Terns Pharmaceuticals announced data from a completed Phase 1 study and full enrollment of its Phase 2 FALCON trial for TERN-601, an oral GLP-1R agonist for obesity. The Phase 1 study showcased a differentiated profile for TERN-601, with the Phase 2 trial expected to confirm its competitive weight loss potential, safety, and tolerability. The company presented these findings at the American Diabetes Association’s 85th Scientific Sessions.
These developments are important because they signal progress in the development of a potentially convenient and effective oral treatment for obesity. The positive Phase 1 results, including significant weight loss and a favorable safety profile, generate excitement for the potential of TERN-601 to address the unmet needs of patients seeking a less invasive alternative to injectable GLP-1R agonists. Full enrollment in the Phase 2 trial sets the stage for generating crucial data on longer-term efficacy and safety.
The Phase 1 study showed dose-dependent weight loss up to 5.5% over 28 days with once-daily dosing. The drug exhibited a favorable pharmacokinetic profile, enabling 24-hour target coverage with once-daily administration. Importantly, TERN-601 was well-tolerated, with mostly mild gastrointestinal side effects and no significant adverse events related to liver function, vital signs, or ECGs. The Phase 2 FALCON trial, now fully enrolled, will evaluate TERN-601 at different doses against a placebo in adults with obesity or who are overweight without diabetes. The primary endpoint is the percent change in body weight from baseline over 12 weeks.
The completion of Phase 1 and full enrollment of the Phase 2 trial mark significant milestones for Terns Pharmaceuticals. Positive results from the FALCON trial could position TERN-601 as a leading oral GLP-1R agonist, potentially disrupting the current treatment landscape for obesity. The upcoming 12-week data readout will be a pivotal catalyst for the company and the broader obesity treatment field.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
