Healthy ParticipantsPhase 1NCT06703658
A Study to Investigate Multiple Ascending Doses of AZD5004 in Healthy Japanese Participants and Participants With Type 2 Diabetes Mellitus
A Phase 1 study testing AZD5004(Part A) and AZD5004(Part B) in people with Healthy Participants and Type 2 Diabetes, run by AstraZeneca at 1 site in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Type 2 Diabetes
- What is being tested?
- AZD5004(Part A) and AZD5004(Part B)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteJapan
- Study dates
- 2 Nov 2024to 13 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- A Screening Period of maximum 28 days.
- A Treatment Period of 1 day(Part A) or 105 days (Part B).
- A final Follow-up Visit approximately 7 days(Part A) or 14 days(Part B) after the last study intervention administration.
- Conditions
- Healthy Participants, Type 2 Diabetes
- Being tested
- AZD5004(Part A), Placebo(Part A), AZD5004(Part B), Placebo(Part B)
- Keywords
- Obesity, Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5004(Part A)Drug
Single dose of AZD5004 oral on Day1
Placebo(Part A)Drug
Single dose of placebo oral on Day1
AZD5004(Part B)Drug
AZD5004 will be administered as an oral tablet once daily.
Placebo(Part B)Drug
Placebo will be administered as an oral tablet once daily.
| Study group | Role | What they receive |
|---|---|---|
| Part A-AZD5004 | Experimental | Participants will receive AZD5004 orally. Receives: Drug: AZD5004(Part A) |
| Part A-Placebo | Placebo comparator | Participants will receive matching Placebo orally. Receives: Drug: Placebo(Part A) |
| Part B-AZD5004 | Experimental | Participants will receive AZD5004 orally. Receives: Drug: AZD5004(Part B) |
| Part B-Placebo | Placebo comparator | Participants will receive matching Placebo orally. Receives: Drug: Placebo(Part B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PartA: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
To assess the safety and tolerability of AZD5004 following single oral doses in healthy participants.
Measured: From screening (Day -28) to last follow up visit (Day 8)
PartB: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
To assess the safety and tolerability of AZD5004 following multiple oral ascending doses in participants with T2DM.
Measured: From screening (Day -28) to last follow up visit (Day 119 )
Secondary outcomes (30)
PartB: AUC0-4 for glucose, insulin and C-peptide for MMTT
To describe the PD of AZD5004 following repeated daily administration in participants with T2DM in MAD
Measured: From Day 1 to Day 105
PartB: Absolute change from baseline to Day 105 in fasting plasma glucose
To describe the PD of AZD5004 following repeated daily administration in participants with T2DM in MAD
Measured: From Day 1 to Day 105
PartB: % change from baseline to Day 105 in HOMA-IR
To describe the PD of AZD5004 following repeated daily administration in participants with T2DM in MAD
Measured: 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
To describe the PD of AZD5004 following repeated daily administration in participants with T2DM in MAD
Measured: From Day 1 to Day 106
PartB: % change from baseline to Day 105 in body weight (kg)
To describe the PD of AZD5004 following repeated daily administration in participants with T2DM in MAD
Measured: From Day 1 to Day 105
PartB: % change from baseline to Day 105 in waist circumference (cm)
To describe the PD of AZD5004 following repeated daily administration in participants with T2DM in MAD
Measured: From Day 1 to Day 105
PartA: Area under the Plasma Concentration vs. Time Curve(AUC0-24)
To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD
Measured: 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)
To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD
Measured: From Day 1 to Day 6
PartA: Area under the Plasma Concentration vs. Time Curve from Zero to Infinity(AUC0-inf)
To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD
Measured: From Day 1 to Day 6
PartA: Maximum Observed Plasma Concentration(Cmax)
To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD
Measured: From Day 1 to Day 6
PartA: Plasma Concentration at 24 Hours Post-Dose(C24h)
To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD
Measured: From Day 1 to Day 6
PartA: Time of Occurrence of Maximum Plasma Concentration(tmax)
To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD
Measured: From Day 1 to Day 6
PartA: Lag Time before Observation of Quantifiable Analyte Concentrations in Plasma(tlag)
To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD
Measured: From Day 1 to Day 6
PartA: Half-Life(t1/2)
To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD
Measured: From Day 1 to Day 6
PartA: Last measurable Non-Zero Concentration(Clast)
To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD
Measured: From Day 1 to Day 6
PartA: Last measurable Non-Zero ConcentrationTime to Last Detectable Concentration(tlast)
To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD
Measured: From Day 1 to Day 6
PartA: Apparent Oral Clearance(CL/F)
To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD
Measured: From Day 1 to Day 6
PartA: Cumulative Urinary Excretion(Ae)
To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD
Measured: From Day 1 to Day 6
PartA: Clearance(CLR)
To describe the PK (plasma and urine) of AZD5004 following a single administration in healthy participants in SAD
Measured: From Day 1 to Day 6
PartB: Area under the Plasma Concentration vs. Time Curve(AUC0-24)
To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD
Measured: Day 1
PartB: Maximum Observed Plasma Concentration(Cmax)
To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD
Measured: Day 1, Day 49, Day 63, Day 77, Day91, Day105
PartB: Plasma Concentration at 24 Hours Post-Dose(C24h)
To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD
Measured: Day 1
PartB: Time of Occurrence of Maximum Plasma Concentration(tmax)
To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD
Measured: Day 1, Day 49, Day 63, Day 77, Day91, Day105
PartB: Lag Time before Observation of Quantifiable Analyte Concentrations in Plasma(tlag)
To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD
Measured: Day 1
PartB: Area under the Plasma Concentration vs. Time Curve over the Dosing Interval(AUC0-τ)
To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD
Measured: Day 49, Day 63, Day 77, Day 91, Day 105
PartB: Observed Concentration at the End of the Dosing Interval(Cτ)
To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD
Measured: Day 49, Day 63, Day 77, Day 91, Day 105
PartB: Half-Life(t1/2)
To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD
Measured: Day 49, Day 63, Day 77, Day 91, Day 105
PartB: Apparent Oral Clearance(CL/F)
To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD
Measured: Day 49, Day 63, Day 77, Day 91, Day 105
PartB: Cumulative Urinary Excretion(Ae)
To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD
Measured: Day 105
PartB: Clearance(CLR)
To describe the PK (plasma and urine) of AZD5004 following repeated daily administration in participants with T2DM in MAD
Measured: Day 105
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start2 Nov 2024
- Primary completion13 Mar 2025
- Study completion13 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703658
- Sponsor's protocol ID
- D7260C00003
- Status last verified
- Mar 2025
- First submitted
- 29 Oct 2024
- Last updated
- 21 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06703658
- Acronym / sponsor ID
- D7260C00003
- Conditions
- Healthy Participants, Type 2 Diabetes
- Keywords
- Obesity, Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2024 (actual)
- Primary completion
- 13 Mar 2025 (actual)
- Study completion
- 13 Mar 2025 (actual)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- A Screening Period of maximum 28 days.
- A Treatment Period of 1 day(Part A) or 105 days (Part B).
- A final Follow-up Visit approximately 7 days(Part A) or 14 days(Part B) after the last study intervention administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A-AZD5004 | Experimental | Drug: AZD5004(Part A)Participants will receive AZD5004 orally. |
| Part A-Placebo | Placebo comparator | Drug: Placebo(Part A)Participants will receive matching Placebo orally. |
| Part B-AZD5004 | Experimental | Drug: AZD5004(Part B)Participants will receive AZD5004 orally. |
| Part B-Placebo | Placebo comparator | Drug: Placebo(Part B)Participants will receive matching Placebo orally. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD5004(Part A)Single dose of AZD5004 oral on Day1 | Drug | Part A-AZD5004 |
| Placebo(Part A)Single dose of placebo oral on Day1 | Drug | Part A-Placebo |
| AZD5004(Part B)AZD5004 will be administered as an oral tablet once daily. | Drug | Part B-AZD5004 |
| Placebo(Part B)Placebo will be administered as an oral tablet once daily. | Drug | Part B-Placebo |
Primary outcome
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.
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.
30 secondary outcomes
PartB: AUC0-4 for glucose, insulin and C-peptide for MMTT
Time frame: 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
PartB: % change from baseline to Day 105 in HOMA-IR
Time frame: 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
PartB: % change from baseline to Day 105 in body weight (kg)
Time frame: 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
PartA: Area under the Plasma Concentration vs. Time Curve(AUC0-24)
Time frame: 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
PartA: Area under the Plasma Concentration vs. Time Curve from Zero to Infinity(AUC0-inf)
Time frame: From Day 1 to Day 6
PartA: Maximum Observed Plasma Concentration(Cmax)
Time frame: From Day 1 to Day 6
PartA: Plasma Concentration at 24 Hours Post-Dose(C24h)
Time frame: From Day 1 to Day 6
PartA: Time of Occurrence of Maximum Plasma Concentration(tmax)
Time frame: 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
PartA: Half-Life(t1/2)
Time frame: From Day 1 to Day 6
PartA: Last measurable Non-Zero Concentration(Clast)
Time frame: 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
PartA: Apparent Oral Clearance(CL/F)
Time frame: From Day 1 to Day 6
PartA: Cumulative Urinary Excretion(Ae)
Time frame: From Day 1 to Day 6
PartA: Clearance(CLR)
Time frame: From Day 1 to Day 6
PartB: Area under the Plasma Concentration vs. Time Curve(AUC0-24)
Time frame: Day 1
PartB: Maximum Observed Plasma Concentration(Cmax)
Time frame: Day 1, Day 49, Day 63, Day 77, Day91, Day105
PartB: Plasma Concentration at 24 Hours Post-Dose(C24h)
Time frame: Day 1
PartB: Time of Occurrence of Maximum Plasma Concentration(tmax)
Time frame: 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
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
PartB: Observed Concentration at the End of the Dosing Interval(Cτ)
Time frame: 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
PartB: Apparent Oral Clearance(CL/F)
Time frame: Day 49, Day 63, Day 77, Day 91, Day 105
PartB: Cumulative Urinary Excretion(Ae)
Time frame: Day 105
PartB: Clearance(CLR)
Time frame: Day 105
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Healthy Participants
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
RecruitingPhase 1
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Healthy Female Participants
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD5004(Part A) and AZD5004(Part B) in people with Healthy Participants and Type 2 Diabetes, run by AstraZeneca at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.