Top-line results indicate oral GLP-1 well-tolerated, tied to weight loss in phase 1 trial
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Key takeaways:
- A novel oral GLP-1 receptor agonist was well-tolerated in a phase 1 study of healthy adults with overweight or obesity.
- The drug was linked with weight loss at 28 days compared with placebo.
A novel oral GLP-1 receptor agonist was well-tolerated and linked with weight loss compared with placebo in healthy adults with overweight or obesity, according to top-line results of a phase 1 study.
In, a phase 1 study of TERN-601 (Terns Pharmaceuticals), an oral GLP-1 receptor agonist, participants assigned to three doses of the drug lost weight compared with those assigned placebo, and did not have any serious adverse events.
The 28-day multiple ascending dose study included 36 healthy adults with overweight or obesity randomly assigned to 240 mg, 500 mg or 740 mg TERN-601 once daily, or placebo.
During the study period, participants from all three TERN-601 dose groups lost weight compared with placebo (240-mg dose, –2.5% vs. –0.6%; placebo-adjusted weight change, –1.9%; exploratory P < .1; 500-mg dose, –4.4% vs. –0.6%; placebo-adjusted weight change, –3.8%; exploratory P < .01; 740-mg dose, –5.5% vs. –0.6%; placebo-adjusted weight change, –4.9%; exploratory P < .0001).
No treatment-related dose interruptions, reductions or discontinuations occurred at any dose despite fast titrations to high doses, and more than 95% of adverse events were mild, according to a press release.
“Its low solubility and high gut permeability may result in prolonged absorption allowing for sustained target coverage and a flat [pharmacokinetics] curve, while high drug levels in the gut wall may lead to robust GLP-1 [receptor] activation in the gut, triggering satiety centers in the brain,” the company stated in the release. “Additionally, TERN-601 has a low free fraction in circulation which, combined with the flat [pharmacokinetics] curve, may be allowing TERN-601 to be well-tolerated when administered at high doses.”
The data will be submitted for presentation at an upcoming medical meeting.
“These compelling results underscore TERN-601’s potential to be a class-leading GLP-1 [receptor] agonist based on its composite profile of initial indications of efficacy, tolerability and manufacturing scalability,” Amy Burroughs, CEO of Terns Pharmaceuticals, said in the release. “These data validate the potential of TERN-601 for the treatment of obesity as monotherapy or in combination with agents such as TERN-501, our internally discovered, clinical stage THR-beta agonist, or a GLP [receptor] modulator from our TERN-800 series. With operational preparations well underway, we look forward to swiftly advancing this promising product candidate into phase 2 clinical development in 2025.”
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