Trial Outcomes & Findings for The Lowering Weight in Severe Obesity by Embolization of the Gastric Artery Trial (NCT NCT03185949)

NCT ID: NCT03185949

Last Updated: 2022-09-28

Results Overview

1. Difference in percent total body weight (% TBWL) loss at 6 months between the Sham Control and Endobar Therapy groups. This is calculated as the difference in body weight from baseline to 6 months, relative to the baseline weight (i.e, initial weight - 6 month weight / initial weight) x 100%). The mean (i.e., average) total body weight loss of both groups was compared to assess whether there was a meaningful difference. 2. Percent total body weight loss (%TBWL) at 12 months in the group randomized to the initial Endobar Therapy alone. This is calculated as the difference in body weight from baseline to 12 months, relative to the baseline weight (i.e, initial weight - 12 month weight / initial weight) x 100%).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 44 participants
• Primary outcome timeframe: 1) 6 months post-procedure/sham and 2) 12 months post-procedure
• Results posted on: 2022-09-28

Participant Flow

Participant milestones

Measure	Sham Control Lidocaine injected at the femoral artery site. This patients will undergo behavioral therapy for 6 months and will crossover and will receive bariatric embolization. Endobar Infusion Catheter System: Bariatric embolization with microspheres using Endobar Infusion Catheter System Behavioral therapy: Healthy diet and exercise	Percutaneous Transcatheter Embolotherapy In patients randomized to intervention bariatric embolization will be performed using Endobar Infusion Catheter System. After procedure patients will undergo behavioral therapy Endobar Infusion Catheter System: Bariatric embolization with microspheres using Endobar Infusion Catheter System Behavioral therapy: Healthy diet and exercise
ITT Analysis STARTED	22	22
ITT Analysis COMPLETED	18	19
ITT Analysis NOT COMPLETED	4	3
PP Analysis STARTED	18	19
PP Analysis COMPLETED	16	15
PP Analysis NOT COMPLETED	2	4
Cross-over at 6 Months STARTED	16	0
Cross-over at 6 Months COMPLETED	15	0
Cross-over at 6 Months NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Sham Control Lidocaine injected at the femoral artery site. This patients will undergo behavioral therapy for 6 months and will crossover and will receive bariatric embolization. Endobar Infusion Catheter System: Bariatric embolization with microspheres using Endobar Infusion Catheter System Behavioral therapy: Healthy diet and exercise	Percutaneous Transcatheter Embolotherapy In patients randomized to intervention bariatric embolization will be performed using Endobar Infusion Catheter System. After procedure patients will undergo behavioral therapy Endobar Infusion Catheter System: Bariatric embolization with microspheres using Endobar Infusion Catheter System Behavioral therapy: Healthy diet and exercise
ITT Analysis Withdrawal by Subject	4	3
PP Analysis Protocol Violation	2	2
PP Analysis Failed/Incomplete LGA embolization	0	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Sham Control n=22 Participants Lidocaine injected at the femoral artery site. This patients will undergo behavioral therapy for 6 months and will crossover and will receive bariatric embolization. Endobar Infusion Catheter System: Bariatric embolization with microspheres using Endobar Infusion Catheter System Behavioral therapy: Healthy diet and exercise	Percutaneous Transcathether Embolotherapy n=22 Participants In patients randomized to intervention bariatric embolization will be performed using Endobar Infusion Catheter System. After procedure patients will undergo behavioral therapy Endobar Infusion Catheter System: Bariatric embolization with microspheres using Endobar Infusion Catheter System Behavioral therapy: Healthy diet and exercise	Total n=44 Participants Total of all reporting groups
Age, Continuous	44.7 years STANDARD_DEVIATION 9.4 • n=22 Participants	46.4 years STANDARD_DEVIATION 10.3 • n=22 Participants	45.55 years STANDARD_DEVIATION 9.7 • n=44 Participants
Sex: Female, Male Female	21 Participants n=22 Participants	15 Participants n=22 Participants	36 Participants n=44 Participants
Sex: Female, Male Male	1 Participants n=22 Participants	7 Participants n=22 Participants	8 Participants n=44 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Czechia	22 participants n=22 Participants	22 participants n=22 Participants	44 participants n=44 Participants
BMI (kg/m^2)	38.93 kg/m^2 STANDARD_DEVIATION 3.8 • n=22 Participants	40.2 kg/m^2 STANDARD_DEVIATION 3.7 • n=22 Participants	39.58 kg/m^2 STANDARD_DEVIATION 3.8 • n=44 Participants

PRIMARY outcome

Timeframe: 1) 6 months post-procedure/sham and 2) 12 months post-procedure

Population: The ITT is representative of all randomized subjects who underwent either the sham or PTE, regardless of follow-up compliance. The PP represents subjects treated and compliant to study treatment and follow-up visits per the protocol, no major protocol deviations, or protocol violations. Note for 12 months post-procedure, only those initially randomized to PTE were followed for 12 months. The sham control, pursuant to the study protocol, were only followed for 6 months post-procedure.

1. Difference in percent total body weight (% TBWL) loss at 6 months between the Sham Control and Endobar Therapy groups. This is calculated as the difference in body weight from baseline to 6 months, relative to the baseline weight (i.e, initial weight - 6 month weight / initial weight) x 100%). The mean (i.e., average) total body weight loss of both groups was compared to assess whether there was a meaningful difference.

2. Percent total body weight loss (%TBWL) at 12 months in the group randomized to the initial Endobar Therapy alone. This is calculated as the difference in body weight from baseline to 12 months, relative to the baseline weight (i.e, initial weight - 12 month weight / initial weight) x 100%).

Outcome measures

Measure	Sham Control n=18 Participants Lidocaine injected at the femoral artery site. This patients will undergo behavioral therapy for 6 months and will crossover and will receive bariatric embolization. Endobar Infusion Catheter System: Bariatric embolization with microspheres using Endobar Infusion Catheter System Behavioral therapy: Healthy diet and exercise	Percutaneous Transcatheter Embolotherapy n=19 Participants • In patients randomized to intervention bariatric embolization will be performed using Endobar Infusion Catheter System. After procedure patients will undergo behavioral therapy Endobar Infusion Catheter System: Bariatric embolization with microspheres using Endobar Infusion Catheter System Behavioral therapy: Healthy diet and exercise
Weight Loss 6 Months: ITT Population	2.8 Percent change Interval 0.9 to 4.7	6.4 Percent change Interval 3.2 to 9.6
Weight Loss 6 Months: PP Population	1.8 Percent change Interval 0.5 to 3.0	8.3 Percent change Interval 4.9 to 11.6
Weight Loss 12 Months: ITT Population	—	6.5 Percent change Interval 3.0 to 10.0
Weight Loss 12 Months: PP Population	—	9.3 Percent change Interval 5.3 to 13.3

PRIMARY outcome

Timeframe: 12 months post-randomization

Population: Safety Population (i.e. any participant who consented to be in the study and underwent either the sham or therapy procedure). Each count indicates a participant who reported experiencing the described event.

The Incidence of device-, procedure- and therapy-related adverse events up to 12 months post-procedure.

Outcome measures

Measure	Sham Control n=20 Participants Lidocaine injected at the femoral artery site. This patients will undergo behavioral therapy for 6 months and will crossover and will receive bariatric embolization. Endobar Infusion Catheter System: Bariatric embolization with microspheres using Endobar Infusion Catheter System Behavioral therapy: Healthy diet and exercise	Percutaneous Transcatheter Embolotherapy n=34 Participants • In patients randomized to intervention bariatric embolization will be performed using Endobar Infusion Catheter System. After procedure patients will undergo behavioral therapy Endobar Infusion Catheter System: Bariatric embolization with microspheres using Endobar Infusion Catheter System Behavioral therapy: Healthy diet and exercise
Number of Patients With Adverse Events Asymptomatic Ulcers	0 participants	5 participants
Number of Patients With Adverse Events Epigastring Pain	3 participants	4 participants
Number of Patients With Adverse Events Epigastric Pressure	0 participants	3 participants
Number of Patients With Adverse Events Nausea	4 participants	7 participants
Number of Patients With Adverse Events Vomitting	5 participants	7 participants

PRIMARY outcome

Timeframe: 6 months post-procedure/sham and 12 months post-procedure

Population: The ITT is representative of all randomized subjects who underwent either the sham or PTE, regardless of follow-up compliance. The PP represents subjects treated and compliant to study treatment and follow-up visits per the protocol, no major protocol deviations, or protocol violations. Note for 12 months post-procedure, only those initially randomized to PTE were followed for 12 months. The sham control, pursuant to the study protocol, were only followed for 6 months post-procedure.

6-month change: The absolute difference in the initial and 6-month weight (kg) (i.e., initial - 6 month weight). These changes were averaged for each group and compared between the two groups to assess whether there was a meaningful difference.

12-month change: The absolute difference in the initial and 12-month weight (kg) (i.e., initial - 12 month weight).

Outcome measures

Measure	Sham Control n=18 Participants Lidocaine injected at the femoral artery site. This patients will undergo behavioral therapy for 6 months and will crossover and will receive bariatric embolization. Endobar Infusion Catheter System: Bariatric embolization with microspheres using Endobar Infusion Catheter System Behavioral therapy: Healthy diet and exercise	Percutaneous Transcatheter Embolotherapy n=19 Participants • In patients randomized to intervention bariatric embolization will be performed using Endobar Infusion Catheter System. After procedure patients will undergo behavioral therapy Endobar Infusion Catheter System: Bariatric embolization with microspheres using Endobar Infusion Catheter System Behavioral therapy: Healthy diet and exercise
Absolute Weight Loss (kg) 6 Months: ITT Population	3.0 kilograms Interval 0.9 to 5.0	7.4 kilograms Interval 3.8 to 11.0
Absolute Weight Loss (kg) 6 Months: PP Population	9.4 kilograms Interval 5.6 to 13.2	1.9 kilograms Interval 0.5 to 3.3
Absolute Weight Loss (kg) 12 Months: ITT	—	7.8 kilograms Interval 3.6 to 12.0
Absolute Weight Loss (kg) 12 Months: PP	—	9.3 kilograms Interval 4.9 to 13.8

SECONDARY outcome

Timeframe: 1) 6 months post-procedure/sham and 2) 12 months post-procedure

Population: The ITT is representative of all randomized subjects who underwent either the sham or PTE, regardless of follow-up compliance. The PP represents subjects treated and compliant to study treatment and follow-up visits per the protocol, no major protocol deviations, or protocol violations. Note for 12 months post-procedure, only those initially randomized to PTE were followed for 12 months. The sham control, pursuant to the study protocol, were only followed for 6 months post-procedure.

Percent excess body weight loss (% EBWL) is calculated by dividing the absolute weight loss divided by baseline excess weight and multiplying by 100% (i.e., excess weight / initial weight x 100%). Excess weight is defined as the difference between current weight and ideal weight.

%EBWL was calculated for the following time points:

1. 6 months: absolute weight loss was the difference from baseline to 6 months. %EBWL was averaged for each group and compared to assess whether there was a meaningful difference between the groups.

2. 12 months: absolute weight loss was the difference from baseline to 12 months.

Note, excess weight was determined from ideal body weights based on a BMI=25 kg/m2.

Outcome measures

Measure	Sham Control n=18 Participants Lidocaine injected at the femoral artery site. This patients will undergo behavioral therapy for 6 months and will crossover and will receive bariatric embolization. Endobar Infusion Catheter System: Bariatric embolization with microspheres using Endobar Infusion Catheter System Behavioral therapy: Healthy diet and exercise	Percutaneous Transcatheter Embolotherapy n=19 Participants • In patients randomized to intervention bariatric embolization will be performed using Endobar Infusion Catheter System. After procedure patients will undergo behavioral therapy Endobar Infusion Catheter System: Bariatric embolization with microspheres using Endobar Infusion Catheter System Behavioral therapy: Healthy diet and exercise
Percent Excess Body Weight (%EBWL) Loss 6 Months: ITT Population	8.6 EBWL % Interval 2.5 to 14.7	17.1 EBWL % Interval 8.5 to 25.7
Percent Excess Body Weight (%EBWL) Loss 6 Months: PP Population	5.4 EBWL % Interval 1.7 to 9.1	22.3 EBWL % Interval 13.4 to 31.1
Percent Excess Body Weight (%EBWL) Loss 12 Months: ITT Population	—	17.3 EBWL % Interval 7.9 to 26.8
Percent Excess Body Weight (%EBWL) Loss 12 Months: PP Population	—	21.8 EBWL % Interval 11.1 to 32.4

SECONDARY outcome

Timeframe: 6 months post-procedure/sham

Population: The intention-to-treat (ITT) and per-protocol (PP) groups. The ITT population is representative of all randomized subjects who underwent either the sham or the therapeutic procedure, regardless of when they withdrew from the study or not post-procedure. The PP population represents subjects treated and complaint to study treatment and follow-up visits per the protocol, no major protocol deviations, or protocol violations.

Proportion of subjects who achieve ≥5% total body weight loss from baseline vs. those who do not

Outcome measures

Measure	Sham Control n=18 Participants Lidocaine injected at the femoral artery site. This patients will undergo behavioral therapy for 6 months and will crossover and will receive bariatric embolization. Endobar Infusion Catheter System: Bariatric embolization with microspheres using Endobar Infusion Catheter System Behavioral therapy: Healthy diet and exercise	Percutaneous Transcatheter Embolotherapy n=19 Participants • In patients randomized to intervention bariatric embolization will be performed using Endobar Infusion Catheter System. After procedure patients will undergo behavioral therapy Endobar Infusion Catheter System: Bariatric embolization with microspheres using Endobar Infusion Catheter System Behavioral therapy: Healthy diet and exercise
Number of Patients With Weight Loss ≥5% ITT Population · < 5%	14 Participants	10 Participants
Number of Patients With Weight Loss ≥5% ITT Population · ≥ 5%	4 Participants	9 Participants
Number of Patients With Weight Loss ≥5% PP Population · < 5%	14 Participants	6 Participants
Number of Patients With Weight Loss ≥5% PP Population · ≥ 5%	2 Participants	9 Participants

SECONDARY outcome

Timeframe: 6 months post-procedure/sham

Population: The ITT is representative of all randomized subjects who underwent either the sham or PTE, regardless of follow-up compliance. The PP represents subjects treated and compliant to study treatment and follow-up visits per the protocol, no major protocol deviations, or protocol violations. Note for 12 months post-procedure, only those initially randomized to PTE were followed for 12 months. The sham control, pursuant to the study protocol, were only followed for 6 months post-procedure.

6-month change (from baseline) in lipids for both groups. Unit of Measure: mg/dL

Outcome measures

Measure	Sham Control n=18 Participants Lidocaine injected at the femoral artery site. This patients will undergo behavioral therapy for 6 months and will crossover and will receive bariatric embolization. Endobar Infusion Catheter System: Bariatric embolization with microspheres using Endobar Infusion Catheter System Behavioral therapy: Healthy diet and exercise	Percutaneous Transcatheter Embolotherapy n=19 Participants • In patients randomized to intervention bariatric embolization will be performed using Endobar Infusion Catheter System. After procedure patients will undergo behavioral therapy Endobar Infusion Catheter System: Bariatric embolization with microspheres using Endobar Infusion Catheter System Behavioral therapy: Healthy diet and exercise
6 Month Change in Lipids Total Cholesterol - Baseline	5.23 mmol/L Standard Deviation 0.81	4.69 mmol/L Standard Deviation 0.71
6 Month Change in Lipids Total Cholesterol - 6 Months	4.99 mmol/L Standard Deviation 0.70	4.94 mmol/L Standard Deviation 0.71
6 Month Change in Lipids Low-Density Lipoprotein (LDL) - Baseline	1.23 mmol/L Standard Deviation 0.74	1.29 mmol/L Standard Deviation 0.69
6 Month Change in Lipids Low-Density Lipoprotein (LDL) - 6 Months	1.26 mmol/L Standard Deviation 0.64	1.28 mmol/L Standard Deviation 0.68
6 Month Change in Lipids High-Density Lipoprotein (HDL) - Baseline	1.23 mmol/L Standard Deviation 0.28	1.29 mmol/L Standard Deviation 0.32
6 Month Change in Lipids High-Density Lipoprotein (HDL) - 6 Months	1.26 mmol/L Standard Deviation 0.21	1.28 mmol/L Standard Deviation 0.26
6 Month Change in Lipids Triglyceride - Baseline	1.29 mmol/L Standard Deviation 0.52	1.34 mmol/L Standard Deviation 0.76
6 Month Change in Lipids Triglyceride - 6 Months	1.41 mmol/L Standard Deviation 0.74	1.40 mmol/L Standard Deviation 1.14

SECONDARY outcome

Timeframe: 6 months post-procedure/sham and 12 months post-procedure

Population: The ITT is representative of all randomized subjects who underwent either the sham or PTE, regardless of follow-up compliance. The PP represents subjects treated and compliant to study treatment and follow-up visits per the protocol, no major protocol deviations, or protocol violations. Note for 12 months post-procedure, only those initially randomized to PTE were followed for 12 months. The sham control, pursuant to the study protocol, were only followed for 6 months post-procedure.

Change in absolute blood pressure levels from baseline to 6 months for both groups and baseline to 12 months for the initial treatment group.

Unit of Measure: mmHg

Outcome measures

Measure	Sham Control n=18 Participants Lidocaine injected at the femoral artery site. This patients will undergo behavioral therapy for 6 months and will crossover and will receive bariatric embolization. Endobar Infusion Catheter System: Bariatric embolization with microspheres using Endobar Infusion Catheter System Behavioral therapy: Healthy diet and exercise	Percutaneous Transcatheter Embolotherapy n=19 Participants • In patients randomized to intervention bariatric embolization will be performed using Endobar Infusion Catheter System. After procedure patients will undergo behavioral therapy Endobar Infusion Catheter System: Bariatric embolization with microspheres using Endobar Infusion Catheter System Behavioral therapy: Healthy diet and exercise
6 and 12 Month Change in Blood Pressure 6 Months: Systolic Blood Pressure	-3.7 mmHg Interval -13.6 to 6.2	2.3 mmHg Interval -5.0 to 9.7
6 and 12 Month Change in Blood Pressure 6 Months: Diastolic Blood Pressure	-0.6 mmHg Interval -6.6 to 5.5	2.8 mmHg Interval -0.3 to 5.9
6 and 12 Month Change in Blood Pressure 12 Months: Systolic Blood Pressure	—	-1.8 mmHg Interval -8.6 to 4.9
6 and 12 Month Change in Blood Pressure 12 Months: Diastolic Blood Pressure	—	-9.7 mmHg Interval -17.7 to -1.7

OTHER_PRE_SPECIFIED outcome

Timeframe: [Time Frame: 6-12 months]

Unit of Measure: pg/mL

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: [Time Frame: 6-12 months]

Changes in Glucagon-like peptide 1 concentrations Unit of Measure: pg/mL

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: [Time Frame: 6-12 months]

Changes in OGTT and Insulin Sensitivity Unit of measure:milligrams/deciliter (mg/dL)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: [Time Frame: 6-12 months]

Unit of measure: mg/min

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: [Time Frame: 6-12 months]

Unit of Measure: Beck Depression Index

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: [Time Frame: 6-12 months]

Change in the subdomains and overall Quality of Life Unit of Measure: IWQOL

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: [Time Frame: 6-12 months]

Unit of Measure: Eating Questionnaire Scores

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: [Time Frame: 6-12 months]

Change in satiety and other parameters associated with this test Unit of Measure: numerical scale from 0-5

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Photos and clinical reports analyzed

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: [Time Frame: 6-12 months]

Unit of Measure: (t 1/2) in minutes

Outcome measures

Outcome data not reported

Adverse Events

Sham Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Percutaneous Transcatheter Embolotherapy

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sham Control n=20 participants at risk Those who were initially randomized to the sham control group and followed up for 6 months post-sham.	Percutaneous Transcatheter Embolotherapy n=34 participants at risk Those initially randomized to PTE and those who crossed over to PTE at 6 months post-sham during unblinding of the study.
Vascular disorders Chronic high-grade atherosclerotic stenosis of the external iliac artery	0.00% 0/20 • 1) 12 Months for those initially randomized to PTE (therapy group); 2) 6 months for those initially randomized to sham group; 3) 6 months for those who crossed over to PTE (therapy group) after unblinding point of the study, pursuant to the study protocol.	2.9% 1/34 • 1) 12 Months for those initially randomized to PTE (therapy group); 2) 6 months for those initially randomized to sham group; 3) 6 months for those who crossed over to PTE (therapy group) after unblinding point of the study, pursuant to the study protocol.

Other adverse events

Measure	Sham Control n=20 participants at risk Those who were initially randomized to the sham control group and followed up for 6 months post-sham.	Percutaneous Transcatheter Embolotherapy n=34 participants at risk Those initially randomized to PTE and those who crossed over to PTE at 6 months post-sham during unblinding of the study.
Gastrointestinal disorders Asymptomatic Ulceration	0.00% 0/20 • 1) 12 Months for those initially randomized to PTE (therapy group); 2) 6 months for those initially randomized to sham group; 3) 6 months for those who crossed over to PTE (therapy group) after unblinding point of the study, pursuant to the study protocol.	14.7% 5/34 • 1) 12 Months for those initially randomized to PTE (therapy group); 2) 6 months for those initially randomized to sham group; 3) 6 months for those who crossed over to PTE (therapy group) after unblinding point of the study, pursuant to the study protocol.

Additional Information

Director, Clinical Affairs

Endobar Solutions LLC

Phone: 8456800424

Email: nodar@endobarsolutions.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place