Roche (USOTC:RHHBY) has reported positive results from a mid-stage clinical trial of its experimental obesity treatment enicepatide, with patients who have type 2 diabetes achieving average weight loss of 15.5% alongside improvements in blood sugar control.
The Swiss pharmaceutical company said the once-weekly injectable treatment met both primary endpoints in the study, which evaluated its effects on body weight and glycated haemoglobin (HbA1c) levels over 48 weeks.
The findings support Roche’s development programme as it seeks to enter the obesity treatment market, where Eli Lilly and Novo Nordisk currently hold leading positions.
Enicepatide Meets Primary Endpoints at 48 Weeks
Patients receiving the highest dose of enicepatide, 24 milligrams, achieved average weight loss of 15.5% during the 48-week trial.
The treatment also reduced HbA1c levels, meeting the study’s other primary endpoint.
HbA1c measures average blood glucose levels over approximately two to three months and is commonly used to assess diabetes management.
Roche reported that approximately 62% of patients achieved HbA1c levels below 5.7%, placing their blood glucose measurements within the non-diabetic range.
These results indicate that enicepatide may offer benefits for both weight management and glycaemic control in patients with type 2 diabetes, although the treatment remains investigational.
Dual-Hormone Treatment Targets Appetite and Blood Sugar
Enicepatide is a once-weekly injection designed to mimic the activity of two hormones involved in metabolic regulation: glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP).
The treatment is intended to reduce appetite and improve blood sugar regulation through its dual-hormone mechanism.
Roche is developing the drug as part of its expansion into the obesity treatment market, competing with established manufacturers Eli Lilly and Novo Nordisk, as well as companies including AstraZeneca and Amgen that are developing their own therapies.
Discontinuation Rate Remains Low in 447-Patient Study
The Phase 2 trial enrolled 447 patients with type 2 diabetes.
Approximately 2% of participants receiving enicepatide discontinued treatment because of adverse events, compared with no patients in the placebo group.
Most gastrointestinal side effects were classified as mild to moderate, according to Roche.
The company did not provide a detailed breakdown of individual adverse events in the reported results.
The findings offer preliminary information on the drug’s tolerability, with larger Phase 3 studies needed to further assess its safety and efficacy.
Previous Trial Showed 22.7% Weight Loss Without Diabetes
The latest results follow separate Phase 2 findings announced by Roche in June.
In that study, enicepatide helped participants with overweight or obesity who did not have diabetes achieve average weight loss of 22.7%.
The two trials evaluated different patient populations, meaning their weight-loss results are not directly comparable.
Together, the studies provide additional clinical data on enicepatide’s potential use in obesity treatment, including among patients with type 2 diabetes.
Phase 3 Studies Planned for First Half of 2027
Roche plans to begin late-stage studies evaluating glycaemic control and cardiovascular outcomes in the first half of 2027.
The planned trials will further investigate enicepatide’s efficacy and safety as the company advances its obesity and diabetes development programme.
Enicepatide has not yet received regulatory approval, and its potential commercial availability will depend on the results of further clinical testing and regulatory review.