Status:
COMPLETED
Liraglutide 3mg (Saxenda) on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With PCOS
Lead Sponsor:
Woman's
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Pre Diabetes
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
Brief 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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2021
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT03480022
Start Date
September 26 2018
End Date
May 19 2021
Last Update
June 7 2021
Active Locations (1)
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1
Woman's Hospital
Baton Rouge, Louisiana, United States, 70817