AMPLITUDE-M: Improved glycemic and weight outcomes with efpeglenatide vs placebo
medwireNews: Treatment with efpeglenatide significantly improves glycemic control and results in weight loss for medication-naïve people with type 2 diabetes, report the AMPLITUDE-M researchers.
Juan Frías (National Research Institute, Los Angeles, USA) presented the findings at the virtual ADA 81st Scientific Sessions. In response to an audience question, he said a decision about whether to submit efpeglenatide for regulatory approval had yet to be made, and would depend in part on the results of the cardiovascular outcomes trial AMPLITUDE-O. These were later reported to be positive.
AMPLITUDE-M involved 406 people with type 2 diabetes of around 5 years’ duration, treated with diet and exercise, who had a glycated hemoglobin (HbA1c) level between 7.0% and 10.0% (53 and 86 mmol/mol).
During 30 weeks of treatment, including a dose-escalation period of up to 4 weeks, the average HbA1c level fell from 8.1% (65 mmol/mol) to 6.9%, 6.6%, and 6.4% (52, 49, and 46 mmol/mol) in participants randomly assigned to take 2, 4, and 6 mg/week efpeglenatide, respectively.
These levels represented significant improvements of 0.51%, 0.83%, and 1.04%, respectively, compared with the change in the placebo group, and the reductions were maintained during an additional 26 weeks of treatment.
Up to 73.8% of people taking efpeglenatide achieved HbA1c levels below 7.0%, compared with 25.5% of the placebo group. The corresponding rates for HbA1c below 6.5% (48 mmol/mol) were 58.3% and 8.8%.
Participants taking efpeglenatide 2 mg/week did not achieve a significant weight reduction versus placebo, but those taking 4 and 6 mg/week achieved weight reductions averaging 3.2 kg more than that in the placebo group.
The weight loss in the 4 mg group was maintained until week 56. By contrast, the average weight of the 6 mg group increased until it was close to that of the placebo group, although Frías noted this was largely explained by a single trial participant gaining 22 kg in that time.
The safety profile of efpeglenatide was as expected for a medication from the glucagon-like peptide-1 receptor agonist class, with diarrhea, nausea, and vomiting the most frequent events.
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