Table 2 Metabolic parameters at TR baseline, DB endpoint and OLE endpoint (ITT analysis set)
Underweight <19 kg/m2 | Normal-weight 19- < 25 kg/m2 | Overweight 25- < 30 kg/m2 | Obese ≥30 kg/m2g | |
|---|---|---|---|---|
Plasma glucose, (mg/dL) | ||||
ITT analysis set with DB endpoint | ||||
n | 5 | 70 | 68 | 52 |
TR baseline | 89.8 (14.65) | 92.6 (15.26) | 93.8 (12.88) | 101.3 (20.02) |
Change from TR baseline to DB endpoint | 14.6 (18.39) | 2.0 (17.89) | 7.0 (20.81) | −2.1 (24.20) |
p-value | 0.1506 | 0.3563 | 0.0068 | 0.5313 |
ITT analysis set with OLE endpoint | ||||
n | 8 | 85 | 77 | 39 |
TR baseline | 90.4 (11.22) | 92.88 (19.71) | 94.64 (12.01) | 100.33. (15.59) |
Change from TR baseline to OLE endpoint | 3.9 (18.36) | 10.2 (29.17) | 9.9 (29.00) | 3.5 (30.34) |
p-value | 0.5694 | 0.0019 | 0.0036 | 0.4772 |
Insulin, (μU/mL) | ||||
ITT analysis set with DB endpoint | ||||
n | 4 | 61 | 63 | 50 |
TR baseline | 17.0 (13.44) | 11.5 (15.23) | 12.6 (11.43) | 25.6 (32.12) |
Change from TR baseline to DB endpoint | −2.5 (4.36) | −0.6 (16.56) | 3.2 (21.64) | −4.3 (21.25) |
p-value | 0.3345 | 0.7900 | 0.2517 | 0.1562 |
ITT analysis set with OLE endpoint | ||||
n | 7 | 72 | 76 | 40 |
TR baseline | 12.3 (11.23) | 11.1 (14.16) | 14.0 (12.37) | 25.0 (34.45) |
Change from TR baseline to OLE endpoint | 0.3 (17.59) | 0.8 (13.71) | 1.5 (19.62) | −5.25 (36.13) |
p-value | 0.9671 | 0.6288 | 0.4928 | 0.3642 |
Cholesterol, (mg/dL) | ||||
ITT analysis set with DB endpoint | ||||
n | 5 | 71 | 64 | 52 |
TR baseline | 170.8 (27.09) | 180.1 (39.40) | 192.7 (34.14) | 203.3 (39.23) |
Change from TR baseline to DB endpoint | −10.2 (36.27) | −1.7 (28.87) | −8.9 (26.99) | −17.2 (34.78) |
p-value | 0.5636 | 0.6320 | 0.0104 | 0.0008 |
ITT analysis set with OLE endpoint | ||||
n | 8 | 85 | 75 | 40 |
TR baseline | 161.9 (26.55) | 176.6 (34.37) | 194.0 (33.87) | 199.3 (31.05) |
Change from TR baseline to OLE endpoint | −3.25 (28.96) | 7.9 (30.87) | −1.0 (36.04) | 1.0 (22.43) |
p-value | 0.7602 | 0.0202 | 0.8034 | 0.7741 |
HDL, (mg/dL) | ||||
ITT analysis set with DB endpoint | ||||
n | 5 | 71 | 64 | 51 |
TR baseline | 60.0 (6.44) | 55.9 (16.53) | 51.0 (12.16) | 46.5 (14.16) |
Change from TR baseline to DB endpoint | −2.8 (2.86) | −1.6 (12.83) | 0.13 (8.93) | −0.2 (9.27) |
p-value | 0.0941 | 0.2828 | 0.9112 | 0.8805 |
ITT analysis set with OLE endpoint | ||||
n | 8 | 85 | 75 | 39 |
TR baseline | 56.7 (8.38) | 53.6 (14.15) | 50.7 (12.31) | 48.1 (10.75) |
Change from TR baseline to OLE endpoint | −0.2 (7.92) | 0.3 (13.46) | −1.6 (10.75) | 1.0 (10.92) |
p-value | 0.9314 | 0.8095 | 0.1869 | 0.5514 |
LDL, (mg/dL) | ||||
ITT analysis set with DB endpoint | ||||
n | 5 | 71 | 61 | 45 |
TR baseline | 85.4 (18.80) | 101.7 (34.37) | 113.2 (30.01) | 126.3 (35.45) |
Change from TR baseline to DB endpoint | −6.0 (23.64) | 0.2 (26.18) | −9.6 (23.10) | −18.8 (28.82) |
p-value | 0.6007 | 0.9388 | 0.0020 | 0.0001 |
ITT analysis set with OLE endpoint | ||||
n | 8 | 82 | 72 | 38 |
TR baseline | 83.2 (20.35) | 99.9 (30.97) | 113.3 (28.35) | 122.9 (28.98) |
Change from TR baseline to OLE endpoint | 1.7 (21.67) | 6.8 (26.86) | −0.1 (30.29) | −2.1 (20.97) |
p-value | 0.8259 | 0.0249 | 0.9814 | 0.5347 |
Triglycerides, (mg/dL) | ||||
ITT analysis set with DB endpoint | ||||
n | 5 | 71 | 64 | 52 |
TR baseline | 124.4 (95.27) | 111.4 (57.31) | 155.6 (132.87) | 172.2 (101.48) |
Change from TR baseline to DB endpoint | −5.4 (79.94) | −1.8 (54.93) | −8.5 (129.2) | −0.8 (97.12) |
p-value | 0.8872 | 0.7813 | 0.5985 | 0.9535 |
ITT analysis set with OLE endpoint | ||||
n | 8 | 85 | 75 | 40 |
TR baseline | 107.7 (77.00) | 117.00 (72.70) | 158.7 (134.11) | 150.5 (67.13) |
Change from TR baseline to OLE endpoint | −22.6 (65.95) | 5.3 (87.44) | −3.57 (135.8) | 13.8 (65.18) |
p-value | 0.3642 | 0.5765 | 0.8203 | 0.1875 |