Roche Holding AG's experimental obesity drug enicepatide delivered promising results in a mid-stage clinical trial for type 2 diabetes patients. According to the latest announcement, 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. The company stated that weight loss had not yet reached a plateau by the end of the study. Chief Medical Officer and Head of Global Product Development Levi Garraway emphasized that "combined with sustained weight loss, enicepatide offers a potential best-in-disease profile capable of reducing and preventing complications as well as enhancing metabolic health for people living with type 2 diabetes." The trial, CT-388-104, was a randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of once-weekly enicepatide administered subcutaneously for 48 weeks in 447 adults living with T2DM and overweight or obesity.
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. As reported by Bloomberg, the approach is similar to Eli Lilly's Zepbound, positioning 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 showed a relatively low rate of treatment discontinuation linked to side effects, with only 2.0% of participants stopping treatment for that reason by the 48-week mark, compared to discontinuation rates of 5% to 24.5% in a shorter mid-stage trial of Lilly's Mounjaro among patients with diabetes. The most common side effects in the new trial are predominantly mild-to-moderate gastrointestinal effects, with only 0.0% taking a placebo discontinuing.
According to Roche, the company is advancing a broad late-stage development program for enicepatide, including two ongoing Phase III studies in chronic weight management (ENITH-1 and ENITH-2) and plans to initiate a Phase III glycemic-control program and cardiovascular outcomes trials in the first half of 2027. The company is also preparing to study higher doses of enicepatide and combinations with other weight-loss medicines. Teresa Graham, Roche's pharmaceuticals chief, stated that "these results reinforce our confidence in enicepatide and our ambition to rapidly advance its development for people living with obesity, diabetes, and cardiovascular disease." Roche gained enicepatide, previously known as CT-388, through its $3.1 billion acquisition of Carmot Therapeutics in 2023.
As reported by Bloomberg, 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 forecast approval by 2030 and estimated potential peak sales of about $4 billion. Bloomberg Intelligence analysts wrote in June that previous data suggested enicepatide is "as good as rivals on weight loss," with the drug expected to win approval by 2030 and could have peak sales of $4 billion.
