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Testing a new oral medication for adults with type 2 diabetes

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.

Phase 2 Interventional AstraZeneca · NCT06579105

This study is testing a new oral medication for adults with type 2 diabetes to see if it works better than a placebo and another diabetes drug called Semaglutide.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment384 (estimated)
SexAll
SponsorAstraZeneca Industry-sponsored
Locations121 sites (Mobile, Alabama and 120 other locations)
Trial IDNCT06579105 on ClinicalTrials.gov

What this trial studies

This Phase IIb clinical trial evaluates the efficacy, safety, and tolerability of AZD5004, an oral medication, in adults diagnosed with type 2 diabetes mellitus. The study is designed as a randomized, double-blind, parallel-group, placebo-controlled trial, comparing AZD5004 to a placebo and an active comparator, Semaglutide. Conducted across approximately 90 sites in 15 countries, the trial aims to gather comprehensive data on the medication's performance over a 26-week period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of type 2 diabetes for at least 6 months and specific HbA1c levels.

Not a fit: Patients with type 1 diabetes, secondary diabetes forms, or severe diabetic complications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for managing type 2 diabetes.

How similar studies have performed: Other studies have shown success with similar approaches in diabetes management, indicating potential for this trial's success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

Adults ≥ 18 years of age.

Diagnosed with T2DM for at least 6 months.

HbA1c ≥ 7.0% and ≤ 10.5% managed with diet and exercise alone or with a stable dose of metformin or an SGLT2 inhibitor for at least one month prior to screening.

Body mass index of ≥ 23 kg/m2.

Stable self-reported body weight for 3 months prior to randomization (+/- 5% body weight change).

Exclusion Criteria:

Type 1 diabetes mellitus, secondary forms of diabetes or history of ketoacidosis or hyperosmolar coma.

History of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy that required immediate treatment.

Have had more than one episode of severe hypoglycemia within 6 months prior to screening, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.

Received medication for weight loss within the last 3 months prior to screening.

Clinically significant inflammatory bowel disease, gastroparesis, severe disease or surgery affecting the upper GI tract.

Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier).

History of acute or chronic pancreatitis.

Where this trial is running

Mobile, Alabama and 120 other locations

+71 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Diabetes Mellitus, Type 2
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.