NCT07017179

This is a Multi-centre, Multi-drug, Platform Study in Chinese Participants Living With Obesity / Overweight

A Phase IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AZD6234, AZD9550, and AZD6234 in Combination With AZD9550 in Chinese Participants Living With Obesity/Overweight

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 871 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This study is to assess the safety and tolerability, PK characterisation, efficacy, and immunogenicity of the study intervention, and it allows assessment of the monotherapy or combination therapy of AZD6234 and AZD9550 in different sub-studies.

Detailed description

This is a Phase Ⅱa, multi-centre, multi-drug, platform study in Chinese participants living with obesity/overweight. This platform study will consist of several sub-studies. Eligible participants will be allocated to one sub-study to receive the study intervention(s). Each sub-study will consist of a screening period, a treatment period, and a follow-up period. Sub-study 1: AZD6234 Monotherapy This study will explore the safety, tolerability, pharmacokinetic (PK), efficacy, and immunogenicity of AZD6234 in Chinese participants with obesity/overweight, approximate 18 participants will be randomised in sub-study 1. The sub-study will comprise 3 periods totalling up to approximately 23 weeks. Sub-study 2: AZD9550 Monotherapy and AZD6234 in combination with AZD9550 This study will explore the safety, tolerability, PK, efficacy, and immunogenicity of AZD9550 and of AZD6234 in combination with AZD9550 in Chinese participants with obesity/overweight, approximately 30 participants will be randomised in sub-study 2 (15 in Cohort A and 15 in Cohort B). The sub-study will comprise 3 periods totalling up to approximately 35 weeks.

Conditions

• Obesity/Overweight

Interventions

Type	Name	Description
DRUG	AZD6234	Participants will receive a subcutaneous injection weekly
DRUG	Placebo	Participants will receive a subcutaneous injection weekly.
DRUG	AZD9550	Participants will receive a subcutaneous injection weekly
DRUG	Plocebo	Participants will receive a subcutaneous injection weekly
DRUG	AZD6234 in combination with AZD9550	Participants will receive a subcutaneous injection weekly
DRUG	Placebo	Participants will receive a subcutaneous injection weekly

Timeline

• Start date: 2025-05-20
• Primary completion: 2026-08-06
• Completion: 2026-08-06
• First posted: 2025-06-12
• Last updated: 2026-01-27

Locations

3 sites across 1 country: China