Table 1.
Inclusion criteria ► PCOS as diagnosed by the Rotterdam criteria ► BMI ≥ 30 kg/m2 ► Age 18–45 years ► Informed written consent | |
Exclusion criteria ► Patients diagnosed with any known serious chronic illness, including type 1 or 2 diabetes (or a randomly measured fasting plasma glucose > 7 mmol/l) ► Angina pectoris, coronary heart disease or congestive heart failure (NYHA Classes III–IV) ► Severe renal impairment (creatinine clearance (GFR) < 30 mL/min) ► Severe hepatic impairment ► Inflammatory bowel disease ► Gastroparesis ► Cancer ► Chronic obstructive lung disease ► Psychiatric disease, a history of major depressive or other severe psychiatric disorders ►Bleeding diathesis or anticoagulant treatment ► Current or history of neurological disease including traumatic brain injury ► Contraindications for MR scanning (implants, claustrophobia, etc.) ► The use of medications that cause clinically significant weight gain or loss ► Previous bariatric surgery ► A history of idiopathic acute pancreatitis ► A family or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma ► Current smoking ► Pregnancy, expecting pregnancy or breastfeeding ► Allergy to any of the ingredients of the study medication: semaglutide, disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid and sodium hydroxide ► Anticipated change in lifestyle (e.g. eating, exercise or sleeping pattern) during the trial ► Any condition that the investigator feels would interfere with trial participation (such as inability to follow frequent trial visits according to protocol schedule) |
Abbreviations: PCOS polycystic ovary syndrome, BMI body mass index, GFR glomerular filtration rate, MR scanning magnetic resonance scanning