A Phase I, Randomised, Single-blind, Placebo-controlled, Single and Repeated Dose-escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD5004 in Healthy Japanese Participants with Type 2 Diabetes Mellitus

A Study to Investigate Multiple Ascending Doses of AZD5004 in Healthy Japanese Participants and Participants with 2 Diabetes Mellitus

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2051240164

Enrollment

Registered

2024-10-17

Start date

2024-11-02

Completion date

Unknown

Last updated

2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants Type 2 Diabetes

Interventions

> Arms (Arm Title/Type/Description) - Part A-AZD5004/Experimental/Participants will receive AZD5004 orally. - Part A-Placebo/Placebo Comparator/Participants will receive matching Placebo orally. - Par

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: > Inclusion Criteria: - Japanese men or women, and 18-65 years of age inclusive, at the time of signing the informed consent. > Inclusion Criteria for Part A: - HbA1c 6.0% or less. - Body weight 50.0 kg or more and BMI within the range 18.0-32.0 kg/m2. > Inclusion Criteria for Part B: - HbA1c 6.5% or more and 10.5% or less. - Not on any other diabetic medications. - Body weight 60.0 kg or more and BMI within the range 24.0-35.0 kg/m2.

Exclusion criteria

Exclusion criteria: - Has a clinically relevant acute or chronic medical condition or disease. - History of acute pancreatitis and chronic pancreatitis, gallstones. - Abnormal renal function. - Known clinically significant gastric emptying abnormality - Significant hepatic disease. - Uncontrolled thyroid disease

Design outcomes

Primary

Measure	Time frame
> Outcome Measure: AZD5004 safety parameters: adverse events, post-baseline values and changes from baseline over time of clinical laboratory evaluations, vital signs, and ECG parameters > TimeFrame: From screening (Day -28) to last follow up visit > Description: To investigate the safety and tolerability of AZD5004 following a single administration in healthy participants in SAD and repeated daily administration in participants with T2DM in MAD	—

Measure

Time frame

> Outcome Measure: AZD5004 safety parameters: adverse events, post-baseline values and changes from baseline over time of clinical laboratory evaluations, vital signs, and ECG parameters > TimeFrame: From screening (Day -28) to last follow up visit > Description: To investigate the safety and tolerability of AZD5004 following a single administration in healthy participants in SAD and repeated daily administration in participants with T2DM in MAD

—

Contacts

Public ContactYuji Ageishi

Astrazeneka K.K

RD-clinical-information-Japan@astrazeneca.com+81-6-4802-3533

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026