Phase 2 Trial Success for Enicepatide
Roche’s dual GLP-1/GIP receptor agonist has met its primary endpoints in a phase 2 trial, putting it in a position to be a treatment for patients with type 2 diabetes and obesity.
One of the molecules Roche acquired as part of its $2.7 billion deal with Carmot Therapeutics is called enicepatide. Enicepatide, also known as CT-388, targets the same pathways as Eli Lilly’s drug Mounjaro and Zepbound. However, Roche has singled out the fact that enicepatide acts on two receptors as a point of difference, saying that it will have a long-lasting pharmacological action.
Roche released weight-loss results earlier this month, and it released results from another phase 2 trial. The most recent trial was conducted on patients with type 2 diabetes, unlike the previous study, which was a positive factor when considering the prospects for the injectable drug candidate beyond obesity.
Strong Glycemic Control Performance
Patients treated with the highest 24-mg dose of enicepatide per week for 48 weeks had a 2.65% reduction in HbA1C, a blood sugar level measurement. Roche viewed the result as a marker of the enicepatide’s best-in-class potential.
In its phase 3 trial of Mounjaro, Lilly reported up to 1.8% reductions in HbA1c levels at Week 40. In a phase 3 trial, HbA1c was reduced up to 1.94% in people who took retatrutide, Lilly’s investigational triple agonist, for 40 weeks. Novo announced (PDF) that Week 30 of its phase 3 Ozempic study showed a 1.6% decrease.
Other endpoints indicated that enicepatide is at least as effective as the competition, but comparisons between trials can be fallible. Notably, this is because Roche measured its endpoints eight weeks later than Lilly, so direct comparisons are not possible.
Taking that into account, up to 90% of the enicepatide patients achieved an HbA1c of 6.5% or lower, while up to 85% of those treated with retatrutide did. The difference was even wider when considering the patients with an HbA1C of 5.7% or lower, 62% of whom received enicepatide and 46% retatrutide.
Competitive Weight Loss Results
Weight loss on enicepatide is also found to be competitive with earlier observations in the obesity trial, which suggests that it is equally effective as other drugs. Roche said at the 48-week mark, the average weight loss in patients on the high dose of enicepatide was 15.5% and without a “plateau.” The absence of a plateau means that more weight loss may be achieved during extended trials. Lilly’s Week 40 weight loss results with retatrutide were up to 15.3%.
Roche has yet to share detailed safety and tolerability data. Consistent with other molecules in its class, enicepatide mostly caused mild-to-moderate gastrointestinal effects. The drug candidate group had 2% of patients who discontinued due to adverse events compared with 0% for the placebo group.
These data indicate that enicepatide can be competitive. However, the earlier obesity data also painted enicepatide as competitive but failed to quell analyst doubts about Roche’s place in the market. In a note to investors in July, BMO Capital Markets analysts noted that while enicepatide’s weight loss was notable, “Lilly’s retatrutide is likely to stay the go-to high-efficacy weight loss agent for now.”
Roche’s Phase 3 Expansion Strategy
Despite all of this, Roche, which has ambitions to become a “top three” obesity firm, is continuing to roll out a wide phase 3 program. The Swiss pharma is conducting three late-stage enicepatide obesity trials, two of which are worldwide and the third is focused on China. Roche plans to start a phase 3 glycemic-control program and cardiovascular outcomes trials in the first half of next year.
Enicepatide Shows Strong Phase 2 Diabetes Results
Roche’s Enicepatide has generated fresh interest after positive Phase 2 results in adults living with type 2 diabetes and overweight or obesity.
The latest clinical findings add to growing interest in dual incretin therapies that aim to address both blood glucose and excess body weight. The study evaluated adults with type 2 diabetes who were also overweight or living with obesity, providing data across multiple dose levels.
The reported improvements in HbA1c and body weight suggest that the treatment may have potential to address two closely connected metabolic challenges with a single weekly therapy. Roche also reported that reductions in body weight continued through the 48-week assessment period.
Safety and Tolerability
As with other medicines in the GLP-1 and GIP class, gastrointestinal adverse events were among the commonly reported side effects. Roche said most gastrointestinal events were mild or moderate, and discontinuation rates were relatively low across the study groups.
Longer and larger clinical studies will be important for understanding the treatment’s safety profile, durability of weight reduction and effectiveness in broader patient populations.
Competitive GLP-1 and GIP Landscape
The results arrive as pharmaceutical companies continue developing next-generation obesity and diabetes medicines.
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