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

What Was Tested

In this phase 2 trial, researchers set out to test Semaglutide.

It had 12 arms (groups): Part A, Arm 1: Placebo (placebo comparator), one (active comparator), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 330 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Have a diagnosis of Type 2 diabetes mellitus (T2D) for at least 6 months before screening. Body mass index (BMI) ≥23.0 kg/m\^2 at screening.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Semaglutide group and the comparison group ran side by side rather than switching.

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2025-08-19 with completion listed for 2028-02-05.

It ran at 46 sites in United States (21), Spain (14), Poland (10) and Hungary (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): RO7795081 vs. Placebo: Change in Glycated Hemoglobin (HbA1c) from Baseline at Week 30 (time frame: Baseline to Week 30).

It also tracked 9 secondary outcomes, for example RO7795081 vs. Semaglutide (Part A): Change in HbA1c from Baseline at Week 30, Change in Fasting Plasma Glucose from Baseline at Week 30, Percent Change in Body Weight from Baseline at Week 30, Absolute Change in Body Weight (kg) from Baseline at Week 30, Incidence of Adverse Events (AEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs) and Number of Participants with Documented Hypoglycemia (Level 1, 2, or 3 per American Diabetes Association 2025).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 330 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.