A Phase 3 interventional study of Liraglutide Pen Injector [Saxenda] and Placebo Liraglutide Pen Injector in Pre Diabetes, Polycystic Ovary Syndrome and Obesity Android, sponsored by Woman's. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2021-06-07.
Sponsored by Woman's · Phase 3, Interventional, and Treatment
Among 350 studies in Glucose Intolerance with a site in United States — 44 open to participants now, 66 under way, none of them phase 3. Glucose Intolerance · United States.
Among the 350 studies in Glucose Intolerance with a site in United States, this one is the 97th largest by enrollment of the 307 interventional ones that give a count, is one of 21 that started in 2018, is one of 13 in phase 3, and was the 193rd registered.
793 studies on the registry are indexed under Glucose Intolerance; 115 are open to participants now.
Browse Glucose Intolerance studies →44 of the 350 studies in Glucose Intolerance with a site in United States are open now. Recruiting first, the newest first:
Arizona State University · Sites in United States
Applied Science & Performance Institute · Sites in United States
Johns Hopkins University · Sites in United States
Pennington Biomedical Research Center · Sites in United States
Albert Einstein College of Medicine · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 70 Glucose Intolerance studies recruiting now, 14 (20%) set no upper age limit and 51 (73%) stop at 75 or younger; 10 take children under 18; 33 take healthy volunteers.
This study: 18 Years to 45 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
350 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 23 · Phase 2 36 · Phase 3 15 · Phase 4 28
First in 1994; this study’s year is marked. 21 started in 2018.
This study's enrollment of 88 is above the median of 56 across 661 interventional studies indexed under Glucose Intolerance.
Median enrollment 50 across the 307 interventional studies, 107 across the 40 observational. Of the 260 that completed or were terminated, 100 (38%) have results posted.
This tab as a report to print or save as PDF → With an account.
49 of 350 have an industry lead sponsor. The 10 most frequent:
Woman's is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Woman's has 4 studies filed under Glucose Intolerance — fewer than ten, so there is no comparison to draw.
25 of the studies in Glucose Intolerance with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07543068Sam Houston State UniversityDiabetes Prevention by Group Intervention and CGM Use in Pre-diabetic Adults | 2026-11 |
| NCT05067621Yale UniversitySemaglutide Effects in Obese Youth With Prediabetes/New Onset Type 2 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease | 2026-12 |
| NCT06921902Abbott Diabetes CareGlycemic Metrics and Patterns in People With and Without Prediabetes | 2026-12 |
| NCT05465616ViomeEfficacy of Viome's Precision Nutrition Program Towards Reducing HbA1c | 2026-12-13 |
| NCT06607341Johns Hopkins UniversityCommunity Engagement Alliance Against Disparities | 2026-12-20 |
Among the 350 studies in Glucose Intolerance with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Willing to use effective consistently during therapy which is defined as:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Liraglutide Pen Injector [Saxenda]
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
Drug: Placebo Liraglutide Pen Injector
daily sc injection of liraglutide with final dose of 3mg daily
Also known as: Liraglutide 3mg, Saxenda
daily sc injection of placebo liraglutide with final dose of 3mg daily of placebo
Also known as: Placebo Saxenda, Placebo liraglutide 3 mg
Absolute Body Weight (BW)
Treatment impact on change in body weight after 32 weeks of treatment.
Time frame: 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).
Time frame: 32 weeks of treatment
Body Mass Index (BMI)
Treatment effect in reducing body mass
Time frame: 32 weeks of treatment
Change in Percent Body Weight
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)
5% Weight Loss From Baseline
Frequency of patients achieving 5% weight loss from baseline with treatment
Time frame: 32 weeks of treatment
10% Body Weight Loss From Baseline
Frequency of patients with at least 10% reduction in body weight from baseline
Time frame: 32 weeks of treatment
Abdominal Adiposity (Waist Circumference [WC]
Treatment effect on loss of WC (abdominal adiposity) with drug treatment
Time frame: 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.
Time frame: 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.
Time frame: 32 weeks of treatment
Total Fat Mass Evaluated by DEXA
Treatment effect on reduction of fat mass (kg)
Time frame: 32 weeks of treatment
Total Body Fat (%) by DXA
Treatment effect on reduction of percent body fat by DXA
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 32 weeks of treatment
Total Testosterone Concentrations (T)
Drug treatment effect on total testosterone concentrations
Time frame: 32 weeks of treatment
Adrenal Dehydroepiandrosterone Sulfate (DHEAS)
Treatment efficacy in reducing adrenal hyperandrogenism
Time frame: 32 weeks of treatment
Fasting Blood Glucose (FG)
Treatment effect on fasting glucose prior to an oral glucose tolerance test (OGTT)
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 32 weeks of treatment
Total Cholesterol Levels
Treatment impact on improving total cholesterol levels
Time frame: 32 weeks of treatment
High Density Lipoprotein Cholesterol (HDL-C)
Impact of treatment on HDL levels after 32 weeks of treatment
Time frame: 32 weeks of treatment
Triglyceride Levels (TRG)
Drug effect of TRG levels after treatment
Time frame: 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.
Time frame: 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.
Time frame: 32 weeks of treatment
Systolic Blood Pressure
Treatment impact on systolic blood pressure
Time frame: 32 weeks of treatment
Diastolic Blood Pressure (BP)
Treatment impact on reducing diastolic blood pressure
Time frame: 32 weeks of treatment
88 recruited, 82 met criteria and randomized Six excluded after consenting
| Milestone | Liraglutide Pen Injector (Saxenda) | Placebo Liraglutide Pen Injector |
|---|---|---|
| Started | 55 | 27 |
| Completed | 44 | 23 |
| Not completed | 11 | 4 |
| Withdrew: Pregnancy | 2 | 0 |
| Withdrew: Adverse event | 6 | 0 |
| Withdrew: Lack of efficacy | 0 | 2 |
| Withdrew: Physician decision | 0 | 1 |
| Withdrew: Withdrawal by subject | 2 | 0 |
| Withdrew: Medication concerns | 1 | 0 |
| Withdrew: Family member covid exposure | 0 | 1 |
Treatment impact on change in body weight after 32 weeks of treatment.
| kilogram | Liraglutide Pen Injector (Saxenda) | Placebo Liraglutide Pen Injector |
|---|---|---|
| Absolute Body Weight (BW) | 104.7 ± 2.9 | 117.9 ± 5 |
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).
| index score | Liraglutide Pen Injector (Saxenda) | Placebo Liraglutide Pen Injector |
|---|---|---|
| Free Androgen Index (FAI) | 5.98 ± 0.6 | 6.4 ± .75 |
Treatment effect in reducing body mass
| kilogram/meter squared | Liraglutide Pen Injector (Saxenda) | Placebo Liraglutide Pen Injector |
|---|---|---|
| Body Mass Index (BMI) | 39.1 ± 1.1 | 43.4 ± 1.8 |
Treatment effect on reducing body weight expressed as percent body weight loss from baseline
| percentage loss in body weight | Liraglutide Pen Injector (Saxenda) | Placebo Liraglutide Pen Injector |
|---|---|---|
| Change in Percent Body Weight | 5.7 ± 0.75 | 1.4 ± 1.09 |
Frequency of patients achieving 5% weight loss from baseline with treatment
| Participants | Liraglutide Pen Injector (Saxenda) | Placebo Liraglutide Pen Injector |
|---|---|---|
| 5% Weight Loss From Baseline | 25 | 5 |
Frequency of patients with at least 10% reduction in body weight from baseline
| Participants | Liraglutide Pen Injector (Saxenda) | Placebo Liraglutide Pen Injector |
|---|---|---|
| 10% Body Weight Loss From Baseline | 13 | 2 |
Treatment effect on loss of WC (abdominal adiposity) with drug treatment
| centimeters | Liraglutide Pen Injector (Saxenda) | Placebo Liraglutide Pen Injector |
|---|---|---|
| Abdominal Adiposity (Waist Circumference [WC] | 100.9 ± 2.0 | 109.9 ± 3.3 |
Change in central adiposity with treatment as measured by WHR. A reduction in ratio indicates a decrease in truncal fat.
| ratio | Liraglutide Pen Injector (Saxenda) | Placebo Liraglutide Pen Injector |
|---|---|---|
| Waist-to-Hip Ratio | 0.81 ± 0.009 | 0.85 ± 0.015 |
Treatment effect on loss of central adiposity as determined by WHt ratio. The lower the ratio indicates less abdominal adiposity.
| ratio | Liraglutide Pen Injector (Saxenda) | Placebo Liraglutide Pen Injector |
|---|---|---|
| Waist-to Height Ratio [WHtR]) | 0.62 ± 0.014 | 0.67 ± 0.02 |
Treatment effect on reduction of fat mass (kg)
| kilogram | Liraglutide Pen Injector (Saxenda) | Placebo Liraglutide Pen Injector |
|---|---|---|
| Total Fat Mass Evaluated by DEXA | 49.3 ± 2.1 | 56.8 ± 3.3 |
Treatment effect on reduction of percent body fat by DXA
| percent fat mass | Liraglutide Pen Injector (Saxenda) | Placebo Liraglutide Pen Injector |
|---|---|---|
| Total Body Fat (%) by DXA | 46.0 ± 0.9 | 47.9 ± 0.96 |
Treatment impact on AGR, measure of central adiposity, as determined by DXA. A lower AGR indicates a reduction in central adiposity.
| ratio | Liraglutide Pen Injector (Saxenda) | Placebo Liraglutide Pen Injector |
|---|---|---|
| Android-Gynoid Ratio (AGR) by DXA | 1.05 ± 0.01 | 1.08 ± 0.03 |
Treatment impact on TLR after 32 weeks. A reduction in TLR indicates a loss of central fat.
| ratio | Liraglutide Pen Injector (Saxenda) | Placebo Liraglutide Pen Injector |
|---|---|---|
| Trunk/Leg Fat Ratio (TLR) by DXA | 1.02 ± 0.03 | 1.07 ± 0.04 |
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.
| menses per year | Liraglutide Pen Injector (Saxenda) | Placebo Liraglutide Pen Injector |
|---|---|---|
| Menstrual Cycle Frequency | 8.65 ± 0.4 | 4.8 ± 0.65 |
Drug treatment effect on total testosterone concentrations
| ng/dL | Liraglutide Pen Injector (Saxenda) | Placebo Liraglutide Pen Injector |
|---|---|---|
| Total Testosterone Concentrations (T) | 45.4 ± 3.0 | 46.8 ± 4.1 |
Treatment efficacy in reducing adrenal hyperandrogenism
| mcg/dL | Liraglutide Pen Injector (Saxenda) | Placebo Liraglutide Pen Injector |
|---|---|---|
| Adrenal Dehydroepiandrosterone Sulfate (DHEAS) | 177.1 ± 14.2 | 171.3 ± 16.8 |
Treatment effect on fasting glucose prior to an oral glucose tolerance test (OGTT)
| mg/dL | Liraglutide Pen Injector (Saxenda) | Placebo Liraglutide Pen Injector |
|---|---|---|
| Fasting Blood Glucose (FG) | 90.2 ± 1.3 | 94.3 ± 2.2 |
Treatment effect on MBG measured during the oral glucose tolerance test. A decrease in MBG shows improvement in glycemia.
| mg/dL | Liraglutide Pen Injector (Saxenda) | Placebo Liraglutide Pen Injector |
|---|---|---|
| OGTT Mean Blood Glucose (MBG) | 109.4 ± 2.9 | 125.5 ± 4.8 |
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.
| index score | Liraglutide Pen Injector (Saxenda) | Placebo Liraglutide Pen Injector |
|---|---|---|
| Fasting Insulin Sensitivity (HOMA-IR) | 4.1 ± 0.6 | 5.2 ± 1.1 |
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
| index score | Liraglutide Pen Injector (Saxenda) | Placebo Liraglutide Pen Injector |
|---|---|---|
| Matsuda Insulin Sensitivity Index Derived From the OGTT (SI OGTT) | 3.7 ± 0.43 | 3.0 ± 0.48 |
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.
| index score | Liraglutide Pen Injector (Saxenda) | Placebo Liraglutide Pen Injector |
|---|---|---|
| Corrected First Phase Insulin Secretion (IGI/HOMA-IR) | 1.01 ± 0.18 | 0.8 ± 0.16 |
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.
| index score | Liraglutide Pen Injector (Saxenda) | Placebo Liraglutide Pen Injector |
|---|---|---|
| Insulin Secretion- Insulin Sensitivity Index (Oral Disposition Index-IS-SI) | 532 ± 91 | 416 ± 69.7 |
Treatment impact on improving total cholesterol levels
| mg/dL | Liraglutide Pen Injector (Saxenda) | Placebo Liraglutide Pen Injector |
|---|---|---|
| Total Cholesterol Levels | 176 ± 5.3 | 178 ± 8.8 |
Impact of treatment on HDL levels after 32 weeks of treatment
| mg/dL | Liraglutide Pen Injector (Saxenda) | Placebo Liraglutide Pen Injector |
|---|---|---|
| High Density Lipoprotein Cholesterol (HDL-C) | 41 ± 1.8 | 42 ± 2.3 |
Drug effect of TRG levels after treatment
| mg/dL | Liraglutide Pen Injector (Saxenda) | Placebo Liraglutide Pen Injector |
|---|---|---|
| Triglyceride Levels (TRG) | 109 ± 7.7 | 114 ± 11 |
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.
| ratio | Liraglutide Pen Injector (Saxenda) | Placebo Liraglutide Pen Injector |
|---|---|---|
| Triglyceride to HDL-Cholesterol Ratio (TRG/HDL-C) | 2.9 ± 0.26 | 3.0 ± 0.45 |
Treatment impact on the TyG index which estimates insulin resistance. A reduction in TyG indicates an improvement in insulin action.
| index score | Liraglutide Pen Injector (Saxenda) | Placebo Liraglutide Pen Injector |
|---|---|---|
| Triglyceride and Glucose Index (TyG) | 8.39 ± 0.07 | 8.5 ± 0.09 |
Treatment impact on systolic blood pressure
| mmHg | Liraglutide Pen Injector (Saxenda) | Placebo Liraglutide Pen Injector |
|---|---|---|
| Systolic Blood Pressure | 116.8 ± 2.7 | 123.3 ± 2.4 |
Treatment impact on reducing diastolic blood pressure
| mmHg | Liraglutide Pen Injector (Saxenda) | Placebo Liraglutide Pen Injector |
|---|---|---|
| Diastolic Blood Pressure (BP) | 77.6 ± 1.6 | 78.1 ± 1.3 |
Collected over 36 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Liraglutide Pen Injector (Saxenda) | 0/55 (0%) | 0/55 (0%) | 40/55 (72.7%) |
| Placebo Liraglutide Pen Injector | 0/27 (0%) | 0/27 (0%) | 8/27 (29.6%) |
| Event | Liraglutide Pen Injector (Saxenda) | Placebo Liraglutide Pen Injector |
|---|---|---|
| NauseaGastrointestinal disorders | 14/55 | 3/27 |
| VomitingGastrointestinal disorders | 5/55 | 0/27 |
| DiarrheaGastrointestinal disorders | 4/55 | 0/27 |
| ConstipationGastrointestinal disorders | 3/55 | 1/27 |
| Injection site reactionSkin and subcutaneous tissue disorders | 3/55 | 0/27 |
| prolonged menstrual bleedingReproductive system and breast disorders | 3/55 | 1/27 |
| HeartburnGastrointestinal disorders | 2/55 | 1/27 |
| no mensesReproductive system and breast disorders | 0/55 | 1/27 |
| COVID-19Infections and infestations | 0/55 | 1/27 |
| PregnancyPregnancy, puerperium and perinatal conditions | 2/55 | 0/27 |
| Age, Continuous(years) | Liraglutide Pen Injector (Saxenda) | Placebo Liraglutide Pen Injector | Total |
|---|---|---|---|
| Mean | 31.1 ± 6 | 31.8 ± 5.6 | 31.3 ± 5.8 |
| Sex: Female, Male(Participants) | Liraglutide Pen Injector (Saxenda) | Placebo Liraglutide Pen Injector | Total |
|---|---|---|---|
| Female | 55 | 27 | 82 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Liraglutide Pen Injector (Saxenda) | Placebo Liraglutide Pen Injector | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 13 | 9 | 22 |
| White | 42 | 18 | 60 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Liraglutide Pen Injector (Saxenda) | Placebo Liraglutide Pen Injector | Total |
|---|---|---|---|
| United States | 55 | 27 | 82 |
| Body mass Index(kg/m^2) | Liraglutide Pen Injector (Saxenda) | Placebo Liraglutide Pen Injector | Total |
|---|---|---|---|
| Mean | 42 ± 6.7 | 43.9 ± 7.5 | 42.4 ± 7 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2018 to primary completion in Feb 2021, 28 months.
Results were first posted in Jun 2021, 3 months after primary completion.
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Studies of the drug tested here: Liraglutide
Woman's