On 23 October 2025, Terns Pharmaceuticals Inc. disclosed the topline results of its FALCON Phase 2 trial of the oral GLP‑1 receptor agonist TERN‑601, enrolling 134 adults with obesity. The study evaluated three dose levels—250 mg, 500 mg (slow titration), and 500 mg (full dose)—and a 750 mg arm, with a 12‑week treatment period.
Efficacy data showed a dose‑dependent weight loss. The 250 mg dose produced a placebo‑adjusted mean loss of 1.8 % (p = 0.056), while the 500 mg slow‑titration arm achieved 3.6 % and the 500 mg full‑dose arm 4.6 % weight loss. The 750 mg dose yielded approximately 3 % loss. No statistically significant difference was observed at the 250 mg level, but the higher doses approached the 5 % threshold seen in earlier Phase 1 work.
Safety outcomes were consistent with the Phase 1 profile. Eleven point nine percent of participants discontinued treatment and eight point two percent required dose modification due to adverse events, primarily gastrointestinal (nausea 56 %, vomiting 26.9 %, constipation 11.9 %, diarrhea 9.7 %). Three participants experienced grade 3 liver‑function‑test elevations; two in the 500 mg arm were consistent with drug‑induced liver injury, while the third at 750 mg was attributed to gallstones. Overall, AST, ALT, alkaline phosphatase, and bilirubin remained stable across the cohort.
These topline results provide the first evidence of TERN‑601’s efficacy and safety in a larger, longer‑duration setting. The data will inform the company’s decision on whether to advance the obesity program into a pivotal Phase 3 trial and will shape its positioning against injectable GLP‑1 therapies. The disclosure marks a significant milestone for Terns Pharmaceuticals’ obesity pipeline and is the most recent material event for the company as of 24 October 2025.
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