Table 4 Double-blind baseline values and change at week 26 in weight, body mass index, metabolic parameters, and prolactin (safety population; observed case analysis).

Safety parameter	Double-blind baseline		Week 26
Safety parameter	N	Ulotaront	N	Ulotaront
Weight, kg, mean (SD)	156	75.4 (13.9)	104	−0.3 (3.7)
Body mass index, kg/m², mean (SD)	156	25.1 (3.9)	104	−0.1 (1.2)
Total cholesterol, mg/dL, median	156	174.5	111	−2.0
LDL cholesterol, mg/dL, median	156	101.5	111	−9.0
HDL cholesterol, mg/dL, median	156	48.0	111	0.0
Triglycerides, mg/dL, median	156	101.0	111	−5.0
Glucose, mg/dL, median	156	92.0	109	+2.0
HbA1c, %, median	155	5.2	109	0.0
Prolactin, ng/mL, median
Female	54	16.1	39	−3.4
Male	102	11.6	73	−2.7

Lipid and glucose data are shown for total available patients at week 26; 96.4% (107/111) of lipid results were fasted at week 26, 96.3% (105/109) of glucose results were fasted at week 26.
Ulotaront data are shown for all extension phase patients; mean baseline and change values are shown for weight and BMI; median baseline and change values are shown for laboratory parameters.
HDL high-density lipoprotein, LDL low-density lipoprotein.

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