Skip to main content
OpenTrials
Completed

NCT Number: NCT06703658

A Study to Investigate Multiple Ascending Doses of AZD5004 in Healthy Japanese Participants and Participants 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Participants Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Osaka, 532-0003, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 25, 2024
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.