A Study to Compare Different Doses of RO7795081 With a Placebo or Semaglutide in People With Type 2 Diabetes

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Hoffmann-La Roche
Study ID
NCT07112872
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • RO7795081 — DRUG
    RO7795081 will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment period.
  • Semaglutide — DRUG
    Semaglutide 14 mg will be taken orally QD, with up-titration as per label, during the 30-week treatment period.
  • Placebo — DRUG
    Placebo will be taken orally QD during the 30-week treatment period.

Study Details

This multicenter, randomized, double-blind, placebo- and open-label active comparator-controlled, parallel-group, dose-range-finding, Phase II study aims to evaluate the efficacy, tolerability, and safety of RO7795081 for glycemic control in adult participants with Type 2 diabetes mellitus (T2D).

Key Dates

Start date
Aug 19, 2025
Status verified
Apr 2026
Primary completion
Nov 27, 2026
Completion
Nov 27, 2026

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Arm 1: Placebo
  • Active Comparator: Arm 2: Semaglutide 14 mg
  • Experimental: Arm 3: RO7795081 Dosing Regimen 1
  • Experimental: Arm 4: RO7795081 Dosing Regimen 2
  • Experimental: Arm 5: RO7795081 Dosing Regimen 3
  • Experimental: Arm 6: RO7795081 Dosing Regimen 4
  • Experimental: Arm 7: RO7795081 Dosing Regimen 5
  • Experimental: Arm 8: RO7795081 Dosing Regimen 6
  • Experimental: Arm 9: RO7795081 Dosing Regimen 7

Primary Outcome Measure

RO7795081 vs. Placebo: Change in Glycated Hemoglobin (HbA1c) from Baseline at Week 30 [ Time Frame: Baseline to Week 30 ]

Locations (24)

FacilityCityStateZIPSite coordinators
Arizona Liver Health - TucsonTucsonArizona85712-
Orange County Research CenterLake ForestCalifornia92630-
Prospective Research Innovations Inc.Rancho CucamongaCalifornia91730-
Encompass Clinical ResearchSpring ValleyCalifornia91978-
Chase Medical ResearchWaterburyConnecticut06708-3346-
Emerson Clinical Research InstituteWashington D.C.District of Columbia20009-
K2 Medical Research South Orlando, LLCClermontFlorida34711-
Center for Diabetes, Obesity and Metabolism IncPembroke PinesFlorida33024-
Rophe Adult and Pediatric Medicine/SKYCRNGUnion CityGeorgia30291-
Accellacare of Duly Health and CareOak LawnIllinois60453-
Mercury Street Medical Group, PLLCButteMontana59701-
Neurobehavioral Research, Inc.CedarhurstNew York11516-
Accellacare of Piedmont HealthcareStatesvilleNorth Carolina28625-
Accellacare of Wilmington, LLCWilmingtonNorth Carolina28401-
NexGen ResearchLimaOhio45801-
Tristar Clinical InvestigationsPhiladelphiaPennsylvania19114-
Alliance for Multispecialty Research. LLCKnoxvilleTennessee37909-
Clinical Research AssociatesNashvilleTennessee37203-
Texas Diabetes & Endocrinology, P.A.AustinTexas78731-
Apex Mobile Clinical ResearchBellaireTexas77401-
Velocity Clinical ResearchDallasTexas75230-
Velocity Clinical Research (Impact Research Institute)WacoTexas76710-
Chrysalis Clinical ResearchSt. GeorgeUtah84790-
Manassas Clinical Research CenterManassasVirginia20110-

Find similar trials in Tucson, AZ

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Arizona Liver Health - Tucson· Tucson, AZOrange County Research Center· Lake Forest, CAProspective Research Innovations Inc.· Rancho Cucamonga, CAEncompass Clinical Research· Spring Valley, CAChase Medical Research· Waterbury, CTEmerson Clinical Research Institute· Washington D.C., DC

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