Current partner codePEPTIDESDE
NCT07112872·Phase 2·INTERVENTIONAL

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

Status

Active, not recruiting

Phase

Phase 2

Enrollment

240

Locations

50

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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).

Interventions

Treatment arms and agents.

DRUG

RO7795081

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

DRUG

Semaglutide

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

DRUG

Placebo

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

Timeline

From registration to results.

  1. First posted

    Aug 8, 2025

  2. Study start

    Aug 19, 2025

  3. Primary completion

    Nov 27, 2026

  4. Study completion

    Nov 27, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Jul 7, 2026

Outcomes

What the study measures.

Primary outcomes

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

Time frame · Baseline to Week 30

Secondary outcomes

RO7795081 vs. Semaglutide: 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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

Study locations

50 registered sites.

Hungary · Poland · Spain · United States. Showing up to 24 locations stored in the fast local snapshot.

Arizona Liver Health - Tucson

Tucson, Arizona, United States

Orange County Research Center

Lake Forest, California, United States

Prospective Research Innovations Inc.

Rancho Cucamonga, California, United States

Encompass Clinical Research

Spring Valley, California, United States

Chase Medical Research

Waterbury, Connecticut, United States

Emerson Clinical Research Institute

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

K2 Medical Research South Orlando, LLC

Clermont, Florida, United States

Center for Diabetes, Obesity and Metabolism Inc

Pembroke Pines, Florida, United States

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, United States

Accellacare of Duly Health and Care

Oak Lawn, Illinois, United States

Mercury Street Medical Group, PLLC

Butte, Montana, United States

Neurobehavioral Research, Inc.

Cedarhurst, New York, United States

Accellacare of Piedmont Healthcare

Statesville, North Carolina, United States

Accellacare of Wilmington, LLC

Wilmington, North Carolina, United States

NexGen Research

Lima, Ohio, United States

Tristar Clinical Investigations

Philadelphia, Pennsylvania, United States

Alliance for Multispecialty Research. LLC

Knoxville, Tennessee, United States

Clinical Research Associates

Nashville, Tennessee, United States

Texas Diabetes & Endocrinology, P.A.

Austin, Texas, United States

Apex Mobile Clinical Research

Bellaire, Texas, United States

Velocity Clinical Research

Dallas, Texas, United States

Velocity Clinical Research (Impact Research Institute)

Waco, Texas, United States

Chrysalis Clinical Research

St. George, Utah, United States

Manassas Clinical Research Center

Manassas, Virginia, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Semaglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.