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

NCT06579105 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 406

Last updated 2026-01-13

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-08
Primary Completion
2025-12-19
Completion
2025-12-19
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Germany
  • Hungary
  • Japan
  • Poland
  • Slovakia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06579105 on ClinicalTrials.gov