Absolute Body Weight (BW)
| Group | Value (kilogram) | Spread |
|---|---|---|
| Liraglutide Pen Injector (Saxenda) | 104.7 | 2.9 |
| Placebo Liraglutide Pen Injector | 117.9 | 5 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataShort name SAXAPCOS
United States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Experimental
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 comparator
Placebo liraglutide pen injector
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 the sponsor listed as primary.
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).
Body Mass Index (BMI)
Time frame · 32 weeks of treatment
Treatment effect in reducing body mass
Change in Percent Body Weight
Time frame · Change from baseline (time 0) to study end (32 weeks)
Treatment effect on reducing body weight expressed as percent body weight loss from baseline
5% Weight Loss From Baseline
Time frame · 32 weeks of treatment
Frequency of patients achieving 5% weight loss from baseline with treatment
10% Body Weight Loss From Baseline
Time frame · 32 weeks of treatment
Frequency of patients with at least 10% reduction in body weight from baseline
Abdominal Adiposity (Waist Circumference [WC]
Time frame · 32 weeks of treatment
Treatment effect on loss of WC (abdominal adiposity) with drug treatment
Waist-to-Hip Ratio
Time frame · 32 weeks of treatment
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])
Time frame · 32 weeks of treatment
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
Time frame · 32 weeks of treatment
Treatment effect on reduction of fat mass (kg)
Total Body Fat (%) by DXA
Time frame · 32 weeks of treatment
Treatment effect on reduction of percent body fat by DXA
Android-Gynoid Ratio (AGR) by DXA
Time frame · 32 weeks of treatment
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
Time frame · 32 weeks of treatment
Treatment impact on TLR after 32 weeks. A reduction in TLR indicates a loss of central fat.
Menstrual Cycle Frequency
Time frame · 32 weeks of treatment
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)
Time frame · 32 weeks of treatment
Drug treatment effect on total testosterone concentrations
Adrenal Dehydroepiandrosterone Sulfate (DHEAS)
Time frame · 32 weeks of treatment
Treatment efficacy in reducing adrenal hyperandrogenism
Fasting Blood Glucose (FG)
Time frame · 32 weeks of treatment
Treatment effect on fasting glucose prior to an oral glucose tolerance test (OGTT)
OGTT Mean Blood Glucose (MBG)
Time frame · 32 weeks of treatment
Treatment effect on MBG measured during the oral glucose tolerance test. A decrease in MBG shows improvement in glycemia.
Fasting Insulin Sensitivity (HOMA-IR)
Time frame · 32 weeks of treatment
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)
Time frame · 32 weeks of treatment
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)
Time frame · 32 weeks of treatment
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)
Time frame · 32 weeks of treatment
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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (kilogram) | Spread |
|---|---|---|
| Liraglutide Pen Injector (Saxenda) | 104.7 | 2.9 |
| Placebo Liraglutide Pen Injector | 117.9 | 5 |
| Group | Value (index score) | Spread |
|---|---|---|
| Liraglutide Pen Injector (Saxenda) | 5.98 | 0.6 |
| Placebo Liraglutide Pen Injector | 6.4 | .75 |
| Group | Value (kilogram/meter squared) | Spread |
|---|---|---|
| Liraglutide Pen Injector (Saxenda) | 39.1 | 1.1 |
| Placebo Liraglutide Pen Injector | 43.4 | 1.8 |
| Group | Value (percentage loss in body weight) | Spread |
|---|---|---|
| Liraglutide Pen Injector (Saxenda) | 5.7 | 0.75 |
| Placebo Liraglutide Pen Injector | 1.4 | 1.09 |
| Group | Value (Participants) |
|---|---|
| Liraglutide Pen Injector (Saxenda) | 25 |
| Placebo Liraglutide Pen Injector | 5 |
| Group | Value (Participants) |
|---|---|
| Liraglutide Pen Injector (Saxenda) | 13 |
| Placebo Liraglutide Pen Injector | 2 |
| Group | Value (centimeters) | Spread |
|---|---|---|
| Liraglutide Pen Injector (Saxenda) | 100.9 | 2.0 |
| Placebo Liraglutide Pen Injector | 109.9 | 3.3 |
| Group | Value (ratio) | Spread |
|---|---|---|
| Liraglutide Pen Injector (Saxenda) | 0.81 | 0.009 |
| Placebo Liraglutide Pen Injector | 0.85 | 0.015 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| 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 Liraglutide Pen Injector \[Saxenda\]: daily sc injection of liraglutide with final dose of 3mg daily | 0 / 55 | 0 / 55 | 40 / 55 |
| 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 Placebo Liraglutide Pen Injector: daily sc injection of placebo liraglutide with final dose of 3mg daily of placebo | 0 / 27 | 0 / 27 | 8 / 27 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
Indexing hint: Randomized controlled trial · 2022
Elkind-Hirsch et al. 2022Fertility and sterilitycited by 121
PMID 35710599DOI 10.1016/j.fertnstert.2022.04.027PUB-35710599
Who could join, as posted.
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