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EndoBarrier adolescent study

Enrolment complete in EndoBarrier morbidly obese adolescents study

First study of EndoBarrier in adolescents shows acceptable safety profile and improvement in metabolic parameters

GI Dynamics has announced it has completed enrolment in the first clinical trial evaluating EndoBarrier in adolescents.  The study was conducted at the University Children’s Hospital (UCH) in Ljubljana, Slovenia. This investigator-initiated prospective single-arm study was led by Dr Tadej Battelino, Professor of Pediatrics at UCH, and was designed to determine the efficacy and safety of the EndoBarrier treatment for up to one year in morbidly obese adolescents.

“The preliminary data show that treatment with EndoBarrier has the potential to treat prediabetic, severely obese adolescents, especially those with metabolic complications,” said Battelino. “In this study, relevant weight loss was achieved in most of the subjects, with clinically relevant improvements in metabolic stabilization in prediabetic patients. Our cohort also saw an acceptable safety profile with no serious adverse events.”

Preliminary data show that patients who received the treatment saw an average of 10 percent decrease in BMI (Table 1), metabolic improvements and no serious adverse effects.

Table 1: Preliminary relevant metrics

In addition, EndoBarrier demonstrated therapeutic benefit in treating prediabetes, as blood sugar levels (HbA1c) were reduced by 6 percent and BMI was reduced by an average of 10 percent in study subjects. Most notable was the 49% improvement in HOMA-IR (Homeostatic Model Assessment), a critical measure of insulin resistance and beta-cell function. In addition, the study noted clinically significant reductions in triglycerides (43 percent) and systolic blood pressure (6 percent).

The EndoBarrier also demonstrated an acceptable safety profile, with all study subjects completing treatment to the intended twelve-month implant duration. No devices were removed due to adverse events; there were no serious device-related adverse effects. Some patients reported abdominal discomfort, mild pain, nausea and gastrointestinal issues.

“Obesity in adolescents has risen to epidemic levels globally with serious individual and public health consequences, and long-term implications that we only have just begun to understand,” said Scott Schorer, GI Dynamics president and CEO. “This study, in conjunction with many additional investigator-initiated studies around the world, is completing a picture of clinical evidence that further reinforces the broader safety and efficacy profile of EndoBarrier.”

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