Table 1.

Baseline demographics, primary and secondary efficacy outcomes, and safety variables of the population under study (full analysis set). Data are presented as mean ± s.d. or median (Q1 and Q3).

Variable	Placebo	AZD4017	Total
n	14	14	28
Demographics
Age
Mean ± s.d.	60.3 ± 13.4	60.1 ± 14.5	60.2 ± 13.7
Range	31–84	28–75	28–84
Male, n/N (%)	12/14 (86)	10/14 (71)	22/28 (79)
Primary outcome
Skin 11β-HSD1 activity (% conversion/24 h)
Radioassay	15.3 (11.6, 18.4)	10.7 (9.4, 17.4)	13.6 (9.8, 17.9)
ELISA	6.8 (5.5, 15.6)	6.4 (4.2, 8.5)	6.8 (4.8, 10.7)
Secondary outcomes
Systemic 11β-HSD1 activity
Urinary (THF+alloTHF)/THE ratio	1.0 (0.8, 1.2)	1.0 (0.8, 1.1)	1.0 (0.8, 1.1)
Cortisol (µg/24 h)	68.5 (40.0, 101.0)	75.5 (48.0, 84.0)	74.5 (47.5, 94.0)
Epidermal barrier TEWL (g/h/m2)*	2.1 ± 0.4 (8.2)	2.2 ± 0.3 (9.1)†	2.2 ± 0.4 (8.6)‡
Epidermal integrity (tape strips)*	3.8 ± 0.4 (44.5)	3.9 ± 0.5 (50.5)†	3.9 ± 0.4 (47.5)‡
Epidermal thickness (μm)	62.8 (54.5, 69.2)	65.7 (60.7, 69.3)	63.8 (58.4, 69.3)
Skin hydration (AU)	40.5 (34.5, 46.2)	40.4 (36.7, 45.5)	40.5 (36.1, 45.8)
Sudomotor nerve function (μS)
Left hand	54.0 (47.0, 63.0)	57.5 (39.0, 71.0)	56.0 (46.5, 68.5)
Right hand	54.0 (47.0, 60.0)	56.5 (41.0, 67.0)	56.0 (45.5, 61.5)
Hands	53.8 (48.0, 60.5)	56.8 (40.0, 70.5)	56.8 (47.3, 65.0)
Left foot	65.5 (46.0, 78.0)	79.0 (63.0, 84.0)	74.5 (57.0, 81.5)
Right foot	69.5 (48.0, 79.0)	77.0 (69.0, 82.0)	74.0 (54.5, 79.0)
Feet	67.5 (44.5, 76.5)	78.0 (64.0, 83.5)	75.0 (55.8, 79.8)
Overall	61.0 (46.8, 67.8)	66.6 (63.3, 71.3)	64.6 (50.3, 69.8)
Safety variables
BMI (kg/m2)	33.67 ± 13.47	35.05 ± 5.68	34.36± 10.17
Waist–hip ratio	0.98 ± 0.08	1.03 ± 0.08	1.01 ± 0.08
HbA1c (mmol/mol)	72.29 ± 19.43	66.00 ± 14.91	69.14 ± 17.29
Blood pressure (mmHg)
Systolic	135.71 ± 21.01	140.43 ± 12.02	138.07 ± 16.97
Diastolic	83.86 ± 8.91	72.64 ± 9.96	78.25 ± 10.89
Full blood count
Hemoglobin (g/L)	139.21 ± 14.12	139.43 ± 11.35	139.32 ± 12.57
White blood cells (×109/L)	6.46 ± 2.55	7.34 ± 2.04	6.90 ± 2.31
Platelets (×109/L)	218.71 ± 61.85	273.14 ± 81.37	245.93 ± 76.15
Red blood cells (×1012/L)	4.84 ± 0.49	4.71 ± 0.48	4.78 ± 0.48
Mean corpuscular volume (fL)	88.43 ± 4.64	91.21 ± 6.96	89.82 ± 5.98
Hematocrit (packed cell volume)	0.43 ± 0.04	0.43 ± 0.03	0.43 ± 0.03
Mean corpuscular hemoglobin (pg)	28.82 ± 2.09	29.74 ± 2.47	29.28 ± 2.29
Corpuscular hemoglobin (g/L)	325.57 ± 10.43	326.64 ± 8.29	326.11 ± 9.26
Red blood cell distribution width (%)	13.88 ± 0.98	14.12 ± 1.10	14.00 ± 1.03
Lipid profile
High density lipoprotein (mmol/L)	1.24 ± 0.31	1.19 ± 0.27	1.21 ± 0.29
Cholesterol (mmol/L)	4.36 ± 1.13	3.95 ± 0.75	4.15 ± 0.97
Triglycerides (mmol/L)	1.68 ± 0.74	2.02 ± 1.02	1.85 ± 0.89
Liver function
Albumin (g/L)	39.43 ± 2.56	39.50 ± 2.44	39.46 ± 2.46
Bilirubin (µmol/L)	8.93 ± 2.97	8.14 ± 2.82	8.54 ± 2.87
Alkaline phosphatase (U/L)	80.43 ± 23.76	85.07± 26.08	82.75 ± 24.59
Alanine aminotransferase (IU/L)	24.64 ± 7.10	27.43± 10.91	26.04± 9.14
Aspartate aminotransferase (IU/L)	21.00 ± 4.95	22.64± 5.50	21.82 ± 5.20
Gamma-glutamyl transpeptidase (IU/L)	41.86 ± 33.87	39.29 ± 29.87	40.57 ± 31.37
Kidney functioL
eGFR (mL/min/1.73 m2)	81.86 ± 9.69	79.21 ± 13.59	80.54 ± 11.66
Sodium (mmol/L)	138.93 ± 2.06	140.71 ± 5.47	139.82 ± 4.15
Potassium (mmol/L)	4.46 ± 0.33	4.63 ± 0.41	4.55 ± 0.37
Urea (mmol/L)	6.96 ± 2.81	7.25 ± 2.17	7.10 ± 2.47
Creatinine (µmol/L)	76.64 ± 15.36	76.21 ± 20.04	76.43 ± 17.52
Adrenal function
Testosterone (nmol/L)	11.10 ± 6.25	6.97± 5.48	9.04± 6.14
DHEAS (µmol/L)	3.53 ± 2.19	2.91± 1.69	3.22 ± 1.95
Thyroid function
Free thyroxine (pmol/L)	14.86 ± 2.20	15.73 ± 1.58	15.30 ± 1.93
Thyroid stimulating hormone (mlU/L)	1.74 ± 0.66	1.72 ± 0.63	1.73 ± 0.64

*values are log mean ± s.d. and values in parentheses is the geometric mean; ^† n  = 13; ^‡ n  = 27.

n, number non-missing; Q1, first quartile; Q3, third quartile.