WC45726: RO7795068 in Participants with Obesity or Overweight and Type 2 Diabetes (Enith 2)
Research type
Research Study
Full title
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 Administered to Participants With Obesity or Overweight and Type 2 Diabetes
IRAS ID
1013409
Contact name
Head of Clinical Trial Regulatory Management
Contact email
Sponsor organisation
F. Hoffmann-La Roche AG
Clinicaltrials.gov Identifier
Research summary
This Phase III study is addressing the need for effective, long-term treatments for chronic weight management, specifically in patients also living with Type 2 Diabetes Mellitus (T2DM). T2DM is a condition where the body doesn't use insulin properly, leading to high blood sugar levels. It often occurs in people who are overweight or obese. Over time, high blood sugar can cause serious health problems like heart disease, nerve damage, and kidney issues. Managing weight through diet, exercise, and sometimes medication can help control blood sugar levels and improve overall health.
The aim of this study is to find out if a new drug called RO7795068, taken once a week by injection, is safe and effective for people who are overweight or obese and have T2DM. The study will compare the effects of RO7795068 to a placebo to see if it helps improve their condition.
This is a randomized, double-blind, placebo-controlled study, meaning neither the participants nor the study doctors will know who is receiving the active drug or the placebo. There will be 3 RO7795068 treatment groups and 1 placebo group in the study, so there is a 3/4 chance of a participant receiving RO7795068 in this study,
People with type 2 diabetes and a body mass index (BMI) of 27 or higher who are 18 years or older can take part in the study if they meet certain criteria. They must be willing to follow the study rules, take the study medication, monitor their blood sugar, and have tried to lose weight through diet and exercise before without success.
The study will last approximately 79 weeks for each participant (which is about 1.5 years). This includes a screening period, a 72-week treatment period, and a safety follow-up period.
There will be approximately 73 participants recruited at 10 UK sites and 2000 participants worldwide.
The study is sponsored by F. Hoffmann- La Roche
Lay summary based on the WC45726 Protocol Number, Version 1, dated 24 September 2025.REC name
Wales REC 5
REC reference
26/WA/0048
Date of REC Opinion
11 May 2026
REC opinion
Further Information Favourable Opinion