Compare different doses of RO7795081 with a placebo or semaglutide in people with Type 2 Diabetes
Research type
Research Study
Full title
A RANDOMIZED, DOUBLE-BLIND, PLACEBO- AND OPEN-LABEL ACTIVE COMPARATOR-CONTROLLED, PARALLEL-GROUP, MULTICENTER PHASE II STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF ONCE-DAILY RO7795081 ADMINISTERED FOR 30 WEEKS TO PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS
IRAS ID
1012189
Contact name
Lynsey Kennedy
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Research summary
This trial is testing medications in participants with type 2 diabetes (T2D) who have difficulty controlling their blood sugar levels with diet & exercise alone or after treatment with certain drugs such as metformin. T2D is caused by the inability of insulin to properly control blood glucose & can be fatal if left untreated. T2D accounts for 95% of all diabetes cases worldwide & 88% of T2D sufferers are overweight or obese. Changes in lifestyle, diet & exercise can help T2D patients but there is a need for more assistance to help those patients who cannot control their T2D with these measures alone. The purpose of this clinical trial is to compare the effects (good or bad) of a drug called RO7795081 versus placebo or an approved drug called semaglutide in T2D. The trial will last up to 38 weeks including a screening period of up to 4 weeks (to check participants on the study are all suitable), a treatment period of 30 weeks when participants will receive either RO7795081, placebo, or semaglutide depending on the group they are randomly assigned to & a follow-up period of 4 weeks after treatment stops. The trial will be made up of male & female participants aged 18+ with diagnosed T2D. Participants will be randomly assigned to a treatment group which will mean they either receive RO7795081 at one of the 7 dosages being tested, semaglutide or a placebo, which looks exactly like RO7795081 but does not have an active effect. Participants have a 75% chance of being placed in a group receiving RO7795081, a 16.7% chance of placement in the placebo group & an 8.3% chance of being placed in the semaglutide group. Participants & their study doctors in the semaglutide group will be told that they are receiving semaglutide but the participants in the RO7795081 & placebo groups & their study doctors will not be informed of their assigned treatment.
REC name
Wales REC 5
REC reference
25/WA/0206
Date of REC Opinion
19 Aug 2025
REC opinion
Further Information Unfavourable Opinion