Trial Outcomes & Findings for ELIRA 2: Safety and Effectiveness of TENS Assisted Weight Loss and Appetite Suppression (NCT NCT03936699)

Last Updated: 2022-02-02

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

161 participants

Primary outcome timeframe

12 weeks

Results posted on

2022-02-02

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment 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. 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. Diet \& Exercise: Subjects to be instructed on a healthy 1200 calorie diet.	Control Open label diet and exercise counseling only. Subjects will be instructed to follow a healthy 1200 calorie diet and record any changes in appetite. Diet \& Exercise: Subjects to be instructed on a healthy 1200 calorie diet.
Overall Study STARTED	83	78
Overall Study COMPLETED	61	55
Overall Study NOT COMPLETED	22	23

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=83 Participants 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. 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. Diet \& Exercise: Subjects to be instructed on a healthy 1200 calorie diet.	Control n=78 Participants Open label diet and exercise counseling only. Subjects will be instructed to follow a healthy 1200 calorie diet and record any changes in appetite. Diet \& Exercise: Subjects to be instructed on a healthy 1200 calorie diet.	Total n=161 Participants Total of all reporting groups
Age, Continuous	48 years n=99 Participants	48 years n=107 Participants	48 years n=206 Participants
Sex: Female, Male Female	77 Participants n=99 Participants	73 Participants n=107 Participants	150 Participants n=206 Participants
Sex: Female, Male Male	6 Participants n=99 Participants	5 Participants n=107 Participants	11 Participants n=206 Participants
Race/Ethnicity, Customized White, non-Hispanic	69 Participants n=99 Participants	66 Participants n=107 Participants	135 Participants n=206 Participants
Race/Ethnicity, Customized Black	9 Participants n=99 Participants	9 Participants n=107 Participants	18 Participants n=206 Participants
Race/Ethnicity, Customized Asian	2 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants
Race/Ethnicity, Customized Other	3 Participants n=99 Participants	2 Participants n=107 Participants	5 Participants n=206 Participants
Region of Enrollment United States	83 participants n=99 Participants	78 participants n=107 Participants	161 participants n=206 Participants
BMI	31.6 kg/m^2 n=99 Participants	31.5 kg/m^2 n=107 Participants	31.6 kg/m^2 n=206 Participants

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	Treatment n=61 Participants 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. 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. Diet \& Exercise: Subjects to be instructed on a healthy 1200 calorie diet.	Control n=55 Participants Open label diet and exercise counseling only. Subjects will be instructed to follow a healthy 1200 calorie diet and record any changes in appetite. Diet \& Exercise: Subjects to be instructed on a healthy 1200 calorie diet.
Number of Participants With Treatment Emergent Adverse Events	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Treatment n=71 Participants 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. 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. Diet \& Exercise: Subjects to be instructed on a healthy 1200 calorie diet.	Control n=65 Participants Open label diet and exercise counseling only. Subjects will be instructed to follow a healthy 1200 calorie diet and record any changes in appetite. Diet \& Exercise: Subjects to be instructed on a healthy 1200 calorie diet.
Change in Appetite as Measured by a Visual Analogue Scale From Baseline VAS Satisfaction	-4.1 percentage of change Interval -16.4 to 8.1	16.6 percentage of change Interval 3.8 to 29.3
Change in Appetite as Measured by a Visual Analogue Scale From Baseline VAS Fullness	36.6 percentage of change Interval 24.0 to 49.3	10.9 percentage of change Interval -2.3 to 24.2
Change in Appetite as Measured by a Visual Analogue Scale From Baseline VAS Hunger	28.2 percentage of change Interval 18.0 to 38.4	8.2 percentage of change Interval -2.5 to 18.8
Change in Appetite as Measured by a Visual Analogue Scale From Baseline VAS Amount Able to Eat	-15 percentage of change Interval -22.7 to -7.3	7.7 percentage of change Interval -0.4 to 15.8

SECONDARY outcome

Timeframe: 3 months

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.

Outcome measures

Outcome measures
Measure	Treatment n=63 Participants 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. 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. Diet \& Exercise: Subjects to be instructed on a healthy 1200 calorie diet.	Control n=59 Participants Open label diet and exercise counseling only. Subjects will be instructed to follow a healthy 1200 calorie diet and record any changes in appetite. Diet \& Exercise: Subjects to be instructed on a healthy 1200 calorie diet.
Change in Percent Total Body Weight Loss	-2.56 percent total body weight loss Interval -11.88 to 6.4	-1.09 percent total body weight loss Interval -12.59 to 4.77

SECONDARY outcome

Timeframe: 3 months

Changes in BMI \[ Time Frame: 3 months \]

Outcome measures

Outcome measures
Measure	Treatment n=63 Participants 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. 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. Diet \& Exercise: Subjects to be instructed on a healthy 1200 calorie diet.	Control n=59 Participants Open label diet and exercise counseling only. Subjects will be instructed to follow a healthy 1200 calorie diet and record any changes in appetite. Diet \& Exercise: Subjects to be instructed on a healthy 1200 calorie diet.
Changes in BMI	0.79 kg/m^2 Interval -3.21 to 5.76	0.14 kg/m^2 Interval -3.55 to 4.29

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 55 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Stephanie Amlung, PhD, RN, Vice President, Clinical Affairs

Elira Therapeutics, Inc.

Phone: 513.236.6799

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Treatment n=83 participants at risk 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. 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. Diet \& Exercise: Subjects to be instructed on a healthy 1200 calorie diet.	Control n=78 participants at risk Open label diet and exercise counseling only. Subjects will be instructed to follow a healthy 1200 calorie diet and record any changes in appetite. Diet \& Exercise: Subjects to be instructed on a healthy 1200 calorie diet.
Skin and subcutaneous tissue disorders Rash, Hives	18.1% 15/83 • Number of events 15 • Adverse Events [Time Frame: 12 weeks]	2.6% 2/78 • Number of events 2 • Adverse Events [Time Frame: 12 weeks]
Cardiac disorders Atypical chest pain	0.00% 0/83 • Adverse Events [Time Frame: 12 weeks]	1.3% 1/78 • Number of events 1 • Adverse Events [Time Frame: 12 weeks]
Gastrointestinal disorders Heartburn	2.4% 2/83 • Number of events 2 • Adverse Events [Time Frame: 12 weeks]	0.00% 0/78 • Adverse Events [Time Frame: 12 weeks]
Gastrointestinal disorders Abdominal cramping / stomach pain	4.8% 4/83 • Number of events 4 • Adverse Events [Time Frame: 12 weeks]	0.00% 0/78 • Adverse Events [Time Frame: 12 weeks]
Musculoskeletal and connective tissue disorders Back spasms / pain / cramping	3.6% 3/83 • Number of events 3 • Adverse Events [Time Frame: 12 weeks]	0.00% 0/78 • Adverse Events [Time Frame: 12 weeks]
Skin and subcutaneous tissue disorders Bruise on abdomen	1.2% 1/83 • Number of events 1 • Adverse Events [Time Frame: 12 weeks]	0.00% 0/78 • Adverse Events [Time Frame: 12 weeks]
Respiratory, thoracic and mediastinal disorders Bronchitis	1.2% 1/83 • Number of events 1 • Adverse Events [Time Frame: 12 weeks]	1.3% 1/78 • Number of events 1 • Adverse Events [Time Frame: 12 weeks]
Musculoskeletal and connective tissue disorders Carpal tunnel repair	0.00% 0/83 • Adverse Events [Time Frame: 12 weeks]	1.3% 1/78 • Number of events 1 • Adverse Events [Time Frame: 12 weeks]
Infections and infestations Flu	1.2% 1/83 • Number of events 1 • Adverse Events [Time Frame: 12 weeks]	1.3% 1/78 • Number of events 1 • Adverse Events [Time Frame: 12 weeks]
Gastrointestinal disorders Gastroenteritis	2.4% 2/83 • Number of events 2 • Adverse Events [Time Frame: 12 weeks]	1.3% 1/78 • Number of events 1 • Adverse Events [Time Frame: 12 weeks]
Metabolism and nutrition disorders Hypothyroidism	0.00% 0/83 • Adverse Events [Time Frame: 12 weeks]	1.3% 1/78 • Number of events 1 • Adverse Events [Time Frame: 12 weeks]
Musculoskeletal and connective tissue disorders Left foot injury	0.00% 0/83 • Adverse Events [Time Frame: 12 weeks]	1.3% 1/78 • Number of events 1 • Adverse Events [Time Frame: 12 weeks]
Musculoskeletal and connective tissue disorders Plantar fascitis	0.00% 0/83 • Adverse Events [Time Frame: 12 weeks]	1.3% 1/78 • Number of events 1 • Adverse Events [Time Frame: 12 weeks]
Musculoskeletal and connective tissue disorders Posterior tibial tendon insufficiency	0.00% 0/83 • Adverse Events [Time Frame: 12 weeks]	1.3% 1/78 • Number of events 1 • Adverse Events [Time Frame: 12 weeks]
Infections and infestations Stomach flu	0.00% 0/83 • Adverse Events [Time Frame: 12 weeks]	1.3% 1/78 • Number of events 1 • Adverse Events [Time Frame: 12 weeks]
General disorders Tooth pain	0.00% 0/83 • Adverse Events [Time Frame: 12 weeks]	1.3% 1/78 • Number of events 1 • Adverse Events [Time Frame: 12 weeks]
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	10.8% 9/83 • Number of events 9 • Adverse Events [Time Frame: 12 weeks]	7.7% 6/78 • Number of events 6 • Adverse Events [Time Frame: 12 weeks]
Renal and urinary disorders Urinary tract infection	1.2% 1/83 • Number of events 1 • Adverse Events [Time Frame: 12 weeks]	2.6% 2/78 • Number of events 2 • Adverse Events [Time Frame: 12 weeks]
Musculoskeletal and connective tissue disorders Broken ankle / fracture	1.2% 1/83 • Number of events 1 • Adverse Events [Time Frame: 12 weeks]	1.3% 1/78 • Number of events 1 • Adverse Events [Time Frame: 12 weeks]
Nervous system disorders Migraine	0.00% 0/83 • Adverse Events [Time Frame: 12 weeks]	1.3% 1/78 • Number of events 1 • Adverse Events [Time Frame: 12 weeks]
Musculoskeletal and connective tissue disorders Bunion surgery	1.2% 1/83 • Number of events 1 • Adverse Events [Time Frame: 12 weeks]	0.00% 0/78 • Adverse Events [Time Frame: 12 weeks]
Musculoskeletal and connective tissue disorders Gout	1.2% 1/83 • Number of events 1 • Adverse Events [Time Frame: 12 weeks]	0.00% 0/78 • Adverse Events [Time Frame: 12 weeks]
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	1.2% 1/83 • Number of events 1 • Adverse Events [Time Frame: 12 weeks]	0.00% 0/78 • Adverse Events [Time Frame: 12 weeks]
Gastrointestinal disorders Loose stools	1.2% 1/83 • Number of events 1 • Adverse Events [Time Frame: 12 weeks]	0.00% 0/78 • Adverse Events [Time Frame: 12 weeks]
Musculoskeletal and connective tissue disorders Hip pain	2.4% 2/83 • Number of events 2 • Adverse Events [Time Frame: 12 weeks]	0.00% 0/78 • Adverse Events [Time Frame: 12 weeks]
Musculoskeletal and connective tissue disorders Sciatica	2.4% 2/83 • Number of events 2 • Adverse Events [Time Frame: 12 weeks]	0.00% 0/78 • Adverse Events [Time Frame: 12 weeks]
Infections and infestations Shingles	3.6% 3/83 • Number of events 3 • Adverse Events [Time Frame: 12 weeks]	0.00% 0/78 • Adverse Events [Time Frame: 12 weeks]
Musculoskeletal and connective tissue disorders Slipped disc / back injury	2.4% 2/83 • Number of events 2 • Adverse Events [Time Frame: 12 weeks]	0.00% 0/78 • Adverse Events [Time Frame: 12 weeks]
Infections and infestations Toe fungus	1.2% 1/83 • Number of events 1 • Adverse Events [Time Frame: 12 weeks]	0.00% 0/78 • Adverse Events [Time Frame: 12 weeks]
Musculoskeletal and connective tissue disorders Shoulder pain	1.2% 1/83 • Number of events 1 • Adverse Events [Time Frame: 12 weeks]	0.00% 0/78 • Adverse Events [Time Frame: 12 weeks]
Gastrointestinal disorders Cholelithitis	1.2% 1/83 • Number of events 1 • Adverse Events [Time Frame: 12 weeks]	0.00% 0/78 • Adverse Events [Time Frame: 12 weeks]