease, viral hepatitis, toxic hepatic damage, jaundice of unknown etiology) or severe hepatic insufficiency and/or significant abnormal liver function tests defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN

•Renal impairment (e.g., serum creatinine levels ≥1.4 mg/dL for women, or eGFR <60 mL/min/1.73 m2) or history of unstable or rapidly progressing renal disease or end stage renal disease.

•Uncontrolled thyroid disease (documented normal TSH), Cushing's syndrome, congenital adrenal hyperplasia or clinically significant elevations in prolactin levels. The clinical significance of prolactin levels will be determined by the treating physician

•Significantly elevated triglyceride levels (fasting triglyceride > 400 mg %)

•Untreated or poorly controlled hypertension (sitting blood pressure > 160/95 mm Hg)

•Use of hormonal medications, the use of medications that cause clinically significant weight gain or loss (prescription or OTC) and medications known to exacerbate glucose tolerance (such as isotretinoin, hormonal contraceptives, GnRH analogues, glucocorticoids, anabolic steroids, C-19 progestins) including herbal medicines for at least 8 weeks. Use of anti-androgens that act peripherally to reduce hirsutism such as 5-alpha reductase inhibitors (finasteride, spironolactone, flutamide) for at least 4 weeks

•Prior history of a malignant disease requiring chemotherapy

•Family or personal history of familial medullary thyroid carcinoma or multiple endocrine neoplasia type 2

•Known hypersensitivity or contraindications to use GLP1 receptor agonists

•Use of metformin, thiazolidinediones, GLP-1 receptor agonists, dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium/glucose co-transporter 2 (SGLT2) inhibitors or weight loss medications (prescription or OTC) stopped for at least 4 weeks

•Prior use of medication to treat diabetes except gestational diabetes

•Eating disorders (anorexia, bulimia) or gastrointestinal disorders

•Suspected pregnancy (documented negative serum pregnancy test), desiring pregnancy in next 15 months, breastfeeding, or known pregnancy in last three months

•Active or prior history of substance abuse (smoke or tobacco use within past 6 months) or significant intake of alcohol

•Previous bariatric surgery or device intervention for obesity

•Patient not willing to use barrier contraception during study period (unless sterilized or have an IUD)

•History of major depressive or other severe psychiatric disorders

•Inability or refusal to comply with protocol

•Currently participating or having participated in an experimental drug study in previous three months

Endpoints (58)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Glycemic / diabetes

Cardiometabolic biomarkers

Other clinical outcomes

Weight & body composition

24 endpoints

Primary/registry result

Absolute Body Weight (BW)

Time frame:32 weeks of treatment

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kilogram	95% CI
Liraglutide Pen Injector (Saxenda)	104.7	—
Placebo Liraglutide Pen Injector	117.9	—

p<0.002ANOVA

Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect

Primary/protocol endpoint

Absolute Body Weight (BW)

Time frame:32 weeks of treatment

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/registry result

Body Mass Index (BMI)

Time frame:32 weeks of treatment

BMI, change

change from baseline, improvement

Posted result

Group	Value (mean), kilogram/meter squared	95% CI
Liraglutide Pen Injector (Saxenda)	39.1	—
Placebo Liraglutide Pen Injector	43.4	—

p<0.001ANOVA

Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect

Secondary/registry result

Change in Percent Body Weight

Time frame:Change from baseline (time 0) to study end (32 weeks)

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), percentage loss in body weight	95% CI
Liraglutide Pen Injector (Saxenda)	5.7	—
Placebo Liraglutide Pen Injector	1.4	—

p<0.002ANOVA

Secondary/registry result

5% Weight Loss From Baseline

Time frame:32 weeks of treatment

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Liraglutide Pen Injector (Saxenda)	25	—
Placebo Liraglutide Pen Injector	5	—

p<0.007Wilcoxon (Mann-Whitney)

Secondary/registry result

10% Body Weight Loss From Baseline

Time frame:32 weeks of treatment

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Liraglutide Pen Injector (Saxenda)	13	—
Placebo Liraglutide Pen Injector	2	—

p<0.049Wilcoxon (Mann-Whitney)

Secondary/registry result

Abdominal Adiposity (Waist Circumference [WC]

Time frame:32 weeks of treatment

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), centimeters	95% CI
Liraglutide Pen Injector (Saxenda)	100.9	—
Placebo Liraglutide Pen Injector	109.9	—

p<0.011ANOVA

Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect

Secondary/registry result

Waist-to-Hip Ratio

Time frame:32 weeks of treatment

ratio, improvement

Posted result

Group	Value (mean), ratio	95% CI
Liraglutide Pen Injector (Saxenda)	0.81	—
Placebo Liraglutide Pen Injector	0.85	—

p<0.038ANOVA

Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect

Secondary/registry result

Waist-to Height Ratio [WHtR])

Time frame:32 weeks of treatment

ratio, improvement

Posted result

Group	Value (mean), ratio	95% CI
Liraglutide Pen Injector (Saxenda)	0.62	—
Placebo Liraglutide Pen Injector	0.67	—

p<0.048ANOVA

Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect

Secondary/registry result

Total Fat Mass Evaluated by DEXA

Time frame:32 weeks of treatment

Total fat mass

change from baseline, improvement

Posted result

Group	Value (mean), kilogram	95% CI
Liraglutide Pen Injector (Saxenda)	49.3	—
Placebo Liraglutide Pen Injector	56.8	—

p<0.018ANOVA

Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect

Secondary/registry result

Total Body Fat (%) by DXA

Time frame:32 weeks of treatment

Total fat mass

change from baseline, improvement

Posted result

Group	Value (mean), percent fat mass	95% CI
Liraglutide Pen Injector (Saxenda)	46.0	—
Placebo Liraglutide Pen Injector	47.9	—

p<0.028ANOVA

Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect

Secondary/registry result

Android-Gynoid Ratio (AGR) by DXA

Time frame:32 weeks of treatment

ratio, improvement

Posted result

Group	Value (mean), ratio	95% CI
Liraglutide Pen Injector (Saxenda)	1.05	—
Placebo Liraglutide Pen Injector	1.08	—

p<0.034ANOVA

Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect

Secondary/registry result

Trunk/Leg Fat Ratio (TLR) by DXA

Time frame:32 weeks of treatment

ratio, improvement

Posted result

Group	Value (mean), ratio	95% CI
Liraglutide Pen Injector (Saxenda)	1.02	—
Placebo Liraglutide Pen Injector	1.07	—

p<0.035ANOVA

Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect

Secondary/protocol endpoint

Body Mass Index (BMI)

Time frame:32 weeks of treatment

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Percent Body Weight

Time frame:Change from baseline (time 0) to study end (32 weeks)

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

5% Weight Loss From Baseline

Time frame:32 weeks of treatment

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

10% Body Weight Loss From Baseline

Time frame:32 weeks of treatment

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Abdominal Adiposity (Waist Circumference [WC]

Time frame:32 weeks of treatment

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Waist-to-Hip Ratio

Time frame:32 weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint

Waist-to Height Ratio [WHtR])

Time frame:32 weeks of treatment

ratio, improvement

Secondary/protocol endpoint

Total Fat Mass Evaluated by DEXA

Time frame:32 weeks of treatment

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Total Body Fat (%) by DXA

Time frame:32 weeks of treatment

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Android-Gynoid Ratio (AGR) by DXA

Time frame:32 weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint

Trunk/Leg Fat Ratio (TLR) by DXA

Time frame:32 weeks of treatment

change from baseline, improvement

Glycemic / diabetes

14 endpoints

Secondary/registry result

Fasting Blood Glucose (FG)

Time frame:32 weeks of treatment

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mg/dL	95% CI
Liraglutide Pen Injector (Saxenda)	90.2	—
Placebo Liraglutide Pen Injector	94.3	—

p<0.021ANOVA

Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect

Secondary/registry result

OGTT Mean Blood Glucose (MBG)

Time frame:32 weeks of treatment

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mg/dL	95% CI
Liraglutide Pen Injector (Saxenda)	109.4	—
Placebo Liraglutide Pen Injector	125.5	—

p<0.009ANOVA

Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect

Secondary/registry result

Fasting Insulin Sensitivity (HOMA-IR)

Time frame:32 weeks of treatment

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Posted result

Group	Value (mean), index score	95% CI
Liraglutide Pen Injector (Saxenda)	4.1	—
Placebo Liraglutide Pen Injector	5.2	—

p<0.035ANOVA

Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect

Secondary/registry result

Matsuda Insulin Sensitivity Index Derived From the OGTT (SI OGTT)

Time frame:32 weeks of treatment

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Posted result

Group	Value (mean), index score	95% CI
Liraglutide Pen Injector (Saxenda)	3.7	—
Placebo Liraglutide Pen Injector	3.0	—

p<0.028ANOVA

Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect

Secondary/registry result

Corrected First Phase Insulin Secretion (IGI/HOMA-IR)

Time frame:32 weeks of treatment

HOMA-IR (insulin sensitivity)

descriptive, improvement

Posted result

Group	Value (mean), index score	95% CI
Liraglutide Pen Injector (Saxenda)	1.01	—
Placebo Liraglutide Pen Injector	0.8	—

p<0.042ANOVA

Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect

Secondary/registry result/low confidence

Insulin Secretion- Insulin Sensitivity Index (Oral Disposition Index-IS-SI)

Time frame:32 weeks of treatment

change from baseline, improvement

Posted result

Group	Value (mean), index score	95% CI
Liraglutide Pen Injector (Saxenda)	532	—
Placebo Liraglutide Pen Injector	416	—

p<0.033ANOVA

Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect

Secondary/registry result

Triglyceride and Glucose Index (TyG)

Time frame:32 weeks of treatment

change from baseline, improvement

Posted result

Group	Value (mean), index score	95% CI
Liraglutide Pen Injector (Saxenda)	8.39	—
Placebo Liraglutide Pen Injector	8.5	—

p<0.01ANOVA

Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect

Secondary/protocol endpoint

Fasting Blood Glucose (FG)

Time frame:32 weeks of treatment

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

OGTT Mean Blood Glucose (MBG)

Time frame:32 weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint

Fasting Insulin Sensitivity (HOMA-IR)

Time frame:32 weeks of treatment

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Matsuda Insulin Sensitivity Index Derived From the OGTT (SI OGTT)

Time frame:32 weeks of treatment

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Corrected First Phase Insulin Secretion (IGI/HOMA-IR)

Time frame:32 weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint

Insulin Secretion- Insulin Sensitivity Index (Oral Disposition Index-IS-SI)

Time frame:32 weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint

Triglyceride and Glucose Index (TyG)

Time frame:32 weeks of treatment

change from baseline, improvement

Cardiometabolic biomarkers

12 endpoints

Secondary/registry result

Total Cholesterol Levels

Time frame:32 weeks of treatment

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

Group	Value (mean), mg/dL	95% CI
Liraglutide Pen Injector (Saxenda)	176	—
Placebo Liraglutide Pen Injector	178	—

p>0.05ANOVA

Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect

Secondary/registry result

High Density Lipoprotein Cholesterol (HDL-C)

Time frame:32 weeks of treatment

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

Group	Value (mean), mg/dL	95% CI
Liraglutide Pen Injector (Saxenda)	41	—
Placebo Liraglutide Pen Injector	42	—

p>0.05ANOVA

Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect

Secondary/registry result

Triglyceride Levels (TRG)

Time frame:32 weeks of treatment

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

Group	Value (mean), mg/dL	95% CI
Liraglutide Pen Injector (Saxenda)	109	—
Placebo Liraglutide Pen Injector	114	—

p<0.016ANOVA

Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect

Secondary/registry result

Triglyceride to HDL-Cholesterol Ratio (TRG/HDL-C)

Time frame:32 weeks of treatment

ratio, improvement

Posted result

Group	Value (mean), ratio	95% CI
Liraglutide Pen Injector (Saxenda)	2.9	—
Placebo Liraglutide Pen Injector	3.0	—

p<0.028ANOVA

Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect

Secondary/registry result

Systolic Blood Pressure

Time frame:32 weeks of treatment

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (mean), mmHg	95% CI
Liraglutide Pen Injector (Saxenda)	116.8	—
Placebo Liraglutide Pen Injector	123.3	—

p>0.05ANOVA

Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect

Secondary/registry result

Diastolic Blood Pressure (BP)

Time frame:32 weeks of treatment

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Value (mean), mmHg	95% CI
Liraglutide Pen Injector (Saxenda)	77.6	—
Placebo Liraglutide Pen Injector	78.1	—

p>0.05ANOVA

Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect

Secondary/protocol endpoint

Total Cholesterol Levels

Time frame:32 weeks of treatment

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

High Density Lipoprotein Cholesterol (HDL-C)

Time frame:32 weeks of treatment

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Triglyceride Levels (TRG)

Time frame:32 weeks of treatment

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Triglyceride to HDL-Cholesterol Ratio (TRG/HDL-C)

Time frame:32 weeks of treatment

ratio, improvement

Secondary/protocol endpoint

Systolic Blood Pressure

Time frame:32 weeks of treatment

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Diastolic Blood Pressure (BP)

Time frame:32 weeks of treatment

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Other clinical outcomes

8 endpoints

Primary/registry result

Free Androgen Index (FAI)

Time frame:32 weeks of treatment

Androgen, change

change from baseline, improvement

Posted result

Group	Value (mean), index score	95% CI
Liraglutide Pen Injector (Saxenda)	5.98	—
Placebo Liraglutide Pen Injector	6.4	—

p<0.006ANOVA

Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect

Primary/protocol endpoint

Free Androgen Index (FAI)

Time frame:32 weeks of treatment

Androgen, change

change from baseline, improvement

Secondary/registry result

Menstrual Cycle Frequency

Time frame:32 weeks of treatment

Menstrual cyclicity

descriptive, improvement

Posted result

Group	Value (mean), menses per year	95% CI
Liraglutide Pen Injector (Saxenda)	8.65	—
Placebo Liraglutide Pen Injector	4.8	—

p<0.0001ANOVA

Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect

Secondary/registry result

Total Testosterone Concentrations (T)

Time frame:32 weeks of treatment

Androgen, change

change from baseline, improvement

Posted result

Group	Value (mean), ng/dL	95% CI
Liraglutide Pen Injector (Saxenda)	45.4	—
Placebo Liraglutide Pen Injector	46.8	—

p>0.05ANOVA

Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect

Secondary/registry result

Adrenal Dehydroepiandrosterone Sulfate (DHEAS)

Time frame:32 weeks of treatment

Androgen, change

change from baseline, improvement

Posted result

Group	Value (mean), mcg/dL	95% CI
Liraglutide Pen Injector (Saxenda)	177.1	—
Placebo Liraglutide Pen Injector	171.3	—

p>0.05ANOVA

Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect

Secondary/protocol endpoint

Menstrual Cycle Frequency

Time frame:32 weeks of treatment

Menstrual cyclicity

change from baseline, improvement

Secondary/protocol endpoint

Total Testosterone Concentrations (T)

Time frame:32 weeks of treatment

Androgen, change

change from baseline, improvement

Secondary/protocol endpoint

Adrenal Dehydroepiandrosterone Sulfate (DHEAS)

Time frame:32 weeks of treatment

Androgen, change

change from baseline, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Liraglutide 3 mg on weight, body composition, and hormonal and metabolic parameters in women with obesity and polycystic ovary syndrome: a randomized placebo-controlled-phase 3 study.
Fertility and sterility2022 Aug (month)PMID35710599doi:10.1016/j.fertnstert.2022.04.027via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.