Introduction and Objective: Utreglutide (UTG, GL0034), a once weekly glucagon-like peptide-1 receptor agonist, demonstrated body weight (BW) reduction up to 3.3 kg after single dose and improvements in cardio-metabolic biomarkers after multiple ascending doses in obese subjects. This phase 1 trial assessed the safety and efficacy of UTG in overweight and obese subjects.Methods: The study enrolled 20 male and female subjects with BMI between 28 and 45 kg/m2, which were randomized (16:4) to weekly subcutaneous UTG or placebo following an up-titration scheme (1×0.4, 2×0.8, 3×1.4, 4×2.0 mg).Results: At visit 11, BW reduction after UTG treatment was 6.8%; leptin, LDL, apolipoprotein B, total cholesterol, non-HDL and hs-CRP were significantly reduced by 28.1%, 13.4%, 17.7%, 12.1%, 15.4% and 30.8% respectively. HbA1c reduction was significant on visit 10. Reduction of hs-CRP along with LDL may confer added benefit to patients with obesity or obesity and T2DM with cardiovascular risk linked to increased inflammatory markers. Gastrointestinal adverse events were consistent with the class. Lipase and amylase levels were unaffected (Table).Conclusion: In individuals with overweight and obesity, once weekly UTG dosing for ten weeks, demonstrated clinically relevant changes in BW and biomarkers of cardio-metabolism with an overall good tolerability.
R. Thennati: Employee; Sun Pharmaceutical Industries Ltd. V.S. Burade: None. M. Natarajan: None. P. Shahi: None. R. Nagaraja: None. P. Battisti: None. T. Duvauchelle: Consultant; Sun Pharmaceutical Industries Ltd, Bioprojet. B. Thorens: Advisory Panel; Sun Pharmaceutical Industries Ltd. R.E. Pratley: Consultant; AbbVie Inc. Stock/Shareholder; Altanine, Inc. Consultant; Amgen Inc, AstraZeneca. Other Relationship; Bayer AG, Bayer Pharmaceuticals, Inc, Biomea Fusion. Consultant; Boehringer-Ingelheim. Other Relationship; Carmot Therapeutics, Inc, Corcept Therapeutics, Dompé, Eli Lilly and Company, Endogenex. Consultant; Endogenex. Other Relationship; Fractyl Health, Inc., Gasherbrum Bio, Inc. Consultant; Genprex, Getz Pharma, Hanmi Pharm. Co., Ltd, Intas Pharmaceuticals Ltd, Lexicon Pharmaceuticals, Inc, Lilly USA LLC. Speaker’s Bureau; Lilly USA LLC. Other Relationship; Metavention, Novo Nordisk, Novo Nordisk. Speaker’s Bureau; Novo Nordisk. Other Relationship; Pfizer Inc, Poxel SA. Consultant; Regeneron Pharmaceuticals. Other Relationship; Sanofi. Consultant; Scholar Rock. Other Relationship; Sun Pharmaceutical Industries Ltd. T. Vilsbøll: Advisory Panel; Boehringer-Ingelheim, AstraZeneca, Bristol-Myers Squibb Company, Carmot Therapeutics, Inc. Research Support; Dexcom, Inc. Advisory Panel; Eli Lilly and Company, GlaxoSmithKline plc. Speaker’s Bureau; Medscape. Advisory Panel; Novo Nordisk, Sun Pharmaceutical Industries Ltd, Roche Diabetes Care, Amgen Inc, Sanofi, Zealand Pharma A/S.
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