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

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.

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.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is between 18 - 65 years of age inclusive.
2. Subject has a BMI of 25-35 kg/ m2 inclusive.
3. Subject has signed the informed consent form and is able to comply with study protocol and adhere to study visit schedule.
4. Subject is able to wear and use a wearable, patch TENS system.
5. Subject is able to use a touch screen hand held smart phone.
6. Subject is fluent in English and can complete questionnaires.
7. Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at screening or enrollment visit, prior to placement of ELIRA device.
8. Subject is male or non-pregnant, non-lactating female, who agrees to use effective contraceptive methods throughout the length of the trial based on PI approval.

Exclusion Criteria:

1. Subject has any known gastrointestinal disorder that in the opinion of the PI precludes enrollment into the trial.
2. Subject has had a prior bariatric procedure or any previous procedure on the stomach.
3. Subject has any significant multisystem disease in the opinion of the PI.
4. Subject has \> 6.5 HbA1c.
5. Subject has significant cardiac arrhythmia, ectopy, or significant cardiovascular disease.
6. Subject has an existing implanted electrical stimulator (e.g., pacemaker, AICD).
7. Subject is a female of child-bearing potential who is pregnant or intends to become pregnant during the trial period.
8. Subject has current and/or a history of cancer within the past 5 years (not including basal cell carcinoma or cervical carcinoma in situ).
9. Subject has had a weight change of + 5% of his/her Total Body Weight in the 3 months prior to screening.
10. Subject has a moderate / severe psychiatric disorder.
11. Subject has a diagnosed neurological disease.
12. Subject has a diagnosed eating disorder.
13. Subject has a skin disorder affecting the thoracic dermatomes.
14. Subject has active or /has ever had shingles in the abdominal area.
15. Subject has abdominal surgery or other scars which may interfere with TENS stimulation in the opinion of the PI.
16. Subject is currently enrolled in other potentially confounding research.
17. Subject has known allergic reaction to materials in the TENS electrodes and/or is otherwise unable to tolerate stimulation with the wearable TENS system. This includes known allergies to latex, nickel and/or hydrogels.
18. Subject has a history of sensitive skin, including eczema wheel-and-flare or other skin irritation, per PI discretion.
19. Subject is actively participating or unwilling to discontinue participation in another weight loss program. Subjects may not enroll in paid or unpaid programs that involve in-person or online apps or coaching, beginning new fitness regimens or utilizing meal planning or paid nutritional coaching during the course of the ELIRA study
20. Subject is taking weight loss control medications including but not limited to Over The Counter (OTC) medications, Metformin, and Belviq. (See Appendix 8)
21. Subject is planning any major medical treatments or surgeries that could cause weight loss.
22. Subject is unable to take anti-nausea medications planned for the study.
23. Inability to walk at least 0.8 kilometers per day (10 minutes of continuous walking).
24. Current smoker or user of nicotine product or smoking cessation within 1 year of the screening date.
25. History of treatment for or current abuse of drug or alcohol.
26. A score of ≥10 on the Patient Health Questionnaire 9 (PHQ-9), demonstrating moderate depression.
27. Any subject that the investigator considers inappropriate for the study for medical reasons.
28. Subject has a history of moderate/severe migraines or other severe headache disorders requiring the treatment of Topiramate.
29. Subject is on drug therapy which may alter antral motility or appetite, per PI discretion.