NCT06942923

A Study to Investigate the Safety, Tolerability and Pharmacodynamics of AZD4144 in Participants With Obesity

A Phase I, Randomised, Investigator- and Participant-blinded, Placebo-Controlled, Study to Assess the Safety, Tolerability, and Pharmacodynamics of AZD4144 in Participants With Obesity

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to evaluate the safety and tolerability, and pharmacodynamics (PD) of AZD4144 administered as repeated daily oral dosing.

Detailed description

This is placebo-controlled, parallel group and single centre study in healthy male and female participants with obesity and no known Atherosclerotic cardiovascular disease (ASCVD), chronic kidney disease (CKD), or Type 2 Diabetes Mellitus. Participants will be randomized in the ratio of 1:1 to receive either AZD4144 or placebo. This study will comprise of: * A screening period of 28 days. * The treatment duration will be up to 28 days. * The visit frequency will be weekly up to a Follow-up Visit, followed by a Final Follow-up Visit 28 days after the final dose of AZD4144.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	AZD4144	AZD4144 will be administered orally as per arms they have been assigned.
DRUG	Placebo	Placebo will be administered orally as per arms they have been assigned.

Timeline

• Start date: 2025-04-22
• Primary completion: 2025-09-29
• Completion: 2025-09-29
• First posted: 2025-04-24
• Last updated: 2025-10-07

Locations

1 site across 1 country: Germany