Roche announced positive topline results from its Phase II clinical trial for CT-388, an investigational dual GLP-1/GIP receptor agonist for obesity. The study showed a statistically significant placebo-adjusted weight loss of 22.5% at 48 weeks for participants on the highest dose (24 mg), without reaching a weight loss plateau. For all participants, the placebo-adjusted weight loss was 18.3%. Notably, 54% of participants on the 24 mg dose achieved resolution of obesity (BMI <30 kg/m2) compared to 13% in the placebo group. The drug also showed a strong impact on blood sugar levels, with 73% of pre-diabetic participants on the 24 mg dose achieving normal blood glucose levels by week 48, compared to 7.5% in the placebo group.
The experimental drug, a once-weekly injection, also demonstrated a favorable safety and tolerability profile, consistent with its drug class. Most gastrointestinal-related adverse events were mild-to-moderate, and the discontinuation rate due to adverse events was low at 5.9% in the CT-388 arms versus 1.3% in the placebo arm. Roche's Chief Medical Officer, Levi Garraway, expressed confidence in the clinical development program, citing the robust weight loss and well-tolerated safety profile as it progresses to Phase III trials.
These results position Roche to challenge dominant rivals like Eli Lilly and Novo Nordisk in the lucrative obesity market, which analysts project could exceed $100 billion annually in the coming decade. While investors were initially lukewarm on the results due to the crowded market, the drug's efficacy and safety profile underscore Roche's efforts to catch up, showing results comparable to or exceeding some existing treatments. Roche is one of several large drugmakers, including AstraZeneca and Amgen, aiming to compete for a share of this rapidly expanding market.
