Roche reports positive data from mid-stage trial of experimental obesity drug Roche reports encouraging on Novel obesity drug Enicepatide weekly injections led to an average 15.5% reduction in body weight and also offered dramatic benefits for blood sugar among adults with type 2 diabetes and overweight or obesity.
The findings are from a Phase II study named CT-388-104 of enicepatide in a 447 adults. “The most recent data from this trial demonstrated that the 24-mg dose achieved both primary study endpoints, demonstrating clinically relevant HbA1c and body weight reductions in anti-diabetic effects of enicepatide following 48 weeks of dosing, ” said Roche.
Significant Weight Loss After 48 Weeks
Roche observed weight loss averaging 15.5% among subjects given the highest dose of 24 mg after 48 weeks. Roche also noted that weight loss was not yet stable at the end of the study (point at which all data is collected), implying that the participants continued to lose weight when they were measured at 48 weeks.
This is mainly impressive as the research was conducted on those individuals who had both type 2 diabetes and obese or overweight. It is difficult to treat obesity in individuals who already have diabetes as it is necessary to optimise the body’s weight and blood sugar together.
Enicepatide is a once-weekly injection Enicepatide is a dual GLP-1/GIP receptor agonist, a type of drug, which acts on two class of hormones that will help to regulate appetite, blood sugar control and energy expenditure.
Strong Improvement in Blood Sugar
The blood sugar results were yet another element of the launch in: Roche announced that at a dose of 24 m g, the average decrease in HbA1c after 48 weeks was 2.65%. The average Hb A1c at baseline for this dose was 8.1%.
Based on Roche, 90% of patients on the highest dose achieved a HbA 1c of 6.5% or less, with a much larger 62% achieving a HbA 1c of less than 5.7% – a level in Roche’s own words within the range of normoglycemia.
In participants with in particular bad blood sugar levels pre-treatment (with a HbA1c reading of over 8.5%), the 24 mg dose resulted in an average of a 4.13% decrease in HbA1c at week 48.
How Enicepatide Works
Enicepatide (ex-CT-388) is a dual GLP-1/GIP agonist. The naturally occurring hormone signaling pathways are involved in the regulation of appetite and food consumption and glucose control.
The drug is given one a week via a subcutaneous injection. Roche’s developing the drug to treat obesity, type 2 diabetes and other cardiovascular conditions. The firm is also investigating possible combination studies of the drug within its expanding metabolic health portfolio.
The newly announced trial results are a further development of prior Phase II data. In January, Roche revealed that CT-388 achieved 22.5% placebo-adjusted weight loss at 48 weeks in a different phase II trial of people with obesity but no type 2 diabetes.
Side Effects Remain an Important Consideration
Like any other medicine in the class of incretins, gastrointestinal effects were among the most frequent side effects in the study. Roche said these was mostly mild to moderate and that there were no new safety risks.
