Roche Advances Obesity Pipeline As New Drug Shows Strong Phase II Results

Roche has announced positive topline results from CT388-103, a Phase II clinical trial evaluating CT-388, an investigational dual GLP-1/GIP receptor agonist for the treatment of obesity.

The study found that once-weekly subcutaneous injections of CT-388, titrated up to 24 mg, produced statistically significant and clinically meaningful weight loss without reaching a plateau at 48 weeks.

Participants receiving the highest dose (24 mg) achieved a placebo-adjusted weight loss of 22.5% (p < 0.001). At this dose, 54% of participants reduced their body mass index (BMI) below 30 kg/m², compared with 13% in the placebo group. Additional analysis showed that 95.7% of participants achieved at least 5% weight loss, 87% reached ≥10%, 47.8% achieved ≥20%, and 26.1% attained ≥30% weight loss. Among pre-diabetic participants, 73% attained normal blood glucose levels by week 48, versus 7.5% in the placebo group.

The treatment was generally well tolerated, with most gastrointestinal adverse events classified as mild to moderate, consistent with the incretin drug class. Discontinuation due to adverse events was low, occurring in 5.9% of CT-388 participants compared with 1.3% in the placebo group. Roche plans to present the full study results at an upcoming medical congress.

CT-388 is being advanced as a fast-track asset within Roche’s obesity pipeline. An additional Phase II trial (CT388-104) is ongoing to assess efficacy, safety, and tolerability in individuals with obesity or overweight who also have type 2 diabetes. Phase III trials, Enith1 and Enith2, are expected to begin this quarter.

The CT388-103 study was a multi-center, randomized, double-blind, placebo-controlled, parallel-group trial in 469 adults with obesity (BMI ≥30) or overweight (BMI 27–30) with at least one weight-related comorbidity. The trial evaluated five dosing cohorts with titration up to 24 mg, measuring percent change in body weight from baseline to week 48 as the primary endpoint.

CT-388 is designed to activate both GLP-1 and GIP receptors to reduce appetite and regulate blood sugar, while minimizing receptor desensitization to prolong pharmacological activity. The therapy is being investigated for obesity, type 2 diabetes, and related comorbidities, both as a standalone treatment and in combination with other agents in Roche’s obesity portfolio.

Obesity is recognized as a major global risk factor for chronic disease, with projections suggesting that over four billion people worldwide could be living with excess weight or obesity by 2035.

The positive Phase II results position CT-388 as a potential new therapy to address the growing global obesity burden.

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