Efficacy, Safety, and Tolerability of Once Daily Oral Administration of AZD5004 Versus Placebo for 26 Weeks in Adults With Type 2 Diabetes Mellitus.
NCT06579105 · Completed
Last updated 2026-05-28This clinical trial tests whether taking AZD5004 once daily for 26 weeks lowers blood sugar levels in adults with type 2 diabetes compared to a placebo.
Status Completed The study has finished.
Phase Phase 2 Tests whether it works and watches safety in a moderate group.
Type Interventional (clinical trial)
Design Randomized, triple-blind treatment study
Participants 406 people
Who can join Ages 18+ · all sexes
Timeline Started 2024-10 · est. completion 2025-12
Where 97 sites · Canada, Germany, Hungary, Japan, Poland, Slovakia, Spain, United Kingdom, United States
What this study is testing ClinicalTrials.gov NCT06579105 ↗
Description as written by the study sponsor.
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.
Treatments tested
- Placebo (placebo matching AZD5004 film-coated tablet) Drug
Placebo film-coated tablet (matching AZD5004)
- AZD5004 Drug
AZD5004 film-coated tablet, once daily during 26 weeks
- Semaglutide also known as Rybelsus Drug
3-14 mg tablets of Semaglutide
| Main thing measured | Change in HbA1c |
|---|---|
| Sponsor | AstraZeneca |
| Conditions studied | Diabetes Mellitus, Type 2 |
| GLP-1 drugs | — |
Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06579105 ↗