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NCT07112872Active, not recruitingPhase 2

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

A Randomized, Double-Blind, Placebo- and Open-Label Active Comparator- Controlled, Parallel-Group, Multi-Center Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of Once-Daily RO7795081 Administered for 30 Weeks to Participants With Type 2 Diabetes Mellitus

Source: ClinicalTrials.gov · Last updated 1 Oct 2026

Brief summary (registry, in English)

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 different doses of RO7795081 for glycemic control in adult participants with Type 2 diabetes mellitus (T2D).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
330 (estimated)
First submitted
1 Aug 2025
Start date
19 Aug 2025
Primary completion date
5 Feb 2028
Lead sponsor
Hoffmann-La Roche
NCT number
NCT07112872
EU CT number
2024-520322-11-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 330
  • From 19 Aug 2025 to the primary completion date, 5 Feb 2028
  • 53 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Have had 1 or more episodes of Level 3 hypoglycemia or has hypoglycemia unawareness within the 6 months prior to screening
  • Current treatment or treatment within 3 months of screening with any other anti-hyperglycemic medication except metformin or SGLT-2 inhibitors
  • Have any of the following cardiovascular conditions within 3 months prior to screening: Acute myocardial infarction; Cerebrovascular accident (stroke)/transient ischemic attack; Unstable angina; Hospitalization due to congestive heart failure

Other illness

  • Have Type 1 diabetes (T1D), history of ketosis or hyperosmolar state/coma, or any other types of diabetes except T2D
  • Have obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin-4 receptor deficiency or Prader-Willi Syndrome)
  • Have poorly controlled hypertension at screening, untreated renal artery stenosis, or evidence of labile blood pressure including symptomatic postural hypotension

Other

  • History or presence of proliferative diabetic retinopathy, diabetic macular edema, or non-proliferative diabetic retinopathy that requires acute treatment
  • Evidence of clinically significant/active nephropathy or neuropathy (including resting tachycardia, orthostatic hypotension, and diabetic diarrhea)
  • Have a known, clinically significant gastric emptying abnormality

Who the study is looking for

  • Have a diagnosis of Type 2 diabetes mellitus (T2D) for at least 6 months before screening
  • Have an HbA1c ≥7% and ≤10.5% at screening
  • Management of T2D with diet and exercise alone or with either a stable dose of metformin or/and sodium-glucose cotransporter-2 (SGLT-2) inhibitors
  • Body mass index (BMI) ≥23.0 kg/m\^2 at screening
  • A stable body weight within 3 months prior to screening (maximum 5% self-reported body weight gain and/or loss)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (53)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Complexo Hospitalario Universitario A Coruña
Coordinator of this site? Confirm its status
A CoruñaSpainActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainActive, not recruiting
Centro Medico Teknon - Grupo Quironsalud
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BarcelonaSpainActive, not recruiting
Hospital Nisa Sevilla Aljarafe
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Castilleja De La CuestaSpainActive, not recruiting
Area Sanitaria De Ferrol
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FerrolSpainActive, not recruiting
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainActive, not recruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainActive, not recruiting
Hospital Universitario Regional de Málaga
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MálagaSpainActive, not recruiting
Hospital Universitario Virgen de la Victoria
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MálagaSpainActive, not recruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainActive, not recruiting
Hospital Universitario Virgen De La Macarena
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SevillaSpainActive, not recruiting
Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional
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SevillaSpainActive, not recruiting
Hospital Quironsalud Infanta Luisa
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SevillaSpainActive, not recruiting
Hospital Clinico Universitario de Valencia
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ValenciaSpainActive, not recruiting
Qualiclinic Kft.
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BudapestHungaryActive, not recruiting
Clinexpert Kft.
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Budapest IIIHungaryActive, not recruiting
Obudai Egeszseguegyi Centrum Kft.
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Budapest IIIHungaryActive, not recruiting
University of Debrecen
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DebrecenHungaryActive, not recruiting
Borbanya Praxis Egeszsegugyi Kft
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NyíregyházaHungaryActive, not recruiting
University of Szeged
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SzegedHungaryActive, not recruiting
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointézet
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SzolnokHungaryActive, not recruiting
Osteo Medic s.c. Artur Racewicz, Jerzy Supronik
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BiałystokPolandActive, not recruiting
Centrum Medyczne INTERCOR Sp. z o.o.
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BydgoszczPolandActive, not recruiting
Centrum Badan Klinicznych PI-House sp. z o.o.
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GdanskPolandActive, not recruiting
Pro Familia Altera Sp. z o.o.
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KatowicePolandActive, not recruiting
EKAMED sp. z o.o.
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LublinPolandActive, not recruiting
ETG Lublin Sp. z o.o.
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LublinPolandActive, not recruiting
Metabolica Sp. z o.o.
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TarnówPolandActive, not recruiting
Etg Warszawa Sp. z o.o.
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WarsawPolandActive, not recruiting
Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p.
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WroclawPolandActive, not recruiting
Etg Zamosc Sp. z o.o.
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ZamośćPolandActive, not recruiting
Texas Diabetes & Endocrinology, P.A.
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AustinUnited StatesUnknown status
Apex Mobile Clinical Research
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BellaireUnited StatesUnknown status
Neurobehavioral Research, Inc.
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CedarhurstUnited StatesUnknown status
K2 Medical Research South Orlando, LLC
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ClermontUnited StatesUnknown status
Velocity Clinical Research
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DallasUnited StatesUnknown status
Orange County Research Center
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Lake ForestUnited StatesUnknown status
NexGen Research
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LimaUnited StatesUnknown status
Manassas Clinical Research Center
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ManassasUnited StatesUnknown status
Clinical Research Associates
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NashvilleUnited StatesUnknown status
Accellacare of Duly Health and Care
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Oak LawnUnited StatesUnknown status
Center for Diabetes, Obesity and Metabolism Inc
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Pembroke PinesUnited StatesUnknown status
Tristar Clinical Investigations
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PhiladelphiaUnited StatesUnknown status
Prospective Research Innovations Inc
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Rancho CucamongaUnited StatesUnknown status
Encompass Clinical Research
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Spring ValleyUnited StatesUnknown status
Accellacare of Piedmont HealthCare
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StatesvilleUnited StatesUnknown status
Chrysalis Clinical Research
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St. GeorgeUnited StatesUnknown status
Arizona Liver Health - Tucson
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TucsonUnited StatesUnknown status
Rophe Adult and Pediatric Medicine/SKYCRNG
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Union CityUnited StatesUnknown status
Emerson Clinical Research Institute
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Washington D.C.United StatesUnknown status
Chase Medical Research
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WaterburyUnited StatesUnknown status
Accellacare of Wilmington, LLC
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WilmingtonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.