Clinical trial • Phase II • Endocrinology
RO7795081 for Type 2 diabetes mellitus
Phase II trial of RO7795081 for Type 2 diabetes mellitus.
Overview
- Trial Therapeutic Area
- Endocrinology
- Trial Disease
- Type 2 diabetes mellitus
- Trial Stage
- Phase II
- Drug Modality
- Small molecule|Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 19-05-2025
- First CTIS Authorization Date
- 05-09-2025
Trial design
Randomised, open-label, rybelsus (semaglutide) oral tablets: 1.5 mg, 3 mg, 4 mg, 7 mg, 9 mg, 14 mg (doses listed as comparator products). schedule not specified in the record.-controlled Phase II trial across 32 sites in Spain, Poland, Hungary.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Rybelsus (semaglutide) oral tablets: 1.5 mg, 3 mg, 4 mg, 7 mg, 9 mg, 14 mg (doses listed as comparator products). Schedule not specified in the record.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 162
- Trial Duration For Participant
- 210
Eligibility
Recruits 162 Vulnerable population selected (isVulnerablePopulationSelected: true). Subject information and informed consent forms available include age-specific/issue-specific documents such as L1_SIS-ICF_Infant_FP, L1_SIS-ICF_Infant_Health_FP, L1_SIS-ICF_Preg Participant_FP, genetic ICFs and main ICFs; recruitment/ICF process documents available in multiple country-specific packages (e.g. K1_Recruit-ICF process_en_FP, K1_Recruit-ICF process_pl_FP) indicating tailored consent materials for infants and genetic testing..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected: true). Subject information and informed consent forms available include age-specific/issue-specific documents such as L1_SIS-ICF_Infant_FP, L1_SIS-ICF_Infant_Health_FP, L1_SIS-ICF_Preg Participant_FP, genetic ICFs and main ICFs; recruitment/ICF process documents available in multiple country-specific packages (e.g. K1_Recruit-ICF process_en_FP, K1_Recruit-ICF process_pl_FP) indicating tailored consent materials for infants and genetic testing.
Inclusion criteria
- {"criterion_text":"- Have a diagnosis of T2D according to the WHO classification or other locally applicable standards for at least 6 months before screening\n- Have an HbA1c ≥ 7% and ≤ 10.5% at screening\n- 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 per approved local label. Participants on metformin, SGLT-2 inhibitor, or metformin and SGLT-2 inhibitors must be on a stable therapy for ≥ 3 months prior to the screening visit\n- BMI ≥ 23.0 kg/m2 at screening\n- Have had a stable body weight within 3 months prior to screening (maximum 5% self-reported body weight gain and/or loss)\n- Agreement to adhere to the contraception requirements"}
Exclusion criteria
- {"criterion_text":"- Have Type 1 diabetes (T1D), history of ketosis or hyperosmolar state/coma, or any other types of diabetes except T2D\n- Have had 1 or more episodes of Level 3 hypoglycemia or has hypoglycemia unawareness within the 6 months prior to screening. Any participant who the Investigator feels would not be able to communicate an understanding of hypoglycemic symptoms and the appropriate treatment of hypoglycemia should also be excluded\n- History or presence of proliferative diabetic retinopathy, diabetic macular edema, or non-proliferative diabetic retinopathy that requires acute treatment based on a dilated fundoscopic examination or with retinal photography as part of a quality assured diabetes retinal screening program (WHO 2020) performed within 12 months prior to screening. If the participant has not had a dilated fundoscopic examination or retinal photography within 12 months prior to screening, or if the Investigator believes further examination is required, then participants are allowed to have one performed during the screening period before randomization.\n- Evidence of clinically significant/active nephropathy or neuropathy (including resting tachycardia, orthostatic hypotension, and diabetic diarrhea)\n- Current treatment or treatment within 3 months of screening with any other anti-hyperglycemic medication except metformin or SGLT-2 inhibitors, including but not limited to insulin, dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide 1 (GLP-1) or GLP-1/ glucose-dependent insulinotropic polypeptide (GIP) receptor agonists (RAs), sulfonylurea, and amylin analogs"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change in HbA1c from baseline at Week 30","definition_or_measurement_approach":"Change from baseline in glycated hemoglobin (HbA1c) measured at Week 30"}
Secondary endpoints
- {"endpoint_text":"- Change in HbA1c from baseline at Week 30","definition_or_measurement_approach":"Change from baseline in HbA1c measured at Week 30"}
- {"endpoint_text":"- Percentage of participants with HbA1c < 5.7%, ≤ 6.5%, and < 7.0% at Week 30","definition_or_measurement_approach":"Proportion of participants meeting specified HbA1c thresholds measured at Week 30"}
- {"endpoint_text":"- Change in fasting plasma glucose from baseline at Week 30","definition_or_measurement_approach":"Change from baseline in fasting plasma glucose measured at Week 30"}
- {"endpoint_text":"- Percent (%) change in body weight from baseline at Week 30","definition_or_measurement_approach":"Percent change from baseline in body weight measured at Week 30"}
- {"endpoint_text":"- Absolute change in body weight (kg) from baseline at Week 30","definition_or_measurement_approach":"Absolute change in body weight in kilograms from baseline to Week 30"}
- {"endpoint_text":"- Percentage of participants who achieve ≥ 5%, ≥ 10%, or ≥ 15% body weight reduction at Week 30","definition_or_measurement_approach":"Proportion of participants achieving specified percent reductions in body weight at Week 30"}
- {"endpoint_text":"- Incidence of AEs, AESIs, and SAEs","definition_or_measurement_approach":"Incidence rates of adverse events (AEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) collected throughout the study"}
- {"endpoint_text":"- Number of participants with documented hypoglycemia (Level 1, 2, or 3 per ADA 2024)","definition_or_measurement_approach":"Count of participants with documented hypoglycemia events classified as Level 1, 2, or 3 according to ADA 2024 criteria"}
- {"endpoint_text":"- Change in safety laboratory values and vital signs","definition_or_measurement_approach":"Change from baseline in standard safety laboratory parameters and vital signs assessed during the study"}
- {"endpoint_text":"- Change in ECG parameters","definition_or_measurement_approach":"Change from baseline in electrocardiogram (ECG) parameters assessed during the study"}
- {"endpoint_text":"- Plasma concentrations of RO7795081","definition_or_measurement_approach":"Measurement of plasma concentrations of RO7795081 (pharmacokinetic sampling)"}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 162
- Recruitment Window Months
- 11
- Consent Approach
- Informed consent is documented using subject information and informed consent forms (multiple ICF documents listed). Age- and issue-specific consent materials are provided (e.g. L1_SIS-ICF_Main_FP, L1_SIS-ICF_Infant_FP, L1_SIS-ICF_Infant_Health_FP, L1_SIS-ICF_Preg Participant_FP, genetic ICFs). Recruitment/ICF process documents are available in multiple languages/country-specific packages (e.g. K1_Recruit-ICF process_en_FP, K1_Recruit-ICF process_pl_FP). Specifics on who signs (participant vs legal representative) are not detailed in the record, but age-specific ICFs indicate tailored consent materials for infants/other vulnerable groups.
Methods
- Country-specific recruitment materials and channels: brochures (K2_Brochure_FP), patient letters (K2_Patient Letter_FP), posters (K2_Poster_FP), flyers (K2_Flyer_FP), print advertisements (K2_Print Ad_FP), video scripts for recruitment videos (K2_Video Script_FP), and ICF flipbooks (K2_ICF Flipbook_FP). These materials are provided in country packages for Spain, Poland and Hungary (associatedEntityId entries for each country). Target audience: people with Type 2 diabetes.
Geography
- Total Number Of Sites
- 32
- Total Number Of Participants
- 74
Spain
- Earliest CTIS Part Ii Submission Date
- 12-08-2025
- Latest Decision Or Authorization Date
- 19-03-2026
- Processing Time Days
- 219
- Number Of Sites
- 15
- Number Of Participants
- 35
Sites
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Unidad de Endocrinología y Nutrición
- Principal Investigator Name
- Francisco José Tinahones Madueño
- Principal Investigator Email
- fjtinahones@uma.es
- Contact Person Name
- Francisco José Tinahones Madueño
- Contact Person Email
- fjtinahones@uma.es
- Site Name
- Hospital Nisa Sevilla Aljarafe
- Department Name
- Servicio de Endocrinología y Nutrición
- Principal Investigator Name
- Cristóbal Jesús Morales Portillo
- Principal Investigator Email
- moralespcj@vithas.es
- Contact Person Name
- Cristóbal Jesús Morales Portillo
- Contact Person Email
- moralespcj@vithas.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Servicio de Endocrinología y Nutrición
- Principal Investigator Name
- Andreea Ciudin Mihai
- Principal Investigator Email
- andreea.ciudin@vhir.org
- Contact Person Name
- Andreea Ciudin Mihai
- Contact Person Email
- andreea.ciudin@vhir.org
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- Servicio de Endocrinología y Nutrición
- Principal Investigator Name
- Alfonso Soto González
- Principal Investigator Email
- alfonso.soto.gonzalez@sergas.es
- Contact Person Name
- Alfonso Soto González
- Contact Person Email
- alfonso.soto.gonzalez@sergas.es
- Site Name
- Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional
- Principal Investigator Name
- Alberto Aliaga Verdugo
- Principal Investigator Email
- a.aliga@ntde.es
- Contact Person Name
- Alberto Aliaga Verdugo
- Contact Person Email
- a.aliga@ntde.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Servicio de Endocrinología y Nutrición
- Principal Investigator Name
- Antonio Jesús Amor Fernández
- Principal Investigator Email
- ajamor@clinic.cat
- Contact Person Name
- Antonio Jesús Amor Fernández
- Contact Person Email
- ajamor@clinic.cat
- Site Name
- Centro Medico Teknon-Grupo Quironsalud
- Department Name
- CPEN Endocrinologia i Nutrició
- Principal Investigator Name
- Guillem Cuatrecasas Cambra
- Principal Investigator Email
- gcuatrecasas@cpen.cat
- Contact Person Name
- Guillem Cuatrecasas Cambra
- Contact Person Email
- gcuatrecasas@cpen.cat
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Servicio de Endocrinología, Diabetes y Nutrición
- Principal Investigator Name
- Luis Alberto Vázquez Salvi
- Principal Investigator Email
- luisalberto.vazquez@scsalud.es
- Contact Person Name
- Luis Alberto Vázquez Salvi
- Contact Person Email
- luisalberto.vazquez@scsalud.es
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Servicio de Endocrinología y Nutrición
- Principal Investigator Name
- María Olga González Albarrán
- Principal Investigator Email
- ogonzaleza@salud.madrid.org
- Contact Person Name
- María Olga González Albarrán
- Contact Person Email
- ogonzaleza@salud.madrid.org
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Unidad de Endocrinología y Nutrición
- Principal Investigator Name
- María Asunción Martínez Brocca
- Principal Investigator Email
- masuncion.martinez.sspa@juntadeandalucia.es
- Contact Person Name
- María Asunción Martínez Brocca
- Contact Person Email
- masuncion.martinez.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Servicio de Endocrinología y Nutrición
- Principal Investigator Name
- Clotilde Vázquez Martínez
- Principal Investigator Email
- clotilde.vazquez@quironsalud.es
- Contact Person Name
- Clotilde Vázquez Martínez
- Contact Person Email
- clotilde.vazquez@quironsalud.es
- Site Name
- Hospital Quironsalud Infanta Luisa
- Department Name
- Servicio de Endocrinología
- Principal Investigator Name
- Margarita Rivas Fernández
- Principal Investigator Email
- unidaddediabetes.hil@quironsalud.es
- Contact Person Name
- Margarita Rivas Fernández
- Contact Person Email
- unidaddediabetes.hil@quironsalud.es
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Unidad de Gestión Clínica de Endocrinología y Nutrición
- Principal Investigator Name
- Gabriel Olveira Fuster
- Principal Investigator Email
- gabrielm.olveira.sspa@juntadeandalucia.es
- Contact Person Name
- Gabriel Olveira Fuster
- Contact Person Email
- gabrielm.olveira.sspa@juntadeandalucia.es
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Servicio de Endocrinología y Nutrición
- Principal Investigator Name
- Francisco Javier Ampudia Blasco
- Principal Investigator Email
- ampudia_fra@gva.es
- Contact Person Name
- Francisco Javier Ampudia Blasco
- Contact Person Email
- ampudia_fra@gva.es
- Site Name
- Area Sanitaria De Ferrol
- Department Name
- Servicio de Endocrinología y Nutrición
- Principal Investigator Name
- Diego Bellido Guerrero
- Principal Investigator Email
- diego.bellido.guerrero@sergas.es
- Contact Person Name
- Diego Bellido Guerrero
- Contact Person Email
- diego.bellido.guerrero@sergas.es
Poland
- Earliest CTIS Part Ii Submission Date
- 25-08-2025
- Latest Decision Or Authorization Date
- 23-03-2026
- Processing Time Days
- 210
- Number Of Sites
- 10
- Number Of Participants
- 33
Sites
- Site Name
- Osteo Medic s.c. Artur Racewicz, Jerzy Supronik
- Department Name
- NZOZ ZDROWIE ”OSTEO-MEDIC”
- Principal Investigator Name
- Katarzyna Wasilewska
- Principal Investigator Email
- osteo_medic_bial@op.pl
- Contact Person Name
- Katarzyna Wasilewska
- Contact Person Email
- osteo_medic_bial@op.pl
- Site Name
- Metabolica Sp. z o.o.
- Department Name
- Ośrodek Badań Klinicznych "METABOLICA" Lek. R. Witek
- Principal Investigator Name
- Robert Witek
- Principal Investigator Email
- robertwitek1@gmail.com
- Contact Person Name
- Robert Witek
- Contact Person Email
- robertwitek1@gmail.com
- Site Name
- ETG Lublin Sp. z o.o.
- Department Name
- ETG Lublin
- Principal Investigator Name
- Katarzyna Strawa-Zakościelna
- Principal Investigator Email
- k.zakoscielna@etg-network.com
- Contact Person Name
- Katarzyna Strawa-Zakościelna
- Contact Person Email
- k.zakoscielna@etg-network.com
- Site Name
- Etg Warszawa Sp. z o.o.
- Department Name
- ETG Warszawa
- Principal Investigator Name
- Agnieszka Tiuryn-Petrulewicz
- Principal Investigator Email
- warszawa@etg-network.com
- Contact Person Name
- Agnieszka Tiuryn-Petrulewicz
- Contact Person Email
- warszawa@etg-network.com
- Site Name
- Ekamed Sp. z o.o.
- Department Name
- Centrum Medyczne EKAMED
- Principal Investigator Name
- Ewa Szyprowska
- Principal Investigator Email
- ekamed@ekamed.pl
- Contact Person Name
- Ewa Szyprowska
- Contact Person Email
- ekamed@ekamed.pl
- Site Name
- Pro Familia Altera Sp. z o.o.
- Department Name
- Pro Familia Altera Poradnia Wielospecjalistyczna
- Principal Investigator Name
- Danuta Wrońska
- Principal Investigator Email
- dwronska@profamilia.katowice.pl
- Contact Person Name
- Danuta Wrońska
- Contact Person Email
- dwronska@profamilia.katowice.pl
- Site Name
- Centrum Medyczne Intercor Sp. z o.o.
- Department Name
- Centrum Medyczne „INTERCOR”
- Principal Investigator Name
- Roman Junik
- Principal Investigator Email
- ada.fiedorowicz@farmepo.com
- Contact Person Name
- Roman Junik
- Contact Person Email
- ada.fiedorowicz@farmepo.com
- Site Name
- Etg Zamosc Sp. z o.o.
- Department Name
- ETG Zamość
- Principal Investigator Name
- Katarzyna Wójcik
- Principal Investigator Email
- k.wojcik@etg-network.com
- Contact Person Name
- Katarzyna Wójcik
- Contact Person Email
- k.wojcik@etg-network.com
- Site Name
- Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.
- Department Name
- CBK Piotr Napora Lekarze sp.p. Centrum Badań Klinicznych Ośrodek Badań Wczesnej Fazy
- Principal Investigator Name
- Piotr Napora
- Principal Investigator Email
- napora.piotr@cbk.wroc.pl
- Contact Person Name
- Piotr Napora
- Contact Person Email
- napora.piotr@cbk.wroc.pl
- Site Name
- Centrum Badan Klinicznych Pi-House Sp. z o.o.
- Department Name
- Centrum Badań Klinicznych PI-House
- Principal Investigator Name
- Monika Łukaszewicz
- Principal Investigator Email
- pihouse@pihouse.pl
- Contact Person Name
- Monika Łukaszewicz
- Contact Person Email
- pihouse@pihouse.pl
Hungary
- Earliest CTIS Part Ii Submission Date
- 14-08-2025
- Latest Decision Or Authorization Date
- 19-03-2026
- Processing Time Days
- 217
- Number Of Sites
- 7
- Number Of Participants
- 6
Sites
- Site Name
- Clinexpert Kft.
- Department Name
- Clinexpert Óbuda Health Center
- Principal Investigator Name
- István Páll
- Principal Investigator Email
- pall_istvan@yahoo.com
- Contact Person Name
- István Páll
- Contact Person Email
- pall_istvan@yahoo.com
- Site Name
- University Of Debrecen
- Department Name
- Internal Medicine Clinic
- Principal Investigator Name
- Dénes Páll
- Principal Investigator Email
- pall.denes@unideb.hu
- Contact Person Name
- Dénes Páll
- Contact Person Email
- pall.denes@unideb.hu
- Site Name
- University Of Szeged
- Department Name
- Szent-Gyorgyi Albert Clinical Center, Internal Medicine Clinic Western Branch, Endocrinology
- Principal Investigator Name
- Róbert Takács
- Principal Investigator Email
- takacs.robert@med.u-szeged.hu
- Contact Person Name
- Róbert Takács
- Contact Person Email
- takacs.robert@med.u-szeged.hu
- Site Name
- Borbanya Praxis Egeszsegugyi Kft.
- Principal Investigator Name
- Szilárd Vasas
- Principal Investigator Email
- szilard.vasas@gmail.com
- Contact Person Name
- Szilárd Vasas
- Contact Person Email
- szilard.vasas@gmail.com
- Site Name
- Qualiclinic Kft.
- Principal Investigator Name
- Janos Tibor Kis
- Principal Investigator Email
- kis.janos.tibor.dr@gmail.com
- Contact Person Name
- Janos Tibor Kis
- Contact Person Email
- kis.janos.tibor.dr@gmail.com
- Site Name
- Obudai Egeszseguegyi Centrum Kft.
- Principal Investigator Name
- Viktor Vass
- Principal Investigator Email
- viktor.vass@oec.hu
- Contact Person Name
- Viktor Vass
- Contact Person Email
- viktor.vass@oec.hu
- Site Name
- Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
- Department Name
- Endocrinology
- Principal Investigator Name
- György Barta
- Principal Investigator Email
- barthagy@t-online.hu
- Contact Person Name
- György Barta
- Contact Person Email
- barthagy@t-online.hu
Sponsor
Primary sponsor
- Full Name
- F. Hoffmann-La Roche AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Icon Clinical Research Limited
- Responsibilities
- Global CRO
Third parties
- {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"Central Lab North America","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Central Lab Europe","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Switzerland","full_name":"F. Hoffmann-La Roche AG","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Labcorp Early Development Laboratories Limited","duties_or_roles":"Laboratory for analysis of PK samples","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"MicroCoat Biotechnologie GmbH","duties_or_roles":"Microcoat Biotechnologie GmbH, Biomarker Plasma /urine PD","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Global CRO","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Group Limited","duties_or_roles":"IxRS Provider","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Quest Diagnostics Nichols Institute Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"France","full_name":"Cerba","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- RO7795081
- Active Substance
- RO7795081
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Investigational / not authorised (no marketing authorisation listed)
- Investigational Product Name
- Rybelsus (semaglutide) — multiple tablet strengths
- Active Substance
- Semaglutide
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised (marketing authorisation numbers listed)
- Dose Levels
- 1.5 mg|3 mg|4 mg|7 mg|9 mg|14 mg
- Maximum Dose
- 14 mg (max daily dose amount listed)
- Investigational Product Name
- oral GLP-1R agonist (CT-996) Capsule, hard 0 mg / 1 EA - F10 (placebo)
- Modality
- Other
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