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

NCT07112872 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: BP457032024-520322-11-00
• Study Type: interventional
• Target: 240
• Locations: 4 countries
• Sites: 50

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

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

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

  Baseline to Week 30

Secondary Outcomes (9)

• RO7795081 vs. Semaglutide: Change in HbA1c from Baseline at Week 30

  Baseline to Week 30

• Percentage of Participants with HbA1c <5.7%, ≤6.5%, and <7.0% at Week 30

  Week 30

• Change in Fasting Plasma Glucose from Baseline at Week 30

  Baseline to Week 30

• Percent Change in Body Weight from Baseline at Week 30

  Baseline to Week 30

• Absolute Change in Body Weight (kg) from Baseline at Week 30

  Baseline to Week 30

Study Arms (9)

Arm 1: Placebo

PLACEBO COMPARATOR

Drug: Placebo

Arm 2: Semaglutide 14 mg

ACTIVE COMPARATOR

Drug: Semaglutide

Arm 3: RO7795081 Dosing Regimen 1

EXPERIMENTAL

Drug: RO7795081

Arm 4: RO7795081 Dosing Regimen 2

EXPERIMENTAL

Drug: RO7795081

Arm 5: RO7795081 Dosing Regimen 3

EXPERIMENTAL

Drug: RO7795081

Arm 6: RO7795081 Dosing Regimen 4

EXPERIMENTAL

Drug: RO7795081

Arm 7: RO7795081 Dosing Regimen 5

EXPERIMENTAL

Drug: RO7795081

Arm 8: RO7795081 Dosing Regimen 6

EXPERIMENTAL

Drug: RO7795081

Arm 9: RO7795081 Dosing Regimen 7

EXPERIMENTAL

Drug: RO7795081

Interventions

RO7795081 DRUG

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

Also known as: CT-996, RG6652

Arm 3: RO7795081 Dosing Regimen 1; Arm 4: RO7795081 Dosing Regimen 2; Arm 5: RO7795081 Dosing Regimen 3; Arm 6: RO7795081 Dosing Regimen 4; Arm 7: RO7795081 Dosing Regimen 5; Arm 8: RO7795081 Dosing Regimen 6; Arm 9: RO7795081 Dosing Regimen 7

Semaglutide DRUG

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

Arm 2: Semaglutide 14 mg

Placebo DRUG

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

Arm 1: Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (50)

Arizona Liver Health - Tucson

Tucson, Arizona, 85712, United States

Location

Orange County Research Center

Lake Forest, California, 92630, United States

Location

Prospective Research Innovations Inc.

Rancho Cucamonga, California, 91730, United States

Location

Encompass Clinical Research

Spring Valley, California, 91978, United States

Location

Chase Medical Research

Waterbury, Connecticut, 06708-3346, United States

Location

Emerson Clinical Research Institute

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

Location

K2 Medical Research South Orlando, LLC

Clermont, Florida, 34711, United States

Location

Center for Diabetes, Obesity and Metabolism Inc

Pembroke Pines, Florida, 33024, United States

Location

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, 30291, United States

Location

Accellacare of Duly Health and Care

Oak Lawn, Illinois, 60453, United States

Location

Mercury Street Medical Group, PLLC

Butte, Montana, 59701, United States

Location

Neurobehavioral Research, Inc.

Cedarhurst, New York, 11516, United States

Location

Accellacare of Piedmont Healthcare

Statesville, North Carolina, 28625, United States

Location

Accellacare of Wilmington, LLC

Wilmington, North Carolina, 28401, United States

Location

NexGen Research

Lima, Ohio, 45801, United States

Location

Tristar Clinical Investigations

Philadelphia, Pennsylvania, 19114, United States

Location

Alliance for Multispecialty Research. LLC

Knoxville, Tennessee, 37909, United States

Location

Clinical Research Associates

Nashville, Tennessee, 37203, United States

Location

Texas Diabetes & Endocrinology, P.A.

Austin, Texas, 78731, United States

Location

Apex Mobile Clinical Research

Bellaire, Texas, 77401, United States

Location

Velocity Clinical Research

Dallas, Texas, 75230, United States

Location

Velocity Clinical Research (Impact Research Institute)

Waco, Texas, 76710, United States

Location

Chrysalis Clinical Research

St. George, Utah, 84790, United States

Location

Manassas Clinical Research Center

Manassas, Virginia, 20110, United States

Location

Obudai Egeszsegugyi Centrum Kft.

Budapest, 1036, Hungary

Location

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

Bialystok, Podlaskie Voivodeship, 15-351, Poland

Location

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

Gdansk, Pomeranian Voivodeship, 80-546, Poland

Location

Centrum Medyczne INTERCOR Sp. z o.o.

Bydgoszcz, 85-605, Poland

Location

Pro Familia Altera Sp z o.o.

Katowice, 40-648, Poland

Location

ETG Lublin

Lublin, 20-412, Poland

Location

Ekamed sp. z o.o.

Lublin, 20-718, Poland

Location

NZOZ METABOLICA O?rodek Bada? Klinicznych

Tarnów, 33-100, Poland

Location

ETG Warszawa

Warsaw, 02-677, Poland

Location

Centrum Badan Klinicznych

Wroclaw, 51-162, Poland

Location

ETG Zamosc

Zamość, 22-400, Poland

Location

Universidad de Sevilla - Hospital Universitario Virgen Macarena

Seville, Barcelona, 41009, Spain

Location

Instituto De Investigacion Marques De Valdecilla (IDIVAL)

Santander, Cantabria, 39008, Spain

Location

Hospital Vithas Nisa Sevilla

Castilleja de la Cuesta, Granada, 41950, Spain

Location

Hospital Universitario A Coruna

A Coruña, LA Coruna, 15006, Spain

Location

Complexo Hospitalario Universitario de Ferrol (CHUF)

Ferrol, LA Coruna, 15405, Spain

Location

Hospital Regional Universitario de Malaga

Malaga, Madrid, 29011, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, Malaga, 29010, Spain

Location

centro Medico Teknon

Barcelona, 08022, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona (Hospital Clinic i Provincial)

Barcelona, 08036, Spain

Location

Hospital General Universitario Gregorio Maranon (HGUGM)

Madrid, 28007, Spain

Location

Hospital Universitario Fundación Jimenez Díaz

Madrid, 28040, Spain

Location

Nuevas Tecnologias en Diabetes y Endocrinologia

Seville, 41003, Spain

Location

Hospital Quironsalud Infanta Luisa

Seville, 41010, Spain

Location

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

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 8, 2025
• Study Start: August 19, 2025
• Primary Completion (Estimated): November 27, 2026
• Study Completion (Estimated): November 27, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (24); HU (1); PL (10); ES (15)