drugset / Trial / NCT03675191

Orlistat/Phentermine Versus Placebo/Phentermine

NCT03675191

Completed 114 enrolled Gangnam Severance Hospital
RandomizedParallel-groupTriple-blindTreatment

Summary

The prevalence of obesity is increasing worldwide and obesity is an important risk factor for cardiovascular disease. In addition, back pain has been increasing steadily due to sitting life, lack of exercise, wrong posture, and obesity. Recent studies found that obesity and back pain are common diseases and are closely related to each other. People with back pain have lower physical activity, which in turn leads to an weight gain and a deterioration in physical performance. Among the drugs used for obesity, orlistat has been approved for long-term use, and phentermine, the most commonly used drug, has been approved for short-term use. However, phentermine can increase blood pressure and pulse rate. Meanwhile, several studies have shown that orlistat, a pancreatic lipase inhibitor, lowers blood pressure and pulse rate and diminish LDL-cholesterol. Lowering LDL-C could lead to improved vascular endothelial function. The investigators aimed to investigate the effect of orlistat and phentermine combination therapy on weight loss and improvement of vascular function compared to phentermine monotherapy in obese patients (BMI 27 kg/m2) with metabolic risk and back pain.

Timeline

Start
2018-10-16
Primary completion
2019-07-12
Completion
2019-08-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Orlistat Small molecule 120 mg
Background Phentermine Small molecule 37.5 mg

Indications