search
Back to results

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

Primary Purpose

Pre Diabetes, Polycystic Ovary Syndrome, Obesity Android

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Liraglutide Pen Injector [Saxenda]
Placebo Liraglutide Pen Injector
Sponsored by
Woman's
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pre Diabetes focused on measuring prediabetes, PCOS, GLP-1 agonist, weight loss

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Woman's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Liraglutide Pen Injector (Saxenda)

Placebo liraglutide pen injector

Arm Description

Start injection liraglutide 0.6 mg subcutaneously (SC) 1week daily (QD), step up to 1.2 mg SC QD for 1week, to 1.8 mg SC QD for 1 week, 2.4 mg SC QD for 1week, to a final dose of 3.0 mg liraglutide SQ daily

Start injection of placebo liraglutide 0.6 mg subcutaneously (SC) 1week daily (QD), step up to 1.2 mg SC QD for 1week, to 1.8 mg SC QD for 1 week, 2.4 mg SC QD for 1week, to a final dose of 3.0 mg placebo liraglutide SQ daily

Outcomes

Primary Outcome Measures

Absolute Body Weight (BW)
Treatment impact on change in body weight after 32 weeks of treatment.
Free Androgen Index (FAI)
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 Outcome Measures

Body Mass Index (BMI)
Treatment effect in reducing body mass
Change in Percent Body Weight
Treatment effect on reducing body weight expressed as percent body weight loss from baseline
5% Weight Loss From Baseline
Frequency of patients achieving 5% weight loss from baseline with treatment
10% Body Weight Loss From Baseline
Frequency of patients with at least 10% reduction in body weight from baseline
Abdominal Adiposity (Waist Circumference [WC]
Treatment effect on loss of WC (abdominal adiposity) with drug treatment
Waist-to-Hip Ratio
Change in central adiposity with treatment as measured by WHR. A reduction in ratio indicates a decrease in truncal fat.
Waist-to Height Ratio [WHtR])
Treatment effect on loss of central adiposity as determined by WHt ratio. The lower the ratio indicates less abdominal adiposity.
Total Fat Mass Evaluated by DEXA
Treatment effect on reduction of fat mass (kg)
Total Body Fat (%) by DXA
Treatment effect on reduction of percent body fat by DXA
Android-Gynoid Ratio (AGR) by DXA
Treatment impact on AGR, measure of central adiposity, as determined by DXA. A lower AGR indicates a reduction in central adiposity.
Trunk/Leg Fat Ratio (TLR) by DXA
Treatment impact on TLR after 32 weeks. A reduction in TLR indicates a loss of central fat.
Menstrual Cycle Frequency
Drug treatment impact on normalization of cycle frequency (cycle every 28-30 days). All cycle data is expressed as number of menses annualized to one year.
Total Testosterone Concentrations (T)
Drug treatment effect on total testosterone concentrations
Adrenal Dehydroepiandrosterone Sulfate (DHEAS)
Treatment efficacy in reducing adrenal hyperandrogenism
Fasting Blood Glucose (FG)
Treatment effect on fasting glucose prior to an oral glucose tolerance test (OGTT)
OGTT Mean Blood Glucose (MBG)
Treatment effect on MBG measured during the oral glucose tolerance test. A decrease in MBG shows improvement in glycemia.
Fasting Insulin Sensitivity (HOMA-IR)
Treatment effect on the HOMA-IR which is an insulin resistance measured derived from fasting blood glucose and insulin . The higher the number the more insulin resistant.
Matsuda Insulin Sensitivity Index Derived From the OGTT (SI OGTT)
The SI OGTT is a measure of peripheral insulin sensitivity derived from the insulin and glucoses measured during an OGTT. A increase in SI OGTTindicates greater insulin sensitivity
Corrected First Phase Insulin Secretion (IGI/HOMA-IR)
Treatment effect on insulin secretion from 0 to 30 minutes after glucose load corrected for by fasting insulin sensitivity. A higher score shows improved first phase insulin secretion in response to glucose.
Insulin Secretion- Insulin Sensitivity Index (Oral Disposition Index-IS-SI)
Treatment effect on an estimation of Beta cell compensatory function, the IS-SI is derived by applying the concept of the disposition index to measurements obtained during the 2 hour OGTT and calculated as the index of insulin secretion factored by insulin sensitivity. A higher score shows improved pancreatic beta cell function relative to insulin sensitivity.
Total Cholesterol Levels
Treatment impact on improving total cholesterol levels
High Density Lipoprotein Cholesterol (HDL-C)
Impact of treatment on HDL levels after 32 weeks of treatment
Triglyceride Levels (TRG)
Drug effect of TRG levels after treatment
Triglyceride to HDL-Cholesterol Ratio (TRG/HDL-C)
Treatment impact on TRG/HDL-C ratio which is a simple measure to estimate insulin action. A decrease in ratio indicates improvement in insulin sensitivity.
Triglyceride and Glucose Index (TyG)
Treatment impact on the TyG index which estimates insulin resistance. A reduction in TyG indicates an improvement in insulin action.
Systolic Blood Pressure
Treatment impact on systolic blood pressure
Diastolic Blood Pressure (BP)
Treatment impact on reducing diastolic blood pressure

Full Information

First Posted
March 13, 2018
Last Updated
June 3, 2021
Sponsor
Woman's
Collaborators
Novo Nordisk A/S
search

1. Study Identification

Unique Protocol Identification Number
NCT03480022
Brief Title
Liraglutide 3mg (Saxenda) on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With PCOS
Acronym
SAXAPCOS
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 26, 2018 (Actual)
Primary Completion Date
February 22, 2021 (Actual)
Study Completion Date
May 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Woman's
Collaborators
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
There is a growing need to develop pharmacologic interventions to improve metabolic function in women with polycystic ovary syndrome (PCOS). Given that PCOS is a frequent condition and weight loss is essential but difficult to achieve, it is important to study if the effect on body weight reported in other studies can be confirmed in a selected population of hyperandrogenic patients, especially with medications currently approved for weight reduction. High dose liraglutide alone results in significant weight reduction in obese women without PCOS. There is limited data on weight loss with high dose liraglutide in non-diabetic females with PCOS treated with this agent . Studies on the effect of anti-obesity medication combined with lifestyle changes on body weight and composition and androgen excess in obese women diagnosed with PCOS are lacking. The investigators aim to elucidate the most efficacious weight reduction regime in obese PCOS women. The investigators further hope to determine which treatment(s) addressing the multifaceted disturbances of this disorder in patients with PCOS and obesity emerges as the preferable therapy.
Detailed Description
The drug, liraglutide 3.0 mg was approved for chronic weight management in management in obese adults with an initial BMI of 30 kg/m2 or greater or in overweight adults BMI of 27 kg/m2 or greater with at least one weight-related co-morbid condition as an adjunct to a reduced-calorie diet and increased physical activity. Liraglutide is an acylated human glucagon-like peptide -1 (GLP-1) analog that binds to and activates the GLP-1 receptor. It lowers body weight through decreased caloric intake while stimulating insulin secretion and reducing glucagon via a glucose-dependent mechanism. For obesity management, patients may lose weight with GLP-1 receptor agonists due to other unique actions. Glucagon-like peptide-1 receptor agonists (GLP-1RAs) can slow gastric emptying and increase satiety. While predictors of weight loss success for the general population are available (protein intake, weight loss medications), predictors of weight loss success may differ between normal and hyperandrogenic women. Glucagon-like peptide 1 agonists are linked with dose dependent weight lowering potential in different obesity related populations. The weight loss effects of GLP-1RAs previously demonstrated in diabetic and obese non-diabetic patients, offer a unique opportunity to expand the medical options available to patients with PCOS. Given this lack of information, the aim of the present study was to investigate the effects of liraglutide 3mg vs. placebo on body composition as well as hormonal and metabolic features in non-diabetic obese women with PCOS.The non-diabetic obese female with PCOS offers a unique model to study the relationship between insulin resistance and adiposity. The investigators propose a double-blind, placebo-controlled 30-week trial designed to directly examine the therapeutic effects of liraglutide 3 mg (LIRA 3 mg) compared to placebo on body weight, hormonal and cardiometabolic parameters in obese non-diabetic women with PCOS. All patients will receive diet and lifestyle counseling, including advice on exercise commencing during the lead-in period and continuing throughout the study. In this study, the investigators will examine the efficacy of LIRA 3mg on body weight and body composition, reproductive function metabolic parameters and cardiovascular risk factors in a well-defined group of pre-menopausal obese non-diabetic women with hyperandrogenism, focusing on the relationship to obesity and insulin resistance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre Diabetes, Polycystic Ovary Syndrome, Obesity Android
Keywords
prediabetes, PCOS, GLP-1 agonist, weight loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double- Blind 2:1 Drug: Placebo
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liraglutide Pen Injector (Saxenda)
Arm Type
Experimental
Arm Description
Start injection liraglutide 0.6 mg subcutaneously (SC) 1week daily (QD), step up to 1.2 mg SC QD for 1week, to 1.8 mg SC QD for 1 week, 2.4 mg SC QD for 1week, to a final dose of 3.0 mg liraglutide SQ daily
Arm Title
Placebo liraglutide pen injector
Arm Type
Placebo Comparator
Arm Description
Start injection of placebo liraglutide 0.6 mg subcutaneously (SC) 1week daily (QD), step up to 1.2 mg SC QD for 1week, to 1.8 mg SC QD for 1 week, 2.4 mg SC QD for 1week, to a final dose of 3.0 mg placebo liraglutide SQ daily
Intervention Type
Drug
Intervention Name(s)
Liraglutide Pen Injector [Saxenda]
Other Intervention Name(s)
Liraglutide 3mg, Saxenda
Intervention Description
daily sc injection of liraglutide with final dose of 3mg daily
Intervention Type
Drug
Intervention Name(s)
Placebo Liraglutide Pen Injector
Other Intervention Name(s)
Placebo Saxenda, Placebo liraglutide 3 mg
Intervention Description
daily sc injection of placebo liraglutide with final dose of 3mg daily of placebo
Primary Outcome Measure Information:
Title
Absolute Body Weight (BW)
Description
Treatment impact on change in body weight after 32 weeks of treatment.
Time Frame
32 weeks of treatment
Title
Free Androgen Index (FAI)
Description
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).
Time Frame
32 weeks of treatment
Secondary Outcome Measure Information:
Title
Body Mass Index (BMI)
Description
Treatment effect in reducing body mass
Time Frame
32 weeks of treatment
Title
Change in Percent Body Weight
Description
Treatment effect on reducing body weight expressed as percent body weight loss from baseline
Time Frame
Change from baseline (time 0) to study end (32 weeks)
Title
5% Weight Loss From Baseline
Description
Frequency of patients achieving 5% weight loss from baseline with treatment
Time Frame
32 weeks of treatment
Title
10% Body Weight Loss From Baseline
Description
Frequency of patients with at least 10% reduction in body weight from baseline
Time Frame
32 weeks of treatment
Title
Abdominal Adiposity (Waist Circumference [WC]
Description
Treatment effect on loss of WC (abdominal adiposity) with drug treatment
Time Frame
32 weeks of treatment
Title
Waist-to-Hip Ratio
Description
Change in central adiposity with treatment as measured by WHR. A reduction in ratio indicates a decrease in truncal fat.
Time Frame
32 weeks of treatment
Title
Waist-to Height Ratio [WHtR])
Description
Treatment effect on loss of central adiposity as determined by WHt ratio. The lower the ratio indicates less abdominal adiposity.
Time Frame
32 weeks of treatment
Title
Total Fat Mass Evaluated by DEXA
Description
Treatment effect on reduction of fat mass (kg)
Time Frame
32 weeks of treatment
Title
Total Body Fat (%) by DXA
Description
Treatment effect on reduction of percent body fat by DXA
Time Frame
32 weeks of treatment
Title
Android-Gynoid Ratio (AGR) by DXA
Description
Treatment impact on AGR, measure of central adiposity, as determined by DXA. A lower AGR indicates a reduction in central adiposity.
Time Frame
32 weeks of treatment
Title
Trunk/Leg Fat Ratio (TLR) by DXA
Description
Treatment impact on TLR after 32 weeks. A reduction in TLR indicates a loss of central fat.
Time Frame
32 weeks of treatment
Title
Menstrual Cycle Frequency
Description
Drug treatment impact on normalization of cycle frequency (cycle every 28-30 days). All cycle data is expressed as number of menses annualized to one year.
Time Frame
32 weeks of treatment
Title
Total Testosterone Concentrations (T)
Description
Drug treatment effect on total testosterone concentrations
Time Frame
32 weeks of treatment
Title
Adrenal Dehydroepiandrosterone Sulfate (DHEAS)
Description
Treatment efficacy in reducing adrenal hyperandrogenism
Time Frame
32 weeks of treatment
Title
Fasting Blood Glucose (FG)
Description
Treatment effect on fasting glucose prior to an oral glucose tolerance test (OGTT)
Time Frame
32 weeks of treatment
Title
OGTT Mean Blood Glucose (MBG)
Description
Treatment effect on MBG measured during the oral glucose tolerance test. A decrease in MBG shows improvement in glycemia.
Time Frame
32 weeks of treatment
Title
Fasting Insulin Sensitivity (HOMA-IR)
Description
Treatment effect on the HOMA-IR which is an insulin resistance measured derived from fasting blood glucose and insulin . The higher the number the more insulin resistant.
Time Frame
32 weeks of treatment
Title
Matsuda Insulin Sensitivity Index Derived From the OGTT (SI OGTT)
Description
The SI OGTT is a measure of peripheral insulin sensitivity derived from the insulin and glucoses measured during an OGTT. A increase in SI OGTTindicates greater insulin sensitivity
Time Frame
32 weeks of treatment
Title
Corrected First Phase Insulin Secretion (IGI/HOMA-IR)
Description
Treatment effect on insulin secretion from 0 to 30 minutes after glucose load corrected for by fasting insulin sensitivity. A higher score shows improved first phase insulin secretion in response to glucose.
Time Frame
32 weeks of treatment
Title
Insulin Secretion- Insulin Sensitivity Index (Oral Disposition Index-IS-SI)
Description
Treatment effect on an estimation of Beta cell compensatory function, the IS-SI is derived by applying the concept of the disposition index to measurements obtained during the 2 hour OGTT and calculated as the index of insulin secretion factored by insulin sensitivity. A higher score shows improved pancreatic beta cell function relative to insulin sensitivity.
Time Frame
32 weeks of treatment
Title
Total Cholesterol Levels
Description
Treatment impact on improving total cholesterol levels
Time Frame
32 weeks of treatment
Title
High Density Lipoprotein Cholesterol (HDL-C)
Description
Impact of treatment on HDL levels after 32 weeks of treatment
Time Frame
32 weeks of treatment
Title
Triglyceride Levels (TRG)
Description
Drug effect of TRG levels after treatment
Time Frame
32 weeks of treatment
Title
Triglyceride to HDL-Cholesterol Ratio (TRG/HDL-C)
Description
Treatment impact on TRG/HDL-C ratio which is a simple measure to estimate insulin action. A decrease in ratio indicates improvement in insulin sensitivity.
Time Frame
32 weeks of treatment
Title
Triglyceride and Glucose Index (TyG)
Description
Treatment impact on the TyG index which estimates insulin resistance. A reduction in TyG indicates an improvement in insulin action.
Time Frame
32 weeks of treatment
Title
Systolic Blood Pressure
Description
Treatment impact on systolic blood pressure
Time Frame
32 weeks of treatment
Title
Diastolic Blood Pressure (BP)
Description
Treatment impact on reducing diastolic blood pressure
Time Frame
32 weeks of treatment

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Patients must be female to have the disorder being studied since it involved the female reproductive system
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peggy Dean, PharmD
Organizational Affiliation
Woman's Hospital Foundation IRB
Official's Role
Study Chair
Facility Information:
Facility Name
Woman's Hospital
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70817
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35710599
Citation
Elkind-Hirsch KE, Chappell N, Shaler D, Storment J, Bellanger D. 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. Fertil Steril. 2022 Aug;118(2):371-381. doi: 10.1016/j.fertnstert.2022.04.027. Epub 2022 Jun 13.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs