US-based biopharmaceutical company Terns Pharmaceuticals has reported positive topline results from its Phase I clinical trial of TERN-601, a once-daily oral GLP-1R agonist designed to treat obesity.
The randomised, placebo-controlled trial consisted of a single-ascending dose (SAD) portion and a subsequent multiple-ascending dose (MAD) segment.
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It aimed to assess TERN-601’s safety, tolerability, pharmacokinetics (PK) and pharmacodynamics.
The SAD portion evaluated five different dose levels of TERN-601 in participants with a body mass index (BMI) of between 25kg/m² and 40kg/m².
In the MAD segment, participants were given TERN-601 for 28 days at doses determined by safety and PK data from preclinical studies.
Evaluating the drug’s safety and tolerability when administered once daily for 28 days was the trial’s primary endpoint.
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By GlobalDataSecondary endpoints included PK, efficacy as measured by body weight loss after 28 days of treatment, and other exploratory markers.
Results indicated that TERN-601 was well-tolerated and caused dose-dependent, statistically significant placebo-adjusted mean weight losses across all three doses evaluated in the 28-day MAD study.
Most of the treatment-emergent adverse events observed in the trial were mild, with all gastrointestinal events reported as mild to moderate and consistent with the GLP-1R agonist class.
Terns Pharmaceuticals CEO Amy Burroughs said: “These compelling results underscore TERN-601’s potential to be a class-leading GLP-1R agonist based on its composite profile of initial indications of efficacy, tolerability and manufacturing scalability.
“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-β agonist, or a GIPR modulator from our TERN-800 series.
“With operational preparations well underway, we look forward to swiftly advancing this promising product candidate into Phase II clinical development in 2025.”
Based in California, Terns Pharmaceuticals currently has three clinical-stage development programmes for small-molecule product candidates targeting a range of serious diseases.
