Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT02040012
Brief Summary:
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:
NCT02040012
Study Brief:
Protocol Section:
NCT02040012