ライフサイエンスコーパス: semaglutide

1 outcome that confirmed the noninferiority of semaglutide.

2 The GLP-1R affinity of semaglutide (0.38 +/- 0.06 nM) was three-fold decreased

3 standard-care regimen to receive once-weekly semaglutide (0.5 mg or 1.0 mg) or placebo for 104 weeks.

4 o either once-weekly subcutaneously injected semaglutide (0.5 mg or 1.0 mg), or volume-matched placeb

5 dent range, -0.7% to -1.9%) and subcutaneous semaglutide (-1.9%) and placebo (-0.3%); oral semaglutid

6 dication (128 0.5 mg semaglutide, 130 1.0 mg semaglutide, 129 placebo).

7 ast one dose of study medication (128 0.5 mg semaglutide, 130 1.0 mg semaglutide, 129 placebo).

8 was reported in 16 (13%) who received 0.5 mg semaglutide, 14 (11%) who received 1.0 mg semaglutide, a

9 17 (13%) of those assigned to 0.5 mg semaglutide, 16 (12%) assigned to 1.0 mg semaglutide, an

10 iovascular and Other Long-term Outcomes with Semaglutide], -24%).

11 was reported in 26 (20%) who received 0.5 mg semaglutide, 31 (24%) who received 1.0 mg semaglutide, a

12 isted of 362 participants assigned to 0.5 mg semaglutide, 360 to 1.0 mg semaglutide, and 360 to insul

13 range, -2.1 kg to -6.9 kg) and subcutaneous semaglutide (-6.4 kg) vs placebo (-1.2 kg), and signific

14 The cardiovascular effects of semaglutide, a glucagon-like peptide 1 analogue with an

15 We assessed the efficacy and safety of semaglutide, a glucagon-like peptide-1 (GLP-1) analogue

16 8.17% (SD 0.89), at week 30, 0.5 and 1.0 mg semaglutide achieved reductions of 1.21% (95% CI 1.10-1.

17 45 kg (SD 21.79); at week 30, 0.5 and 1.0 mg semaglutide achieved weight losses of 3.47 kg (95% CI 3.

18 peptide-1 receptor agonists liraglutide and semaglutide also reduced CV death and/or major adverse C

19 e -0.38% (95% CI -0.52 to -0.24) with 0.5 mg semaglutide and -0.81% (-0.96 to -0.67) with 1.0 mg sema

20 -4.62 kg (95% CI -5.27 to -3.96) with 0.5 mg semaglutide and -6.33 kg (-6.99 to -5.67) with 1.0 mg se

21 reported by 16 (4%) participants with 0.5 mg semaglutide and 20 (6%) with 1.0 mg semaglutide versus 3

22 n occurred in 2.9% of the patients receiving semaglutide and in 3.9% of those receiving placebo (haza

23 isenatide), LEADER (liraglutide), SUSTAIN 6 (semaglutide), and EXSCEL (extended-release exenatide).

24 mg semaglutide, 31 (24%) who received 1.0 mg semaglutide, and 10 (8%) who received placebo, and diarr

25 mg semaglutide, 16 (12%) assigned to 1.0 mg semaglutide, and 14 (11%) assigned to placebo discontinu

26 y, compared with 55 (15%) assigned to 1.0 mg semaglutide, and 26 (7%) assigned to insulin glargine.

27 ssigned to 0.5 mg semaglutide, 360 to 1.0 mg semaglutide, and 360 to insulin glargine.

28 ular efficacy for lixisenatide, liraglutide, semaglutide, and extended-release exenatide.

29 th 0.5 mg semaglutide, five (1%) with 1.0 mg semaglutide, and five (1%) with insulin glargine.

30 adverse events-mostly gastrointestinal with semaglutide, and others such as skin and subcutaneous ti

31 mg semaglutide, 14 (11%) who received 1.0 mg semaglutide, and three (2%) who received placebo.

32 de and -6.33 kg (-6.99 to -5.67) with 1.0 mg semaglutide (both p<0.0001).

33 tide and -0.81% (-0.96 to -0.67) with 1.0 mg semaglutide (both p<0.0001).

34 Data were unavailable for semaglutide, definitions of outcomes were heterogeneous,

35 49 (14%) participants assigned to 0.5 mg semaglutide discontinued treatment prematurely, compared

36 from baseline to week 26 decreased with oral semaglutide (dosage-dependent range, -0.7% to -1.9%) and

37 ctions in body weight were greater with oral semaglutide (dosage-dependent range, -2.1 kg to -6.9 kg)

38 placebo (-1.2 kg), and significant for oral semaglutide dosages of 10 mg or more vs placebo (dosage-

39 er subcutaneous once-weekly 0.5 mg or 1.0 mg semaglutide (doses reached after following a fixed dose-

40 by 1.45% (95% CI -1.65 to -1.26) with 0.5 mg semaglutide (estimated treatment difference vs placebo -

41 reased by 1.55% (-1.74 to -1.36) with 1.0 mg semaglutide (estimated treatment difference vs placebo -

42 3.73 kg (95% CI -4.54 to -2.91) with 0.5 mg semaglutide (estimated treatment difference vs placebo -

43 ased by 4.53 kg (-5.34 to -3.72) with 1.0 mg semaglutide (estimated treatment difference vs placebo -

44 ported by two (<1%) participants with 0.5 mg semaglutide, five (1%) with 1.0 mg semaglutide, and five

45 eaths were reported: four (1%) in the 0.5 mg semaglutide group (three cardiovascular deaths, one panc

46 curred in 108 of 1648 patients (6.6%) in the semaglutide group and in 146 of 1649 patients (8.9%) in

47 Fewer serious adverse events occurred in the semaglutide group, although more patients discontinued t

48 81% (56 of 69 patients) in the subcutaneous semaglutide group, and 68% (48 of 71 patients) in the pl

49 w or worsening nephropathy were lower in the semaglutide group, but rates of retinopathy complication

50 t frequently reported adverse events in both semaglutide groups were gastrointestinal in nature: naus

51 63% to 86% (371 of 490 patients) in the oral semaglutide groups, 81% (56 of 69 patients) in the subcu

52 mini-pigs following i.v. administration, and semaglutide has an MRT of 63.6 h after s.c. dosing to mi

53 Semaglutide has two amino acid substitutions compared to

54 iovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes [SUSTAIN-6]

55 Semaglutide is a glucagon-like peptide-1 (GLP-1) analogu

56 Semaglutide is currently in phase 3 clinical testing.

57 ed the efficacy, safety, and tolerability of semaglutide monotherapy, compared with placebo, in treat

58 1; double-blind) or once-weekly subcutaneous semaglutide of 1.0 mg (n = 70) for 26 weeks.

59 Once-daily oral semaglutide of 2.5 mg (n = 70), 5 mg (n = 70), 10 mg (n

60 emaglutide (-1.9%) and placebo (-0.3%); oral semaglutide reductions were significant vs placebo (dosa

61 tly reported adverse events were nausea with semaglutide, reported in 77 (21%) patients with 0.5 mg a

62 Among patients with type 2 diabetes, oral semaglutide resulted in better glycemic control than pla

63 ERPRETATION: Compared with insulin glargine, semaglutide resulted in greater reductions in HbA1c and

64 lacebo (primary) and open-label subcutaneous semaglutide (secondary) on glycemic control in patients

65 Semaglutide showed no increase in pancreas weight and no

66 INTERPRETATION: Semaglutide significantly improved HbA1c and bodyweight

67 f Cardiovascular Ourcome Results], -13%) and semaglutide (SUSTAIN-6 trial [Trial to Evaluate Cardiova

68 se when compared with placebo in the case of semaglutide (SUSTAIN-6).

69 significantly lower among patients receiving semaglutide than among those receiving placebo, an outco

70 caemic drugs empagliflozin, liraglutide, and semaglutide-the latter being under review for approval b

71 the pancreas associated with liraglutide or semaglutide, two structurally different GLP-1 receptor a

72 h 0.5 mg semaglutide and 20 (6%) with 1.0 mg semaglutide versus 38 (11%) with insulin glargine (p=0.0

73 (p=0.0021 and p=0.0202 for 0.5 mg and 1.0 mg semaglutide vs insulin glargine, respectively).

74 ed treatment difference [ETD] range for oral semaglutide vs placebo, -0.4% to -1.6%; P = .01 for 2.5

75 Semaglutide was selected as the optimal once weekly cand

76 To compare the effects of oral semaglutide with placebo (primary) and open-label subcut

77 We hypothesized that semaglutide would be noninferior to placebo for the prim