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Roche's Enicepatide Shows Weight Loss, HbA1c Gains in Phase II Study
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Key Takeaways
Roche's enicepatide delivered dose-dependent HbA1c and weight reductions at 48 weeks in T2D patients.
At 24 mg, enicepatide cut HbA1c 2.65% and body weight 15.5%, with no weight-loss plateau.
Roche is advancing two phase III weight-management studies and plans glycemic and cardiovascular trials.
Roche (RHHBY - Free Report) reported encouraging top-line results from a mid-stage study of enicepatide (CT-388), its investigational once-weekly dual GLP-1/GIP receptor agonist, in adults with type 2 diabetes (T2D) and overweight or obesity.
Enicepatide met both primary endpoints at 48 weeks, delivering dose-dependent reductions in HbA1c and body weight.
The encouraging results strengthen Roche’s prospects of establishing a foothold in the rapidly expanding obesity and metabolic disease market.
Year to date, shares of Roche have risen 9.8% compared with the industry’s rise of 7%.
Image Source: Zacks Investment Research
More on RHHBY’s Obesity Study Results
Enicepatide is an investigational once-weekly subcutaneous injectable, dual-biased GLP-1/GIP receptor agonist in development for the treatment of obesity, T2D and additional cardiovascular indications.
The CT-388-104 study is a randomized, double-blind, placebo-controlled, parallel-group, multi-center phase II study evaluating the efficacy, safety and tolerability of once-weekly enicepatide administered subcutaneously for 48 weeks in 447 adults living with type 2 diabetes mellitus and overweight or obesity. The dual primary outcomes are – changes from baseline in HbA1c and body weight at week 48.
At the highest titrated dose of 24 mg, enicepatide reduced HbA1c by 2.65% from a baseline of 8.1%. About 90% of patients achieved an HbA1c of 6.5% or lower, while 62% reached normoglycemia, with HbA1c below 5.7%. Mean body-weight loss was 15.5% at 48 weeks, with no evidence of a plateau.
In patients with poor baseline glycemic control (HbA1c >8.5%), enicepatide 24 mg led to an HbA1c reduction of 4.13% at 48 weeks.
The efficacy profile is encouraging as Roche seeks to compete in the increasingly crowded incretin market, which includes established therapies from Eli Lilly (LLY - Free Report) and Novo Nordisk (NVO - Free Report) .
The drug was generally well tolerated, with adverse events primarily consisting of mild-to-moderate gastrointestinal effects. Discontinuations due to adverse events were low at 2.0% in the enicepatide groups versus 0% for placebo. Enicepatide’s dual GLP-1/GIP mechanism and biased signaling approach could potentially differentiate it from existing treatments.
Roche is advancing a broad late-stage development program for enicepatide, with two ongoing phase III studies in chronic weight management (ENITH-1 and ENITH-2). The company plans to initiate a phase III glycemic-control program and cardiovascular outcomes trials in the first half of 2027.
While the phase II data strengthen the prospects of enicepatide, its eventual commercial opportunity will depend on phase III efficacy and safety results, differentiation from competing incretin therapies and Roche’s ability to establish a competitive position in the obesity market.
Apart from enicepatide, RHHBY’s obesity pipeline includes petrelintide, an investigational long-acting amylin analog suitable for once-weekly subcutaneous administration.
The drug is being co-developed with Zealand Pharma expanding Roche’s exposure to the high-growth obesity therapeutics market.
Per the deal with ZEAL, the two companies are co-developing petrelintide, Zealand Pharma’s amylin analog, as a standalone therapy as well as a fixed-dose combination with CT-388.
Eli Lilly currently leads the obesity market with its tirzepatide-based dual GLP-1/GIP receptor agonists, Mounjaro and Zepbound.
LLY’s arch rival Novo Nordisk also commands a strong position with its semaglutide-based GLP-1 therapies, Ozempic and Wegovy, which are used to treat type 2 diabetes and obesity.
With LLY and NVO deriving a significant portion of their revenues from cardiometabolic medicines, Roche faces an uphill battle to gain meaningful market share despite its expanding late-stage pipeline.
Update on Roche’s Susvimo
Roche also announced that the European Commission has approved Susvimo (ranibizumab 100 mg/mL solution for injection) for the treatment of neovascular age-related macular degeneration (nAMD).
Susvimo uses the Contivue refillable ocular implant to continuously deliver ranibizumab into the eye, offering patients an alternative to frequent standard-of-care eye injections. It is the first and only continuous-delivery treatment approved for nAMD in Europe.
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Roche's Enicepatide Shows Weight Loss, HbA1c Gains in Phase II Study
Key Takeaways
Roche (RHHBY - Free Report) reported encouraging top-line results from a mid-stage study of enicepatide (CT-388), its investigational once-weekly dual GLP-1/GIP receptor agonist, in adults with type 2 diabetes (T2D) and overweight or obesity.
Enicepatide met both primary endpoints at 48 weeks, delivering dose-dependent reductions in HbA1c and body weight.
The encouraging results strengthen Roche’s prospects of establishing a foothold in the rapidly expanding obesity and metabolic disease market.
Year to date, shares of Roche have risen 9.8% compared with the industry’s rise of 7%.
Image Source: Zacks Investment Research
More on RHHBY’s Obesity Study Results
Enicepatide is an investigational once-weekly subcutaneous injectable, dual-biased GLP-1/GIP receptor agonist in development for the treatment of obesity, T2D and additional cardiovascular indications.
The CT-388-104 study is a randomized, double-blind, placebo-controlled, parallel-group, multi-center phase II study evaluating the efficacy, safety and tolerability of once-weekly enicepatide administered subcutaneously for 48 weeks in 447 adults living with type 2 diabetes mellitus and overweight or obesity. The dual primary outcomes are – changes from baseline in HbA1c and body weight at week 48.
At the highest titrated dose of 24 mg, enicepatide reduced HbA1c by 2.65% from a baseline of 8.1%. About 90% of patients achieved an HbA1c of 6.5% or lower, while 62% reached normoglycemia, with HbA1c below 5.7%. Mean body-weight loss was 15.5% at 48 weeks, with no evidence of a plateau.
In patients with poor baseline glycemic control (HbA1c >8.5%), enicepatide 24 mg led to an HbA1c reduction of 4.13% at 48 weeks.
The efficacy profile is encouraging as Roche seeks to compete in the increasingly crowded incretin market, which includes established therapies from Eli Lilly (LLY - Free Report) and Novo Nordisk (NVO - Free Report) .
The drug was generally well tolerated, with adverse events primarily consisting of mild-to-moderate gastrointestinal effects. Discontinuations due to adverse events were low at 2.0% in the enicepatide groups versus 0% for placebo.
Enicepatide’s dual GLP-1/GIP mechanism and biased signaling approach could potentially differentiate it from existing treatments.
Roche is advancing a broad late-stage development program for enicepatide, with two ongoing phase III studies in chronic weight management (ENITH-1 and ENITH-2). The company plans to initiate a phase III glycemic-control program and cardiovascular outcomes trials in the first half of 2027.
While the phase II data strengthen the prospects of enicepatide, its eventual commercial opportunity will depend on phase III efficacy and safety results, differentiation from competing incretin therapies and Roche’s ability to establish a competitive position in the obesity market.
Apart from enicepatide, RHHBY’s obesity pipeline includes petrelintide, an investigational long-acting amylin analog suitable for once-weekly subcutaneous administration.
The drug is being co-developed with Zealand Pharma expanding Roche’s exposure to the high-growth obesity therapeutics market.
Per the deal with ZEAL, the two companies are co-developing petrelintide, Zealand Pharma’s amylin analog, as a standalone therapy as well as a fixed-dose combination with CT-388.
Eli Lilly currently leads the obesity market with its tirzepatide-based dual GLP-1/GIP receptor agonists, Mounjaro and Zepbound.
LLY’s arch rival Novo Nordisk also commands a strong position with its semaglutide-based GLP-1 therapies, Ozempic and Wegovy, which are used to treat type 2 diabetes and obesity.
With LLY and NVO deriving a significant portion of their revenues from cardiometabolic medicines, Roche faces an uphill battle to gain meaningful market share despite its expanding late-stage pipeline.
Update on Roche’s Susvimo
Roche also announced that the European Commission has approved Susvimo (ranibizumab 100 mg/mL solution for injection) for the treatment of neovascular age-related macular degeneration (nAMD).
Susvimo uses the Contivue refillable ocular implant to continuously deliver ranibizumab into the eye, offering patients an alternative to frequent standard-of-care eye injections. It is the first and only continuous-delivery treatment approved for nAMD in Europe.
RHHBY’s Zacks Rank
Roche currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.