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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name SAXAPCOS

Overview

Status
Completed
Phase
Phase 3
Enrollment
88 participants (actual)
Sponsor
Woman's · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
26 Sept 2018
Primary completion
22 Feb 2021
Completion
19 May 2021
First posted
27 Mar 2018
Last update posted
7 Jun 2021
Conditions
Pre Diabetes · Polycystic Ovary Syndrome · Obesity Android

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20182019202020212022
  1. Ph 3

    SAXAPCOS

    NCT03480022

    26 Sept 2018 to 19 May 2021

Registry summary

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.

Interventions

  • Liraglutide Pen Injector [Saxenda]Drug
  • Placebo Liraglutide Pen InjectorDrug

Arms2

  • 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

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Absolute Body Weight (BW)

    Time frame · 32 weeks of treatment

    Registry description

    Treatment impact on change in body weight after 32 weeks of treatment.

  2. Free Androgen Index (FAI)

    Time frame · 32 weeks of treatment

    Registry 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).

Secondary outcomes(20)
  1. Body Mass Index (BMI)

    Time frame · 32 weeks of treatment

    Registry description

    Treatment effect in reducing body mass

  2. Change in Percent Body Weight

    Time frame · Change from baseline (time 0) to study end (32 weeks)

    Registry description

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

  3. 5% Weight Loss From Baseline

    Time frame · 32 weeks of treatment

    Registry description

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

  4. 10% Body Weight Loss From Baseline

    Time frame · 32 weeks of treatment

    Registry description

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

  5. Abdominal Adiposity (Waist Circumference [WC]

    Time frame · 32 weeks of treatment

    Registry description

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

  6. Waist-to-Hip Ratio

    Time frame · 32 weeks of treatment

    Registry description

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

  7. Waist-to Height Ratio [WHtR])

    Time frame · 32 weeks of treatment

    Registry description

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

  8. Total Fat Mass Evaluated by DEXA

    Time frame · 32 weeks of treatment

    Registry description

    Treatment effect on reduction of fat mass (kg)

  9. Total Body Fat (%) by DXA

    Time frame · 32 weeks of treatment

    Registry description

    Treatment effect on reduction of percent body fat by DXA

  10. Android-Gynoid Ratio (AGR) by DXA

    Time frame · 32 weeks of treatment

    Registry description

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

  11. Trunk/Leg Fat Ratio (TLR) by DXA

    Time frame · 32 weeks of treatment

    Registry description

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

  12. Menstrual Cycle Frequency

    Time frame · 32 weeks of treatment

    Registry 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.

  13. Total Testosterone Concentrations (T)

    Time frame · 32 weeks of treatment

    Registry description

    Drug treatment effect on total testosterone concentrations

  14. Adrenal Dehydroepiandrosterone Sulfate (DHEAS)

    Time frame · 32 weeks of treatment

    Registry description

    Treatment efficacy in reducing adrenal hyperandrogenism

  15. Fasting Blood Glucose (FG)

    Time frame · 32 weeks of treatment

    Registry description

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

  16. OGTT Mean Blood Glucose (MBG)

    Time frame · 32 weeks of treatment

    Registry description

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

  17. Fasting Insulin Sensitivity (HOMA-IR)

    Time frame · 32 weeks of treatment

    Registry 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.

  18. Matsuda Insulin Sensitivity Index Derived From the OGTT (SI OGTT)

    Time frame · 32 weeks of treatment

    Registry 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

  19. Corrected First Phase Insulin Secretion (IGI/HOMA-IR)

    Time frame · 32 weeks of treatment

    Registry 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.

  20. Insulin Secretion- Insulin Sensitivity Index (Oral Disposition Index-IS-SI)

    Time frame · 32 weeks of treatment

    Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 32 weeks of treatment

Absolute Body Weight (BW)

GroupValue (kilogram)Spread
Liraglutide Pen Injector (Saxenda)104.72.9
Placebo Liraglutide Pen Injector117.95
Primary outcomeMean· 32 weeks of treatment

Free Androgen Index (FAI)

GroupValue (index score)Spread
Liraglutide Pen Injector (Saxenda)5.980.6
Placebo Liraglutide Pen Injector6.4.75
Secondary and other outcome results(6)
Secondary outcomeMean· 32 weeks of treatment

Body Mass Index (BMI)

GroupValue (kilogram/meter squared)Spread
Liraglutide Pen Injector (Saxenda)39.11.1
Placebo Liraglutide Pen Injector43.41.8
Secondary outcomeMean· Change from baseline (time 0) to study end (32 weeks)

Change in Percent Body Weight

GroupValue (percentage loss in body weight)Spread
Liraglutide Pen Injector (Saxenda)5.70.75
Placebo Liraglutide Pen Injector1.41.09
Secondary outcomeCount of participants· 32 weeks of treatment

5% Weight Loss From Baseline

GroupValue (Participants)
Liraglutide Pen Injector (Saxenda)25
Placebo Liraglutide Pen Injector5
Secondary outcomeCount of participants· 32 weeks of treatment

10% Body Weight Loss From Baseline

GroupValue (Participants)
Liraglutide Pen Injector (Saxenda)13
Placebo Liraglutide Pen Injector2
Secondary outcomeMean· 32 weeks of treatment

Abdominal Adiposity (Waist Circumference [WC]

GroupValue (centimeters)Spread
Liraglutide Pen Injector (Saxenda)100.92.0
Placebo Liraglutide Pen Injector109.93.3
Secondary outcomeMean· 32 weeks of treatment

Waist-to-Hip Ratio

GroupValue (ratio)Spread
Liraglutide Pen Injector (Saxenda)0.810.009
Placebo Liraglutide Pen Injector0.850.015

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther 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 daily0 / 550 / 5540 / 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 placebo0 / 270 / 278 / 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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2022

4 results

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.

Elkind-Hirsch et al. 2022Fertility and sterilitycited by 121

PMID 35710599DOI 10.1016/j.fertnstert.2022.04.027PUB-35710599

Full text at the publisher4 results

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 45 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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