Type 2 Diabetes MellitusPhase 1IRAK4NCT07433062

A Study to Evaluate the Effect of AZD6793 on the Pharmacokinetics and Pharmacodynamics of Metformin in Participants With Type 2 Diabetes Mellitus

A Phase 1 study testing AZD6793 in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 1 site in Germany.

Suspended

Paused. Enrolment is on hold for now and may resume.

Trial summary

The purpose of this study is to examine the effect of AZD6793 on the Pharmacokinetics and Pharmacodynamics of Metformin in Participants with Type 2 Diabetes Mellitus. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: AZD6793
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 28 participants
Where: 1 siteGermany
Study dates: 14 Jan 2026to 18 Jun 2026
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Physician-diagnosis of T2DM
On a stable dose of metformin 2000 mg per day for at least 3 months prior to screening.
stable glycaemic control indicated by no change in treatment for diabetes within 3 months prior to screening
HbA1c (Hemoglobin A1c) ≤ 8.5% at screening
Body Mass Index (BMI) within the range 18.5 to 35 kg/m2 , inclusive, at screening.

Who cannot join

Physician diagnosis of type 1 diabetes.
History of any clinically important disease or disorder.
History or presence of chronic Gastrointestinal, hepatic, renal, or pancreatic disease
History of Human immunodeficiency viruses (HIV) infection or a positive HIV test.
History of prior episode(s) of lactic acidosis.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Research Site
Neuss, 41460

Other trials in Germany

About this study

Official title: A Double-blind, Placebo-controlled, Multiple-Dose, 2-Period Crossover Study to Evaluate the Effect of Steady-state AZD6793 on the Steady-state Pharmacokinetics and Pharmacodynamics of Metformin in Participants With Type 2 Diabetes Mellitus

The purpose of this study is to examine the effect of AZD6793 on the Pharmacokinetics and Pharmacodynamics of Metformin in Participants with Type 2 Diabetes Mellitus.

Read the detailed description

This is a double-blind, placebo-controlled, 2-period cross-over study conducted at a single study centre to assess the pharmacokinetics and pharmacodynamics (ie, glucose lowering effect) of metformin in participants with T2DM when metformin is administered alone and in combination with multiple doses of AZD6793. This study will consist of 2 treatment periods separated by a washout period of 7 to 14 days.

Approximately 28 eligible participants will be randomized to study intervention such that 24 evaluable participants complete the study (12 participants in each treatment sequence).

Conditions: Type 2 Diabetes Mellitus
Being tested: AZD6793, AZD6793 Placebo
Keywords: Diabetes, T2DM
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD6793Drug
Also called Active
Participants will receive oral doses of metformin with an interval of 12 hours between doses. The morning doses of metformin will be administered together with AZD6793 (Treatment A).
AZD6793 PlaceboDrug
Also called Placebo
Participants will receive oral doses of metformin with an interval of 12 hours between doses. The morning doses of metformin will be administered together with AZD6793 placebo (Treatment B).

Study groups in NCT07433062
Study group	Role	What they receive
Treatment A	Experimental	AZD6793 and metformin Receives: Drug: AZD6793
Treatment B	Experimental	Placebo and metformin Receives: Drug: AZD6793 Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean glucose levels
Mean glucose levels on Day 7 of each treatment period as assessed by Continuous Glucose Monitoring (CGM)
Measured: Day 7

Secondary outcomes (26)

CGM Metric (Time in range)
The percentage of time (or hours/day) that blood glucose levels remain within a target
Measured: Day 7 of each treatment period
CGM Metric (Time in tight range)
A metric measuring the percentage of time blood glucose remains between a pre-defined range.
Measured: Day 7 of each treatment period
CGM Metric (time below range)
A metric representing the percentage of time and minutes per day spent with blood glucose below a certain range.
Measured: Day 7 of each treatment period
CGM Metric (time above range)
A metric representing the percentage of time and minutes per day spent with blood glucose above a certain range.
Measured: Day 7 of each treatment period
CGM Metric (AUC(0-24))
area under the concentration-time curve from time 0 to 24 hours postdose
Measured: Day 7 of each treatment period
CGM Measure (Plasma fasting glucose)
A measure of glucose levels when a participant is in a fasting state.
Measured: Day 7 of each treatment period
CGM Measure (AUC(0-4) after each meal)
area under the concentration-time curve from time 0 to 4 hours postdose after each meal
Measured: Day 7 of each treatment period
CGM Measure (Total glucose AUC(0-24))
area under the concentration-time curve from time 0 to 24 hours postdose
Measured: Day 7 of each treatment period
Metformin Plasma PK (AUC(0-12))
area under the concentration-time curve from time 0 to 12 hours postdose
Measured: Day 7 of each treatment period
Metformin Plasma PK (Cmax)
maximum observed concentration
Measured: Day 7 of each treatment period
Metformin Plasma PK (tmax)
time to reach maximum observed plasma concentration
Measured: Day 7 of each treatment period
Metformin Plasma PK (t1/2λz)
Terminal elimination half-life
Measured: Day 7 of each treatment period
Metformin Plasma PK (CL/F)
apparent total body clearance
Measured: Day 7 of each treatment period
Metformin Plasma PK (Vz/F)
apparent volume of distribution during the terminal phase.
Measured: Day 7 of each treatment period
Metformin Plasma PK (R AUC(0-12))
Ratio of test to reference based on AUC(0-12)
Measured: Day 7 of each treatment period
Metformin Plasma PK (R Cmax)
Ratio of test to reference based on Cmax
Measured: Day 7 of each treatment period
Metformin Urine PK (Ae(0-12))
cumulative amount excreted into the urine from time 0 to 12 hours postdose
Measured: Day 7 of each treatment period
Metformin Urine PK (fe(0-12))
Percentage of dose excreted unchanged in urine from time zero to 12 hours post-dose
Measured: Day 7 of each treatment period
Metformin Urine PK (CLR)
renal clearance from plasma
Measured: Day 7 of each treatment period
AZD6793 plasma PK (AUC(0-24))
area under the concentration-time curve from time 0 to 24 hours postdose
Measured: Days 1 through 7 of each treatment period
AZD6793 plasma PK (Cmax)
maximum observed concentration
Measured: Days 1 through 7 of each treatment period
AZD6793 plasma PK (tmax)
time to reach maximum observed plasma concentration
Measured: Days 1 through 7 of each treatment period
AZD6793 plasma PK (t1/2λz)
Terminal elimination half-life
Measured: Days 1 through 7 of each treatment period
AZD6793 plasma PK (Ctrough)
concentration observed immediately prior to dosing
Measured: Days 1 through 7 of each treatment period
AZD6793 plasma PK (Rac AUC(0-24))
accumulation ratio based on AUC(0-24)
Measured: Days 1 through 7 of each treatment period
AZD6793 plasma PK (Rac Cmax)
Accumulation ration based on Cmax
Measured: Days 1 through 7 of each treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jan 202618 Jun 2026

First posted25 Feb 2026
Study start14 Jan 2026
Primary completion18 Jun 2026 (estimated)
Study completion18 Jun 2026 (estimated)

Why it stopped: Safety issue was identified in the Phase2b D7860C00006 study, evaluating AZD6793 in moderate to very severe COPD participants. D7860C00005 study is temporary halted to amend the design to reflect changes implemented in the ongoing D7860C00006 study

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type 2 Diabetes MellitusStudies 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: Other
Allocation: Randomised
Intervention model: Crossover
Model description: Potential participants will be screened to assess their eligibility to enter the study up to 21 days prior to the start of the 14-day outpatient run-in period. Eligible participants will return to the study site for an outpatient visit on Day -14 and enter a 14-day outpatient run-in period. During this period they will receive metformin twice a day. Upon completion of the metformin run-in period, eligible participants will be admitted to the study site on Day -1 of Period 1 and randomized on Day 1 of Period 1 in a 1:1 ratio to one of two treatment sequences, AB or BA. AB being the test compound with metformin first and then metformin alone. BA being metformin alone first and then metformin with the test compound following their respective washout periods. After completion of Day 8 of Period 2, participants will receive a follow-up phone call about 5 days after their discharge.
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 28 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07433062
Sponsor's protocol ID: D7860C00005
Acronym: IRAK4
Status last verified: Apr 2026
First submitted: 23 Dec 2025
Last updated: 22 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Placebo-controlled, Multiple-Dose, 2-Period Crossover Study to Evaluate the Effect of Steady-state AZD6793 on the Steady-state Pharmacokinetics and Pharmacodynamics of Metformin in Participants With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT07433062
Acronym / sponsor ID: IRAK4 / D7860C00005
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes, T2DM
Phase: Phase 1
Study type: Interventional
Recruitment status: SuspendedReason stopped: Safety issue was identified in the Phase2b D7860C00006 study, evaluating AZD6793 in moderate to very severe COPD participants. D7860C00005 study is temporary halted to amend the design to reflect changes implemented in the ongoing D7860C00006 study
Enrolment: 28 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 14 Jan 2026 (actual)
Primary completion: 18 Jun 2026 (estimated)
Study completion: 18 Jun 2026 (estimated)
First posted: 25 Feb 2026 (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.

The purpose of this study is to examine the effect of AZD6793 on the Pharmacokinetics and Pharmacodynamics of Metformin in Participants with Type 2 Diabetes Mellitus.

Detailed description

Approximately 28 eligible participants will be randomized to study intervention such that 24 evaluable participants complete the study (12 participants in each treatment sequence).

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: Potential participants will be screened to assess their eligibility to enter the study up to 21 days prior to the start of the 14-day outpatient run-in period. Eligible participants will return to the study site for an outpatient visit on Day -14 and enter a 14-day outpatient run-in period. During this period they will receive metformin twice a day. Upon completion of the metformin run-in period, eligible participants will be admitted to the study site on Day -1 of Period 1 and randomized on Day 1 of Period 1 in a 1:1 ratio to one of two treatment sequences, AB or BA. AB being the test compound with metformin first and then metformin alone. BA being metformin alone first and then metformin with the test compound following their respective washout periods. After completion of Day 8 of Period 2, participants will receive a follow-up phone call about 5 days after their discharge.

Arm	Type	Receives
Treatment A	Experimental	Drug: AZD6793AZD6793 and metformin
Treatment B	Experimental	Drug: AZD6793 PlaceboPlacebo and metformin

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Physician-diagnosis of T2DM
On a stable dose of metformin 2000 mg per day for at least 3 months prior to screening.
stable glycaemic control indicated by no change in treatment for diabetes within 3 months prior to screening
HbA1c (Hemoglobin A1c) ≤ 8.5% at screening
Body Mass Index (BMI) within the range 18.5 to 35 kg/m2 , inclusive, at screening.

Key exclusion criteria (5 listed)

Physician diagnosis of type 1 diabetes.
History of any clinically important disease or disorder.
History or presence of chronic Gastrointestinal, hepatic, renal, or pancreatic disease
History of Human immunodeficiency viruses (HIV) infection or a positive HIV test.
History of prior episode(s) of lactic acidosis.

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
AZD6793Also: ActiveParticipants will receive oral doses of metformin with an interval of 12 hours between doses. The morning doses of metformin will be administered together with AZD6793 (Treatment A).	Drug	Treatment A
AZD6793 PlaceboAlso: PlaceboParticipants will receive oral doses of metformin with an interval of 12 hours between doses. The morning doses of metformin will be administered together with AZD6793 placebo (Treatment B).	Drug	Treatment B

Primary outcome

Mean glucose levels
Time frame: Day 7
Mean glucose levels on Day 7 of each treatment period as assessed by Continuous Glucose Monitoring (CGM)

26 secondary outcomes

CGM Metric (Time in range)
Time frame: Day 7 of each treatment period
CGM Metric (Time in tight range)
Time frame: Day 7 of each treatment period
CGM Metric (time below range)
Time frame: Day 7 of each treatment period
CGM Metric (time above range)
Time frame: Day 7 of each treatment period
CGM Metric (AUC(0-24))
Time frame: Day 7 of each treatment period
CGM Measure (Plasma fasting glucose)
Time frame: Day 7 of each treatment period
CGM Measure (AUC(0-4) after each meal)
Time frame: Day 7 of each treatment period
CGM Measure (Total glucose AUC(0-24))
Time frame: Day 7 of each treatment period
Metformin Plasma PK (AUC(0-12))
Time frame: Day 7 of each treatment period
Metformin Plasma PK (Cmax)
Time frame: Day 7 of each treatment period
Metformin Plasma PK (tmax)
Time frame: Day 7 of each treatment period
Metformin Plasma PK (t1/2λz)
Time frame: Day 7 of each treatment period
Metformin Plasma PK (CL/F)
Time frame: Day 7 of each treatment period
Metformin Plasma PK (Vz/F)
Time frame: Day 7 of each treatment period
Metformin Plasma PK (R AUC(0-12))
Time frame: Day 7 of each treatment period
Metformin Plasma PK (R Cmax)
Time frame: Day 7 of each treatment period
Metformin Urine PK (Ae(0-12))
Time frame: Day 7 of each treatment period
Metformin Urine PK (fe(0-12))
Time frame: Day 7 of each treatment period
Metformin Urine PK (CLR)
Time frame: Day 7 of each treatment period
AZD6793 plasma PK (AUC(0-24))
Time frame: Days 1 through 7 of each treatment period
AZD6793 plasma PK (Cmax)
Time frame: Days 1 through 7 of each treatment period
AZD6793 plasma PK (tmax)
Time frame: Days 1 through 7 of each treatment period
AZD6793 plasma PK (t1/2λz)
Time frame: Days 1 through 7 of each treatment period
AZD6793 plasma PK (Ctrough)
Time frame: Days 1 through 7 of each treatment period
AZD6793 plasma PK (Rac AUC(0-24))
Time frame: Days 1 through 7 of each treatment period
AZD6793 plasma PK (Rac Cmax)
Time frame: Days 1 through 7 of each treatment period

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.

Related trials for Type 2 Diabetes Mellitus

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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 AZD6793 in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 1 site in Germany.

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 5 inclusion and 5 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: paused, as of the sponsor's last update on 22 Apr 2026. 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 Germany. 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. 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?

Results are not available in the source record.

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?

Mean glucose levels (time frame: Day 7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07433062.

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 22 Apr 2026.