ELIRA 2: Safety and Effectiveness of TENS Assisted Weight Loss and Appetite Suppression — ELIRA_2  

Weight Loss Clinical Trial

Official title: Safety and Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS)-Assisted Weight Loss and/or Appetite Suppression

Status Completed

Clinical Trial Summary

The objectives of this study are to demonstrate safety and effectiveness of a wearable patch TENS system (Appendix 2) in driving weight loss and appetite suppression when coupled with an integrated weight loss reduction strategy. The study is designed to demonstrate that TENS stimulation sufficient to drive weight loss and appetite suppression is safe and tolerable when compared to standard of care, and that adverse events/adverse device effects are similar to other TENS device use cases.

Clinical Trial Description

Randomized, adaptive parallel arm study. Subjects will be initially screened during a screening period (+/- 7 days). During this screening period, subjects will sign an Informed Consent Form (ICF), have their weight/height and blood pressure measured as part of a physical exam, take a pregnancy test (females of child bearing potential), get blood drawn for analysis (blood lipids, HbA1c), and complete the PHQ-9 and pre-study survey. At the end of the screening period, eligible subjects will be enrolled/randomized in the study and be randomized to either a treatment or control group. After enrolling, both control and treatment subjects will be instructed to follow a healthy diet and reduce calories as desired for the duration of the study and will receive training on the use of the electronic scale and completion of paper diaries. For the treatment group, subjects will be instructed on use of the Elira wearable patch system. Photographs will be taken at the enrollment visit. Following this, subjects will enter the Therapy Period for ~24-weeks. At the 12 week visit, subjects will be assessed for weight loss, blood pressure, blood lipids, HbA1c, patient preference questionnaire and their participation will continue through months 4-6 for the Safety phase of the Therapy Period. The Therapy Period will be considered complete (pending laboratory results, adverse events or serious adverse events). Patient (treatment) photographs will also be taken at the 12 week visit. The study utilizes an adaptive approach where cohorts of enrolled/randomized subjects (in groups of ~25 per arm) are assessed for dose response and progression to achievement of primary and secondary endpoints. Frequent interim endpoint assessment utilizing Markov-chain Monte Carlo (MCMC) methods coupled with Longitudinal analyses will be utilized to determine sample sizes for future cohorts (assessed primarily via Normal dynamic linear modeling [NDLM]). Long term safety of the device will be shown through 6 months of usage. ;

Related Conditions & MeSH terms

• Body Weight
• Weight Loss

• NCT number: NCT03936699
• Study type: Interventional
• Source: Elira Therapeutics, Inc.
• Status: Completed
• Phase: N/A
• Start date: June 22, 2018
• Completion date: May 30, 2019