BASEL, Switzerland – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive topline results from its Phase II clinical trial (CT388-103) of CT-388, an investigational dual GLP-1/GIP receptor agonist. The study demonstrated that a once-weekly injection of CT-388 led to a significant and clinically meaningful placebo-adjusted weight loss of 22.5% over 48 weeks in adults living with obesity.
The findings underscore CT-388’s potential as a best-in-class therapy in the rapidly evolving metabolic health market. Crucially, researchers noted that weight loss had not yet reached a plateau by the end of the 48-week period, suggesting the potential for further reduction with continued treatment.
Key Clinical Outcomes
The trial, which evaluated 469 participants with obesity or overweight and at least one weight-related comorbidity (excluding type 2 diabetes), highlighted several landmark statistics:
Safety Profile: CT-388 was generally well-tolerated. Adverse events were primarily gastrointestinal—consistent with the incretin class of medicines—and were mostly mild-to-moderate. The discontinuation rate due to side effects remained low at 5.9%.
Substantial Weight Reduction: At the highest dose of 24 mg, nearly all participants (95.7%) achieved at least a 5% reduction in body weight. Impressively, 47.8% of participants lost 20% or more, and 26.1% lost 30% or more of their initial body weight.
Metabolic Recovery: The drug showed profound effects on blood sugar regulation. Among participants who were pre-diabetic at the start of the trial, 73% returned to normal blood glucose levels after 48 weeks of treatment with the 24 mg dose, compared to just 7.5% in the placebo group.
Future Outlook and Phase III Trials
Following these results, Roche has designated CT-388 as a “fast-track asset.” The company confirmed that it will initiate its Phase III clinical programme—titled Enith1 and Enith2—this quarter.
Additionally, Roche is currently investigating the drug in another Phase II study (CT388-104) specifically for participants living with obesity and Type 2 Diabetes. The company is also exploring the potential of combining CT-388 with other assets in its pipeline, such as petrelintide, to further enhance treatment outcomes.
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Addressing a Global Crisis
Obesity is currently recognized as the single largest risk factor for chronic diseases worldwide. Projections suggest that by 2035, more than four billion people over half the global population will be living with excess weight or obesity. This trend is expected to place an unprecedented strain on global healthcare systems due to associated comorbidities such as heart disease, stroke, and diabetes.
Roche’s entry into the dual-agonist space with CT-388 represents a significant move to address this crisis, utilizing a molecule engineered for potent receptor activation with minimal receptor desensitization, potentially allowing for more prolonged and effective pharmacological activity.
The full results of the CT388-103 study are expected to be presented at an upcoming medical congress later this year.
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About CT-388
CT-388 is a once-weekly, subcutaneous, dual GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide) receptor agonist. It is designed to reduce appetite and regulate blood glucose by mimicking naturally occurring hormones involved in energy homeostasis.
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