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FRACTYL HEALTH, INC. (GUTS)

Fractyl Health, Inc., a metabolic therapeutics company, develops therapies for the treatment of type 2 diabetes (T2D) and obesity. The company develops Revita DMR System (Revita), an outpatient procedural therapy designed to durably modify duodenal dysfunction, a pathologic consequence of a high fat and high sugar diet, which can initiate T2D and obesity in humans. It develops Rejuva, a novel adeno-associated virus delivered pancreatic gene therapy platform that is designed to enable long-term remission of T2D and obesity by durably altering metabolic hormone function in the pancreatic islet cells of patients. Fractyl Health, Inc. was formerly known as Fractyl Laboratories Inc. and changed its name to Fractyl Health, Inc. on June 09, 2021. The company was incorporated in 2010 and is headquartered in Burlington, Massachusetts.

Sector: Surgical & Medical Instruments & Apparatus

Industry: Biotechnology

Fractyl Health, Inc. logo

Fractyl Health, Inc.

NASDAQ:GUTSHealthcare
-1.51%$0.9765
AH$0.9800+0.36%vs close
Mkt Cap$12.95M
Float12.38M
O/S13.26M
Vol
$ Vol
RVOL
Inst Own44.5%
Earnings
Dilution
Fractyl Health, Inc. logoNASDAQ:GUTS$0.9765-1.51%
Phase Distribution
7 lead-sponsored trials·1 active·4 completed
Not applicable7
(2 more as collaborator)
Status Overview
Active, not recruiting1
Completed4
Stopped2

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Sponsor role
Status
  • Not applicable
    Completed

    Initial Clinical Evaluation of an Endoscopic Therapy for Type 2 Diabetes

    Fractyl Duodenal Remodeling System

    Type II Diabetes

    Enrollment
    57
    Start
    Jul 2013
    Primary Completion
    Apr 2017
    Completion
    Mar 2018
    NCT01927562
  • Not applicable
    Completed

    Evaluation of Duodenal Mucosal Resurfacing in Subjects With Type 2 Diabetes

    DMR Procedure (Fractyl)

    Diabetes Mellitus, Type 2, Diabetes Mellitus

    Enrollment
    60
    Start
    Mar 2015
    Primary Completion
    Jun 2017
    Completion
    Sep 2019
    NCT02413567
  • Not applicable
    Completed

    Effect of Duodenal Mucosal Resurfacing (DMR) Using the Revita System in the Treatment of Type 2 Diabetes (T2D)

    DMR Procedure, Sham Procedure

    Diabetes Mellitus, Type 2, Noninsulin-Dependent Diabetes Mellitus

    Enrollment
    109
    Start
    Mar 2017
    Primary Completion
    Dec 2019
    Completion
    Dec 2019
    NCT02879383
  • Not applicable
    Completed

    Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes

    Duodenal Mucosal Resurfacing (DMR), Duodenal Mucosal Resurfacing Sham (Sham)

    Type 2 Diabetes

    Enrollment
    9
    Start
    Sep 2018
    Primary Completion
    Aug 2020
    Completion
    Aug 2020
    NCT03653091
  • Not applicable
    Suspended

    Evaluation of the Efficacy and Safety of DMR Using the Revita® in Subjects With Inadequately Controlled Type 2 Diabetes

    Duodenal Mucosal Resurfacing (DMR), Duodenal Mucosal Resurfacing (Sham)

    Type 2 Diabetes

    Enrollment
    320
    Start
    Mar 2021
    Primary Completion
    Jan 2026est.
    Completion
    Jan 2026est.
    NCT04419779
  • Observational
    Suspended

    A Prospective Study to Evaluate Revita DMR Post Market Pilot Clinical Follow-Up Registry in Patient With Type 2 Diabetes

    Duodenal Mucosal Resurfacing (DMR)

    Diabetes Mellitus, Type 2

    Enrollment
    100
    Start
    Jun 2023
    Primary Completion
    Jul 2028est.
    Completion
    Dec 2028est.
    NCT06256497
  • Not applicable
    Active, not recruiting

    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

    Revita Duodenal Mucosal Resurfacing (DMR), Sham

    Obesity, Weight Change Trajectory +1

    Enrollment
    315
    Start
    Sep 2024
    Primary Completion
    Feb 2027est.
    Completion
    Feb 2027est.
    NCT06484114
Search ClinicalTrials.gov for “Fractyl Health”