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Active, not recruitingNCT06484114REMAIN-1Updated Mar 3, 2026

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

An interventional study of Revita Duodenal Mucosal Resurfacing (DMR) and Sham in Obesity, Weight Change Trajectory and Weight Change, Body, sponsored by Fractyl Health Inc.. Active, not recruiting at 32 sites in United States. Open to participants aged 21 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-03.

Sponsored by Fractyl Health Inc. · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
315
Allocation
Randomized
Ages
21 Years to 70 Years
Sex
All
01

Study 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. 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.

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.

02

Conditions studied

  • Obesity
  • Weight Change Trajectory
  • Weight Change, Body

Keywords

  • Weight Management
  • Obesity
  • Overweight
  • Weight
  • Duodenum
  • Revita
  • GLP-1
  • Tirzepatide
  • Endoscopic
  • Weight Maintenance
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 315 is above the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Fractyl Health Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Participant-provided, written to participate in the study in accordance with local regulations
  2. Adult participants aged 21-70 years, inclusive
  3. Prior to tirzepatide therapy, have a of ≥ 30 kg/m2 (obesity) and ≤ 45 kg/m2.
  4. 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)
  5. Have a history of at least 1 self-reported, unsuccessful, dietary effort to lose body weight
  6. All female participants of must have a negative urine pregnancy test at screening and a negative urine pregnancy test at study visit 7 prior to study intervention. 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
  7. 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

  8. If sexually active, WOCBP must use one of the following 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

Exclusion criteria

Exclusion Criteria:

  1. Medical conditions that contraindicate the use of tirzepatide for weight management, as detailed in the tirzepatide prescribing information
  2. ≥ 40 kg/m2 at Visit 7
  3. Females who are or intend to be pregnant or breastfeeding during the study
  4. Known serious to tirzepatide or any of the in tirzepatide
  5. History of infectious liver disease excluding recovered Hepatitis A infection
  6. History of pancreatitis within 6 months of screening or any prior history of recurrent pancreatitis (i.e., two or more episodes of pancreatitis)
  7. Potentially unreliable participants or those judged by the investigator to be unsuitable for the study
  8. Unable or unwilling to follow the dietary restrictions specified by the clinical protocol
  9. Known history of or active binge eating disorder or suspected binge eating disorder based on binge eating disorder assessment questionnaire
  10. 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

  11. 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:

  12. History of type 1 or type 2 diabetes (T2D) or screening values consistent with T2D, or history of any genetic form of diabetes

  13. > 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:

  14. Estimated (eGFR) \< 50 mL/min/1.73m2 at screening, as assessed by serum creatinine using the revised 2021 CKD-EPI equation
  15. 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
  16. Fasting triglycerides > 500 mg/dL (> 5.6 mmol/L)
  17. Abnormal liver function at screening, defined as any of the following: (AST) > 3X reference range (ULN), ALT > 3X ULN, or serum total (TB) > 3X ULN
  18. Values of systolic blood pressure (SBP) > 180 mmHg and/or diastolic blood pressure (DBP) > 110 mmHg
  19. Any or clinical laboratory abnormality which precludes safe involvement in the study in the opinion of the investigator Gastrointestinal
  20. Known structural or functional disorder of the esophagus including any swallowing disorder, esophageal chest pain disorders, drug- esophageal reflux symptoms, or active and uncontrolled GERD defined as Los Angeles Grade C or D esophagitis
  21. 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
  22. 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
  23. 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
  24. Known intestinal disease including celiac disease, ulcerative colitis, Crohn's disease, lupus erythematosus, scleroderma, or other autoimmune or connective tissue disorder that affects the small intestine
  25. Any history of or current other gastrointestinal condition which would preclude an upper GI endoscopy in the opinion of the investigator Cardiovascular
  26. Class III or IV heart failure within 3 months prior to screening
  27. History of myocardial infarction or stroke within 6 months of screening

  28. 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:

  29. 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
  30. Self-reported weight gain > 5 kg within 3 months prior to screening
  31. Family history or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) syndrome 2
  32. History of an active or untreated 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)
  33. 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)
  34. Known thyroid cancer
  35. Any uncontrolled endocrine condition such as multiple endocrine neoplasia
  36. History of hemoglobinopathies (sickle cell anemia, thalassemia major, sideroblastic anemia) or other blood disorder
  37. Any uncontrolled psychiatric disorder as assessed by the investigator
  38. Any history of known genetic cause of obesity such as Prader-Willi Syndrome

  39. History of COVID infection with prolonged symptoms for >4 weeks

    Related to past or current medication use:

  40. Administration of any drug or participation in an interventional clinical research study within 30 days or 5 half-lives (whichever is longer) of screening visit
  41. 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)
  42. Use of any other medications known to cause weight gain or weight loss in the opinion of the investigator
  43. Receiving or have received, within 3 months prior to screening, chronic (>14 days) systemic (excluding inhaled, intraocular, intra-articular or topical) 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
  44. 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
  45. Treatment with thyroid hormones which are not on a stable dose for at least 8 weeks prior to screening
  46. Use of anticoagulation therapy (e.g., warfarin, coumadin, or novel oral anticoagulants [NOACs]) or anti- agents (e.g., thienopyridine) which cannot be discontinued for 5-7 days or 2 drug half-lives before the procedure Other Exclusions
  47. 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
  48. Fractyl Health employees
Terms in these criteria, in plain language(21)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
315 participants (estimated)

Study arms

  • Other
    Training

    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

    Device: Revita Duodenal Mucosal Resurfacing (DMR)

  • Active comparator
    Active

    Patients who have achieved \>15% weight loss from baseline will receive the Revita DMR Procedure

    Device: Revita Duodenal Mucosal Resurfacing (DMR)

  • Sham comparator
    Sham

    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

    Device: Sham

Interventions

  • DeviceRevita 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.

  • DeviceSham

    An endoscopic review with non active catheter introduction

This study also gives Tirzepatide. No intervention listed here names it: that was found by reading the record.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 26 Weeks

  2. 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

    Time frame: 52 weeks

Secondary outcomes

  1. 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.

    Time frame: 26 & 52 weeks

  2. 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

    Time frame: 52 Weeks

  3. 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

    Time frame: 26 & 52 Weeks

  4. 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

    Time frame: 26 & 52 Weeks

  5. 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

    Time frame: 26 & 52 Weeks

07

Study locations

32 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2024 (actual). Primary completion is estimated for Feb 2027, 29 months after the start.

Of 163 industry-sponsored interventional studies with no phase under Obesity, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 27. This study's planned 29 months is above that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 25, 2024
First posted
Jul 3, 2024
StartActual
Sep 1, 2024
Primary completionEst.
Feb 15, 2027
CompletionEst.
Feb 26, 2027
Last update
Mar 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06484114
Lead sponsor
Fractyl Health Inc.
Responsible party
Sponsor
First posted
Jul 3, 2024
Start date
Sep 1, 2024
Primary completion
Feb 15, 2027 (estimated)
Completion
Feb 26, 2027 (estimated)
Last update
Mar 3, 2026

Study contacts

Shelby Sullivan, MD
principal investigator · Dartmouth-Hitchcock Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Obesity →

Other studies from this sponsor

Fractyl Health Inc.

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