Clinical Trials Logo
NCT number NCT03299881
Study type Interventional
Source Elira Therapeutics, Inc.
Contact Brad Stengel
Phone 314-991-7979
Email bstengel@eliratherapeutics.com
Status Recruiting
Phase N/A
Start date September 5, 2017
Completion date April 2018

Clinical Trial Summary

This study is a randomized, adaptive, parallel arm study. The treatment group will receive the Elira wearable patch system and provided instructions for use and advised to follow a 1200 calorie diet. The control group will be asked to follow a 12 calorie diet only. Each group will be followed for 12 weeks. Total body weight loss will be measured as well as appetite changes. Safety data will be collected throughout the study period. Safety and effectiveness will be determined based on differences between the groups.


Clinical Trial Description

This study employs a randomized, adaptive, parallel arm study in which, cohorts of enrolled subjects (25 per arm) are assessed for dose response and progression to achievement of primary and secondary endpoints. Enrollment will be up to 300 subjects at 4 US centers.

After signing informed consent, subjects will be screened during a one week screening/baseline period to determine if they meet the inclusion criteria and exhibit none of the exclusion criteria. Weight, blood pressure, blood lipids, HgA1c, pregnancy test (for women of childbearing age), and patient questionnaires will be collected. If eligible, subjects will be randomized to treatment or control groups. The treatment group will receive training on the Elira Wearable Patch System and the first TENS session will be administered in the investigators office. Both groups will receive an electronic scale and instructions on 1200 calorie diet as well as diary completion requirements to be completed throughout the study. All subjects will be required to have in office follow-up visits every 4 weeks for 12 weeks. Up to 2 additional follow-up visits will be permitted within that 12 week time period.


Study Design


Related Conditions & MeSH terms


See also
  Status Clinical Trial Phase
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Recruiting NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Active, not recruiting NCT03317587 - Inspiring Nutritious Selections and Positive Intentions Regarding Eating and Exercise (INSPIRE) N/A
Enrolling by invitation NCT03063606 - Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Specialist Treatment Phase 2/Phase 3
Completed NCT02235961 - Investigate Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-0530 Alone and in Combination With Liraglutide in Overweight to Obese But Otherwise Healthy Male Subjects Phase 1
Completed NCT03195712 - Metabolically Healthy Obesity: Correlations Between BMI and Metabolic Syndrome Biomarkers N/A
Recruiting NCT00341406 - Fat Cell Size in Insulin Resistance N/A
Recruiting NCT03241121 - Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome N/A
Recruiting NCT02918279 - Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity Phase 3
Completed NCT00494767 - Investigation Of Weight Loss And Body Composition Changes After Dosing With Either Placebo Or One Of Two Active Drugs Phase 1
Recruiting NCT03338296 - Study to Evaluate the Efficacy and Safety of Belviq XR® in Conjunction With Lifestyle Modification for Weight Loss in Obese Adolescents, Age 12 to 17 Years Phase 4
Recruiting NCT03345368 - Effect of rTMS in Combination With a Low-carb Diet in Patients With Obesity N/A
Recruiting NCT03277040 - Diet, Eating, and Lifestyle Improvement for Valued Employees and Their Relatives N/A
Completed NCT01222793 - Effects of Antipsychotics on Eating and Food Craving in People With Schizophrenia N/A
Recruiting NCT03334266 - Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months N/A
Recruiting NCT03119610 - The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity Phase 1/Phase 2
Completed NCT00976105 - Effects of Repeat Dosing of GSK1521498 Phase 1
Recruiting NCT03141346 - Improving the Eating Habits of Mother and Her Infant Via Sugar Reduction N/A
Completed NCT00535600 - Effects of Bariatric Surgery on Insulin N/A
Not yet recruiting NCT03104205 - MOWI Home-Based Pilot N/A