Skip to main content
. 2021 Jul 19;22:464. doi: 10.1186/s13063-021-05442-y

Table 1.

Eligibility criteria for participants

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