Objectives: Primary Objectives * To investigate the safety and tolerability of single ascending doses of AZP- 531 in healthy volunteers. * To investigate the safety and tolerability of single and multiple ascending doses of AZP-531 in overweight/obese volunteers. * To investigate the safety and tolerability of single and multiple ascending doses of AZP-531 in patients with type 2 diabetes mellitus. Secondary Objectives • To determine the plasma pharmacokinetic (PK) profile of AZP-531 after single and multiple doses. Exploratory Objectives • To obtain exploratory data on the effects of AZP-531 on the pharmacodynamic (PD) markers of blood glucose, interstitial glucose, insulin, and plasma acylated ghrelin (AG) and unacylated ghrelin (UAG)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
108
Quintiles Drug Research Unit at Guy's Hospital
London, London, United Kingdom
To investigate the number of adverse events of single and multiple ascending doses AZP-531 in healthy volunteers, in overweight/obese volunteers, in patients with type 2 diabetes mellitus.
Time frame: 1 to 14 days
To determine the plasma pharmacokinetic (PK) profile of AZP-531 after single and multiple doses
Time frame: 1 to 14 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.