Roche Holdings AG (OTC:RHHBY) on Tuesday released topline results from the CT388-103 Phase 2 trial of CT-388 for obesity.
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.
Trial Data
The 469-patient trial was designed to evaluate the efficacy and safety of CT-388 at low, middle, and high doses.
It includes adults with obesity (BMI≥30.0 kg/m2) or overweight (BMI ≥27.0 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.
The primary endpoint was the percent change in body weight from baseline to week 48.
The study found 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.
A clear dose-response relationship for weight loss was observed.
For the treatment regimen estimand, the placebo-adjusted weight loss achieved with CT-388 was 18.3% (p-value < 0.001).
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%.
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.
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.
In addition, the treatment discontinuation rate due to adverse events was low (5.9% in CT-388 arms; 1.3% in placebo arm).
Why It Matters
The therapy entered Roche’s pipeline through its 2023 acquisition of Carmot Therapeutics.
Since integrating CT-388 into its pipeline, Roche said it has designated it as a fast-track asset and significantly accelerated its clinical development.
CT-388 is currently being investigated in an additional Phase 2 study (CT388-104) of CT-388 in obese participants who have type 2 T2D diabetes.
The phase 3 clinical trial program of CT-388 in obesity (Enith1 and Enith2) is expected to start this quarter.
Roche on Tuesday said in addition to offering robust efficacy as a standalone therapy, CT-388 also plays a key role in unlocking the promise obesity pipeline and is considered a combination asset for petrelintide.
In September 2025, Roche outlined its plan to become a leading player in the surging weight-loss drug market, pushing its obesity pipeline farther into late-stage development as it eyes competition with Eli Lilly and Co. (NYSE:LLY) and Novo Nordisk A/S (NYSE:NVO).
Price Action: RHHBY stock closed at $56.12 on Monday, according to Benzinga Pro data.
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