Roche GLP-1 produces “robust” weight loss in late-stage obesity trial

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New phase II findings uphold Roche’s once-weekly subcutaneous injectable, dual GLP-1/GIP receptor agonist (GLP1-RA) as a promising obesity contender.

Topline results from the CT388-103 study showed that a 24mg dose of CT-388 enabled 54 percent of participants to attain resolution of obesity.

The GLP-1 therapy provided a significant and clinically meaningful weight loss of 22.5 percent (efficacy estimand) in participants without reaching a weight loss plateau at 48 weeks.

At Week 48, 95.7 percent achieved a weight loss of greater than or equal to five percent, with 87 percent achieving this level to 10, 47.8 percent 20 percent, and 26.1 percent 30 percent.

The GLP-1/GIP receptor agonist also showed promising benefit in pre-diabetic patients. A total of 73 percent of these participants achieved normal blood glucose levels at Week 48. This statistic was 7.5 percent in the placebo group. 

Dr Levi Garraway, PhD, Roche’s Chief Medical Officer and Head of Global Product Development, said: “We are pleased to see such meaningful weight loss in people treated with CT-388. The robust weight loss combined with a well-tolerated safety profile reinforces our confidence in the clinical development programme as we advance to phase III trials.” 

CT-388 is an important asset for “unlocking the promise of our obesity pipeline”, according to Roche, who added that the treatment is considered as a combination asset for petrelintide, an amylin analogue.

CT-388 is also being investigated in an additional phase II study (CT388-104) to evaluate CT-388 in obesity or those with excess weight and have type 2 diabetes.

These new clinical findings from Roche add to further developments in the GLP-1 space. Last month Pfizer paid a $2 billion license agreement for China-based manufacturer YaoPharma’s GLP-1 drug. Last November the pharmaceutical giant agreed a $10 billion acquisition of the obesity-focused biopharma company Metsera, beating fellow market competitor Novo Nordisk after a lengthy contention.