Key Takeaways:
- Roche's dual GLP-1/GIP agonist enicepatide delivered 22.7% mean weight loss at 48 weeks
- Over a quarter of patients on the highest dose lost at least 30% of their body weight
- More than half of participants no longer met the definition of obesity after treatment
Roche said Friday that its dual-acting experimental obesity drug enicepatide (CT-388) helped patients lose 22.7% of their body weight in a Phase 2 trial, with more than a quarter of those who received the highest dose achieving at least 30% weight loss.
"The reason why that's important is because we know that when you achieve certain thresholds of weight loss, you actually unlock significant health benefits," such as reversal of diabetes and other comorbidities associated with obesity, Manu Chakravarthy, global head of Cardiovascular, Renal and Metabolism Product Development at Roche, told BioSpace ahead of the American Diabetes Association conference in New Orleans.
The placebo-adjusted weight reduction of 22.5% after 48 weeks in the CT388-103 trial positions enicepatide among the most potent obesity candidates in development. Almost 40% of participants shed 25% or more of their body weight, and more than half of those who entered the trial with obesity — defined as a BMI over 30 — no longer met that classification by the study's end. The discontinuation rate due to adverse events was 5.9% in the treatment arm versus 1.3% in the placebo group, with safety consistent with the incretin class of medicines.
Roche is pursuing a portfolio strategy in the obesity market, projected to reach $200 billion by 2027, according to IQVIA. The Swiss pharma also holds rights to petrelintide, an amylin analog partnered with Zealand Pharma that showed 9% weight loss in Phase 2 — a result the companies frame as a tolerability-first option rather than a peak-efficacy competitor. Roche has already initiated two Phase 3 studies of enicepatide as a standalone treatment and plans to begin a mid-stage combination trial of enicepatide and petrelintide in the second half of 2026. The data positions Roche to challenge market leaders Eli Lilly and Novo Nordisk, whose next-generation candidates retatrutide and CagriSema have shown 28.3% and 23% weight loss, respectively.
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