Introduction and Objective: TERN-601 is a novel once-daily oral small molecule GLP-1 receptor agonist, in development for chronic weight management. This first-in-human (FIH) study evaluated the safety, tolerability, and effect on body weight of TERN-601 in participants with obesity or overweight.Methods: Participants (N=12/cohort) with BMI ≥27 to <40 kg/m2 were randomized 3:1 to receive TERN-601 or placebo once daily for 28 days in 3 cohorts. TERN-601 was titrated within 2 weeks from 100 mg to target doses of 240, 500, or 740 mg. Safety assessments were performed throughout the study.Results: There were no treatment-related dose interruptions, reductions, or discontinuations. Despite rapid titration, most adverse events (AEs) were mild and gastrointestinal; no Grade ≥3 AEs were reported. No nausea/vomiting in 240 mg group. There were no clinically meaningful changes in HR, BP or ECGs. All TERN-601 doses showed continuous mean weight loss (up to -5.5%) over 28 days (Figure). At TERN-601 740 mg, 67% of participants achieved ≥5% weight loss.Conclusion: TERN-601 demonstrated favorable safety and tolerability in this FIH study in participants with obesity or overweight. TERN-601 led to clinically meaningful reductions in body weight. These results support further clinical development of TERN-601 for chronic weight management.
C.H. Nelson: Employee; TERNS Pharmaceuticals. Stock/Shareholder; TERNS Pharmaceuticals, Gilead Sciences, Inc. C. Jones: Employee; TERNS Pharmaceuticals. E. Kwan: Employee; TERNS Pharmaceuticals. E.N. Castelloe: Consultant; TERNS Pharmaceuticals, Ascendis Pharma A/S, Artelo Biosciences, Dianthus Therapeutics, Soleno Therapeutics, Plexium, Sustained Therapeutics, Virogenics, Nobias Therapeutics. T. Marmon: None. E.T. Kuriakose: Employee; TERNS Pharmaceuticals.
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