January 27, 2026
2 min read
Key takeaways:
- Adults receiving 24 mg of CT-388 achieved a placebo-adjusted weight loss of 22.5% according to the efficacy estimand.
- Of adults in the highest-dose group, 87% lost at least 10% of their body weight at 48 weeks.
A once-weekly injectable GIP/GLP-1 dual agonist conferred up to 22.5% weight loss at 48 weeks for adults with overweight or obesity, according to topline results from a phase 2 trial.
CT-388 (Roche) is an investigational incretin-based medication being developed for the treatment of obesity, type 2 diabetes and obesity-related comorbidities. In a phase 2, randomized, double-blind placebo-controlled trial, 469 adults with obesity or overweight with at least one weight-related comorbidity and without type 2 diabetes were randomly assigned to one of five CT-388 dosing cohorts or placebo for 48 weeks. The group receiving the highest dose was titrated up to 24 mg. Change in body weight from baseline to 48 weeks was the trial’s primary endpoint.
CT-388 conferred a placebo-adjusted weight loss of up to 22.5% at 48 weeks with a 24 mg dose in a phase 2 trial. Image: Adobe Stock
According to the efficacy estimand, adults receiving 24 mg CT-388 achieved a placebo-adjusted weight loss of 22.5% at 48 weeks. The placebo-adjusted weight loss for the 24 mg group according to the treatment-regimen estimand was 18.3% (P < .001).
Among the 24-mg dose group, 95.7% lost at least 5% of their body weight at 48 weeks, 87% achieved at least a 10% weight loss, 47.8% lost at least 20% of their body weight, and 26.1% had a weight loss of at least 30%.
Of those with prediabetes at baseline receiving 24 mg CT-388, 73% achieved normal glucose levels at 48 weeks vs. 7.5% of the placebo group.
According to the press release, CT-388 was well tolerated. Most gastrointestinal adverse events were mild or moderate and consistent with other incretin-based drugs. Of those receiving CT-388, 5.9% discontinued treatment due to adverse events compared with 1.3% of the placebo group.
“We are pleased to see such meaningful weight loss in people treated with CT-388,” Levi Garraway, MD, PhD, chief medical officer and head of global product development for Roche, said in a press release. “The robust weight loss combined with a well-tolerated safety profile reinforces our confidence in the clinical development program as we advance to phase 3 trials.”
According to the press release, full results from the phase 2 trial will be presented at an upcoming medical conference.
Sources/Disclosures
Source:
Press Release
Disclosures:
Garraway is an employee of Roche.
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