Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06151964
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2023-09-22
Brief Title:
A Trial to Learn How Safe AZD9550 is in People With or Without Type 2 Diabetes Who Are Overweight or Obese
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase III Randomised Single-blind Placebo-controlled Multiple-ascending-dose Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of AZD9550 in Overweight and Obese Participants With or Without Type 2 Diabetes Mellitus
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONTEMPO
Brief Summary:
AZD9550 is in early development for the treatment of NASH a type of liver disease that commonly affects overweight and obese participants living with or without T2DM
The purpose of this study is to investigate the safety tolerability and effects of increasing doses of AZD9550 in overweight and obese participants aged 18 through 65 years living with or without T2DM and to investigate how AZD9550 is absorbed distributed and eliminated from the body
The purpose of this study is to investigate the safety tolerability and effects of increasing doses of AZD9550 in overweight and obese participants aged 18 through 65 years living with or without T2DM and to investigate how AZD9550 is absorbed distributed and eliminated from the body
Detailed Description:
This Phase III randomised single-blind placebo-controlled MAD study will assess the safety and tolerability of AZD9550 and characterise the PK and PD of AZD9550 following SC administration to overweight and obese participants living with or without T2DM including men and women of non-childbearing potential Inclusion of participants receiving placebo is appropriate for benchmarking the safety and tolerability of AZD9550 A randomised and single-blind study design has been chosen to minimise bias and includes placebo to facilitate identification of effects related to administration of study intervention rather than the study procedures or situation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-504215-32-00 | REGISTRY | EU CT | None |