NCT06595238

A Study in Participants With Obesity or Overweight With at Least One Weight-related Comorbidity

A Phase IIb Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AZD6234 in Participants Living With Obesity or Overweight With Comorbidity

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 262 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Phase IIb Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AZD6234 compared with placebo, given once a week as subcutaneous injection for 36 weeks, in male and female participants of at least 18 years of age who are living with obesity (body mass index \[BMI\] ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) and at least one weight-related comorbidity

Detailed description

The study will comprise of: A screening period of maximum 28 days A treatment period of 36 weeks A follow up period after last dose of study drug This study will consist of 4 cohorts. Approximately 231 eligible participants will be randomized to AZD6234 or placebo

Conditions

• Obesity or Overweight

Interventions

Type	Name	Description
DRUG	AZD6234	IMP injected subcutaneously, once a week. Unit dose strength as per CSP
DRUG	Placebo comparator	Placebo matching IMP dose injected subcutaneously, once a week.

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-08-08
• Completion: 2025-12-03
• First posted: 2024-09-19
• Last updated: 2025-12-17

Locations

41 sites across 5 countries: United States, Australia, Canada, Japan, United Kingdom

Regulatory

• FDA-regulated drug study