Terns Pharmaceuticals Presents Positive Data from Phase 1 Study of TERN-601 Once-daily Oral GLP-1R Agonist for Treatment of Obesity at 85th Annual American Diabetes Association Scientific Sessions

Core Insights - Terns Pharmaceuticals announced positive results from the Phase 1 clinical study of TERN-601, a novel oral GLP-1 receptor agonist, which demonstrated a differentiated profile in weight loss and tolerability [1][2] - The Phase 2 FALCON trial has completed enrollment, with topline data expected in the fourth quarter of 2025, focusing on weight loss efficacy and safety [1][2] Efficacy - The Phase 1 study showed statistically significant and dose-dependent weight loss of up to 5.5% over 28 days with once-daily dosing, with 67% of patients losing 5% or more body weight at the highest dose [5] - Unique pharmacological properties of TERN-601 resulted in a flat pharmacokinetic curve, allowing for 24-hour target coverage with a half-life of 9-10 hours [5] Safety - TERN-601 was well-tolerated, with no treatment-related interruptions or discontinuations at any dose, and over 95% of gastrointestinal adverse events were mild [5] - There were no significant changes in liver enzymes, vital signs, or ECGs observed during the trial [5] Tolerability and Ease of Use - TERN-601 features the simplest dose titration among GLP-1 receptor agonist therapies, allowing for dosing with or without food and compatibility with PPIs, H2RA, and/or antacids [5] Trial Details - The Phase 1 trial was a randomized, double-blind, placebo-controlled study assessing safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy adults with obesity or overweight [7] - The ongoing FALCON Phase 2 trial is evaluating the efficacy and safety of TERN-601 in adults with obesity or overweight, with a primary endpoint of percent change in body weight compared to placebo over 12 weeks [8] Company Overview - Terns Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing small-molecule product candidates for serious diseases, including oncology and obesity [9] - The company's pipeline includes multiple clinical-stage programs, highlighting its commitment to addressing significant health challenges [9]