Weight LossELIRA_2NCT03936699
ELIRA 2: Safety and Effectiveness of TENS Assisted Weight Loss and Appetite Suppression
A study testing Transcutaneous Nerve Stimulator (TENS) and Diet & Exercise in people with Weight Loss, run by Elira Therapeutics, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Weight Loss
- What is being tested?
- Transcutaneous Nerve Stimulator (TENS) and Diet & Exercise
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2018to 30 May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is between 18 - 65 years of age inclusive.
- Subject has a BMI of 25-35 kg/ m2 inclusive.
- Subject has signed the informed consent form and is able to comply with study protocol and adhere to study visit schedule.
- Subject is able to wear and use a wearable, patch TENS system.
- Subject is able to use a touch screen hand held smart phone.
- Subject is fluent in English and can complete questionnaires.
- Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at screening or enrollment visit, prior to placement of ELIRA device.
- 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.
Who cannot join
- Subject has any known gastrointestinal disorder that in the opinion of the PI precludes enrollment into the trial.
- Subject has had a prior bariatric procedure or any previous procedure on the stomach.
- Subject has any significant multisystem disease in the opinion of the PI.
- Subject has > 6.5 HbA1c.
- Subject has significant cardiac arrhythmia, ectopy, or significant cardiovascular disease.
- Subject has an existing implanted electrical stimulator (e.g., pacemaker, AICD).
Show all 29Show fewer
- Subject is a female of child-bearing potential who is pregnant or intends to become pregnant during the trial period.
- Subject has current and/or a history of cancer within the past 5 years (not including basal cell carcinoma or cervical carcinoma in situ).
- Subject has had a weight change of + 5% of his/her Total Body Weight in the 3 months prior to screening.
- Subject has a moderate / severe psychiatric disorder.
- Subject has a diagnosed neurological disease.
- Subject has a diagnosed eating disorder.
- Subject has a skin disorder affecting the thoracic dermatomes.
- Subject has active or /has ever had shingles in the abdominal area.
- Subject has abdominal surgery or other scars which may interfere with TENS stimulation in the opinion of the PI.
- Subject is currently enrolled in other potentially confounding research.
- 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.
- Subject has a history of sensitive skin, including eczema wheel-and-flare or other skin irritation, per PI discretion.
- 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
- Subject is taking weight loss control medications including but not limited to Over The Counter (OTC) medications, Metformin, and Belviq. (See Appendix 8)
- Subject is planning any major medical treatments or surgeries that could cause weight loss.
- Subject is unable to take anti-nausea medications planned for the study.
- Inability to walk at least 0.8 kilometers per day (10 minutes of continuous walking).
- Current smoker or user of nicotine product or smoking cessation within 1 year of the screening date.
- History of treatment for or current abuse of drug or alcohol.
- A score of ≥10 on the Patient Health Questionnaire 9 (PHQ-9), demonstrating moderate depression.
- Any subject that the investigator considers inappropriate for the study for medical reasons.
- Subject has a history of moderate/severe migraines or other severe headache disorders requiring the treatment of Topiramate.
- Subject is on drug therapy which may alter antral motility or appetite, per PI discretion.
Trial locations and contacts
1 site in 1 country.
United States1 site
West County OB/GYN Specialists
St Louis, Missouri, 63141
About this study
Official title: Safety and Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS)-Assisted Weight Loss and/or 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.
Read the detailed 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.
- Conditions
- Weight Loss
- Being tested
- Transcutaneous Nerve Stimulator (TENS), Diet & Exercise
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Nerve Stimulator (TENS)Device
The Elira wearable patch system is a Radio Frequency (RF) coupled, wearable transcutaneous electrical nerve stimulator (TENS) device controlled via Bluetooth by a smart phone unit running a custom application which directs therapy from the patch within safe limits set by a clinician and also includes a weight loss diary.
Behavioral: Diet \& Exercise Subjects to be instructed on a healthy 1200 calorie diet.
Diet & ExerciseBehavioural
Subjects to be instructed on a healthy 1200 calorie diet.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | The Transcutaneous Nerve Stimulator (TENS) Elira wearable patch system will be applied to varying locations on the T6/T7 dermatome for 30 minutes three times a day after meals. Subjects will be instructed to follow a 1200 calorie healthy diet and record any changes in appetite. Receives: Device: Transcutaneous Nerve Stimulator (TENS); Behavioral: Diet & Exercise |
| Control | Active comparator | Open label diet and exercise counseling only. Subjects will be instructed to follow a healthy 1200 calorie diet and record any changes in appetite. Receives: Behavioral: Diet & Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events
Treatment Emergent Adverse Events [Time Frame: 12 weeks] Safety/Tolerability will be assessed by the non-inferiority of incidence of serious adverse events (SAEs), unanticipated serious adverse events (USAEs), device-related SAEs (DSAEs), and unanticipated device-related SAEs (UDAEs) that are associated with the TENS therapy throughout the stimulation and the follow-up period versus historical control (compared with other TENS systems).
Measured: 12 weeks
Change in Appetite as Measured by a Visual Analogue Scale From Baseline
Appetite Changes [Time Frame: 12 weeks] Percent change in appetite scores at the end of the trial compared to Baseline between Treatment and Control.
Subjects are asked to score level of satisfaction, fullness, hunger and ability to eat on a Visual Analogue Scale of 1 to 100 before and after meals with lower scores indicating lower satisfaction, fullness, hunger or ability to eat, respectively. Scores are captured in a diary once a week with 8 time points. The weeks are captured as week 0 through week 12. The time points at each week include:
- 30 minutes before breakfast
- 30, 60, and 90 minutes after breakfast
- Pre-lunch
- Midafternoon
- 30 minutes before dinner
- Bedtime For each of the four appetite suppression variables (satisfaction, fullness, hunger and ability to eat), the 8 time points at week zero will be averaged for the baseline score (baseline), and the 8 time points at week 12 will be averaged for the 3-month score (3month).
Measured: 3 months
Secondary outcomes (2)
Change in Percent Total Body Weight Loss
Percent reduction in total body weight loss (%TBWL), measured as End Weight - Initial Weight, multiplied by 100, at the end of Experimental period compared to Baseline between Treatment and Control.
Measured: 3 months
Changes in BMI
Changes in BMI [ Time Frame: 3 months ]
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start22 Jun 2018
- Primary completion30 May 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Weight LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, adaptive parallel arm study.
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elira Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936699
- Sponsor's protocol ID
- CD-005
- Acronym
- ELIRA_2
- Status last verified
- Dec 2021
- First submitted
- 29 Jun 2018
- Last updated
- 2 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS)-Assisted Weight Loss and/or Appetite Suppression
- ClinicalTrials.gov ID
- NCT03936699
- Acronym / sponsor ID
- ELIRA_2 / CD-005
- Conditions
- Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Elira Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Jun 2018 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 3 May 2019 (actual)
- Results
- Posted 2 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, adaptive parallel arm study.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Transcutaneous Nerve Stimulator (TENS), Behavioral: Diet & ExerciseThe Transcutaneous Nerve Stimulator (TENS) Elira wearable patch system will be applied to varying locations on the T6/T7 dermatome for 30 minutes three times a day after meals. Subjects will be instructed to follow a 1200 calorie healthy diet and record any changes in appetite. |
| Control | Active comparator | Behavioral: Diet & ExerciseOpen label diet and exercise counseling only. Subjects will be instructed to follow a healthy 1200 calorie diet and record any changes in appetite. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is between 18 - 65 years of age inclusive.
- Subject has a BMI of 25-35 kg/ m2 inclusive.
- Subject has signed the informed consent form and is able to comply with study protocol and adhere to study visit schedule.
- Subject is able to wear and use a wearable, patch TENS system.
- Subject is able to use a touch screen hand held smart phone.
Key exclusion criteria (29 listed)
- Subject has any known gastrointestinal disorder that in the opinion of the PI precludes enrollment into the trial.
- Subject has had a prior bariatric procedure or any previous procedure on the stomach.
- Subject has any significant multisystem disease in the opinion of the PI.
- Subject has > 6.5 HbA1c.
- Subject has significant cardiac arrhythmia, ectopy, or significant cardiovascular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Nerve Stimulator (TENS)The Elira wearable patch system is a Radio Frequency (RF) coupled, wearable transcutaneous electrical nerve stimulator (TENS) device controlled via Bluetooth by a smart phone unit running a custom application which directs therapy from the patch within safe limits set by a clinician and also includes a weight loss diary. Behavioral: Diet \& Exercise Subjects to be instructed on a healthy 1200 calorie diet. | Device | Treatment |
| Diet & ExerciseSubjects to be instructed on a healthy 1200 calorie diet. | Behavioural | Control, Treatment |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events
Time frame: 12 weeks
Treatment Emergent Adverse Events [Time Frame: 12 weeks] Safety/Tolerability will be assessed by the non-inferiority of incidence of serious adverse events (SAEs), unanticipated serious adverse events (USAEs), device-related SAEs (DSAEs), and unanticipated device-related SAEs (UDAEs) that are associated with the TENS therapy throughout the stimulation and the follow-up period versus historical control (compared with other TENS systems).
Change in Appetite as Measured by a Visual Analogue Scale From Baseline
Time frame: 3 months
Appetite Changes [Time Frame: 12 weeks] Percent change in appetite scores at the end of the trial compared to Baseline between Treatment and Control. Subjects are asked to score level of satisfaction, fullness, hunger and ability to eat on a Visual Analogue Scale of 1 to 100 before and after meals with lower scores indicating lower satisfaction, fullness, hunger or ability to eat, respectively. Scores are captured in a diary once a week with 8 time points. The weeks are captured as week 0 through week 12. The time points at each week include: * 30 minutes before breakfast * 30, 60, and 90 minutes after breakfast * Pre-lunch * Midafternoon * 30 minutes before dinner * Bedtime For each of the four appetite suppression variables (satisfaction, fullness, hunger and ability to eat), the 8 time points at week zero will be averaged for the baseline score (baseline), and the 8 time points at week 12 will be averaged for the 3-month score (3month).
2 secondary outcomes
Change in Percent Total Body Weight Loss
Time frame: 3 months
Changes in BMI
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Weight Loss
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
RecruitingPhase 1/2
Phase 1/2 Study of DS010 in Advanced Cancer Patients With Cachexia
Cancer, Cachexia
Active, not recruitingPhase 3
AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
Diabetes Mellitus, Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Nerve Stimulator (TENS) and Diet & Exercise in people with Weight Loss, run by Elira Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Adverse Events (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022.