Trial Outcomes & Findings for Liraglutide 3mg (Saxenda) on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With PCOS (NCT NCT03480022)

88 recruited, 82 met criteria and randomized Six excluded after consenting

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

Treatment impact on change in body weight after 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).

Treatment effect in reducing body mass

Treatment effect on reducing body weight expressed as percent body weight loss from baseline

Frequency of patients achieving 5% weight loss from baseline with treatment

Frequency of patients with at least 10% reduction in body weight from baseline

Treatment effect on loss of WC (abdominal adiposity) with drug treatment

Change in central adiposity with treatment as measured by WHR. A reduction in ratio indicates a decrease in truncal fat.

Treatment effect on loss of central adiposity as determined by WHt ratio. The lower the ratio indicates less abdominal adiposity.

Treatment effect on reduction of fat mass (kg)

Treatment effect on reduction of percent body fat by DXA

Treatment impact on AGR, measure of central adiposity, as determined by DXA. A lower AGR indicates a reduction in central adiposity.

Treatment impact on TLR after 32 weeks. A reduction in TLR indicates a loss of central fat.

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.

Drug treatment effect on total testosterone concentrations

Treatment efficacy in reducing adrenal hyperandrogenism

Treatment effect on fasting glucose prior to an oral glucose tolerance test (OGTT)

Treatment effect on MBG measured during the oral glucose tolerance test. A decrease in MBG shows improvement in glycemia.

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.

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

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.

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.

Treatment impact on improving total cholesterol levels

Impact of treatment on HDL levels after 32 weeks of treatment

Drug effect of TRG levels after treatment

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.

Treatment impact on the TyG index which estimates insulin resistance. A reduction in TyG indicates an improvement in insulin action.

Treatment impact on systolic blood pressure

Treatment impact on reducing diastolic blood pressure