Table 1 Clinical trials outcomes studies for anti-obesity agents
Study | Intervention | Population | N enrolled | Design | Primary outcome | Result |
|---|---|---|---|---|---|---|
XENDOS [59] | Orlistat | Obese | 3305 | Phase III | Weight loss | 2.7Â kg orlistat |
Phase III [58] | Orlistat | Obese | 80 | Phase III | Weight loss | 4.6Â kg orlistat 2.5Â kg placebo |
Orlistat | Overweight or obese | 6021 | Meta-analysis | Weight loss | 2.9% orlistat Reduce blood pressure Reduce LDL cholesterol Reduce fasting glucose | |
SCALE Obesity and Pre-diabetes [61] | Liraglutide 3.0Â mg | Overweight or obese | 3731 | Phase III | Weight loss | 8.4Â kg liraglutide 2.8Â kg placebo Reduce blood pressure Improvement in fasting lipids, C-reactive protein, plasminogen activator inhibitor-1, adiponectin |
SCALE Maintenance [64] | Liraglutide 3.0Â mg | Overweight or obese with comorbidities | 422 | Phase III | Weight loss maintenance | 6.2% liraglutide 3.0Â mg 0.2% placebo Reduce BMI, waist circumference, glycemic parameters, hsCRP, systolic blood pressure |
SCALE Obesity and Pre-diabetes (3-year assessment) [65] | Liraglutide 3.0Â mg | Overweight or obese prediabetic with comorbidities | 2210 | Phase III | Reduce bodyweight and onset of T2D | 6.1% liraglutide 3.0Â mg 1.9% placebo Reduce BMI, waist circumference, glycemic parameters, systolic blood pressure |
Post-hoc MACE-SCALE analysis [66] | Liraglutide 3.0Â mg | Overweight or obese | 5908 | Pooled data | 1st occurrence of CV death, nonfatal MI or nonfatal stroke | 1.54 CV events/1000 person-years liraglutide 3.0Â mg 3.65 CV events/1000 person-years comparator (placebo/orlistat) Reduce blood pressure No increased CV risk |
LEADER [67] | Liraglutide 1.8Â mg | High-risk population | 9340 | Phase III | CV safety | 13.0% CV events liraglutide 14.9% CV events placebo 4.7% CV deaths liraglutide 6.0% CV deaths placebo |
Lorcaserin hydrochloride | Overweight or obese | 3182 | Phase III | Weight loss | 5.8Â kg lorcaserin 2.2Â kg placebo | |
Lorcaserin hydrochloride | Overweight or obese with comorbid risk factors | 4008 | Phase III | Weight loss | 5.8Â kg lorcaserin bid 4.7Â kg lorcaserin od 2.9Â kg placebo | |
Lorcaserin hydrochloride | Obese and diabetic | 604 | Phase III | Weight loss | 5.9Â kg lorcaserin tid 5.6Â kg lorcaserin od 1.9Â kg placebo | |
CAMELLIA-TIMI 61 [68] | Lorcaserin hydrochloride | Overweight or obese at high CV and metabolic risk | 12,000 | Phase IV | CV safety | 38.7% lorcaserin (≥ 5%) 17.4% placebo (≥ 5%) 2.0% CV events/year lorcaserin 2.1% CV events/year placebo 4.1% major CV events/year lorcaserin 4.2% major CV events/year placebo Slightly better values blood pressure, heart rate, glycemic control, lipids More serious hypoglycemia |
Naltrexone hydrochloride/bupropion hydrochloride | Overweight or obese | 1742 | Phase III | Weight loss | 4.8% NB32 3.7% NB16 Reduce waist circumference, triglycerides, hsCRP Increase HDL cholesterol 1 death due to acute myocardial infarction in NB32 patient 0.2% CV events NB patients 0.3% CV events placebo | |
Naltrexone hydrochloride/bupropion hydrochloride | Overweight or obese | 1496 | Phase III | Weight loss | 5.2% NB32 Reduce waist circumference, triglycerides, hsCRP Increase HDL cholesterol | |
Naltrexone hydrochloride/bupropion hydrochloride | Overweight or obese with controlled hypertension and/or dyslipidemia with or without lifestyle modification | 793 | Phase III | Weight loss | 54.3% NB32 (≥ 5%) 41.6% placebo (≥ 5%) Improvement in hsCRP, fasting blood glucose | |
Naltrexone hydrochloride/bupropion hydrochloride | Overweight or obese diabetic | 505 | Phase III | Weight loss | 3.2% NB32 No increase of hypoglycemia Decrease in HbA1c | |
Naltrexone hydrochloride/bupropion hydrochloride | Overweight or obese at increased risk | 8900 | Phase III | MACE | Early terminated | |
EQUATE [60] | PHEN/TPM | Overweight or obese | 776 | Phase II | Weight loss | 9.2% PHEN/TPM 15/92 8.5% PHEN/TPM 7.5/46 6.4% topiramate 92Â mg 6.1% phentermine 15Â mg 1.7% placebo |
PHEN/TPM | Overweight or obese | 2487 | Phase III | Weight loss and comorbidities | 10.2Â kg PHEN/TPM 15/92 8.1Â kg PHEN/TPM 7.5/46 1.4Â kg placebo Improvement in waist circumference, blood pressure, lipids | |
EQUIP [69] | PHEN/TPM | Obese | 1267 | Phase III | Weight loss | 10.9% PHEN/TPM 15/92 5.1% PHEN/TPM 3.75/23 1.6% placebo Improvements in fasting blood glucose, blood pressure, cholesterol, waist circumference in PHEN/TPM ER 15/92Â mg |
AQCLAIM | PHEN/TPM | Overweight or obese with documented CVD | Target 540 | Phase III | Time to 1st occurrence of nonfatal MI, nonfatal stroke or CV death | On going |
SCOUT [74] | Sibutramine | Overweight or obese + 55-year at high CV risk | 10,744 |  | CV events | − 1.7 kg (1 year) sibutramine + 0.7 kg (1 year) placebo Higher risk of a primary outcome event, nonfatal myocardial infarction Increased blood pressure, pulse rate, cardiovascular events (tachycardia, hypertension, arrhythmias) |
Meta-analysis [59] | Sibutramine | Overweight or obese | 929 | Phase III | Weight loss | 4.6% (1Â year) |
Phase III [75] | Sibutramine | Obese | 224 | Phase III | Weight loss | 5.0Â kg (1Â year) |