People who volunteered to receive a once-a-day oral candidate weight reduction pill lost up to 13 per cent of their body weight over three months, researchers have said, announcing the results of the first clinical trial on the new molecule.
If it lives up to its early promise, the candidate drug called amycretin under development by the Danish pharmaceutical company Novo Nordisk could emerge as an alternative to existing drugs that need to be taken via injections, doctors familiar with the research said.
The first-in-human study conducted by a clinical research unit in the US has found that participants who received 50mg amycretin reduced their body weight by 10.4 per cent on average within 12 weeks of treatment. Another set of participants who received two 50mg pills achieved a body weight reduction of 13.1 per cent. Those who received placebo — sham pills — showed a 1.1 per cent weight loss.
Amycretin is a single molecule that mimics the action of two peptide hormones — amylin and so-called glucagon-like peptide-1 (GLP-1) receptor agonist. Both of these play a key role in appetite regulation and the feeling of hunger and have been shown to lead to weight loss.
Current GLP-1-based treatment options are primarily administered through injections, and a candidate molecule to deliver amylin-based treatment also through injections is under clinical development. At present there are no tablet-based treatment options for either of these biological substances.
“The daily oral amycretin treatment in adult participants with overweight or obesity demonstrated acceptable safety and tolerability and led to remarkable reductions in body weight reductions over only 12 weeks,” Novo Nordisk researcher A Gasiorek and colleagues have said in their study.
“What makes this unique is that it is a single molecule that targets two biological pathways and it is an oral tablet,” said Ambrish Mithal, chair and head of endocrinology at Max Healthcare hospital in New Delhi, who was not associated with the study.
Mithal noted that the first study was on people who were overweight or obese and not on patients with diabetes. “The early results are encouraging and the oral option makes it potentially very attractive,” he said.