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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Participants; Type 2 Diabetes

Treatments: Drug: Placebo(Part A); Drug: AZD5004(Part A); Drug: AZD5004(Part B); Drug: Placebo(Part B)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06703658

D7260C00003

Details and patient eligibility

About

This Phase I study will gather important information on the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5004 in both healthy Japanese participants and Japanese participants with T2DM.

Full description

This is a placebo-controlled study to assess the safety, efficacy, tolerability, and PK of single and repeated dosing of AZD5004 compared with placebo.

Participants who are eligible according to the inclusion/exclusion criteria will be randomized to receive AZD5004 or matching placebo.

The study will comprise:

1. A Screening Period of maximum 28 days.
2. A Treatment Period of 1 day(Part A) or 105 days (Part B).
3. A final Follow-up Visit approximately 7 days(Part A) or 14 days(Part B) after the last study intervention administration.

Enrollment: 35 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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%.
• Body weight ≥ 50.0 kg and BMI within the range 18.0-32.0 kg/m2.

Inclusion Criteria for Part B:

• HbA1c ≥ 6.5% and ≤ 10.5%.
• Not on any other diabetic medications.
• Body weight ≥ 60.0 kg and BMI within the range 24.0-35.0 kg/m2

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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35 participants in 4 patient groups, including a placebo group

Part A-AZD5004

Experimental group

Description:

Participants will receive AZD5004 orally.

Treatment:

Drug: AZD5004(Part A)

Part A-Placebo

Placebo Comparator group

Description:

Participants will receive matching Placebo orally.

Treatment:

Drug: Placebo(Part A)

Part B-AZD5004

Experimental group

Description:

Participants will receive AZD5004 orally.

Treatment:

Drug: AZD5004(Part B)

Part B-Placebo

Placebo Comparator group

Description:

Participants will receive matching Placebo orally.

Treatment:

Drug: Placebo(Part B)