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New diabetes pill shows promise in Mid-Stage trial

NCT ID NCT07112872

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

Anyone

Healthy volunteers

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

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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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

  • Accellacare of Duly Health and Care

    Oak Lawn, Illinois, 60453, United States

  • Accellacare of Piedmont Healthcare

    Statesville, North Carolina, 28625, United States

  • Accellacare of Wilmington, LLC

    Wilmington, North Carolina, 28401, United States

  • Alliance for Multispecialty Research. LLC

    Knoxville, Tennessee, 37909, United States

  • Apex Mobile Clinical Research

    Bellaire, Texas, 77401, United States

  • Arizona Liver Health - Tucson

    Tucson, Arizona, 85712, United States

  • Center for Diabetes, Obesity and Metabolism Inc

    Pembroke Pines, Florida, 33024, United States

  • Centro Medico Teknon

    Barcelona, 08022, Spain

  • Centrum Badan Klinicznych

    Wroclaw, 51-162, Poland

  • Centrum Badan Klinicznych PI-House sp. z o.o.

    Gdansk, Pomeranian Voivodeship, 80-546, Poland

  • Centrum Medyczne INTERCOR Sp. z o.o.

    Bydgoszcz, 85-605, Poland

  • Chase Medical Research

    Waterbury, Connecticut, 06708-3346, United States

  • Chrysalis Clinical Research

    St. George, Utah, 84790, United States

  • Clinical Research Associates

    Nashville, Tennessee, 37203, United States

  • Complexo Hospitalario Universitario de Ferrol (CHUF)

    Ferrol, LA Coruna, 15405, Spain

  • ETG Lublin

    Lublin, 20-412, Poland

  • ETG Warszawa

    Warsaw, 02-677, Poland

  • ETG Zamosc

    Zamość, 22-400, Poland

  • Ekamed sp. z o.o.

    Lublin, 20-718, Poland

  • Emerson Clinical Research Institute

    Washington D.C., District of Columbia, 20009, United States

  • Encompass Clinical Research

    Spring Valley, California, 91978, United States

  • Hospital Clinic de Barcelona (Hospital Clinic i Provincial)

    Barcelona, 08036, Spain

  • Hospital Clinico Universitario de Valencia (Instituto de Investigacion Sanitaria INCLIVA)

    Valencia, 46010, Spain

  • Hospital General Universitario Gregorio Maranon (HGUGM)

    Madrid, 28007, Spain

  • Hospital Quironsalud Infanta Luisa

    Seville, 41010, Spain

  • Hospital Regional Universitario de Malaga

    Malaga, Madrid, 29011, Spain

  • Hospital Universitario A Coruna

    A Coruña, LA Coruna, 15006, Spain

  • Hospital Universitario Fundación Jimenez Díaz

    Madrid, 28040, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen de la Victoria

    Málaga, Malaga, 29010, Spain

  • Hospital Vithas Nisa Sevilla

    Castilleja de la Cuesta, Granada, 41950, Spain

  • Instituto De Investigacion Marques De Valdecilla (IDIVAL)

    Santander, Cantabria, 39008, Spain

  • K2 Medical Research South Orlando, LLC

    Clermont, Florida, 34711, United States

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110, United States

  • Mercury Street Medical Group, PLLC

    Butte, Montana, 59701, United States

  • NZOZ METABOLICA O?rodek Bada? Klinicznych

    Tarnów, 33-100, Poland

  • NZOZ Osteo-Medic s.c. A. Racewicz, J.Supronik

    Bialystok, Podlaskie Voivodeship, 15-351, Poland

  • Neurobehavioral Research, Inc.

    Cedarhurst, New York, 11516, United States

  • NexGen Research

    Lima, Ohio, 45801, United States

  • Nuevas Tecnologias en Diabetes y Endocrinologia

    Seville, 41003, Spain

  • Obudai Egeszsegugyi Centrum Kft.

    Budapest, 1036, Hungary

  • Orange County Research Center

    Lake Forest, California, 92630, United States

  • Pro Familia Altera Sp z o.o.

    Katowice, 40-648, Poland

  • Prospective Research Innovations Inc.

    Rancho Cucamonga, California, 91730, United States

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City, Georgia, 30291, United States

  • Texas Diabetes & Endocrinology, P.A.

    Austin, Texas, 78731, United States

  • Tristar Clinical Investigations

    Philadelphia, Pennsylvania, 19114, United States

  • Universidad de Sevilla - Hospital Universitario Virgen Macarena

    Seville, Barcelona, 41009, Spain

  • Velocity Clinical Research

    Dallas, Texas, 75230, United States

  • Velocity Clinical Research (Impact Research Institute)

    Waco, Texas, 76710, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.