Type 2 Diabetes MellitusPhase 2NCT07112872
A Study to Compare Different Doses of RO7795081 With Placebo or Semaglutide in People With Type 2 Diabetes
A Phase 2 study testing RO7795081 and Semaglutide in people with Type 2 Diabetes Mellitus, run by Hoffmann-La Roche at 46 sites in 4 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- RO7795081 and Semaglutide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 46 sitesin 4 countries
- Study dates
- 19 Aug 2025to 5 Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Have Type 1 diabetes (T1D), history of ketosis or hyperosmolar state/coma, or any other types of diabetes except T2D
- Have had 1 or more episodes of Level 3 hypoglycemia or has hypoglycemia unawareness within the 6 months prior to screening
- 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)
- Current treatment or treatment within 3 months of screening with any other anti-hyperglycemic medication except metformin or SGLT-2 inhibitors
- 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)
Show all 9Show fewer
- Have a known, clinically significant gastric emptying abnormality
- Have poorly controlled hypertension at screening, untreated renal artery stenosis, or evidence of labile blood pressure including symptomatic postural hypotension
- 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
Trial locations and contacts
46 sites in 4 countries.
46 sites in 4 countries
United States21 sites
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, 78731
Apex Mobile Clinical Research
Bellaire, Texas, 77401
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516
K2 Medical Research South Orlando, LLC
Clermont, Florida, 34711
Velocity Clinical Research
Dallas, Texas, 75230
Orange County Research Center
Lake Forest, California, 92630
NexGen Research
Lima, Ohio, 45801
Manassas Clinical Research Center
Manassas, Virginia, 20110
Clinical Research Associates
Nashville, Tennessee, 37203
Accellacare of Duly Health and Care
Oak Lawn, Illinois, 60453
Center for Diabetes, Obesity and Metabolism Inc
Pembroke Pines, Florida, 33024
Tristar Clinical Investigations
Philadelphia, Pennsylvania, 19114
Prospective Research Innovations Inc.
Rancho Cucamonga, California, 91730
Encompass Clinical Research
Spring Valley, California, 91978
Chrysalis Clinical Research
St. George, Utah, 84790
Accellacare of Piedmont Healthcare
Statesville, North Carolina, 28625
Arizona Liver Health - Tucson
Tucson, Arizona, 85712
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, 30291
Emerson Clinical Research Institute
Washington D.C., District of Columbia, 20009
Chase Medical Research
Waterbury, Connecticut, 06708-3346
Accellacare of Wilmington, LLC
Wilmington, North Carolina, 28401
Spain14 sites
Hospital Universitario A Coruna
A Coruña, LA Coruna, 15006
Centro Medico Teknon
Barcelona, 08022
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
Barcelona, 08036
Hospital Vithas Nisa Sevilla
Castilleja de la Cuesta, Granada, 41950
Complexo Hospitalario Universitario de Ferrol (CHUF)
Ferrol, LA Coruna, 15405
Hospital General Universitario Gregorio Maranon (HGUGM)
Madrid, 28007
Hospital Universitario Fundación Jimenez Díaz
Madrid, 28040
Hospital Regional Universitario de Malaga
Malaga, Madrid, 29011
Hospital Universitario Virgen de la Victoria
Málaga, Malaga, 29010
Instituto De Investigacion Marques De Valdecilla (IDIVAL)
Santander, Cantabria, 39008
Universidad de Sevilla - Hospital Universitario Virgen Macarena
Seville, Barcelona, 41009
Nuevas Tecnologias en Diabetes y Endocrinologia
Seville, 41003
Hospital Quironsalud Infanta Luisa
Seville, 41010
Poland10 sites
NZOZ Osteo-Medic s.c. A. Racewicz, J.Supronik
Bialystok, Podlaskie Voivodeship, 15-351
Centrum Medyczne INTERCOR Sp. z o.o.
Bydgoszcz, 85-605
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship, 80-546
Pro Familia Altera Sp z o.o.
Katowice, 40-648
ETG Lublin
Lublin, 20-412
Ekamed sp. z o.o.
Lublin, 20-718
NZOZ METABOLICA O?rodek Bada? Klinicznych
Tarnów, 33-100
ETG Warszawa
Warsaw, 02-677
Centrum Badan Klinicznych
Wroclaw, 51-162
ETG Zamosc
Zamość, 22-400
About this study
Official title: 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
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).
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- RO7795081, Semaglutide, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7795081Drug
Also called CT-996, RG6652
RO7795081 will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment period.
SemaglutideDrug
Semaglutide 14 mg will be taken orally QD, with up-titration as per label, during the 30-week treatment period.
PlaceboDrug
Placebo matching RO7795081 will be taken orally QD during the 30-week treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Part A, Arm 1: Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Part A, Arm 2: Semaglutide 14 mg | Active comparator | Not described Receives: Drug: Semaglutide |
| Part A, Arm 3: RO7795081 Dosing Regimen 1 | Experimental | Not described Receives: Drug: RO7795081 |
| Part A, Arm 4: RO7795081 Dosing Regimen 2 | Experimental | Not described Receives: Drug: RO7795081 |
| Part A, Arm 5: RO7795081 Dosing Regimen 3 | Experimental | Not described Receives: Drug: RO7795081 |
| Part A, Arm 6: RO7795081 Dosing Regimen 4 | Experimental | Not described Receives: Drug: RO7795081 |
| Part A, Arm 7: RO7795081 Dosing Regimen 5 | Experimental | Not described Receives: Drug: RO7795081 |
| Part A, Arm 8: RO7795081 Dosing Regimen 6 | Experimental | Not described Receives: Drug: RO7795081 |
| Part A, Arm 9: RO7795081 Dosing Regimen 7 | Experimental | Not described Receives: Drug: RO7795081 |
| Part B, Arm 1: Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Part B, Arm 2: RO7795081 Dosing Regimen A | Experimental | Not described Receives: Drug: RO7795081 |
| Part B, Arm 3: RO7795081 Dosing Regimen B | Experimental | Not described Receives: Drug: RO7795081 |
What is being measured
The primary outcome is the main question the study is designed to answer.
RO7795081 vs. Placebo: Change in Glycated Hemoglobin (HbA1c) from Baseline at Week 30
Measured: Baseline to Week 30
Secondary outcomes (9)
RO7795081 vs. Semaglutide (Part A): Change in HbA1c from Baseline at Week 30
Measured: Baseline to Week 30
Percentage of Participants with HbA1c <5.7%, ≤6.5%, and <7.0% at Week 30
Measured: Week 30
Change in Fasting Plasma Glucose from Baseline at Week 30
Measured: Baseline to Week 30
Percent Change in Body Weight from Baseline at Week 30
Measured: Baseline to Week 30
Absolute Change in Body Weight (kg) from Baseline at Week 30
Measured: Baseline to Week 30
Percentage of Participants Who Achieve ≥5%, ≥10%, or ≥15% Body Weight Reduction from Baseline at Week 30
Measured: Baseline and Week 30
Incidence of Adverse Events (AEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs)
Measured: From first dose until 28 days after the final dose of study treatment (34 weeks)
Number of Participants with Documented Hypoglycemia (Level 1, 2, or 3 per American Diabetes Association 2025)
Measured: From first dose until 28 days after the final dose of study treatment (34 weeks)
Plasma Concentrations of RO7795081 at Prespecified Timepoints
Measured: Predose on Day 1 and at prespecified timepoints until Week 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start19 Aug 2025
- Primary completion5 Feb 2028 (estimated)
- Study completion5 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112872
- Sponsor's protocol ID
- BP45703
- Other IDs
- 2024-520322-11-00
- Status last verified
- Sep 2026
- First submitted
- 1 Aug 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07112872
- Acronym / sponsor ID
- BP45703
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 19 Aug 2025 (actual)
- Primary completion
- 5 Feb 2028 (estimated)
- Study completion
- 5 Feb 2028 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Part A, Arm 1: Placebo | Placebo comparator | Drug: Placebo |
| Part A, Arm 2: Semaglutide 14 mg | Active comparator | Drug: Semaglutide |
| Part A, Arm 3: RO7795081 Dosing Regimen 1 | Experimental | Drug: RO7795081 |
| Part A, Arm 4: RO7795081 Dosing Regimen 2 | Experimental | Drug: RO7795081 |
| Part A, Arm 5: RO7795081 Dosing Regimen 3 | Experimental | Drug: RO7795081 |
| Part A, Arm 6: RO7795081 Dosing Regimen 4 | Experimental | Drug: RO7795081 |
| Part A, Arm 7: RO7795081 Dosing Regimen 5 | Experimental | Drug: RO7795081 |
| Part A, Arm 8: RO7795081 Dosing Regimen 6 | Experimental | Drug: RO7795081 |
| Part A, Arm 9: RO7795081 Dosing Regimen 7 | Experimental | Drug: RO7795081 |
| Part B, Arm 1: Placebo | Placebo comparator | Drug: Placebo |
| Part B, Arm 2: RO7795081 Dosing Regimen A | Experimental | Drug: RO7795081 |
| Part B, Arm 3: RO7795081 Dosing Regimen B | Experimental | Drug: RO7795081 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (9 listed)
- Have Type 1 diabetes (T1D), history of ketosis or hyperosmolar state/coma, or any other types of diabetes except T2D
- Have had 1 or more episodes of Level 3 hypoglycemia or has hypoglycemia unawareness within the 6 months prior to screening
- 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)
- Current treatment or treatment within 3 months of screening with any other anti-hyperglycemic medication except metformin or SGLT-2 inhibitors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RO7795081Also: CT-996, RG6652RO7795081 will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment period. | Drug | Part A, Arm 3: RO7795081 Dosing Regimen 1, Part A, Arm 4: RO7795081 Dosing Regimen 2, Part A, Arm 5: RO7795081 Dosing Regimen 3, Part A, Arm 6: RO7795081 Dosing Regimen 4, Part A, Arm 7: RO7795081 Dosing Regimen 5, Part A, Arm 8: RO7795081 Dosing Regimen 6, Part A, Arm 9: RO7795081 Dosing Regimen 7, Part B, Arm 2: RO7795081 Dosing Regimen A, Part B, Arm 3: RO7795081 Dosing Regimen B |
| SemaglutideSemaglutide 14 mg will be taken orally QD, with up-titration as per label, during the 30-week treatment period. | Drug | Part A, Arm 2: Semaglutide 14 mg |
| PlaceboPlacebo matching RO7795081 will be taken orally QD during the 30-week treatment period. | Drug | Part A, Arm 1: Placebo, Part B, Arm 1: Placebo |
Primary outcome
RO7795081 vs. Placebo: Change in Glycated Hemoglobin (HbA1c) from Baseline at Week 30
Time frame: Baseline to Week 30
9 secondary outcomes
RO7795081 vs. Semaglutide (Part A): Change in HbA1c from Baseline at Week 30
Time frame: Baseline to Week 30
Percentage of Participants with HbA1c <5.7%, ≤6.5%, and <7.0% at Week 30
Time frame: Week 30
Change in Fasting Plasma Glucose from Baseline at Week 30
Time frame: Baseline to Week 30
Percent Change in Body Weight from Baseline at Week 30
Time frame: Baseline to Week 30
Absolute Change in Body Weight (kg) from Baseline at Week 30
Time frame: Baseline to Week 30
Percentage of Participants Who Achieve ≥5%, ≥10%, or ≥15% Body Weight Reduction from Baseline at Week 30
Time frame: Baseline and Week 30
Incidence of Adverse Events (AEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs)
Time frame: From first dose until 28 days after the final dose of study treatment (34 weeks)
Number of Participants with Documented Hypoglycemia (Level 1, 2, or 3 per American Diabetes Association 2025)
Time frame: From first dose until 28 days after the final dose of study treatment (34 weeks)
Plasma Concentrations of RO7795081 at Prespecified Timepoints
Time frame: Predose on Day 1 and at prespecified timepoints until Week 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
46 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RO7795081 and Semaglutide in people with Type 2 Diabetes Mellitus, run by Hoffmann-La Roche at 46 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States, Spain, Poland, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RO7795081 vs. Placebo: Change in Glycated Hemoglobin (HbA1c) from Baseline at Week 30 (time frame: Baseline to Week 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.