NCT06579105

Efficacy, Safety, and Tolerability of Once Daily Oral Administration of AZD5004 Versus Placebo for 26 Weeks in Adults With Type 2 Diabetes Mellitus.

A Phase IIb, Randomized, Double-blind, Placebo-controlled and Open-label Active Comparator Study to Evaluate the Efficacy, Safety, and Tolerability of AZD5004 in Adults With Type 2 Diabetes Mellitus.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 406 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase IIb, randomised, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of AZD5004 in adults with type 2 diabetes mellitus, compared to placebo and active comparator.

Detailed description

This is a Phase IIb, randomised, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of AZD5004 in adults with type 2 diabetes mellitus, compared to placebo and active comparator. The study is planned to be conducted in approximately 15 countries, approximately 90 sites will be involved.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Placebo (placebo matching AZD5004 film-coated tablet)	Placebo film-coated tablet (matching AZD5004)
DRUG	AZD5004	AZD5004 film-coated tablet, once daily during 26 weeks
DRUG	Semaglutide	3-14 mg tablets of Semaglutide

Timeline

• Start date: 2024-10-08
• Primary completion: 2025-12-19
• Completion: 2025-12-19
• First posted: 2024-08-30
• Last updated: 2026-01-13

Locations

97 sites across 9 countries: United States, Canada, Germany, Hungary, Japan, Poland, Slovakia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study