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Adipose Tissue_Appetite_and Obesity

SAT-677 - EB618, First-in-Class Oral Tablet of Dual GLP-1/Glucagon Receptor Agonist for Patients with Obesity and Metabolic Disorders: Results from PK-PD Study in Non-Human Primates

Saturday, June 13, 2026
9:30 AM - 4:30 PM CT
Oxyntomodulin (OXM) is a naturally occurring dual GLP‑1/Glucagon receptor agonist hormone that plays a key role in regulating appetite and glucose metabolism, promoting weight loss, and has demonstrated additional cardioprotective and anti‑fibrotic properties. Due to its short plasma half-life, the therapeutic potential of the native hormone is limited. OPK-88006 is a proprietary (OPKO Health Inc.) long‑acting OXM analog that has shown promising activity following subcutaneous administration in rodent models of metabolic disorders. Based on Entera’s oral peptide N-Tab® platform, EB618 (oral OPK-88006) is being developed as the first dual GLP‑1/Glucagon receptor agonist once-daily tablet for patients with obesity and related metabolic disorders. EB618 demonstrated a robust pharmacokinetic and pharmacodynamic profile in rat and minipig models [1]. In this study, EB618 was evaluated in non‑human primates. Tablets of three different strengths were administered to 18 male cynomolgus monkeys (n=6 per arm) following an overnight fast, and PK samples were taken for 120 hours post-dose. Concentrations of the OPK-88006 peptide in plasma samples were analyzed by the LC-MS/MS method. In this non-human primate study, EB618 exhibited a robust pharmacokinetic profile characterized by dose‑proportional systemic exposure and low variability. A dose-proportional pharmacologic effect on postprandial blood glucose levels was also shown. Importantly, the tested drug was tolerable, and no safety concerns were identified, at doses exceeding the anticipated clinical dose range by more than tenfold (mg/kg body weight). Overall, these findings represent a favorable safety, pharmacokinetic, and pharmacodynamic profile for EB618 and justify further clinical development. An IND application for the oral EB618 GLP-1/Glucagon agonist tablet is planned following completion of the single‑ascending‑dose (SAD) and multiple‑ascending‑dose (MAD) phase 1 clinical studies with the subcutaneous injection.
1. Burshtein G, et al. J Endocr Soc 2025;9(Supp 1):bvaf149-190

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