Study identifier:D8460C00002
ClinicalTrials.gov identifier:NCT06151964
EudraCT identifier:N/A
CTIS identifier:2023-504215-32-00
A Phase I/II, 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
Non-alcoholic steatohepatitis (NASH)
Phase 1/2
No
AZD9550, Placebo
All
88
Interventional
18 Years - 65 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Part A: AZD9550 Multiple repeat doses of AZD9550 given as 4 once weekly SC doses for 4 weeks to 2 sequential cohorts in overweight/obese participants with or without T2DM, evaluating 2 low dose levels of AZD9550 | Drug: AZD9550 Part A: A constant dose Part B: Doses of AZD9550 that increase each week Part C: Doses of AZD9550 that increase every 2 weeks, then every 4 weeks Part D: Doses of AZD9550 that increase every 2 weeks, then every 4 weeks |
Experimental: Part B: AZD9550 Once weekly up-titration over 5 doses of AZD9550 in overweight/obese participants with or without T2DM | Drug: AZD9550 Part A: A constant dose Part B: Doses of AZD9550 that increase each week Part C: Doses of AZD9550 that increase every 2 weeks, then every 4 weeks Part D: Doses of AZD9550 that increase every 2 weeks, then every 4 weeks |
Experimental: Part C: AZD9550 Bi-weekly/monthly up-titration of AZD9550 for 24 weeks in overweight/obese participants with or without T2DM. | Drug: AZD9550 Part A: A constant dose Part B: Doses of AZD9550 that increase each week Part C: Doses of AZD9550 that increase every 2 weeks, then every 4 weeks Part D: Doses of AZD9550 that increase every 2 weeks, then every 4 weeks |
Experimental: Part D: AZD9550 Bi-weekly/monthly up-titration of AZD9550 for 24 weeks in overweight/obese Japanese participants with T2DM (Part D). | Drug: AZD9550 Part A: A constant dose Part B: Doses of AZD9550 that increase each week Part C: Doses of AZD9550 that increase every 2 weeks, then every 4 weeks Part D: Doses of AZD9550 that increase every 2 weeks, then every 4 weeks |
Experimental: Part A: placebo Multiple repeat doses of placebo given as 4 once weekly SC doses for 4 weeks to 2 sequential cohorts in overweight/obese participants with or without T2DM, evaluating 2 low dose levels of AZD9550 | Drug: Placebo Matching administration volumes for SC injection |
Experimental: Part B: placebo Once weekly up-titration over 5 doses of placebo in overweight/obese participants with or without T2DM | Drug: Placebo Matching administration volumes for SC injection |
Experimental: Part C: placebo Bi-weekly/monthly up-titration of placebo for 24 weeks in overweight/obese participants with or without T2DM. | Drug: Placebo Matching administration volumes for SC injection |
Experimental: Part D: placebo Bi-weekly/monthly up-titration of placebo for 24 weeks in overweight/obese Japanese participants with T2DM (Part D). | Drug: Placebo Matching administration volumes for SC injection |