NCT03675191

Orlistat/Phentermine Versus Placebo/Phentermine

Completed NA Last updated 4 November 2019

What this trial tests

NA trial testing Orlistat 120Mg Cap in Obesity in 114 participants. Completed in 12 August 2019.

Timeline

16 October 2018

Primary endpoint
12 July 2019

12 August 2019

Quick facts

Lead sponsor	Gangnam Severance Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	114
Start date	16 October 2018
Primary completion	12 July 2019
Estimated completion	12 August 2019
Sites	1 location across South Korea

Drugs / interventions tested

• Orlistat 120Mg Cap — full drug profile →
• Phentermine Pill — full drug profile →

Conditions studied

• Obesity — all drugs for Obesity →
• Overweight — all drugs for Overweight →

Sponsor

Gangnam Severance Hospital

Who can join

20 and older, any sex, with Obesity or Overweight. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Effect of Orlistat on Sterol Metabolism in Obese Patients.
   Kwon YJ, Kwon GE, Lee HS, Choi MH, et al · · 2022 · cited 19× · PMID 35282441 · DOI 10.3389/fendo.2022.824269
2. Effects of Orlistat/Phentermine versus Phentermine on Vascular Endothelial Cell Function in Obese and Overweight Adults: A Randomized, Double-Blinded, Placebo-Controlled Trial.
   Kwon YJ, Lee H, Nam CM, Chang HJ, et al · · 2021 · cited 3× · PMID 33688228 · DOI 10.2147/dmso.s300342