SAT-713 Phase 2 Clinical Trials Of Na-931 To Study Subjects Who Are Obese With At Least One Weight-related Comorbid Condition

Abstract Disclosure: L. Tran: None. F. Vu: None. Z.V. Tran: None. Background and Aim: NA-931 is a small molecule, which is a quadruple receptor agonist of the insulin-like growth hormone- (IGF-1), glucagon-like peptide 1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP) and glucagon receptor agonist. NA-931 is the first-in-class that can be administer orally. The objective of the Phase 2 clinical trials is to study the efficacy and safety of NA-931, administered orally once a day for the treatment of obesity. Methods: This is a phase 2, 13-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the safety, tolerability, weight loss efficacy of NA-931 in adults who are obese (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with at least one weight-related co-morbid condition. Number of enrolled subjects was 125 participants. ClinicalTrials.gov ID NCT06564753 Results: Body Weight Reductions The 13-week MAD study showed NA-931 demonstrated dose-dependent reductions in mean body weight from baseline, up to 13.8 % at 150 mg daily dosage, or 12.4% % relative to placebo. An exploratory assessment of subjects achieving at least 5% weight loss after 13-week demonstrated that up to 72% of NA-931-treated subjects achieved ≥12% weight loss, compared with 2% for placebo. Safety and Tolerability Among subjects receiving NA-931, emergent adverse events (TEAEs) were reported have been insignificant or mild. All observed gastrointestinal (GI) adverse events have been reported as insignificant or mild, with the majority (83%) reported as insignificant. Mild nausea and vomiting were reported as mild in 7.3% in NA-931-treated subjects. Diarrhea was reported in 6.3% of subjects receiving NA-931. No muscle loss was observed. No clinically meaningful differences were reported for GI-related adverse events among subjects treated with NA-931 compared with placebo. Conclusion: The topline results of the Phase 2 of NA-931 showed its potential as a first-in-class oral quadruple receptor agonist for weight loss, with excellent safety and efficacy. The Company is advancing NA-931 to Phase 3 trials. Presentation: Saturday, July 12, 2025