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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-02

Study Completion Date

2025-03-13

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy Participants Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part A-AZD5004

Participants will receive AZD5004 orally.

Group Type EXPERIMENTAL

AZD5004(Part A)

Intervention Type DRUG

Single dose of AZD5004 oral on Day1

Part A-Placebo

Participants will receive matching Placebo orally.

Group Type PLACEBO_COMPARATOR

Placebo(Part A)

Intervention Type DRUG

Single dose of placebo oral on Day1

Part B-AZD5004

Participants will receive AZD5004 orally.

Group Type EXPERIMENTAL

AZD5004(Part B)

Intervention Type DRUG

AZD5004 will be administered as an oral tablet once daily.

Part B-Placebo

Participants will receive matching Placebo orally.

Group Type PLACEBO_COMPARATOR

Placebo(Part B)

Intervention Type DRUG

Placebo will be administered as an oral tablet once daily.

Interventions

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AZD5004(Part A)

Single dose of AZD5004 oral on Day1

Intervention Type DRUG

Placebo(Part A)

Single dose of placebo oral on Day1

Intervention Type DRUG

AZD5004(Part B)

AZD5004 will be administered as an oral tablet once daily.

Intervention Type DRUG

Placebo(Part B)

Placebo will be administered as an oral tablet once daily.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Japanese men or women, and 18-65 years of age inclusive, at the time of signing the informed consent.

* HbA1c ≤ 6.0%.
* Body weight ≥ 50.0 kg and BMI within the range 18.0-32.0 kg/m2.

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes