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

2024-520322-11-00 Protocol BP45703 Therapeutic exploratory (Phase II) Ongoing, recruitment ended

Start 29 Sep 2025 · Status Ongoing, recruitment ended · 3 EU/EEA countries · 32 sites · Protocol BP45703

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ongoing, recruitment ended
Participants planned 236
Countries 3
Sites 32

Type 2 Diabetes Mellitus (T2D)

To evaluate the effect of RO7795081, compared with placebo, on glycated hemoglobin (HbA1c)

Key facts

Sponsor
F. Hoffmann-La Roche AG
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Nutritional and Metabolic Diseases [C18]
Trial duration
29 Sep 2025 → ongoing
Decision date (initial)
2025-09-05
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
F. Hoffmann-La Roche Ltd

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Pharmacokinetic

To evaluate the effect of RO7795081, compared with placebo, on glycated hemoglobin (HbA1c)

Secondary objectives 4

  1. To evaluate the effect of RO7795081, compared with placebo and semaglutide, on glucose homeostasis parameters
  2. To evaluate the effect of RO7795081, compared with placebo and semaglutide, on body weight
  3. To evaluate the safety and tolerability of RO7795081
  4. To characterize the pharmacokinetics of RO7795081

Conditions and MedDRA coding

Type 2 Diabetes Mellitus (T2D)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

  1. Have a diagnosis of T2D according to the WHO classification or other locally applicable standards for at least 6 months before screening
  2. Have an HbA1c ≥ 7% and ≤ 10.5% at screening
  3. 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
  4. BMI ≥ 23.0 kg/m2 at screening
  5. Have had a stable body weight within 3 months prior to screening (maximum 5% self-reported body weight gain and/or loss)
  6. Agreement to adhere to the contraception requirements

Exclusion criteria 5

  1. Have Type 1 diabetes (T1D), history of ketosis or hyperosmolar state/coma, or any other types of diabetes except T2D
  2. 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
  3. 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.
  4. Evidence of clinically significant/active nephropathy or neuropathy (including resting tachycardia, orthostatic hypotension, and diabetic diarrhea)
  5. 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 and secondary outcome measures (English text)

Primary endpoints 1

  1. Change in HbA1c from baseline at Week 30

Secondary endpoints 11

  1. Change in HbA1c from baseline at Week 30
  2. Percentage of participants with HbA1c < 5.7%, ≤ 6.5%, and < 7.0% at Week 30
  3. Change in fasting plasma glucose from baseline at Week 30
  4. Percent (%) change in body weight from baseline at Week 30
  5. Absolute change in body weight (kg) from baseline at Week 30
  6. Percentage of participants who achieve ≥ 5%, ≥ 10%, or ≥ 15% body weight reduction at Week 30
  7. Incidence of AEs, AESIs, and SAEs
  8. Number of participants with documented hypoglycemia (Level 1, 2, or 3 per ADA 2024)
  9. Change in safety laboratory values and vital signs
  10. Change in ECG parameters
  11. Plasma concentrations of RO7795081

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

RO7795081

PRD12210540 · Product

Active substance
RO7795081
Other product name
CT-996
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
30 Week(s)
Authorisation status
Not Authorised
MA holder
F. HOFFMANN-LA ROCHE LTD
Paediatric formulation
No
Orphan designation
No

RO7795081

PRD12210541 · Product

Active substance
RO7795081
Other product name
CT-996
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
30 Week(s)
Authorisation status
Not Authorised
MA holder
F. HOFFMANN-LA ROCHE LTD
Paediatric formulation
No
Orphan designation
No

RO7795081

PRD12210542 · Product

Active substance
RO7795081
Other product name
CT-996
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
30 Week(s)
Authorisation status
Not Authorised
MA holder
F. HOFFMANN-LA ROCHE LTD
Paediatric formulation
No
Orphan designation
No

Comparator 6

Rybelsus 3 mg tablets

PRD7996056 · Product

Active substance
Semaglutide
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
14 mg milligram(s)
Max total dose
2940 mg milligram(s)
Max treatment duration
30 Week(s)
Authorisation status
Authorised
ATC code
A10BJ06 — -
Marketing authorisation
EU/1/20/1430/002
MA holder
NOVO NORDISK A/S
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Rybelsus 7 mg tablets

PRD7996059 · Product

Active substance
Semaglutide
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
14 mg milligram(s)
Max total dose
2940 mg milligram(s)
Max treatment duration
30 Week(s)
Authorisation status
Authorised
ATC code
A10BJ06 — -
Marketing authorisation
EU/1/20/1430/005
MA holder
NOVO NORDISK A/S
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Rybelsus 14 mg tablets

PRD7996062 · Product

Active substance
Semaglutide
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
14 mg milligram(s)
Max total dose
2940 mg milligram(s)
Max treatment duration
30 Week(s)
Authorisation status
Authorised
ATC code
A10BJ06 — -
Marketing authorisation
EU/1/20/1430/008
MA holder
NOVO NORDISK A/S
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Rybelsus 9 mg tablets

PRD11497591 · Product

Active substance
Semaglutide
Substance synonyms
NNC0113-0217
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
14 mg milligram(s)
Max total dose
2940 mg milligram(s)
Max treatment duration
30 Week(s)
Authorisation status
Authorised
ATC code
A10BJ06 — -
Marketing authorisation
EU/1/20/1430/026
MA holder
NOVO NORDISK A/S
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Rybelsus 1.5 mg tablets

PRD11497470 · Product

Active substance
Semaglutide
Substance synonyms
NNC0113-0217
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
14 mg milligram(s)
Max total dose
2940 mg milligram(s)
Max treatment duration
30 Week(s)
Authorisation status
Authorised
ATC code
A10BJ06 — -
Marketing authorisation
EU/1/20/1430/016
MA holder
NOVO NORDISK A/S
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Rybelsus 4 mg tablets

PRD11497509 · Product

Active substance
Semaglutide
Substance synonyms
NNC0113-0217
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
14 mg milligram(s)
Max total dose
2940 mg milligram(s)
Max treatment duration
30 Week(s)
Authorisation status
Authorised
ATC code
A10BJ06 — -
Marketing authorisation
EU/1/20/1430/021
MA holder
NOVO NORDISK A/S
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Placebo 1

oral GLP-1R agonist (CT-996) Capsule, hard 0 mg / 1 EA - F10

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

F. Hoffmann-La Roche AG

213 Total trials 63 Recruiting 141 Ended
Commercial
Sponsor organisation
F. Hoffmann-La Roche AG
Address
Grenzacherstrasse 124
City
Basel
Postcode
4058
Country
Switzerland

Scientific contact point

Organisation
F. Hoffmann-La Roche AG
Contact name
Trial Information System - TISL

Public contact point

Organisation
F. Hoffmann-La Roche AG
Contact name
Trial Information System - TISL

Third parties 9

OrganisationCity, countryDuties
Q Squared Solutions LLC
ORG-100043195
 Durham, United States Other, Laboratory analysis
Q Squared Solutions Limited
ORG-100042527
 Reading, United Kingdom Other, Laboratory analysis
F. Hoffmann-La Roche AG
ORG-100001445
 Basel, Switzerland Laboratory analysis
Labcorp Early Development Laboratories Limited
ORG-100011365
 Harrogate, United Kingdom Other, Laboratory analysis
MicroCoat Biotechnologie GmbH
ORG-100031937
 Bernried Am Starnberger See, Germany Other
Icon Clinical Research Limited
ORG-100008322
 Dublin 18, Ireland Other
Almac Group Limited
ORG-100011829
 Craigavon, United Kingdom (Northern Ireland) Other
Quest Diagnostics Nichols Institute Inc.
ORG-100012789
 San Juan Capistrano, United States Laboratory analysis
Cerba
ORG-100042812
 Frepillon, France Laboratory analysis

Locations

3 EU/EEA countries · 32 investigational sites

By country

CountryMS statusPlanned subjectsSites
Hungary Ongoing, recruitment ended 6 7
Poland Ongoing, recruitment ended 33 10
Spain Ongoing, recruitment ended 35 15
Rest of world
United Kingdom, Canada, United States
 — 162 —

Investigational sites

Hungary

7 sites · Ongoing, recruitment ended
Qualiclinic Kft.
N/A, Dereglye Utca 5 B, Ep I Em 3, Budapest
Obudai Egeszseguegyi Centrum Kft.
N/A, Lajos Utca 74-76, 1036, Budapest III
University Of Debrecen
Internal Medicine Clinic, Nagyerdei Korut 98, 4032, Debrecen
Borbanya Praxis Egeszsegugyi Kft.
N/A, Bazsalikom Utca 1/1, Borbanya, Nyiregyhaza
University Of Szeged
Szent-Gyorgyi Albert Clinical Center, Internal Medicine Clinic Western Branch, Endocrinology, Kalvaria Sugarut 57, 6725, Szeged
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
Endocrinology, Toszegi Ut 21, 5000, Szolnok
Clinexpert Kft.
Clinexpert Óbuda Health Center, Kaszasdulo Utca 5, 1033, Budapest III

Poland

10 sites · Ongoing, recruitment ended
Centrum Medyczne Intercor Sp. z o.o.
Centrum Medyczne „INTERCOR”, Ul. Kasztanowa 57, 85-605, Bydgoszcz
ETG Lublin Sp. z o.o.
ETG Lublin, Ul. Wladyslawa Kunickiego 26a, 20-412, Lublin
Etg Warszawa Sp. z o.o.
ETG Warszawa, Ul. Wynalazek 4, 02-677, Warsaw
Ekamed Sp. z o.o.
Centrum Medyczne EKAMED, Aleja Krasnicka 2j/u1, 20-718, Lublin
Etg Zamosc Sp. z o.o.
ETG Zamość, Ul. Gesia 3, 22-400, Zamosc
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.
CBK Piotr Napora Lekarze sp.p. Centrum Badań Klinicznych Ośrodek Badań Wczesnej Fazy, Ul. Ul. Jana Dlugosza 4, 51-162, Wroclaw
Pro Familia Altera Sp. z o.o.
Pro Familia Altera Poradnia Wielospecjalistyczna, Ul. Stanislawa Letowskiego 16 A, 40-648, Katowice
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Centrum Badań Klinicznych PI-House, Ul. Na Zaspe 3, 80-546, Gdansk
Osteo Medic s.c. Artur Racewicz, Jerzy Supronik
NZOZ ZDROWIE ”OSTEO-MEDIC”, Ul. Wiejska 81, 15-351, Białystok
Metabolica Sp. z o.o.
Ośrodek Badań Klinicznych "METABOLICA" Lek. R. Witek, Ul. Najswietszej Marii Panny 9b, 33-100, Tarnow

Spain

15 sites · Ongoing, recruitment ended
Hospital Universitario Marques De Valdecilla
Servicio de Endocrinología, Diabetes y Nutrición, Avenida Valdecilla Sn, 39008, Santander
Hospital General Universitario Gregorio Maranon
Servicio de Endocrinología y Nutrición, Calle Del Doctor Esquerdo 46, 28007, Madrid
Hospital Quironsalud Infanta Luisa
Servicio de Endocrinología, Calle De San Jacinto 87, 41010, Sevilla
Hospital Universitario Virgen De La Macarena
Unidad de Endocrinología y Nutrición, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Centro Medico Teknon-Grupo Quironsalud
CPEN Endocrinologia i Nutrició, Calle Vilana 12, 08022, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Servicio de Endocrinología y Nutrición, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Complexo Hospitalario Universitario A Coruna
Servicio de Endocrinología y Nutrición, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Universitario Regional De Malaga
Unidad de Gestión Clínica de Endocrinología y Nutrición, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital Clinico Universitario De Valencia
Servicio de Endocrinología y Nutrición, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Virgen De La Victoria
Unidad de Endocrinología y Nutrición, Campus De Teatinos Sn, Puerto De La Torre, Malaga
Hospital Nisa Sevilla Aljarafe
Servicio de Endocrinología y Nutrición, Avenida Placido Fernandez Viagas S/n, 41950, Castilleja De La Cuesta
Hospital Clinic De Barcelona
Servicio de Endocrinología y Nutrición, Calle Villarroel 170, 08036, Barcelona
Hospital Universitari Vall D Hebron
Servicio de Endocrinología y Nutrición, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Area Sanitaria De Ferrol
Servicio de Endocrinología y Nutrición, Avenida Residencia S/n, 15405, Ferrol
Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional
N/A, Calle Alejo Fernandez 9, 41003, Sevilla

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Hungary 2025-12-05 2026-02-09 2026-02-25
Poland 2025-09-29 2025-10-07 2026-03-31
Spain 2025-10-03 2025-10-13 2026-03-30

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 42 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) d1_protocol-2024-520322-11-00 redacted 4
Protocol (for publication) d4_Patient facing documents_placeholder 3
Recruitment arrangements (for publication) K1_Recruit-ICF process_en_FP N/A
Recruitment arrangements (for publication) K1_Recruit-ICF process_FP N/A
Recruitment arrangements (for publication) K1_Recruit-ICF process_pl_FP N/A
Recruitment arrangements (for publication) K2_Brochure_FP 1.0
Recruitment arrangements (for publication) K2_Brochure_FP 1.0
Recruitment arrangements (for publication) K2_Brochure_FP 1.0
Recruitment arrangements (for publication) K2_Flyer_FP 1.0
Recruitment arrangements (for publication) K2_Flyer_FP 1.0
Recruitment arrangements (for publication) K2_Flyer_FP 1.0
Recruitment arrangements (for publication) K2_ICF Flipbook_FP 1.0
Recruitment arrangements (for publication) K2_ICF Flipbook_FP 1.0
Recruitment arrangements (for publication) K2_ICF Flipbook_FP 1.0
Recruitment arrangements (for publication) K2_Patient Letter_FP 1.0
Recruitment arrangements (for publication) K2_Patient Letter_FP 1.0
Recruitment arrangements (for publication) K2_Patient Letter_FP 1.0
Recruitment arrangements (for publication) K2_Poster_FP 1.0
Recruitment arrangements (for publication) K2_Poster_FP 1.0
Recruitment arrangements (for publication) K2_Poster_FP 1.0
Recruitment arrangements (for publication) K2_Print Ad_FP 1.0
Recruitment arrangements (for publication) K2_Print Ad_FP 1.0
Recruitment arrangements (for publication) K2_Print Ad_FP 1.0
Recruitment arrangements (for publication) K2_Video Script_FP 0.3
Recruitment arrangements (for publication) K2_Video Script_FP 0.3
Recruitment arrangements (for publication) K2_Video Script_FP 0.3
Subject information and informed consent form (for publication) L1_SIS-ICF_Genetic ICF_FP 2.0
Subject information and informed consent form (for publication) L1_SIS-ICF_Genetic PIS_FP 2.0
Subject information and informed consent form (for publication) L1_SIS-ICF_Genetic_FP 1.0
Subject information and informed consent form (for publication) L1_SIS-ICF_Infant Health_FP 1.0
Subject information and informed consent form (for publication) L1_SIS-ICF_Infant_FP 1
Subject information and informed consent form (for publication) L1_SIS-ICF_Main_FP 6.0
Subject information and informed consent form (for publication) L1_SIS-ICF_Main_FP 6.0
Subject information and informed consent form (for publication) L1_SIS-ICF_Main_FP 4.1
Subject information and informed consent form (for publication) L1_SIS-ICF_PP_FP 1
Subject information and informed consent form (for publication) L1_SIS-ICF_Preg Participant_FP 2.0
Subject information and informed consent form (for publication) L2_Patient Emergency Card_FP 0.3
Summary of Product Characteristics (SmPC) (for publication) e2_smpc-SEMAGLUTIDE N/A
Synopsis of the protocol (for publication) d1_protocol-synopsis_ENG-2024-520322-11-00 1.0
Synopsis of the protocol (for publication) d1_protocol-synopsis_ES-2024-520322-11-00 1.0
Synopsis of the protocol (for publication) d1_protocol-synopsis_HU-2024-520322-11-00 1.0
Synopsis of the protocol (for publication) d1_protocol-synopsis_PL-2024-520322-11-00 1.0

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-05-19 Spain Acceptable
2025-09-04
 2025-09-05
2 SUBSTANTIAL MODIFICATION SM-1 2025-11-21 Spain Acceptable
2026-03-16
 2026-03-19

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