NCT06132841

A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD6234 After Repeat Dose Administration in Participants Who Are Overweight or Obese

A Phase I Randomized, Single-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD6234 Following Repeat Dose Administration in Participants With Overweight or Obesity

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 142 Years
• Healthy volunteers: Accepted

Summary

A study in healthy male and female participants of non-childbearing and childbearing potential who have overweight or obesity

Detailed description

The study will comprise of: * A Screening Period of maximum 32 days (from Day -35 to Day -3). * A Treatment Period of 6 weeks (Cohort 1), 12 weeks (Cohort 2 and 3) and 26 weeks (Cohort 4) during which the participants will receive the study drug during residency at clinical unit. * A Follow-up Visit after the last dose of study drug. This study with repeated dosing of AZD6234 consists of 4 cohorts. For cohorts 1,2 and 3, eligible participants will be randomized to AZD6234 and placebo in a 3:1 ratio. For Cohort 4, eligible participants will be randomized in a 4:1:4:1 ratio.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	AZD6234	Participants will receive repeated doses of AZD6234 as a solution via SC
DRUG	Placebo	Participants will receive matching volumes of the placebo as a solution via SC

Timeline

• Start date: 2023-11-13
• Primary completion: 2026-02-03
• Completion: 2026-03-07
• First posted: 2023-11-15
• Last updated: 2026-04-03

Locations

3 sites across 2 countries: United States, Japan

Regulatory

• FDA-regulated drug study