Roche: Carmot-acquired obesity pill effective in early study

Roche has introduced promising results from their new once-daily oral weight loss pill, CT-996, at the European Association for the Study of Diabetes annual meeting. The pill demonstrated the ability to help participants lose up to 7.3% of their body weight within a month, a figure that, while notable, is slightly less than that achieved by competitors over longer periods.

CT-996 was tested in a Phase 1 trial on patients with obesity but without type 2 diabetes, focusing on the drug's safety and tolerability, especially with a rapid titration program. This program was designed to understand the pill’s safety by increasing the dosage swiftly, up to 120 mg, through five increments in three weeks. The initial dose started at 10 mg, and increases were sometimes made within days to quickly identify any potential toxicity, particularly signs of liver damage.

In one cohort where patients reached the highest dose, an average weight loss of 7.3% was observed. In another high-dose cohort, where the dosage increased more significantly before reaching the maximum, patients lost an average of 5.8% of their body weight. The most common side effects were gastrointestinal issues, such as nausea and constipation, especially in higher dose groups. However, these side effects were less frequent among patients who experienced a more gradual increase in dosage.

Manu Chakravarthy, leading the cardiovascular, renal, and metabolism product development division at Roche, expressed enthusiasm about the oral program, highlighting the comparable tolerability seen with other molecules, despite the rapid dose escalation, and the high efficacy levels achieved. He emphasized that the pharmacokinetics of CT-996 support a once-daily regimen, unlike some competitors whose plasma half-life does not consistently align with daily dosing, potentially compromising efficacy.

Roche's presentation followed closely on the heels of Novo Nordisk's early data revelation about their pill, amycretin, which showed an average weight loss of 10.4% after three months of daily use. Chakravarthy found it interesting that new weight loss candidates are often judged by small differences in percentage points concerning weight loss. He reaffirmed confidence in CT-996’s once-daily regimen, suggesting that some competitors might be "leaving efficacy on the table" due to inconsistent dosing schedules.

Despite the gastrointestinal side effects observed, no severe treatment-emergent side effects occurred, and no participants discontinued the study because of the drug. Chakravarthy anticipates that the drug will show even better results regarding both efficacy and tolerability in a longer mid-stage study with a less rigorous dosing process. Future studies will also monitor other potential side effects, such as lean muscle loss, which was not tracked in this Phase 1 trial but will be examined in the upcoming Phase 2.

CT-996 was acquired through Roche's $2.7 billion purchase of Carmot Therapeutics, which also included a dual-acting injectable, CT-388. Additional Phase 1 data for CT-388 indicated that patients at the highest dose lost nearly 19% of their body weight over 24 weeks. CT-388 has already progressed to a Phase 2 study, although no specific timeline for interim data has been provided by Roche.

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