Roche, the Swiss pharmaceutical company, said its next-generation obesity treatment under development showed meaningful weight-loss effects in a clinical trial, and the company will move directly into a large-scale phase 3 study.
On the 27th (local time), Roche said its dual-acting obesity drug candidate CT-388 led to an average 22.5% weight reduction at the highest dose after 48 weeks of dosing in phase 2. Based on the results, the company plans to begin phase 3 within this quarter.
CT-388 is an injection that simultaneously stimulates two hormone receptors involved in appetite control and glucose metabolism (GLP-1 and GIP). It belongs to an obesity drug class drawing global attention recently and works in the same way as zepbound from Eli Lilly and Company.
The trial enrolled 469 adults with obesity or who were overweight. Participants received either a placebo (a dummy drug) or CT-388 by subcutaneous injection at three different doses. The primary endpoint compared the change in body weight at 48 weeks versus the start of dosing against the placebo group.
In the highest 24 mg dose group, the average weight-loss rate reached 22.5%. Based on the initial analysis alone, the level is similar to zepbound from Eli Lilly and Company, which showed a 20.9% weight reduction after 36 weeks of dosing.
Roche said that even under a conservative analysis that included patients who discontinued treatment, the CT-388 group saw an 18.3% weight reduction versus placebo. It added that a plateau effect, in which weight loss slows, did not appear at the 48-week mark.
Among patients in the high-dose group, 95.7% lost at least 5% of their weight, and 26.1% lost at least 30%.
Safety was regarded as relatively favorable. Roche plans to present the full data at a conference, but so far, most gastrointestinal side effects such as nausea and diarrhea have been mild to moderate, similar to reactions commonly seen with drugs in the same class.
However, the discontinuation rate among those given CT-388 was 5.9%, higher than the placebo group's 1.3%.
Levi Garraway, Roche's chief medical officer (CMO), said in a statement, "We are encouraged to see meaningful weight loss in patients treated with CT-388," adding, "The clear efficacy and favorable safety profile support our confidence to advance into phase 3."
Roche plans to initiate two phase 3 studies related to obesity within this quarter. At its Pharma Day event in September last year, the company unveiled a strategy to elevate itself to a top-three player in obesity treatment by making CT-388 a core asset. At the time, Roche also laid out a plan to expand its obesity treatments by combining its entire research and development pipeline.