A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes

Part of paid clinical trials in Guntersville, Alabama.

Sponsor
Hoffmann-La Roche
Study ID
NCT07351058
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Placebo — COMBINATION_PRODUCT
    Placebo will be volume-matched and administered once weekly using an integrated drug-device combination product.
  • Enicepatide — COMBINATION_PRODUCT
    Enicepatide will be administered once weekly at the randomized dosing regimen using an integrated drug-device combination product.

Study Details

The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with placebo for weight management in participants with obesity or overweight and Type 2 diabetes mellitus (T2DM).

Key Dates

Start date
Mar 23, 2026
Status verified
May 2026
Primary completion
Aug 7, 2028
Completion
Aug 7, 2028

Study Design

Enrollment
1,600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Arm 1: Placebo
  • Experimental: Arm 2: Enicepatide Dosing Regimen 1
  • Experimental: Arm 3: Enicepatide Dosing Regimen 2
  • Experimental: Arm 4: Enicepatide Dosing Regimen 3

Primary Outcome Measure

Percent (%) Change from Baseline in Body Weight at Week 72 [ Time Frame: Baseline through Week 72 ]

Central Contacts

  • Reference Study ID Number: WC45726 https://forpatients.roche.com/
    888-662-6728 (U.S. Only)
    [email protected]
  • Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (28)

FacilityCityStateZIPSite coordinators
Lakeview Clinical ResearchGuntersvilleAlabama35976-
Arizona Clinical TrialsTucsonArizona85711-
Orange County Research CenterLake ForestCalifornia92630-
Ark Clinical ResearchLong BeachCalifornia90815-
Catalina Research Institute, LLCMontclairCalifornia91763-
Prospective Research Innovations Inc.Rancho CucamongaCalifornia91730-
Encompass Clinical ResearchSpring ValleyCalifornia91978-
Emerson Clinical Research InstituteWashington D.C.District of Columbia20009-
Tampa Bay Medical Research, Inc.ClearwaterFlorida33761-
Center for Diabetes, Obesity and Metabolism IncPembroke PinesFlorida33024-
Progressive Medical ResearchPort OrangeFlorida32127-
Eirvera, LLCSt. PetersburgFlorida33711-
Centricity Research Columbus Georgia MultispecialtyColumbusGeorgia31904-
Rophe Adult and Pediatric Medicine/SKYCRNGUnion CityGeorgia30291-
Elevate Clinical ResearchLake CharlesLouisiana70605-
Centennial Medical GroupColumbiaMaryland21045-5840-
Centricity Research Morehead City MultispecialityMorehead CityNorth Carolina28557-
Remington Davis IncColumbusOhio43215-
Essential Medical ResearchTulsaOklahoma74137-
Coastal Carolina Research CenterNorth CharlestonSouth Carolina29405-
Circle Clinical ResearchSioux FallsSouth Dakota57104-
Velocity Clinical ResearchDallasTexas75230-
Juno Research, LLCHoustonTexas77040-
HRI ? Pasadena, LLCPasadenaTexas77505-
DM Clinical ResearchTomballTexas77375-
Manassas Clinical Research CenterManassasVirginia20110-
Centricity Research Suffolk Primary CareSuffolkVirginia23435-
Era Health ResearchRedmondWashington98052-

Find similar trials in Guntersville, AL

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Type 2 diabetes
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EndocrinologyMetabolic healthWeight loss
By research site
Lakeview Clinical Research· Guntersville, ALArizona Clinical Trials· Tucson, AZOrange County Research Center· Lake Forest, CAArk Clinical Research· Long Beach, CACatalina Research Institute, LLC· Montclair, CAProspective Research Innovations Inc.· Rancho Cucamonga, CA

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