Pre DiabetesPhase 3SAXAPCOSNCT03480022
Liraglutide 3mg (Saxenda) on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With PCOS
A Phase 3 study testing Liraglutide Pen Injector [Saxenda] in people with Pre Diabetes and Polycystic Ovary Syndrome, run by Woman's at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pre Diabetes, Polycystic Ovary Syndrome, Obesity Android
- What is being tested?
- Liraglutide Pen Injector [Saxenda]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2018to 19 May 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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:
Show all 9Show fewer
- 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
Who cannot join
- 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)
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Pre Diabetes, Polycystic Ovary Syndrome, Obesity Android
- Being tested
- Liraglutide Pen Injector [Saxenda], Placebo Liraglutide Pen Injector
- Keywords
- prediabetes, PCOS, GLP-1 agonist, weight loss
- Medical subject headings
- Glucose Intolerance, Polycystic Ovary Syndrome, Obesity, Abdominal, Prediabetic State, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liraglutide Pen Injector [Saxenda]Drug
Also called Liraglutide 3mg, Saxenda
daily sc injection of liraglutide with final dose of 3mg daily
Placebo Liraglutide Pen InjectorDrug
Also called Placebo Saxenda, Placebo liraglutide 3 mg
daily sc injection of placebo liraglutide with final dose of 3mg daily of placebo
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide Pen Injector (Saxenda) | Experimental | 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 Receives: Drug: Liraglutide Pen Injector [Saxenda] |
| Placebo liraglutide pen injector | Placebo comparator | 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 Receives: Drug: Placebo Liraglutide Pen Injector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Body Weight (BW)
Treatment impact on change in body weight after 32 weeks of treatment.
Measured: 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).
Measured: 32 weeks of treatment
Secondary outcomes (27)
Body Mass Index (BMI)
Treatment effect in reducing body mass
Measured: 32 weeks of treatment
Change in Percent Body Weight
Treatment effect on reducing body weight expressed as percent body weight loss from baseline
Measured: Change from baseline (time 0) to study end (32 weeks)
5% Weight Loss From Baseline
Frequency of patients achieving 5% weight loss from baseline with treatment
Measured: 32 weeks of treatment
10% Body Weight Loss From Baseline
Frequency of patients with at least 10% reduction in body weight from baseline
Measured: 32 weeks of treatment
Abdominal Adiposity (Waist Circumference [WC]
Treatment effect on loss of WC (abdominal adiposity) with drug treatment
Measured: 32 weeks of 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.
Measured: 32 weeks of treatment
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.
Measured: 32 weeks of treatment
Total Fat Mass Evaluated by DEXA
Treatment effect on reduction of fat mass (kg)
Measured: 32 weeks of treatment
Total Body Fat (%) by DXA
Treatment effect on reduction of percent body fat by DXA
Measured: 32 weeks of treatment
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.
Measured: 32 weeks of treatment
Trunk/Leg Fat Ratio (TLR) by DXA
Treatment impact on TLR after 32 weeks. A reduction in TLR indicates a loss of central fat.
Measured: 32 weeks of treatment
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.
Measured: 32 weeks of treatment
Total Testosterone Concentrations (T)
Drug treatment effect on total testosterone concentrations
Measured: 32 weeks of treatment
Adrenal Dehydroepiandrosterone Sulfate (DHEAS)
Treatment efficacy in reducing adrenal hyperandrogenism
Measured: 32 weeks of treatment
Fasting Blood Glucose (FG)
Treatment effect on fasting glucose prior to an oral glucose tolerance test (OGTT)
Measured: 32 weeks of treatment
OGTT Mean Blood Glucose (MBG)
Treatment effect on MBG measured during the oral glucose tolerance test. A decrease in MBG shows improvement in glycemia.
Measured: 32 weeks of treatment
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.
Measured: 32 weeks of treatment
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
Measured: 32 weeks of treatment
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.
Measured: 32 weeks of treatment
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.
Measured: 32 weeks of treatment
Total Cholesterol Levels
Treatment impact on improving total cholesterol levels
Measured: 32 weeks of treatment
High Density Lipoprotein Cholesterol (HDL-C)
Impact of treatment on HDL levels after 32 weeks of treatment
Measured: 32 weeks of treatment
Triglyceride Levels (TRG)
Drug effect of TRG levels after treatment
Measured: 32 weeks of 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.
Measured: 32 weeks of treatment
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.
Measured: 32 weeks of treatment
Systolic Blood Pressure
Treatment impact on systolic blood pressure
Measured: 32 weeks of treatment
Diastolic Blood Pressure (BP)
Treatment impact on reducing diastolic blood pressure
Measured: 32 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start26 Sep 2018
- Primary completion22 Feb 2021
- Study completion19 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woman's
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Principal investigator, Karen Elkind-Hirsch, Woman's
- Investigators
- Peggy Dean, PharmD, Study chair, Woman's Hospital Foundation IRB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480022
- Sponsor's protocol ID
- U1111-1198-4126
- Acronym
- SAXAPCOS
- Status last verified
- Jun 2021
- First submitted
- 13 Mar 2018
- Last updated
- 7 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35710599
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03480022
- Acronym / sponsor ID
- SAXAPCOS / U1111-1198-4126
- Conditions
- Pre Diabetes, Polycystic Ovary Syndrome, Obesity Android
- Keywords
- prediabetes, PCOS, GLP-1 agonist, weight loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Woman'sUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 22 Feb 2021 (actual)
- Study completion
- 19 May 2021 (actual)
- First posted
- 27 Mar 2018 (actual)
- Results
- Posted 7 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liraglutide Pen Injector (Saxenda) | Experimental | Drug: Liraglutide Pen Injector [Saxenda]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 |
| Placebo liraglutide pen injector | Placebo comparator | Drug: Placebo Liraglutide Pen InjectorStart 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (20 listed)
- 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 %)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liraglutide Pen Injector [Saxenda]Also: Liraglutide 3mg, Saxendadaily sc injection of liraglutide with final dose of 3mg daily | Drug | Liraglutide Pen Injector (Saxenda) |
| Placebo Liraglutide Pen InjectorAlso: Placebo Saxenda, Placebo liraglutide 3 mgdaily sc injection of placebo liraglutide with final dose of 3mg daily of placebo | Drug | Placebo liraglutide pen injector |
Primary outcome
Absolute Body Weight (BW)
Time frame: 32 weeks of treatment
Treatment impact on change in body weight after 32 weeks of treatment.
Free Androgen Index (FAI)
Time frame: 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).
27 secondary outcomes
Body Mass Index (BMI)
Time frame: 32 weeks of treatment
Change in Percent Body Weight
Time frame: Change from baseline (time 0) to study end (32 weeks)
5% Weight Loss From Baseline
Time frame: 32 weeks of treatment
10% Body Weight Loss From Baseline
Time frame: 32 weeks of treatment
Abdominal Adiposity (Waist Circumference [WC]
Time frame: 32 weeks of treatment
Waist-to-Hip Ratio
Time frame: 32 weeks of treatment
Waist-to Height Ratio [WHtR])
Time frame: 32 weeks of treatment
Total Fat Mass Evaluated by DEXA
Time frame: 32 weeks of treatment
Total Body Fat (%) by DXA
Time frame: 32 weeks of treatment
Android-Gynoid Ratio (AGR) by DXA
Time frame: 32 weeks of treatment
Trunk/Leg Fat Ratio (TLR) by DXA
Time frame: 32 weeks of treatment
Menstrual Cycle Frequency
Time frame: 32 weeks of treatment
Total Testosterone Concentrations (T)
Time frame: 32 weeks of treatment
Adrenal Dehydroepiandrosterone Sulfate (DHEAS)
Time frame: 32 weeks of treatment
Fasting Blood Glucose (FG)
Time frame: 32 weeks of treatment
OGTT Mean Blood Glucose (MBG)
Time frame: 32 weeks of treatment
Fasting Insulin Sensitivity (HOMA-IR)
Time frame: 32 weeks of treatment
Matsuda Insulin Sensitivity Index Derived From the OGTT (SI OGTT)
Time frame: 32 weeks of treatment
Corrected First Phase Insulin Secretion (IGI/HOMA-IR)
Time frame: 32 weeks of treatment
Insulin Secretion- Insulin Sensitivity Index (Oral Disposition Index-IS-SI)
Time frame: 32 weeks of treatment
Total Cholesterol Levels
Time frame: 32 weeks of treatment
High Density Lipoprotein Cholesterol (HDL-C)
Time frame: 32 weeks of treatment
Triglyceride Levels (TRG)
Time frame: 32 weeks of treatment
Triglyceride to HDL-Cholesterol Ratio (TRG/HDL-C)
Time frame: 32 weeks of treatment
Triglyceride and Glucose Index (TyG)
Time frame: 32 weeks of treatment
Systolic Blood Pressure
Time frame: 32 weeks of treatment
Diastolic Blood Pressure (BP)
Time frame: 32 weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35710599Elkind-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peggy Dean, PharmD study chair
Woman's Hospital Foundation IRB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Liraglutide Pen Injector [Saxenda] in people with Pre Diabetes and Polycystic Ovary Syndrome, run by Woman's at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute Body Weight (BW) (time frame: 32 weeks of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03480022, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2021.