pISSN 1226-6051
eISSN 2508-786X

Table. 1.

Table. 1.

Efficacy and safety of once weekly semaglutide subcutaneous injection for weight loss13-20, 22-26)

Trial Study population Trial duration Study drugs Mean body weight change from baseline (ETD, 95% CI, p-value) Proportion achieving body weight reduction of ≥5%, % (OR, 95% CI, p-value) Proportion achieving body weight reduction of ≥10%, % (OR, 95% CI, p-value) Proportion achieving body weight reduction of ≥15%, % (OR, 95% CI, p-value) Proportion achieving body weight reduction of ≥20%, % (OR, 95% CI, p-value) GI adverse events (%) GI adverse events leading to premature treatment discontinuation (%)
Compared to placebo
SUSTAIN 1 Adults with T2DM 30 weeks Semaglutide 0.5 mg (n=128) -3.73 kg (-2.75, -3.92 to -1.58, p<0.0001) 37 (7.88, 3.65 to 17.04, p<0.0001) 8 (3.6, 1.09 to 11.95, p=0.0363) - - 38 4
Semaglutide 1 mg (n=130) -4.53 kg (-3.56, -4.74 to -2.38, p<0.0001) 45 (12.01, 5.53 to 26.07, p<0.0001) 13 (6.23, 19.8 to 19.61, p=0.0018) - - 38 3
Placebo, reference (n=129) -0.98 kg 7 2 - - 15 <1%
SUSTAIN 5 Adults with T2DM 30 weeks Semaglutide 0.5 mg (n=132) -3.7 kg (-2.31, -3.33 to -1.29, p<0.0001) 42 (5.91, 3.08 to 11.31, p<0.0001) 9 (3.18, 1.05 to 9.63, p<0.05) - - 27.3 -
Semaglutide 1 mg (n=131) -6.4 kg (-5.06, -6.08 to -4.04, p<0.0001) 66 (16.59, 8.52 to 32.3, p<0.0001) 26 (12.8, 4.51 to 36.33, p<0.05) - - 37.4 -
Placebo, reference (n=133) -1.4 kg 11 3 - - 9.02 -
SUSTAIN 9 Adults with T2DM 30 weeks Semaglutide 1 mg (n=151; n=150 for adverse events) -4.7 kg (-3.81, -4.7 to -2.93, p<0.0001) 49.9 (12.45, 5.77 to 26.84, p<0.0001) 15.1 (10.11, 2.8 to 36.59, p=0.0004) - - 37.3 6.7
Placebo, reference (n=151) -0.9 kg 8.2 1.4 - - 13.2 0
STEP 1 Overweight or obese adults without T2DM 68 weeks Semaglutide 2.4 mg (n=1,306) -14.85% (-12.44, -13.37 to -11.51, p<0.001) 86.4 (11.2, 8.9 to 14.2, p<0.001) 69.1 (14.7, 11.1 to 19.4, p<0.001) 50.5 (19.3, 12.9 to 28.8, p<0.001) 32 (26.9, 14.2 to 51) 74.2 4.5
Placebo, reference (n=655) -2.41% 31.5 12 4.9 1.7 47.9 0.8
STEP 4 Overweight or obese adults without T2DM 68 weeks Continued semaglutide 2.4 mg (n=535) -7.9% (-14.8, -16 to -13.5, p<0.0001) - - - - 41.9 -
Switched to placebo, reference (n=268) 6.9% - - - - 26.1 -
STEP 3 Overweight or obese adults without T2DM 68 weeks Semaglutide 2.4 mg (n=407) -16% (-10.3, -12 to -8.6, p<0.001) 86.6 (6.1, 4 to 9.3, p<0.001) 75.3 (7.4, 4.9 to 11, p<0.001) 55.8 (7.9, 4.9 to 12.6, p<0.001) 35.7 (13.7, 6.2 to 30.3, p<0.001) 82.2 3.4
Placebo, reference (n=204) -5.7% 47.6 27 13.2 3.7 63.2 0
STEP 5 Overweight or obese adults without T2DM 104 weeks Semaglutide 2.4 mg (n=152) -15.2% (-12.6, -15.3 to -9.3, p<0.0001) 77.1 (5, 3 to 8.4, p<0.0001) 61.8 (7.2, 4 to 13.2, p<0.0001) 52.1 (9.4, 4.4 to 20, p<0.0001) 36.1 (12.8, 3.9 to 41.9) 82.2 3.9
Placebo, reference (n=152) -2.6% 34.4 13.3 7 2.3 53.9 0.7
STEP TEEN Obese adolescents 68 weeks Semaglutide 2.4 mg (n=134; n=133 for adverse events) -15.3 kg (-17.7, -21.8 to -13.7) 73 (14, 6.3 to 31, p<0.001) 62 (23, 8.3 to 63.7) 53 (25.8, 7.6 to 88) 37 (20, 4.6 to 86.3) 62 2
Placebo, reference (n=67) 2.4 kg 18 8 5 3 42 1
Compared to other GLP-1 analogues
SUSTAIN 3 Adults with T2DM 56 weeks Semaglutide 1 mg (n=404) -5.6 kg (-3.78, -4.58 to -2.98, p<0.0001) 52 (p<0.0001) 21 (p<0.0001) - - 41.8 5.7
Exenatide ER 2 mg once weekly, reference (n=405) -1.9 kg 17 4 - - 33.3 2.7
SUSTAIN 7 Adults with T2DM 40 weeks Low dose
Semaglutide 0.5 mg (n=301) -4.6 kg (-2.26, -3.02 to -1.51, p<0.0001) 44 (2.4, 1.65 to 3.47, p<0.0001) 14 (4.79, 2.38 to 9.65, p<0.0001) - - 43 5
Dulaglutide 0.75 mg once weekly, reference (n=299) -2.3 kg 23 3 - - 33 2
High dose
Semaglutide 1 mg (n=300) -6.5 kg (-3.55, -4.32 to -2.78, p<0.0001) 63 (3.03, 2.11 to 4.34, p<0.0001) 27 (4.55, 2.73 to 7.59, p<0.0001) - - 44 6
Dulaglutide 1.5 mg once weekly, reference (n=299) -3 kg 30 8 - - 48 5
SUSTAIN 10 Adults with T2DM 30 weeks Semaglutide 1 mg (n=290; n=289 for adverse events) -5.8 kg (-3.83, -4.57 to -3.09, p<0.0001) 56 (p<0.0001) 19 (p<0.0001) - - 43.9 7.6
Liraglutide 1.2 mg once daily, reference (n=287) -1.9 kg 18 4 - - 38.3 3.8
STEP 8 Overweight or obese adults without T2DM 68 weeks Semaglutide 2.4 mg (n=126) -15.8% (-9.4, -12 to -6.8, p<0.001) 87.2 70.9 (6.3, 3.5 to 11.2, p<0.001) 55.6 (7.9, 4.1 to 15.4, p<0.001) 38.5 (8.2, 3.5 to 19.1, p<0.001) 84.1 0.8
Liraglutide 3 mg once daily, reference (n=127) -6.4% 58.1 25.6 12 6 82.7 6.3
Placebo (n=85) - - - - - 55.3 1.2
SURPASS 2 Adults with T2DM 40 weeks Tirzepatide 5 mg once weekly (n=470) -7.8 kg (-1.7, -2.6 to -0.7, p<0.001) 68.5 35.79 15.18 - 40 -
Tirzepatide 10 mg once weekly (n=469) -10.3 kg (-4.1, -5 to -3.2, p<0.001) 82.35 52.94 27.67 - 46.1 -
Tirzepatide 15 mg once weekly (n=469; n=470 for adverse events) -12.4 kg (-6.2, -7.1 to -5.3, p<0.001) 86.21 64.87 39.87 - 44.9 -
Semaglutide 1 mg, reference (n=468; n=469 for adverse events) -6.2 kg 58.44 25.32 8.66 - 41.2 -
Compared to SGLT-2 inhibitor
SUSTAIN 8 Adults with T2DM 52 weeks Semaglutide 1 mg (n=394; n=392 for adverse events) -5.3 kg (-1.06, -1.76 to -0.36, p=0.0029) 51.1 (1.22, 0.9 to 1.66, p=0.21) 22.3 (2.99, 1.89 to 4.75, p<0.0001) 6.8 (7.45, 2.45 to 22.6, p=0.0004) - 47 7
Canagliflozin 300 mg once daily, reference (n=394) -4.2 kg 46.6 8.9 0.9 - 28 1

CI: confidence interval; ER: extended release; ETD: estimated treatment difference; GI: gastrointestinal; GLP-1: glucagon-like peptide-1; OR: odds ratio; SGLT-2: sodium-glucose transport protein 2; T2DM: type 2 diabetes mellitus

Korean J Clin Pharm 2024;34:1-20 https://doi.org/10.24304/kjcp.2024.34.1.1
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