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

NCT06703658 | Completed Phase 1

• 1 other identifier: D7260C00003
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Participants; Type 2 Diabetes

Keywords

Obesity; Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  From Day 1 to Day 105

• PartB: Absolute change from baseline to Day 105 in fasting plasma glucose

  From Day 1 to Day 105

• PartB: % change from baseline to Day 105 in HOMA-IR

  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

  From Day 1 to Day 106

• PartB: % change from baseline to Day 105 in body weight (kg)

  From Day 1 to Day 105

Study Arms (4)

Part A-AZD5004

EXPERIMENTAL

Participants will receive AZD5004 orally.

Drug: AZD5004(Part A)

Part A-Placebo

PLACEBO COMPARATOR

Participants will receive matching Placebo orally.

Drug: Placebo(Part A)

Part B-AZD5004

EXPERIMENTAL

Participants will receive AZD5004 orally.

Drug: AZD5004(Part B)

Part B-Placebo

PLACEBO COMPARATOR

Participants will receive matching Placebo orally.

Drug: Placebo(Part B)

Interventions

AZD5004(Part A) DRUG

Single dose of AZD5004 oral on Day1

Part A-AZD5004

Placebo(Part A) DRUG

Single dose of placebo oral on Day1

Part A-Placebo

AZD5004(Part B) DRUG

AZD5004 will be administered as an oral tablet once daily.

Part B-AZD5004

Placebo(Part B) DRUG

Placebo will be administered as an oral tablet once daily.

Part B-Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Osaka, 532-0003, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: November 25, 2024
• Study Start: November 2, 2024
• Primary Completion: March 13, 2025
• Study Completion: March 13, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.

Locations

JP (1)