Clinical trial

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

Active, not recruiting · Phase 2 · 4 countries · Registry ID NCT07112872

Active, not recruitingPhase 2Interventional

What this study is about

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 RO7795081 for glycemic control in adult participants with Type 2 diabetes mellitus (T2D).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionType 2 Diabetes Mellitus

Full registry criteria

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

Treatments and study arms

RO7795081

Drug

RO7795081 will be taken orally once daily (QD), according to the randomized dosing regimen, during the 30-week treatment period.

Semaglutide

Drug

Semaglutide 14 mg will be taken orally QD, with up-titration as per label, during the 30-week treatment period.

Placebo

Drug

Placebo will be taken orally QD during the 30-week treatment period.

Primary outcomes

RO7795081 vs. Placebo: Change in Glycated Hemoglobin (HbA1c) from Baseline at Week 30Baseline to Week 30

Study locations

50 locations were listed when this page was built. The first 40 are shown.

Obudai Egeszsegugyi Centrum Kft.🇭🇺 Budapest, Hungary
NZOZ Osteo-Medic s.c. A. Racewicz, J.Supronik🇵🇱 Bialystok, Podlaskie Voivodeship, Poland
Centrum Medyczne INTERCOR Sp. z o.o.🇵🇱 Bydgoszcz, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.🇵🇱 Gdansk, Pomeranian Voivodeship, Poland
Pro Familia Altera Sp z o.o.🇵🇱 Katowice, Poland
ETG Lublin🇵🇱 Lublin, Poland
Ekamed sp. z o.o.🇵🇱 Lublin, Poland
NZOZ METABOLICA O?rodek Bada? Klinicznych🇵🇱 Tarnów, Poland
ETG Warszawa🇵🇱 Warsaw, Poland
Centrum Badan Klinicznych🇵🇱 Wroclaw, Poland
ETG Zamosc🇵🇱 Zamość, Poland
Hospital Universitario A Coruna🇪🇸 A Coruña, LA Coruna, Spain
Centro Medico Teknon🇪🇸 Barcelona, Spain
Hospital Clinic de Barcelona (Hospital Clinic i Provincial)🇪🇸 Barcelona, Spain
Hospital Universitario Vall d'Hebron🇪🇸 Barcelona, Spain
Hospital Vithas Nisa Sevilla🇪🇸 Castilleja de la Cuesta, Granada, Spain
Complexo Hospitalario Universitario de Ferrol (CHUF)🇪🇸 Ferrol, LA Coruna, Spain
Hospital General Universitario Gregorio Maranon (HGUGM)🇪🇸 Madrid, Spain
Hospital Universitario Fundación Jimenez Díaz🇪🇸 Madrid, Spain
Hospital Regional Universitario de Malaga🇪🇸 Malaga, Madrid, Spain
Hospital Universitario Virgen de la Victoria🇪🇸 Málaga, Malaga, Spain
Instituto De Investigacion Marques De Valdecilla (IDIVAL)🇪🇸 Santander, Cantabria, Spain
Hospital Quironsalud Infanta Luisa🇪🇸 Seville, Spain
Nuevas Tecnologias en Diabetes y Endocrinologia🇪🇸 Seville, Spain
Universidad de Sevilla - Hospital Universitario Virgen Macarena🇪🇸 Seville, Barcelona, Spain
Hospital Clinico Universitario de Valencia (Instituto de Investigacion Sanitaria INCLIVA)🇪🇸 Valencia, Spain
Texas Diabetes & Endocrinology, P.A.🇺🇸 Austin, Texas, United States
Apex Mobile Clinical Research🇺🇸 Bellaire, Texas, United States
Mercury Street Medical Group, PLLC🇺🇸 Butte, Montana, United States
Neurobehavioral Research, Inc.🇺🇸 Cedarhurst, New York, United States
K2 Medical Research South Orlando, LLC🇺🇸 Clermont, Florida, United States
Velocity Clinical Research🇺🇸 Dallas, Texas, United States
Alliance for Multispecialty Research. LLC🇺🇸 Knoxville, Tennessee, United States
Orange County Research Center🇺🇸 Lake Forest, California, United States
NexGen Research🇺🇸 Lima, Ohio, United States
Manassas Clinical Research Center🇺🇸 Manassas, Virginia, United States
Clinical Research Associates🇺🇸 Nashville, Tennessee, United States
Accellacare of Duly Health and Care🇺🇸 Oak Lawn, Illinois, United States
Center for Diabetes, Obesity and Metabolism Inc🇺🇸 Pembroke Pines, Florida, United States
Tristar Clinical Investigations🇺🇸 Philadelphia, Pennsylvania, United States