CT-388 is an investigational once-weekly subcutaneous injectable, dual GLP-1\/GIP receptor agonist being developed for the treatment of obesity, type 2 diabetes, and other obesity-related comorbidities.<\/p>\n
Trial Data<\/p>\n
The 469-patient trial was designed to evaluate the efficacy and safety of CT-388 at low, middle, and high doses.<\/p>\n
It includes adults with obesity (BMI\u226530.0 kg\/m2) or overweight (BMI \u226527.0 and <30.0 kg\/m2) with at least one weight-related comorbidity without type 2 diabetes, and evaluated five dosing cohorts with different up-titration schemes, with 24mg being the highest dose tested.<\/p>\n
The primary endpoint was the percent change in body weight from baseline to week 48.<\/p>\n
The study found<\/a> that once-weekly subcutaneous injections of CT-388 (titrated up to 24 mg) resulted in significant and clinically meaningful placebo-adjusted weight loss of 22.5% (efficacy estimand) without reaching a weight loss plateau at 48 weeks.<\/p>\n A clear dose-response relationship for weight loss was observed.<\/p>\n For the treatment regimen estimand, the placebo-adjusted weight loss achieved with CT-388 was 18.3% (p-value < 0.001).<\/p>\n At week 48 for the 24 mg dose, 95.7% of CT-388-treated participants achieved a weight loss of over 5%, 87% achieved over 10%, 47.8% achieved more than 20%, and 26.1% achieved over 30%.<\/p>\n 73% of participants who were pre-diabetic at baseline and treated with CT-388 at 24 mg achieved normal blood glucose levels at week 48 compared to 7.5% in the placebo group.\u00a0<\/p>\n The treatment was well-tolerated, with the majority of gastrointestinal-related adverse events being mild-to-moderate, generally consistent with the incretin class of medicines.<\/p>\n In addition, the treatment discontinuation rate due to adverse events was low (5.9% in CT-388 arms; 1.3% in placebo arm).<\/p>\n Why It Matters<\/p>\n The therapy entered Roche\u2019s pipeline through its 2023 acquisition of Carmot Therapeutics<\/a>.<\/p>\n Since integrating CT-388 into its pipeline, Roche said it has designated it as a fast-track asset and significantly accelerated its clinical development.<\/p>\n CT-388 is currently being investigated in an additional Phase 2 study<\/a> (CT388-104) of CT-388 in obese participants who have type 2 T2D diabetes.<\/p>\n The phase 3 clinical trial program of CT-388 in obesity (Enith1 and Enith2) is expected to start this quarter.<\/p>\n Roche on Tuesday said in addition to offering robust efficacy as a standalone therapy, CT-388\u00a0 also plays a key role in unlocking the promise obesity pipeline and is considered a combination asset for petrelintide<\/a>.<\/p>\n