NCT03936699: ELIRA_2

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

Completed NA Results posted Last updated 2 February 2022

What this trial tests

NA trial testing Transcutaneous Nerve Stimulator (TENS) in Weight Loss in 161 participants. Completed in 30 May 2019.

Timeline

22 June 2018

Primary endpoint
30 May 2019

30 May 2019

Quick facts

Lead sponsor	Elira Therapeutics, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	161
Start date	22 June 2018
Primary completion	30 May 2019
Estimated completion	30 May 2019
Sites	1 location across United States

Drugs / interventions tested

• Transcutaneous Nerve Stimulator (TENS)
• Diet & Exercise

Conditions studied

• Weight Loss — all drugs for Weight Loss →

Sponsor

Elira Therapeutics, Inc.

Who can join

Adults 18 to 65, any sex, with Weight Loss. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Treatment Emergent Adverse Events Primary · 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).

Group	Value	95% CI
Treatment	0
Control	0

Change in Appetite as Measured by a Visual Analogue Scale From Baseline Primary · 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

VAS Satisfaction

Group	Value	95% CI
Treatment	-4.1	-16.4 – 8.1
Control	16.6	3.8 – 29.3

VAS Fullness

Group	Value	95% CI
Treatment	36.6	24 – 49.3
Control	10.9	-2.3 – 24.2

VAS Hunger

Group	Value	95% CI
Treatment	28.2	18 – 38.4
Control	8.2	-2.5 – 18.8

VAS Amount Able to Eat

Group	Value	95% CI
Treatment	-15	-22.7 – -7.3
Control	7.7	-0.4 – 15.8

Change in Percent Total Body Weight Loss Secondary · 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.

Group	Value	95% CI
Treatment	-2.56	-11.88 – 6.4
Control	-1.09	-12.59 – 4.77

Changes in BMI Secondary · 3 months

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

Group	Value	95% CI
Treatment	0.79	-3.21 – 5.76
Control	0.14	-3.55 – 4.29

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Events [Time Frame: 12 weeks]. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment

Serious: 0/83 (0%)

Deaths: 0/83

Control

Serious: 0/78 (0%)

Deaths: 0/78

Other adverse events (31 terms — click to expand)

Reaction	System	Treatment	Control
Rash, Hives	Skin and subcutaneous tissue disorders	—	—
Upper respiratory infection	Respiratory, thoracic and mediastinal disorders	—	—
Abdominal cramping / stomach pain	Gastrointestinal disorders	—	—
Back spasms / pain / cramping	Musculoskeletal and connective tissue disorders	—	—
Shingles	Infections and infestations	—	—
Heartburn	Gastrointestinal disorders	—	—
Gastroenteritis	Gastrointestinal disorders	—	—
Urinary tract infection	Renal and urinary disorders	—	—
Hip pain	Musculoskeletal and connective tissue disorders	—	—
Sciatica	Musculoskeletal and connective tissue disorders	—	—
Slipped disc / back injury	Musculoskeletal and connective tissue disorders	—	—
Atypical chest pain	Cardiac disorders	—	—
Bruise on abdomen	Skin and subcutaneous tissue disorders	—	—
Bronchitis	Respiratory, thoracic and mediastinal disorders	—	—
Carpal tunnel repair	Musculoskeletal and connective tissue disorders	—	—
Flu	Infections and infestations	—	—
Hypothyroidism	Metabolism and nutrition disorders	—	—
Left foot injury	Musculoskeletal and connective tissue disorders	—	—
Plantar fascitis	Musculoskeletal and connective tissue disorders	—	—
Posterior tibial tendon insufficiency	Musculoskeletal and connective tissue disorders	—	—
Stomach flu	Infections and infestations	—	—
Tooth pain	General disorders	—	—
Broken ankle / fracture	Musculoskeletal and connective tissue disorders	—	—
Migraine	Nervous system disorders	—	—
Bunion surgery	Musculoskeletal and connective tissue disorders	—	—
Gout	Musculoskeletal and connective tissue disorders	—	—
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Loose stools	Gastrointestinal disorders	—	—
Toe fungus	Infections and infestations	—	—
Shoulder pain	Musculoskeletal and connective tissue disorders	—	—
Cholelithitis	Gastrointestinal disorders	—	—

Data from ClinicalTrials.gov NCT03936699 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Characterization of medical device randomized controlled trials with adaptive designs.
   Su G, Shen D, Deng D, Bai Q, et al · · 2025 · cited 1× · PMID 39656083 · DOI 10.57264/cer-2024-0011