Table 5.

Twenty-four-week observed change in laboratory safety data in the safety population of a randomized clinical trial of Tesomet for hypopituitary patients with hypothalamic obesity. Data are presented as observed mean (95% CI) change from baseline to week 24 in laboratory safety data for each treatment group in the safety population. Only 12 and 6 patients, respectively, completed the study and could be evaluated.

	Tesomet (n = 12)	Placebo (n = 6)
ALT (U/L)	−1.5 (−6.7; 3.7)	−3.7 (−20.8; 13.4)
AST (U/L)	1.6 (−1.3; 4.4)	0 (−5.7; 5.7)
ALP (U/L)	4.1 (−7.3; 15.5)	−5.2 (−11.9; 1.5)
GGT (U/L)	16.0 (−19.6; 51.6)	−2.3 (−7.5; 2.9)
Haematocrit (%)	0 (−0.1; 0)	0 (−0.1; 0)
Lymphocytes (E9/L)	0.2 (−0.1; 0.4)	0.4 (−0.3; 1.1)
Leukocytes (E9/L)	0.2 (−0.6; 1.0)	−0.1 (−1.2; 1.8)
Creatinine (µmol/L)	0.4 (−3.4; 4.3)	4.8 (−1.7; 11.4)
Sodium (mmol/L)	0.3 (−1.5; 2.2)	0.3 (−3.0; 3.7)
Potassium (mmol/L)	−0.1 (−0.3; 0.1)	−0.2 (−0.5; 0.1)

ALT, alanine aminotransferase; AST, aspartate aminotransferase; ALP, alkaline phosphatase; GGT, gamma glutamyl transferase.