LAUSR

MEDI0382 is under development for the treatment of type 2 diabetes mellitus (T2DM). In a double-blind study (NCT02548585), 51 T2DM patients with BMI 27-40 kg/m 2 were randomized (1:1) to daily SC MEDI0382 200 μg or placebo (PBO). Based on ANCOVA with treatment and baseline (BL) values as covariates, MEDI0382 markedly reduced fasting glucose (change from BL at day 41, -49.9 vs. -19.2 mg/dL; P 0-4h , -32.8 vs. -10.2; P P = 0.0004). Weight loss was 3.8 kg vs. BL (1.7 kg vs. PBO; P = 0.0008); 92% of MEDI0382 patients lost >2 kg. Mean reduction in ambulatory systolic BP was -4.2 for MEDI0382 vs. -1.5 mmHg for PBO ( P = ns). As with marketed GLP-1 analogs, a mean pulse increase of 6.8 BPM for MEDI0382 vs. a fall of 2.0 BPM for PBO was seen ( P 3 severity, 3 led to study discontinuation for MEDI0382 vs. 1 for PBO, and 1 SAE in the PBO arm. Overall, MEDI0382 normalized fasting and postprandial blood glucose, significantly reduced body weight, and had an acceptable safety profile over 41 days of dosing in obese/overweight T2DM patients. Disclosure P. Ambery: Employee; Self; MedImmune. Stock/Shareholder; Self; AstraZeneca. M.W. Stumvoll: Speaker9s Bureau; Self; Novartis Pharmaceuticals Corporation. Advisory Panel; Self; AstraZeneca, Novo Nordisk A/S. Speaker9s Bureau; Self; Merck Foundation. M.G. Posch: None. T. Heise: Research Support; Self; ADOCIA, Boehringer Ingelheim GmbH, Dance Biopharm, Eli Lilly and Company, Janssen Research & Development, MedImmune, Merck Sharp & Dohme Corp., Mylan, Nordic Bioscience, Novo Nordisk A/S, Poxel SA, Roche Diagnostics Corporation, Saniona, Sanofi, Senseonics, Zealand Pharma A/S. Advisory Panel; Self; Novo Nordisk A/S, Mylan. Speaker9s Bureau; Self; Dexcom, Inc., Eli Lilly and Company, Novo Nordisk A/S, Sanofi. L. Plum-Moerschel: None. L. Tsai: Employee; Self; MedImmune. D. Robertson: Employee; Self; MedImmune. Employee; Spouse/Partner; GlaxoSmithKline plc. M. Petrone: Employee; Self; MedImmune. Stock/Shareholder; Self; MedImmune. C. Rondinone: Employee; Self; MedImmune. Stock/Shareholder; Self; AstraZeneca, F. Hoffmann-La Roche Ltd., Abbott, AbbVie Inc. V.E. Parker: Employee; Self; MedImmune. Stock/Shareholder; Self; Accenture. Employee; Self; AstraZeneca. B. Hirshberg: Employee; Self; AstraZeneca, MedImmune. L. Jermutus: Employee; Self; AstraZeneca. Stock/Shareholder; Self; AstraZeneca.