TABLE 2.
Effects of GLP-1 receptor agonists on weight in patients who are overweight or obese
| Study, author, and population | Study design | Sample size and retention | Dose and dosing regimen | Weight loss and time point |
|---|---|---|---|---|
| Astrup et al., 2009 (24) Adults with BMI 30-40 kg m−2 | All subjects on −500 kcal deficit diet and increased physical activity; 2-week placebo run-in, followed by randomization 4-week titration from 0.6 mg; 16-week constant dose treatment. | N = 564; completers: 85/95 (1.2 mg), 74/90 (1.8 mg), 73/93 (2.4 mg), 82/93 (3.0 mg), 79/98 (placebo), 79/95 (orlistat); total 472/564 completers = 84% | Liraglutide 1.2 mg once daily (n = 94) | Change from baseline at 20 weeks: Weight: −4.8 kg; weight loss >5%: 52.1%; weight loss >10%: 7.4% |
| Liraglutide 1.8 mg once daily (n = 90) | Weight: −5.5 kg; weight loss >5%: 53.3%; weight loss >10%: 18.9% | |||
| Liraglutide 2.4 mg once daily (n = 92) | Weight: −6.3 kg; weight loss >5%: 60.8%; weight loss >10%: 22.8% | |||
| Liraglutide 3.0 mg once daily (n = 92) | Weight: −7.2 kg; weight loss >5%: 76.1%; weight loss >10%: 28.3% | |||
| Placebo injection (n = 98) | Weight: −2.8 kg; weight loss >5%: 29.6%; weight loss >10%: 2.0% | |||
| Orlistat 120 mg TID (open-label) (n = 95) | Weight: −4.1 kg; weight loss >5%: 44.2%; weight loss >10%: 9.5% | |||
| Astrup et al., 2012 Adults with BMI 30-40 kg m−2 | 2-year extension of above study. | N = 398 entered the extension; completers: 46/68 (1.2 mg), 38/59 (1.8 mg), 45/65 (2.4 mg), 47/72 (3.0 mg), 47/67 (placebo), 45/67 (orlistat); total 268/398 completers = 67% | Liraglutide 2.4/3.0 mg once daily pooled group (n = 92) | Change from baseline at year 2 (completers): Weight: −7.8 kg; weight loss >5%: 69%; weight loss >10%: 43% |
| Orlistat 120 mg TID (open-label) (n = 45) | Weight: −5.4 kg; weight loss >5%: 49%; weight loss >10%: 31% | |||
| Wadden et al., 2013 (25) Adults with BMI ≥30 or ≥27 kg m−2 | Obese/overweight participants who lost ≥5% of initial weight during a low-calorie diet run-in were randomly assigned to liraglutide 3.0 mg per day or placebo (subcutaneous administration) for 56 weeks. Diet and exercise counseling were provided throughout the trial. | N = 422; completers: 159/212 (3.0 mg), 146/210 (placebo) | Liraglutide 3.0 mg once daily (n = 207) | Change from randomization to 56 weeks (full analysis set with last observation carried forward): Weight: −6.0 kg (−6.2%); weight loss >5%: 50.5%; weight loss >10%: 26.1% |
| Placebo injection (n = 206) | Weight: −0.1 kg (−0.2%); weight loss >5%: 21.8%; weight loss >10%: 6.3% | |||
| Rosenstock et al., 2010 (26) Adults with BMI ≥30 kg m−2 | Obese adults were randomized to exenatide or placebo, combined with lifestyle modification and decreased calorie intake, for 24 weeks. | N = 152; 102 completed the 24-week treatment period | Exenatide 10 μg twice daily (following a 4-week 5 μg dose-initiation period) | Weight from baseline compared with lifestyle modification alone: Exenatide −5.1 kg; placebo −1.6 kg; exenatide − placebo (P < 0.001); placebo-subtracted difference in percent weight loss −3.3 (P < 0.001) |
| Kelly et al., 2013 (27) Adolescents with BMI ≥1.2x the 95th percentile or >35 kg m−2 | 26 adolescents (aged 12-19 years) with severe obesity in double-blind, placebo-controlled study; randomized 3-month period, followed by 3-month open-label extension where all subjects received exenatide 10 mg subcutaneously twice daily. | N = 26; completers at 3 months: 22 total, 12 on exenatide, 10 on placebo; completers at 6 months: 19 | Dose titration from 5 μg twice daily for 1 month and increased to 10 μg twice daily for first 3 months; exenatide (n =13) | Change from randomization to 3 months for completers: BMI −2.90%; BMI −1.18 kg m−2; weight loss −3.26 kg; after open-label extension: BMI −4% from randomization |
| Placebo | BMI −0.15%; BMI −0.04 kg m−2; weight loss −0.32 kg; after open-label extension: BMI +0.25% from randomization | |||
| Dushay et al., 2012 (28) Obese women without type 2 diabetes | 41 obese women (age 48 ± 11 years), BMI 33.1 ± 4.1 kg m−2; double-blind, placebo-controlled cross-over study; two 16-week treatment periods separated by 3-week washout. No lifestyle intervention. | Exenatide 5 μg twice daily for 2 weeks, then 10 μg twice daily for 16 weeks | Overall dropout rate 35%; 17% dropped out before randomization and 18% dropped out after randomization | Change from randomization to week 16: Exenatide: Weight −2.77% |
| Placebo | Placebo: Weight +0.48% |