A Study to Evaluate the Effect of AZD6793 on the Pharmacokinetics and Pharmacodynamics of Metformin in Participants With Type 2 Diabetes Mellitus (IRAK4)

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.

Study Overview

• Status: Suspended
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: AZD6793; Drug: AZD6793 Placebo

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).

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Neuss, Germany, 41460
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment A; AZD6793 and metformin	Drug: AZD6793; 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).; Other Names: Active
Experimental: Treatment B; Placebo and metformin	Drug: AZD6793 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).; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean glucose levels	Mean glucose levels on Day 7 of each treatment period as assessed by Continuous Glucose Monitoring (CGM)	Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CGM Metric (Time in range)	The percentage of time (or hours/day) that blood glucose levels remain within a target	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.	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.	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.	Day 7 of each treatment period
CGM Metric (AUC(0-24))	area under the concentration-time curve from time 0 to 24 hours postdose	Day 7 of each treatment period
CGM Measure (Plasma fasting glucose)	A measure of glucose levels when a participant is in a fasting state.	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	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	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	Day 7 of each treatment period
Metformin Plasma PK (Cmax)	maximum observed concentration	Day 7 of each treatment period
Metformin Plasma PK (tmax)	time to reach maximum observed plasma concentration	Day 7 of each treatment period
Metformin Plasma PK (t1/2λz)	Terminal elimination half-life	Day 7 of each treatment period
Metformin Plasma PK (CL/F)	apparent total body clearance	Day 7 of each treatment period
Metformin Plasma PK (Vz/F)	apparent volume of distribution during the terminal phase.	Day 7 of each treatment period
Metformin Plasma PK (R AUC(0-12))	Ratio of test to reference based on AUC(0-12)	Day 7 of each treatment period
Metformin Plasma PK (R Cmax)	Ratio of test to reference based on Cmax	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	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	Day 7 of each treatment period
Metformin Urine PK (CLR)	renal clearance from plasma	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	Days 1 through 7 of each treatment period
AZD6793 plasma PK (Cmax)	maximum observed concentration	Days 1 through 7 of each treatment period
AZD6793 plasma PK (tmax)	time to reach maximum observed plasma concentration	Days 1 through 7 of each treatment period
AZD6793 plasma PK (t1/2λz)	Terminal elimination half-life	Days 1 through 7 of each treatment period
AZD6793 plasma PK (Ctrough)	concentration observed immediately prior to dosing	Days 1 through 7 of each treatment period
AZD6793 plasma PK (Rac AUC(0-24))	accumulation ratio based on AUC(0-24)	Days 1 through 7 of each treatment period
AZD6793 plasma PK (Rac Cmax)	Accumulation ration based on Cmax	Days 1 through 7 of each treatment period

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2026
• Primary Completion (Estimated): June 18, 2026
• Study Completion (Estimated): June 18, 2026

Study Registration Dates

• First Submitted: December 23, 2025
• First Submitted That Met QC Criteria: February 19, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Diabetes; T2DM
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Diabetes Mellitus; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: D7860C00005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No