The mid-stage readout is one link in a chain of catalysts that analysts were watching for this year from Roche’s metabolic pipeline, which features assets from the $2.7 billion acquisition of Carmot Therapeutics as well as partner Zealand Pharma.
Roche’s injectable GLP-1/GIP dual receptor agonist enicepatide, the lead asset from the $2.7 billion buyout of Carmot Therapeutics in 2023, reduced blood glucose and body weight in patients with type 2 diabetes (T2D) who are overweight or have obesity during a Phase 2 clinical trial.
The reductions, which were the primary endpoints of the study, were dose dependent and clinically meaningful at 48 weeks, Roche said in a Tuesday release, though the pharma did not provide specific values for the placebo group.
The readout, which comes from the CT-388-104 trial, is one link in a chain of catalysts that analysts were watching for this year from Roche’s metabolic pipeline, which features Carmot assets as well as those from partner Zealand Pharma.
Patients who received the highest dose of enicepatide lowered HbA1c—a measure of blood sugar levels over time—by an average of 2.65% at 48 weeks, which Roche heralded as “best-in-disease glycemic control.” Patients who had poor glycemic control at the start of the study experienced a mean HbA1c reduction of 4.13%.
By the end of the term, 90% of patients in the high dose group had met the target HbA1c of 6.5% or lower, which is the diagnostic threshold for T2D, while 62% achieved normal blood sugar levels, or an HbA1c of lower than 5.7%. Both of these results indicate glycemic control in patients with T2D.
As for weight loss, enicepatide spurred a 15.5% mean reduction in body weight without a demonstrable plateau, Roche said.
Safety and tolerability were consistent with other incretin-based medicines, according to Roche, though 2% of patients in the treatment arm discontinued treatment compared to none in the placebo group.
Roche said the results show that enicepatide is “a differentiated molecule designed for potentially greater efficacy with a favorable safety profile.” Chief Medical Officer and Head of Global Product Development Levi Garraway was particularly impressed by the number of patients who achieved normalized glucose levels. The drug could enhance metabolic health in patients with T2D and prevent complications, he said in a statement.
Roche CEO Theresa Graham said the data support the rapid advancement of enicepatide, which is also being tested in two Phase 3 trials for chronic weight management called ENITH-1 and ENITH-2. The company also intends to start a late-stage study for the asset in glycemic control and cardiovascular outcomes in the first half of 2027.
Roche previously presented data for enicepatide at the American Diabetes Association (ADA) conference in May, showcasing the lack of plateau for patients with obesity or overweight who lost weight when taking the high dose in the Phase 2 CT388-103 trial. The company suggested that more weight loss could be possible with higher and longer dosing.
“While enicepatide’s weight loss was significant (22.7% at 48 weeks of treatment), we maintain that Lilly’s retatrutide is likely to remain the preferred high-efficacy weight loss agent at this time (~24% weight loss at the same time point),” BMO Capital Markets wrote in July about the data presented to date.
Roche, which is years behind incumbents Novo and Eli Lilly in weight loss, is trying to show that enicepatide can be differentiated.
Besides enicepatide, analysts such as William Blair are watching for data on Roche’s Zealand-partnered petrelintide, a once-weekly injectable amylin drug. That asset is being combined with enicepatide in some studies as well.
