Table 2.

Study inclusion and exclusion criteria for a randomized clinical trial of Tesomet for hypopituitary patients with hypothalamic obesity.

Inclusion criteria

Age ≥18 and ≤75 years BMI ≥27 kg/m2 Hypothalamic injury-related weight gain Normal blood pressure or well-managed hypertension for >2 months Well-managed and stable hypopituitarism for >2 months

Exclusion criteria

Hypersensitivity to Tesomet or its components Abnormal metabolic conditions: type 1 diabetes, Cushing’s syndrome, acromegaly, hypophysitis, Prader–Willi syndrome Untreated hypo- or hyperthyroidism suicidal indentation or behaviour Clinically significant liver or kidney impairment ≥5% weight loss within the last 3 months Pregnant or lactating women Failure to comply with adequate contraceptive methods NYHAa class ≥2 Myocardial arrhythmias Myocardial infarction or stroke within 5 years Blood pressure ≥160/90 mmHg Heart rate ≥90 or <50 bpm Patients with type 2 diabetes were excluded if HbA1c ≥86 mmol/mol (10%) or fasting plasma glucose ≥11 mmol/L (198 mg/dL). Patients using glucagon-like peptide-1 (GLP-1) analogues for the treatment of type 2 diabetes had to be on a stable dose for >3 months. Psychiatric diagnosis Suicidal indentation or behaviour Clinically significant patient health questionnaire-9 (PHQ-9) score Treatment with beta-blockers or monoaminoxidase-inhibitors Eating disorders Enrolment in another clinical study

^aNew York Heart Association (NYHA) Functional Classification.

HbA1c, haemoglobin A1c.