ObesityREMAIN-1NCT06484114
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
A study testing Revita Duodenal Mucosal Resurfacing (DMR) in people with Obesity and Weight Change Trajectory, run by Fractyl Health Inc. at 32 sites in United States.
Trial summary
Fractyl is evaluating Revita Duodenal Mucosal Resurfacing (DMR) in the REMAIN-1 pivotal study, which is designed to include two cohorts - an open label cohort referred to as REVEAL-1, and a randomized cohort, which includes both a midpoint analysis and a pivotal analysis. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Weight Change Trajectory, Weight Change, Body
- What is being tested?
- Revita Duodenal Mucosal Resurfacing (DMR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 315 participants
- Where
- 32 sitesUnited States
- Study dates
- 1 Sep 2024to 26 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant-provided, written informed consent to participate in the study in accordance with local regulations
- Adult participants aged 21-70 years, inclusive
- Prior to tirzepatide therapy, have a BMI of ≥ 30 kg/m2 (obesity) and ≤ 45 kg/m2.
- Have achieved at least 15% weight loss on tirzepatide therapy at Visit 7 (Participants in Stage 1, who enter the study on tirzepatide, must have a documented pre-tirzepatide weight confirming they have lost at least 15% body weight on tirzepatide)
- Have a history of at least 1 self-reported, unsuccessful, dietary effort to lose body weight
- All female participants of childbearing potential must have a negative urine pregnancy test at screening and a negative urine pregnancy test at study visit 7 prior to study intervention. Postmenopausal females with amenorrhea for at least 2 years will be eligible if they are > 50 years of age. Postmenopausal females with amenorrhea for at least 2 years, who are ≤ 50 years, must also have documented serum follicle stimulating hormone levels > 35 mUI/mL
Show all 12Show fewer
- Able to walk at least 400 yards (roughly the distance of a track) and climb a flight of stairs without difficulty due to either musculoskeletal injuries/diseases or cardiopulmonary diseases
- If sexually active, WOCBP must use one of the following birth control methods during the entire course of the study as specified:
- Intrauterine device in place for at least 3 months before the first dose of tirzepatide and throughout the study
- Barrier method (condom, diaphragm) with spermicide for at least 14 days before the first dose of tirzepatide and throughout the study
- Surgical sterilization of the male partner(s) (vasectomy for at least 6 months before first dose of tirzepatide) or
- Hormonal contraceptives with a barrier method for at least 3 months before the first dose of tirzepatide and throughout the study
Who cannot join
- Medical conditions that contraindicate the use of tirzepatide for weight management, as detailed in the tirzepatide prescribing information
- BMI ≥ 40 kg/m2 at Visit 7
- Females who are or intend to be pregnant or breastfeeding during the study
- Known serious hypersensitivity to tirzepatide or any of the excipients in tirzepatide
- History of infectious liver disease excluding recovered Hepatitis A infection
- History of pancreatitis within 6 months of screening or any prior history of recurrent pancreatitis (i.e., two or more episodes of pancreatitis)
Show all 52Show fewer
- Potentially unreliable participants or those judged by the investigator to be unsuitable for the study
- Unable or unwilling to follow the dietary restrictions specified by the clinical protocol
- Known history of or active binge eating disorder or suspected binge eating disorder based on binge eating disorder assessment questionnaire
- Known history of or active substance abuse including alcohol within the past 2 years that, in the opinion of the investigator, may preclude the participant from following the protocol and completing the study
- Have history of use of marijuana or tetrahydrocannabinol (THC)-containing products within 3 months of screening or unwillingness to abstain from marijuana or THC-containing products use during the study
- Diabetes-related conditions:
- History of type 1 or type 2 diabetes (T2D) or screening values consistent with T2D, or history of any genetic form of diabetes
- HbA1c > 6.5% or fasting glucose > 125 mg/dL consistent with T2D diagnosis according to the American Diabetes Association Standards of Care 2024 (Participants with isolated impaired fasting glucose [100 to 125 mg/dL, inclusive] may enroll in the study)
- Laboratory values or clinical abnormalities:
- Estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2 at screening, as assessed by serum creatinine using the revised 2021 CKD-EPI equation
- Serum calcitonin level ≥ 20 ng/L at screening if eGFR ≥ 60 mL/min/1.73m2 or serum calcitonin level ≥ 35 ng/L if eGFR < 60 mL/min/1.73m2
- Fasting triglycerides > 500 mg/dL (> 5.6 mmol/L)
- Abnormal liver function at screening, defined as any of the following: aspartate aminotransferase (AST) > 3X upper limit of the normal reference range (ULN), ALT > 3X ULN, or serum total bilirubin (TB) > 3X ULN
- Values of systolic blood pressure (SBP) > 180 mmHg and/or diastolic blood pressure (DBP) > 110 mmHg
- Any ECG or clinical laboratory abnormality which precludes safe involvement in the study in the opinion of the investigator Gastrointestinal
- Known structural or functional disorder of the esophagus including any swallowing disorder, esophageal chest pain disorders, drug-refractory esophageal reflux symptoms, or active and uncontrolled GERD defined as Los Angeles Grade C or D esophagitis
- Known structural or functional disorder of the stomach including active gastric ulcer, chronic gastritis, gastric varices, hiatal hernia (a large hiatal hernia or type II and higher paraoesophageal hernia), cancer, or any other disorder of the stomach
- Clinically significant gastric-emptying abnormality (i.e., severe gastroparesis or gastric outlet obstruction) including a drug-induced abnormality or an abnormality experienced in a person who chronically takes drugs that directly affect GI motility such as metoclopromide or erythromycin
- Previous GI surgery to treat the duodenum such as participants who have had a Billroth 2, Roux-en-Y gastric bypass, gastric sleeve, or other similar procedures or conditions
- Known intestinal autoimmune disease including celiac disease, ulcerative colitis, Crohn's disease, lupus erythematosus, scleroderma, or other autoimmune or connective tissue disorder that affects the small intestine
- Any history of or current other gastrointestinal condition which would preclude an upper GI endoscopy in the opinion of the investigator Cardiovascular
- New York Heart Association Class III or IV heart failure within 3 months prior to screening
- History of myocardial infarction or stroke within 6 months of screening
- Unstable symptomatic or life-threatening arrhythmia or heart block. Note: Asymptomatic atrial fibrillation is not considered to be life-threatening, and patients with asymptomatic atrial fibrillation will be permitted to enter the study
- Related to other concomitant conditions or medical history:
- Any concurrent medical condition/disorder or clinically symptomatic cardiovascular, gastrointestinal (including pancreatitis), hematological, pulmonary, psychiatric, acute or chronic infectious disease, active retinal disease or other disorder which, in the investigator's opinion, would interfere with the participant's ability to complete the trial, require administration of treatment that could affect the interpretation of the efficacy or safety variables, or preclude safe involvement in the study
- Self-reported weight gain > 5 kg within 3 months prior to screening
- Family history or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) syndrome 2
- History of an active or untreated malignancy or in remission from a clinically significant malignancy within the last 5 years (except for treated basal cell or squamous small cell carcinoma of the skin with no evidence of recurrence)
- Secondary hypothyroidism or inadequately controlled primary hypothyroidism (thyroid-stimulating hormone [TSH] value outside the range of 0.4 to 6.0 mIU/L at screening)
- Known thyroid cancer
- Any uncontrolled endocrine condition such as multiple endocrine neoplasia
- History of hemoglobinopathies (sickle cell anemia, thalassemia major, sideroblastic anemia) or other blood disorder
- Any uncontrolled psychiatric disorder as assessed by the investigator
- Any history of known genetic cause of obesity such as Prader-Willi Syndrome
- History of COVID infection with prolonged symptoms for >4 weeks
- Related to past or current medication use:
- Administration of any investigational drug or participation in an interventional clinical research study within 30 days or 5 half-lives (whichever is longer) of screening visit
- Use of any oral or injectable hypoglycemic agents or any other prescription or over-the-counter diabetes or weight loss medications within 12 months prior to screening visit, (except in the case of tirzepatide use in the stage 1 training arm of the study only)
- Use of any other medications known to cause weight gain or weight loss in the opinion of the investigator
- Receiving or have received, within 3 months prior to screening, chronic (>14 days) systemic (excluding inhaled, intraocular, intra-articular or topical) corticosteroid treatment or likely to require (in the opinion of the investigator) concurrent treatment with corticosteroids (excluding inhaled, intraocular, intra-articular or topical) during the course of the study
- Treatment with antihypertensive or lipid-modifying medications which are not on a stable dose for at least 8 weeks prior to screening or anticipated changes or dose adjustments within 30 days following randomization into the study
- Treatment with thyroid hormones which are not on a stable dose for at least 8 weeks prior to screening
- Use of anticoagulation therapy (e.g., warfarin, coumadin, or novel oral anticoagulants [NOACs]) or anti-platelet agents (e.g., thienopyridine) which cannot be discontinued for 5-7 days or 2 drug half-lives before the procedure Other Exclusions
- Investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
- Fractyl Health employees
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
University of Michigan
Ann Arbor, Michigan, 48109
Investigators Research Group, LLC
Brownsburg, Indiana, 46112
American Health Network - Franklin
Franklin, Indiana, 46131
American Health Network - Greenfield
Greenfield, Indiana, 46140
Zenith Clinical Research
Hollywood, Florida, 33021
Baylor St. Luke's Medical Center
Houston, Texas, 77030
Juno Research, LLC
Houston, Texas, 77040
Indiana University
Indianapolis, Indiana, 46202
Nature Coast Clinical Research
Inverness, Florida, 32162
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Encore Borland-Groover Clinical Research
Jacksonville, Florida, 32256
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
NYC Research, Inc. (Endocrine Associates of West Village)
Long Island City, New York, 11106
International Research Associates
Miami, Florida, 33183
West Virginia University
Morgantown, West Virginia, 26506
American Health Network - Muncie
Muncie, Indiana, 47304
NYU-Langone
New York, New York, 10016
Hoag Hospital
Newport Beach, California, 92663
Advent Health
Orlando, Florida, 32804
K2 Medical Research South Orlando
Orlando, Florida, 32806
Orlando Health Weight Loss and Bariatric Surgery Institute
Orlando, Florida, 32806
Helios Clinical Research
Phoenix, Arizona, 85028
Preferred Primary Care Physician Pittsburgh
Pittsburgh, Pennsylvania, 15243
Preferred Primary Care Physician
Pittsburgh, Pennsylvania, 15326
UCLA Santa Monica Medical Center
Santa Monica, California, 90095
Honor Health
Scottsdale, Arizona, 85258
University of Washington, Seattle
Seattle, Washington, 98109
Simcare Medical Research LLC
Sugar Land, Texas, 77478
Synexus Clinical Research Institute - The Villages (AES)
The Villages, Florida, 32162
Preferred Primary Care Physician
Uniontown, Pennsylvania, 15401
Metabolic Research Institute
West Palm Beach, Florida, 33401
Cleveland Clinic, Weston
Weston, Florida, 33331
About this study
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
Fractyl is evaluating Revita Duodenal Mucosal Resurfacing (DMR) in the REMAIN-1 pivotal study, which is designed to include two cohorts - an open label cohort referred to as REVEAL-1, and a randomized cohort, which includes both a midpoint analysis and a pivotal analysis. Patients who previously lost at least 15% of their body weight on a GLP-1 can qualify for the open label REVEAL-1 cohort. The data generated from the REVEAL-1 cohort will be used for open label reporting as the study progresses. The REMAIN-1 randomized cohort will enroll patients living with obesity and a body mass index ("BMI") between 30 and 45 kg/m2 who are not currently on a GLP-1 drug. Patients will be prescribed tirzepatide and titrated to achieve at least 15% total body weight loss, at which time tirzepatide will be discontinued and patients will be randomized to Revita versus sham at 2:1.
Midpoint Analysis of Randomized Cohort:
Read more
The midpoint analysis of the randomized cohort will be performed at three months of follow-up on approximately 45 patients, allowing us to assess and report on safety and efficacy signals that could be anticipated in the pivotal analysis. These patients are distinct from those included in the pivotal analysis.
Pivotal Analysis of Randomized Cohort:
The pivotal analysis of the randomized cohort will be performed on approximately 315 patients (distinct from those included in the midpoint analysis) and will evaluate safety and efficacy in the first co-primary endpoint, which is weight regain from the time of tirzepatide discontinuation in Revita DMR versus sham patients at six months, with a primary objective of demonstrating a benefit of Revita DMR versus sham for weight maintenance after GLP-1 discontinuation. The second co-primary endpoint evaluates a responder rate among the Revita DMR treated group at one year to demonstrate the durability of the Revita DMR procedure for weight maintenance after discontinuation of a GLP-1-based therapy.
Secondary objectives will include evaluation of the effectiveness of the Revita DMR procedure on the change in blood glucose levels, cardiovascular disease ("CVD") risk factors, body composition and pre-diabetes status. All patients enrolled in the study will receive diet and lifestyle counseling.
Read the detailed description
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 Who Have Achieved at Least 15% Weight Loss on GLP-1 Based Pharmacotherapy (REMAIN-1)
Short Title Revita® Duodenal Mucosal Resurfacing for Weight Maintenance (REMAIN-1)
Protocol Number C-00700 Study Population Male and non-pregnant non-lactating females aged 21 -70 years, who do not have type 1 or type 2 diabetes mellitus, and with a body mass index (BMI) ≥ 30 kg/m2 Trial Design Study C-00700 is a multi-Stage study which may be conducted in parallel.
Stage 1 is an open-label training Stage enrolling participants already on GLP-1 based therapy (prior to study enrollment) with at least 15% total body weight loss (TBWL) since initiation of the GLP-1 based drug. Those participants who lost at least 15% total body weight on the GLP-1 based drug and wish to discontinue the use, will be eligible to receive Revita DMR procedure.
An open-label training Stage (Stage 1) will require treating endoscopy sites without prior experience with Revita DMR to perform DMR in up to 4 participants per site prior to treating any participant in the randomization Stage (Stage 2) to ensure consistency of study procedures prior to initiating randomization. Sites with prior Revita DMR training and experience may, but are not required to, enroll participants from this stage in parallel to Stage 2.
Stage 2 is a randomized, double-blind, sham-controlled trial that will investigate the impact of Revita® Duodenal Mucosal Resurfacing (DMR), compared with a sham endoscopic procedure, on the maintenance of body weight loss in participants with obesity (BMI ≥ 30 kg/m2). Eligible participants will receive an open-label, tirzepatide run-in, dose-escalation period of approximately 16-26 weeks duration. Those participants who lose at least 15% total body weight during the tirzepatide run-in treatment period will subsequently discontinue tirzepatide and be randomized to either Revita DMR or a sham procedure.
Randomization at the end of the tirzepatide run-in period for eligible participants will be stratified by sex (male, female) and Baseline BMI (<30 or ≥30 kg/m2).
Stage 2 will consist of two independent Stage parts, Stage 2a and Stage 2b, which will enroll sequentially. Both Stages will enroll, randomize, treat, and follow-up participants in the same manner (DMR vs Sham, 2:1, double blind).
- Stage 2a will consist of approximately 45 randomized participants with a range of 30-60. An exploratory safety and efficacy analysis will be performed after the last participant in Stage 2a completes the 12-week visit or discontinues the study.
- Stage 2b will consist of approximately 315 randomized participants. The final efficacy analysis will be performed after the last participant in Stage 2b completes the 52-week visit or discontinues the study.
Phase Pivotal
Sites/Facilities Multicenter trial with up to 35 Revita treatment centers with experience in advanced endoscopy procedures in the United States
Study Intervention and Sham 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 into the duodenum for a minimum of 30 minutes with no manipulation of the device or activation of the catheter.
Number of Participants Approximately 865 participants will be screened for the entire study.
Stage 1 (Open-label). Approximately 175 participants will be screened, and up to 100 participants will be treated with Revita DMR.
Stage 2 (Randomized). For Stage 2a, approximately 90 participants will be screened, and approximately 60 participants will be enrolled into the tirzepatide run-in treatment period to successfully randomize approximately 45 participants with a range of 30-60 to DMR or sham in a 2:1 ratio. For Stage 2b, approximately 600 participants will be screened, and approximately 400 participants will be enrolled into the tirzepatide run-in treatment period to successfully randomize approximately 315 participants in a 2:1 DMR (n=210) or sham (n=105) treatment ratio. An upper limit of 75% enrollment of females will be used to ensure a sufficiently large sample of men. No more than 20% of total number of randomized subjects will be treated at any single site.
Study Duration The total estimated time from open enrollment until completion of data analyses is 128 weeks.
Participant Study Duration Stage 1 (Open-Label)
The total participant study duration is approximately 54 weeks in Stage 1 of the study with the following study periods:
- A screening period up to 1 week
- A run-in period:
- Participants enter the study having already achieved at least a 15% body weight loss on a GLP-1 based drug. After meeting all eligibility criteria in visit 1, participants will go directly to study visit 7, the baseline visit.
Visit 7 (baseline visit): Eligible participants will advance from study visit 1 (screening) immediately to study visit 7 at which time their GLP-1 based drug will be discontinued.
Visit 8 (study intervention): Participants will have study intervention (visit 8) one week after GLP-based drug discontinuation.
For these participants, total participant study duration is approximately 54 weeks.
- Study intervention and follow up: The study intervention and post-study intervention period (52 weeks)-An endoscopic evaluation will first be performed to confirm participant eligibility. Immediately following confirmation of participant eligibility, qualifying participants will receive the DMR intervention. The endoscopy evaluation and study intervention will take place during the same endoscopy session. Post- intervention follow up will occur until 52 weeks after intervention.
Stage 2 (Randomized)
The total participant study duration is approximately 68-78 weeks with the following study periods:
- A screening period up to 1 week
- A tirzepatide run-in dose-escalation period (approximately 16-26 weeks) during which time (and until) participants successfully achieve at least 15% body weight loss.
- Visit 2-6 (tirzepatide run-in): Tirzepatide will be initiated at the end of visit 2, and dose escalation will occur, as tolerated, during study visits 2-6 up to a maximum tolerated dose as per the tirzepatide FDA approved prescribing information or investigator discretion.
- Visit 7 (baseline visit): Once at least 15% weight loss is achieved at any of these visits 2-6, participants will immediately advance to study visit 7 as his/her next scheduled study visit. During the interval between the documented ≥ 15% weight loss and study visit 7, participants will continue to abide by the recommended tirzepatide dose-escalation regimen per protocol. At study visit 7, tirzepatide will be discontinued.
- Visit 8 (study intervention): Participants will have visit 8 one week after tirzepatide discontinuation.
The study intervention and post-study intervention period (52 weeks): An endoscopic evaluation will first be performed to confirm participant eligibility. Immediately following confirmation of participant eligibility, participants will be randomized to receive either the DMR or sham intervention. The endoscopy evaluation and study intervention will take place during the same endoscopy session. Post-study intervention follow up will occur in a blinded manner until 52 weeks after intervention.
- Conditions
- Obesity, Weight Change Trajectory, Weight Change, Body
- Being tested
- Revita Duodenal Mucosal Resurfacing (DMR), Sham
- Keywords
- Weight Management, Obesity, Overweight, Weight, Duodenum, Revita, GLP-1, Tirzepatide, Endoscopic, Weight Maintenance
- Medical subject headings
- Obesity, Body-Weight Trajectory, Body Weight Changes, Overweight, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revita Duodenal Mucosal Resurfacing (DMR)Device
DMR is designed to ablate and re-epithelialize the duodenal mucosal surface, thus allowing nutrients to be exposed to a newly regrown and potentially normalized local mucosa. This implies that the duodenal mucosa surface is abnormal in participants associated with metabolic disorders. The Revita DMR procedure is performed endoscopically with supporting fluoroscopy.
ShamDevice
An endoscopic review with non active catheter introduction
| Study group | Role | What they receive |
|---|---|---|
| Training | Other | Sites will gain experience with the study protocol and the Revita DMR procedure in an open-label, single-arm treatment assignment for participants who previously achieved 15% weight loss using a GLP-1 Receives: Device: Revita Duodenal Mucosal Resurfacing (DMR) |
| Active | Active comparator | Patients who have achieved >15% weight loss from baseline will receive the Revita DMR Procedure Receives: Device: Revita Duodenal Mucosal Resurfacing (DMR) |
| Sham | Sham comparator | Patients who have achieved >15% weight loss from baseline will receive and endoscopic evaluation and will have a catheter introduced but the Revita DMR procedure will not be performed Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate that Revita DMR is superior to sham in percent change in body weight from baseline to week 26
Percent change in total body weight from baseline to week 26, DMR vs sham
Measured: 26 Weeks
To demonstrate that a majority of Revita DMR participants maintain clinically significant weight loss 52 weeks (1 year) after discontinuing tirzepatide therapy
Percentage of DMR participants who maintain at least 5% total body weight loss from pre-tirzepatide (week -21) to week 52
Measured: 52 weeks
Secondary outcomes (5)
To demonstrate durability of DMR
Of patients who maintain at least 5% total body weight loss from baseline at week 26, percentage of patients who maintain at least 5% total body weight loss at week 52.
Measured: 26 & 52 weeks
To demonstrate DMR in comparison to sham in change from baseline for total body weight change
Percent change in total body weight from baseline to week 52, DMR vs sham
Measured: 52 Weeks
To demonstrate DMR in comparison to sham in change from baseline for fating C-peptide
Changes from baseline to week 26 and week 52 in fasting C-peptide (nmol/L) (for the entire population and for the subset population with pre-diabetes* at baseline), DMR vs sham
Measured: 26 & 52 Weeks
To demonstrate DMR in comparison to sham in change from baseline for metabolic health
Changes from baseline to week 26 and week 52 in fasting glucose (mg/dL), fasting insulin (pmol/L), and HbA1c (%) (for the entire population at week 52 only and for the subset population with pre-diabetes* at baseline), DMR vs sham
Measured: 26 & 52 Weeks
To evaluate dimensions of upper gastrointestinal distress throughout the study (tirzepatide open-label run in vs. after randomization)
Changes in Rhodes Index of Nausea and Vomiting score from pre-tirzepatide (week -21) to baseline (visit 7) compared to changes from DMR (visit 8) to week 26 and week 52
Measured: 26 & 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Sep 2024
- Primary completion15 Feb 2027 (estimated)
- Study completion26 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-Blind, Sham-Controlled, Multicenter
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 315 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fractyl Health Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shelby Sullivan, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484114
- Sponsor's protocol ID
- C-00700
- Acronym
- REMAIN-1
- Status last verified
- Feb 2026
- First submitted
- 25 Jun 2024
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06484114
- Acronym / sponsor ID
- REMAIN-1 / C-00700
- Conditions
- Obesity, Weight Change Trajectory, Weight Change, Body
- Keywords
- Weight Management, Obesity, Overweight, Weight, Duodenum, Revita, GLP-1, Tirzepatide
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 315 participants (estimated)
- Lead sponsor
- Fractyl Health Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 26 Feb 2027 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fractyl is evaluating Revita Duodenal Mucosal Resurfacing (DMR) in the REMAIN-1 pivotal study, which is designed to include two cohorts - an open label cohort referred to as REVEAL-1, and a randomized cohort, which includes both a midpoint analysis and a pivotal analysis. Patients who previously lost at least 15% of their body weight on a GLP-1 can qualify for the open label REVEAL-1 cohort. The data generated from the REVEAL-1 cohort will be used for open label reporting as the study progresses. The REMAIN-1 randomized cohort will enroll patients living with obesity and a body mass index ("BMI") between 30 and 45 kg/m2 who are not currently on a GLP-1 drug. Patients will be prescribed tirzepatide and titrated to achieve at least 15% total body weight loss, at which time tirzepatide will be discontinued and patients will be randomized to Revita versus sham at 2:1.
Midpoint Analysis of Randomized Cohort:
The midpoint analysis of the randomized cohort will be performed at three months of follow-up on approximately 45 patients, allowing us to assess and report on safety and efficacy signals that could be anticipated in the pivotal analysis. These patients are distinct from those included in the pivotal analysis.
Pivotal Analysis of Randomized Cohort:
The pivotal analysis of the randomized cohort will be performed on approximately 315 patients (distinct from those included in the midpoint analysis) and will evaluate safety and efficacy in the first co-primary endpoint, which is weight regain from the time of tirzepatide discontinuation in Revita DMR versus sham patients at six months, with a primary objective of demonstrating a benefit of Revita DMR versus sham for weight maintenance after GLP-1 discontinuation. The second co-primary endpoint evaluates a responder rate among the Revita DMR treated group at one year to demonstrate the durability of the Revita DMR procedure for weight maintenance after discontinuation of a GLP-1-based therapy.
Secondary objectives will include evaluation of the effectiveness of the Revita DMR procedure on the change in blood glucose levels, cardiovascular disease ("CVD") risk factors, body composition and pre-diabetes status. All patients enrolled in the study will receive diet and lifestyle counseling.
Detailed description
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 Who Have Achieved at Least 15% Weight Loss on GLP-1 Based Pharmacotherapy (REMAIN-1)
Short Title Revita® Duodenal Mucosal Resurfacing for Weight Maintenance (REMAIN-1)
Protocol Number C-00700 Study Population Male and non-pregnant non-lactating females aged 21 -70 years, who do not have type 1 or type 2 diabetes mellitus, and with a body mass index (BMI) ≥ 30 kg/m2 Trial Design Study C-00700 is a multi-Stage study which may be conducted in parallel.
Stage 1 is an open-label training Stage enrolling participants already on GLP-1 based therapy (prior to study enrollment) with at least 15% total body weight loss (TBWL) since initiation of the GLP-1 based drug. Those participants who lost at least 15% total body weight on the GLP-1 based drug and wish to discontinue the use, will be eligible to receive Revita DMR procedure.
An open-label training Stage (Stage 1) will require treating endoscopy sites without prior experience with Revita DMR to perform DMR in up to 4 participants per site prior to treating any participant in the randomization Stage (Stage 2) to ensure consistency of study procedures prior to initiating randomization. Sites with prior Revita DMR training and experience may, but are not required to, enroll participants from this stage in parallel to Stage 2.
Stage 2 is a randomized, double-blind, sham-controlled trial that will investigate the impact of Revita® Duodenal Mucosal Resurfacing (DMR), compared with a sham endoscopic procedure, on the maintenance of body weight loss in participants with obesity (BMI ≥ 30 kg/m2). Eligible participants will receive an open-label, tirzepatide run-in, dose-escalation period of approximately 16-26 weeks duration. Those participants who lose at least 15% total body weight during the tirzepatide run-in treatment period will subsequently discontinue tirzepatide and be randomized to either Revita DMR or a sham procedure.
Randomization at the end of the tirzepatide run-in period for eligible participants will be stratified by sex (male, female) and Baseline BMI (<30 or ≥30 kg/m2).
Stage 2 will consist of two independent Stage parts, Stage 2a and Stage 2b, which will enroll sequentially. Both Stages will enroll, randomize, treat, and follow-up participants in the same manner (DMR vs Sham, 2:1, double blind).
- Stage 2a will consist of approximately 45 randomized participants with a range of 30-60. An exploratory safety and efficacy analysis will be performed after the last participant in Stage 2a completes the 12-week visit or discontinues the study.
- Stage 2b will consist of approximately 315 randomized participants. The final efficacy analysis will be performed after the last participant in Stage 2b completes the 52-week visit or discontinues the study.
Phase Pivotal
Sites/Facilities Multicenter trial with up to 35 Revita treatment centers with experience in advanced endoscopy procedures in the United States
Study Intervention and Sham 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 into the duodenum for a minimum of 30 minutes with no manipulation of the device or activation of the catheter.
Number of Participants Approximately 865 participants will be screened for the entire study.
Stage 1 (Open-label). Approximately 175 participants will be screened, and up to 100 participants will be treated with Revita DMR.
Stage 2 (Randomized). For Stage 2a, approximately 90 participants will be screened, and approximately 60 participants will be enrolled into the tirzepatide run-in treatment period to successfully randomize approximately 45 participants with a range of 30-60 to DMR or sham in a 2:1 ratio. For Stage 2b, approximately 600 participants will be screened, and approximately 400 participants will be enrolled into the tirzepatide run-in treatment period to successfully randomize approximately 315 participants in a 2:1 DMR (n=210) or sham (n=105) treatment ratio. An upper limit of 75% enrollment of females will be used to ensure a sufficiently large sample of men. No more than 20% of total number of randomized subjects will be treated at any single site.
Study Duration The total estimated time from open enrollment until completion of data analyses is 128 weeks.
Participant Study Duration Stage 1 (Open-Label)
The total participant study duration is approximately 54 weeks in Stage 1 of the study with the following study periods:
- A screening period up to 1 week
- A run-in period:
- Participants enter the study having already achieved at least a 15% body weight loss on a GLP-1 based drug. After meeting all eligibility criteria in visit 1, participants will go directly to study visit 7, the baseline visit.
Visit 7 (baseline visit): Eligible participants will advance from study visit 1 (screening) immediately to study visit 7 at which time their GLP-1 based drug will be discontinued.
Visit 8 (study intervention): Participants will have study intervention (visit 8) one week after GLP-based drug discontinuation.
For these participants, total participant study duration is approximately 54 weeks.
- Study intervention and follow up: The study intervention and post-study intervention period (52 weeks)-An endoscopic evaluation will first be performed to confirm participant eligibility. Immediately following confirmation of participant eligibility, qualifying participants will receive the DMR intervention. The endoscopy evaluation and study intervention will take place during the same endoscopy session. Post- intervention follow up will occur until 52 weeks after intervention.
Stage 2 (Randomized)
The total participant study duration is approximately 68-78 weeks with the following study periods:
- A screening period up to 1 week
- A tirzepatide run-in dose-escalation period (approximately 16-26 weeks) during which time (and until) participants successfully achieve at least 15% body weight loss.
- Visit 2-6 (tirzepatide run-in): Tirzepatide will be initiated at the end of visit 2, and dose escalation will occur, as tolerated, during study visits 2-6 up to a maximum tolerated dose as per the tirzepatide FDA approved prescribing information or investigator discretion.
- Visit 7 (baseline visit): Once at least 15% weight loss is achieved at any of these visits 2-6, participants will immediately advance to study visit 7 as his/her next scheduled study visit. During the interval between the documented ≥ 15% weight loss and study visit 7, participants will continue to abide by the recommended tirzepatide dose-escalation regimen per protocol. At study visit 7, tirzepatide will be discontinued.
- Visit 8 (study intervention): Participants will have visit 8 one week after tirzepatide discontinuation.
The study intervention and post-study intervention period (52 weeks): An endoscopic evaluation will first be performed to confirm participant eligibility. Immediately following confirmation of participant eligibility, participants will be randomized to receive either the DMR or sham intervention. The endoscopy evaluation and study intervention will take place during the same endoscopy session. Post-study intervention follow up will occur in a blinded manner until 52 weeks after intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, Double-Blind, Sham-Controlled, Multicenter
| Arm | Type | Receives |
|---|---|---|
| Training | Other | Device: Revita Duodenal Mucosal Resurfacing (DMR)Sites will gain experience with the study protocol and the Revita DMR procedure in an open-label, single-arm treatment assignment for participants who previously achieved 15% weight loss using a GLP-1 |
| Active | Active comparator | Device: Revita Duodenal Mucosal Resurfacing (DMR)Patients who have achieved >15% weight loss from baseline will receive the Revita DMR Procedure |
| Sham | Sham comparator | Device: ShamPatients who have achieved >15% weight loss from baseline will receive and endoscopic evaluation and will have a catheter introduced but the Revita DMR procedure will not be performed |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participant-provided, written informed consent to participate in the study in accordance with local regulations
- Adult participants aged 21-70 years, inclusive
- Prior to tirzepatide therapy, have a BMI of ≥ 30 kg/m2 (obesity) and ≤ 45 kg/m2.
- Have achieved at least 15% weight loss on tirzepatide therapy at Visit 7 (Participants in Stage 1, who enter the study on tirzepatide, must have a documented pre-tirzepatide weight confirming they have lost at least 15% body weight on tirzepatide)
- Have a history of at least 1 self-reported, unsuccessful, dietary effort to lose body weight
Key exclusion criteria (52 listed)
- Medical conditions that contraindicate the use of tirzepatide for weight management, as detailed in the tirzepatide prescribing information
- BMI ≥ 40 kg/m2 at Visit 7
- Females who are or intend to be pregnant or breastfeeding during the study
- Known serious hypersensitivity to tirzepatide or any of the excipients in tirzepatide
- History of infectious liver disease excluding recovered Hepatitis A infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Revita Duodenal Mucosal Resurfacing (DMR)DMR is designed to ablate and re-epithelialize the duodenal mucosal surface, thus allowing nutrients to be exposed to a newly regrown and potentially normalized local mucosa. This implies that the duodenal mucosa surface is abnormal in participants associated with metabolic disorders. The Revita DMR procedure is performed endoscopically with supporting fluoroscopy. | Device | Active, Training |
| ShamAn endoscopic review with non active catheter introduction | Device | Sham |
Primary outcome
To demonstrate that Revita DMR is superior to sham in percent change in body weight from baseline to week 26
Time frame: 26 Weeks
Percent change in total body weight from baseline to week 26, DMR vs sham
To demonstrate that a majority of Revita DMR participants maintain clinically significant weight loss 52 weeks (1 year) after discontinuing tirzepatide therapy
Time frame: 52 weeks
Percentage of DMR participants who maintain at least 5% total body weight loss from pre-tirzepatide (week -21) to week 52
5 secondary outcomes
To demonstrate durability of DMR
Time frame: 26 & 52 weeks
To demonstrate DMR in comparison to sham in change from baseline for total body weight change
Time frame: 52 Weeks
To demonstrate DMR in comparison to sham in change from baseline for fating C-peptide
Time frame: 26 & 52 Weeks
To demonstrate DMR in comparison to sham in change from baseline for metabolic health
Time frame: 26 & 52 Weeks
To evaluate dimensions of upper gastrointestinal distress throughout the study (tirzepatide open-label run in vs. after randomization)
Time frame: 26 & 52 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shelby Sullivan, MD principal investigator
Dartmouth-Hitchcock Medical Center
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Revita Duodenal Mucosal Resurfacing (DMR) in people with Obesity and Weight Change Trajectory, run by Fractyl Health Inc. at 32 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 52 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate that Revita DMR is superior to sham in percent change in body weight from baseline to week 26 (time frame: 26 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.