Ignite Creation Date:
2024-07-17 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06484114
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-25
Brief Title:
Evaluation of the Safety and Efficacy of Revita DMR on Body Weight Maintenance in Subjects With Obesity Who Have Achieved at Least 15 Weight Loss on Tirzepatide
Sponsor:
Fractyl Health Inc
Organization:
Fractyl Health Inc
Study Overview
Official Title:
A Prospective Randomized Double-Blind Sham-Controlled Multicenter Pivotal Study to Assess the Efficacy of Revita Duodenal Mucosal Resurfacing DMR on Body Weight Maintenance in Participants With Obesity and Who Have Achieved at Least 15 Weight Loss on Tirzepatide Obesity Pharmacotherapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REMAIN-1
Brief Summary:
The REMAIN-1 clinical trial is a prospective pivotal double-blind randomized sham-controlled trial that will investigate the superiority of Revita DMR compared with sham on the maintenance of weight loss after successfully losing at least 15 total body weight on an open-label dose escalation tirzepatide run-in period of approximately 16-20 weeks Study participants are male and non-pregnant non-lactating females aged 21 -70 years who do not have type 1 or type 2 diabetes mellitus with a BMI 30 kgm2 The REMAIN-1 study will consist of 4 periods
A screening period of 1 week
An approximately 16-20-week dose-escalation tirzepatide run-in period
A double-blind intervention period A 21 DMR sham randomization with 48 weeks of blinded post-intervention follow up
An upper limit of 75 enrollment of females will be used to ensure a sufficiently large sample of males
REMAIN-1 will be a multicenter trial in the United States with up to 35 Revita treatment centers that have experience in advanced endoscopy procedures and metabolic obesity treatment Approximately 315 participants will be randomized to DMR n210 or sham n105 treatment The Revita System is an endoscopic treatment consisting of a single catheter and console designed to lift the duodenal mucosa with saline followed by controlled circumferential hydrothermal ablation of the mucosa The sham procedure consists of placing the Revita Catheter described above into the duodenum for a minimum of 30 minutes with no manipulation of the device or activation of the catheter
An interim analysis of the primary endpoint will be performed after at least 75 of participants have been randomized The conditional power CP will be calculated using accumulated trial data at the time of the interim analysis
The study is centrally randomized and assignment to treatment groups will be determined by a computer-generated random sequence Randomization will be stratified by sex male female and BMI 30 or 30 kgm2
An open-label training stage of the study stage 1 will precede the randomized stage stage 2 at study sites The training stage will provide additional safety and efficacy information on DMR in the maintenance of weight loss after DMR in participants who have successfully lost at least 15 total body weight during the tirzepatide run-in period or have already lost a clinically relevant amount of weight at least 15 total body weight on tirzepatide prior to study entry and wish to discontinue therapy for a variety of reasons including cost insurance coverage side effects and patient preference
A screening period of 1 week
An approximately 16-20-week dose-escalation tirzepatide run-in period
A double-blind intervention period A 21 DMR sham randomization with 48 weeks of blinded post-intervention follow up
An upper limit of 75 enrollment of females will be used to ensure a sufficiently large sample of males
REMAIN-1 will be a multicenter trial in the United States with up to 35 Revita treatment centers that have experience in advanced endoscopy procedures and metabolic obesity treatment Approximately 315 participants will be randomized to DMR n210 or sham n105 treatment The Revita System is an endoscopic treatment consisting of a single catheter and console designed to lift the duodenal mucosa with saline followed by controlled circumferential hydrothermal ablation of the mucosa The sham procedure consists of placing the Revita Catheter described above into the duodenum for a minimum of 30 minutes with no manipulation of the device or activation of the catheter
An interim analysis of the primary endpoint will be performed after at least 75 of participants have been randomized The conditional power CP will be calculated using accumulated trial data at the time of the interim analysis
The study is centrally randomized and assignment to treatment groups will be determined by a computer-generated random sequence Randomization will be stratified by sex male female and BMI 30 or 30 kgm2
An open-label training stage of the study stage 1 will precede the randomized stage stage 2 at study sites The training stage will provide additional safety and efficacy information on DMR in the maintenance of weight loss after DMR in participants who have successfully lost at least 15 total body weight during the tirzepatide run-in period or have already lost a clinically relevant amount of weight at least 15 total body weight on tirzepatide prior to study entry and wish to discontinue therapy for a variety of reasons including cost insurance coverage side effects and patient preference
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None