Patients given the highest 24-milligram dose recorded a 2.65 percentage-point decline in HbA1c, a key measure of blood glucose, while their average body weight fell 15.5% after 48 weeks, Roche said on Tuesday (September 22) in a statement seen by Bloomberg. The company said weight loss had not yet reached a plateau by the end of the study.
The results appear competitive with data from rival obesity treatments tested in Phase 3 trials, Goldman Sachs analysts led by James Quigley said. However, they noted that a clearer assessment will require placebo-adjusted results and confirmation in larger late-stage studies.
Roche shares slipped 0.6% in early trading in Zurich.
Roche takes aim at Lilly and Novo in obesity race
Enicepatide is designed as a once-weekly injection and targets two hormones, GLP-1 and GIP, that play a role in appetite, blood sugar and metabolism. The approach is similar to Eli Lilly’s Zepbound, putting Roche in competition with Lilly and Novo Nordisk in a weight-loss drug market that could eventually be worth as much as $150 billion globally.
The drug also showed a relatively low rate of treatment discontinuation linked to side effects. Only 2% of participants had stopped treatment for that reason by the 48-week mark. By comparison, discontinuation rates in a shorter mid-stage trial of Lilly’s Mounjaro among patients with diabetes ranged from 5% to 24.5%.
Roche already has two Phase 3 obesity studies under way. The company plans to broaden testing to patients with diabetes and assess cardiovascular outcomes in early 2027.
It is also preparing to study higher doses of enicepatide and combinations with other weight-loss medicines. Teresa Graham, Roche’s pharmaceuticals chief, said in July that the company was exploring both standalone and combination uses, particularly for patients seeking greater weight reduction or improved blood sugar control.
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From $3.1 billion acquisition to potential blockbuster
Roche gained enicepatide, previously known as CT-388, through its $3.1 billion acquisition of Carmot Therapeutics in 2023.
Vontobel analyst Stefan Schneider described the drug’s profile in patients with type 2 diabetes and obesity as competitive, citing sustained weight loss alongside meaningful improvements in glucose levels. He expects Roche could potentially launch the treatment as early as 2028, with peak sales reaching CHF2.5 billion ($3.05 billion).
Bloomberg Intelligence analysts Michael Shah and Christos Nikoletopoulos previously said in June that enicepatide appeared capable of delivering weight-loss results broadly comparable with rival drugs. They forecast approval by 2030 and estimated potential peak sales of about $4 billion.