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

March 20, 2025 updated by: AstraZeneca

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 and With Type 2 Diabetes Mellitus

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Japan
      • Osaka-shi, Japan, 532-0003
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A-AZD5004
Participants will receive AZD5004 orally.
Drug: AZD5004(Part A)
Single dose of AZD5004 oral on Day1
Placebo Comparator: Part A-Placebo
Participants will receive matching Placebo orally.
Drug: Placebo(Part A)
Single dose of placebo oral on Day1
Experimental: Part B-AZD5004
Participants will receive AZD5004 orally.
Drug: AZD5004(Part B)
AZD5004 will be administered as an oral tablet once daily.
Placebo Comparator: Part B-Placebo
Participants will receive matching Placebo orally.
Drug: Placebo(Part B)
Placebo will be administered as an oral tablet once daily.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PartA: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time Frame: From screening (Day -28) to last follow up visit (Day 8)
To assess the safety and tolerability of AZD5004 following single oral doses in healthy participants.
From screening (Day -28) to last follow up visit (Day 8)
PartB: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time Frame: From screening (Day -28) to last follow up visit (Day 119 )
To assess the safety and tolerability of AZD5004 following multiple oral ascending doses in participants with T2DM.
From screening (Day -28) to last follow up visit (Day 119 )

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PartB: AUC0-4 for glucose, insulin and C-peptide for MMTT
Time Frame: From Day 1 to Day 105
To describe the PD of AZD5004 following repeated daily administration in participants with T2DM in MAD
From Day 1 to Day 105
PartB: Absolute change from baseline to Day 105 in fasting plasma glucose
Time Frame: From Day 1 to Day 105
To describe the PD of AZD5004 following repeated daily administration in participants with T2DM in MAD
From Day 1 to Day 105
PartB: % change from baseline to Day 105 in HOMA-IR
Time Frame: From Day 1 to Day 105
To describe the PD of AZD5004 following repeated daily administration in participants with T2DM in MAD
From Day 1 to Day 105
PartB: The proportion of time in hyperglycaemia /hypoglycaemia over the last 7-day intervals at each dose level in CGM
Time Frame: From Day 1 to Day 106
To describe the PD of AZD5004 following repeated daily administration in participants with T2DM in MAD
From Day 1 to Day 106
PartB: % change from baseline to Day 105 in body weight (kg)
Time Frame: From Day 1 to Day 105
To describe the PD of AZD5004 following repeated daily administration in participants with T2DM in MAD
From Day 1 to Day 105
PartB: % change from baseline to Day 105 in waist circumference (cm)
Time Frame: From Day 1 to Day 105
To describe the PD of AZD5004 following repeated daily administration in participants with T2DM in MAD
From Day 1 to Day 105
PartA: Area under the Plasma Concentration vs. Time Curve(AUC0-24)
Time Frame: From Day 1 to Day 6
To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD
From Day 1 to Day 6
PartA: Area under the Plasma Concentration vs. Time Curve from Zero until the Time of the Last Concentration above the Limit of Quantification(AUC0-tlast)
Time Frame: From Day 1 to Day 6
To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD
From Day 1 to Day 6
PartA: Area under the Plasma Concentration vs. Time Curve from Zero to Infinity(AUC0-inf)
Time Frame: From Day 1 to Day 6
To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD
From Day 1 to Day 6
PartA: Maximum Observed Plasma Concentration(Cmax)
Time Frame: From Day 1 to Day 6
To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD
From Day 1 to Day 6
PartA: Plasma Concentration at 24 Hours Post-Dose(C24h)
Time Frame: From Day 1 to Day 6
To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD
From Day 1 to Day 6
PartA: Time of Occurrence of Maximum Plasma Concentration(tmax)
Time Frame: From Day 1 to Day 6
To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD
From Day 1 to Day 6
PartA: Lag Time before Observation of Quantifiable Analyte Concentrations in Plasma(tlag)
Time Frame: From Day 1 to Day 6
To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD
From Day 1 to Day 6
PartA: Half-Life(t1/2)
Time Frame: From Day 1 to Day 6
To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD
From Day 1 to Day 6
PartA: Last measurable Non-Zero Concentration(Clast)
Time Frame: From Day 1 to Day 6
To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD
From Day 1 to Day 6
PartA: Last measurable Non-Zero ConcentrationTime to Last Detectable Concentration(tlast)
Time Frame: From Day 1 to Day 6
To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD
From Day 1 to Day 6
PartA: Apparent Oral Clearance(CL/F)
Time Frame: From Day 1 to Day 6
To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD
From Day 1 to Day 6
PartA: Cumulative Urinary Excretion(Ae)
Time Frame: From Day 1 to Day 6
To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD
From Day 1 to Day 6
PartA: Clearance(CLR)
Time Frame: From Day 1 to Day 6
To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD
From Day 1 to Day 6
PartB: Area under the Plasma Concentration vs. Time Curve(AUC0-24)
Time Frame: Day 1
To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD
Day 1
PartB: Maximum Observed Plasma Concentration(Cmax)
Time Frame: Day 1, Day 49, Day 63, Day 77, Day91, Day105
To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD
Day 1, Day 49, Day 63, Day 77, Day91, Day105
PartB: Plasma Concentration at 24 Hours Post-Dose(C24h)
Time Frame: Day 1
To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD
Day 1
PartB: Time of Occurrence of Maximum Plasma Concentration(tmax)
Time Frame: Day 1, Day 49, Day 63, Day 77, Day91, Day105
To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD
Day 1, Day 49, Day 63, Day 77, Day91, Day105
PartB: Lag Time before Observation of Quantifiable Analyte Concentrations in Plasma(tlag)
Time Frame: Day 1
To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD
Day 1
PartB: Area under the Plasma Concentration vs. Time Curve over the Dosing Interval(AUC0-τ)
Time Frame: Day 49, Day 63, Day 77, Day 91, Day 105
To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD
Day 49, Day 63, Day 77, Day 91, Day 105
PartB: Observed Concentration at the End of the Dosing Interval(Cτ)
Time Frame: Day 49, Day 63, Day 77, Day 91, Day 105
To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD
Day 49, Day 63, Day 77, Day 91, Day 105
PartB: Half-Life(t1/2)
Time Frame: Day 49, Day 63, Day 77, Day 91, Day 105
To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD
Day 49, Day 63, Day 77, Day 91, Day 105
PartB: Apparent Oral Clearance(CL/F)
Time Frame: Day 49, Day 63, Day 77, Day 91, Day 105
To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD
Day 49, Day 63, Day 77, Day 91, Day 105
PartB: Cumulative Urinary Excretion(Ae)
Time Frame: Day 105
To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD
Day 105
PartB: Clearance(CLR)
Time Frame: Day 105
To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD
Day 105

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 13, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 13, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D7260C00003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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