New diabetes pill shows promise in Mid-Stage trial
NCT ID NCT07112872
First seen Jun 26, 2026 · Last updated Jul 08, 2026 · Updated 3 times
Summary
This Phase 2 study tests a new once-daily pill called RO7795081 for people with type 2 diabetes. About 240 adults whose diabetes is not well controlled will take the drug, a placebo, or an existing medication (semaglutide) for 30 weeks. The main goal is to see if RO7795081 lowers blood sugar better than placebo and how it compares to semaglutide.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RO7795081 (an oral drug for blood sugar control)
- What this could lead to
- If successful, this could lead to a new once-daily pill to help manage blood sugar and weight in people with type 2 diabetes.
- What could go wrong
- This is an early Phase 2 trial with only 240 participants, so results may not apply to everyone. The drug may not work better than existing treatments or could have side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 240 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Aug 2025
- Expected to finish
-
Nov 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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) Exclusion Criteria: * 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) * 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
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Get notified about this study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Accellacare of Duly Health and Care
Oak Lawn, Illinois, 60453, United States
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Accellacare of Piedmont Healthcare
Statesville, North Carolina, 28625, United States
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Accellacare of Wilmington, LLC
Wilmington, North Carolina, 28401, United States
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Alliance for Multispecialty Research. LLC
Knoxville, Tennessee, 37909, United States
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Apex Mobile Clinical Research
Bellaire, Texas, 77401, United States
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Arizona Liver Health - Tucson
Tucson, Arizona, 85712, United States
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Center for Diabetes, Obesity and Metabolism Inc
Pembroke Pines, Florida, 33024, United States
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Centro Medico Teknon
Barcelona, 08022, Spain
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Centrum Badan Klinicznych
Wroclaw, 51-162, Poland
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Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship, 80-546, Poland
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Centrum Medyczne INTERCOR Sp. z o.o.
Bydgoszcz, 85-605, Poland
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Chase Medical Research
Waterbury, Connecticut, 06708-3346, United States
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Chrysalis Clinical Research
St. George, Utah, 84790, United States
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Clinical Research Associates
Nashville, Tennessee, 37203, United States
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Complexo Hospitalario Universitario de Ferrol (CHUF)
Ferrol, LA Coruna, 15405, Spain
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ETG Lublin
Lublin, 20-412, Poland
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ETG Warszawa
Warsaw, 02-677, Poland
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ETG Zamosc
Zamość, 22-400, Poland
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Ekamed sp. z o.o.
Lublin, 20-718, Poland
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Emerson Clinical Research Institute
Washington D.C., District of Columbia, 20009, United States
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Encompass Clinical Research
Spring Valley, California, 91978, United States
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Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
Barcelona, 08036, Spain
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Hospital Clinico Universitario de Valencia (Instituto de Investigacion Sanitaria INCLIVA)
Valencia, 46010, Spain
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Hospital General Universitario Gregorio Maranon (HGUGM)
Madrid, 28007, Spain
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Hospital Quironsalud Infanta Luisa
Seville, 41010, Spain
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Hospital Regional Universitario de Malaga
Malaga, Madrid, 29011, Spain
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Hospital Universitario A Coruna
A Coruña, LA Coruna, 15006, Spain
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Hospital Universitario Fundación Jimenez Díaz
Madrid, 28040, Spain
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Hospital Universitario Vall d'Hebron
Barcelona, 08035, Spain
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Hospital Universitario Virgen de la Victoria
Málaga, Malaga, 29010, Spain
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Hospital Vithas Nisa Sevilla
Castilleja de la Cuesta, Granada, 41950, Spain
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Instituto De Investigacion Marques De Valdecilla (IDIVAL)
Santander, Cantabria, 39008, Spain
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K2 Medical Research South Orlando, LLC
Clermont, Florida, 34711, United States
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Manassas Clinical Research Center
Manassas, Virginia, 20110, United States
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Mercury Street Medical Group, PLLC
Butte, Montana, 59701, United States
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NZOZ METABOLICA O?rodek Bada? Klinicznych
Tarnów, 33-100, Poland
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NZOZ Osteo-Medic s.c. A. Racewicz, J.Supronik
Bialystok, Podlaskie Voivodeship, 15-351, Poland
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Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516, United States
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NexGen Research
Lima, Ohio, 45801, United States
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Nuevas Tecnologias en Diabetes y Endocrinologia
Seville, 41003, Spain
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Obudai Egeszsegugyi Centrum Kft.
Budapest, 1036, Hungary
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Orange County Research Center
Lake Forest, California, 92630, United States
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Pro Familia Altera Sp z o.o.
Katowice, 40-648, Poland
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Prospective Research Innovations Inc.
Rancho Cucamonga, California, 91730, United States
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Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, 30291, United States
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Texas Diabetes & Endocrinology, P.A.
Austin, Texas, 78731, United States
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Tristar Clinical Investigations
Philadelphia, Pennsylvania, 19114, United States
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Universidad de Sevilla - Hospital Universitario Virgen Macarena
Seville, Barcelona, 41009, Spain
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Velocity Clinical Research
Dallas, Texas, 75230, United States
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Velocity Clinical Research (Impact Research Institute)
Waco, Texas, 76710, United States
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