A Phase Ib Study of AZD5004 in Chinese Participants With Overweight/Obesity With or Without Type 2 Diabetes Mellitus

A Phase Ib, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AZD5004 in Chinese Participants With Overweight/Obesity With or Without Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the safety, tolerability, and PK of AZD5004 compared with placebo in Chinese participants with overweight/obesity with or without T2DM.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes; Obesity or Overweight
• Intervention / Treatment: Drug: AZD5004; Drug: Placebo

Detailed Description

This is a Phase Ib, randomized, parallel-group, double-blind, placebo-controlled, multicentre, 2-arm treatment study to investigate the safety, tolerability, and PK of AZD5004 compared with placebo in Chinese male and female participants aged 18 to 74 years, who are overweight/obese with or without T2DM. The primary endpoints are incidence of AEs, SAEs, DAEs, death, AESIs, laboratory parameters, 12-lead ECG, and vital signs.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Ha’erbin, China
    • The Fourth Affiliated Hospital of Harbin Medical University
  • Hefei, China
    • The Second People's Hospital of Hefei
  • Jinan, China
    • Jinan Central Hospital
  • Shanghai, China
    • Shanghai Pudong New District People's Hospital
  • Tianjin, China
    • General Hospital of Tianjin Medical University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Aged 18 to 74 years inclusive at the time of signing the informed consent.
• Stable self-reported body weight for 3 months prior to Screening.

Inclusion Criteria for Cohort A:

- 27 kg/m2 ≤ BMI ≤ 35 kg/m2 and weigh at least 60 kg at Screening.

Inclusion Criteria for Cohort B:

• Diagnosed with T2DM for at least 6 months prior to signing the informed consent.
• HbA1c value at Screening of ≥ 7.0% and ≤ 10.5%
• BMI of ≥ 24 kg/m2 at the Screening Visit.

Exclusion Criteria:

• History of, or any existing condition that influence the participant's ability to participate or affect the interpretation of the results of the study.
• Known clinically significant gastric emptying abnormality.
• Significant hepatic disease.
• Abnormal renal function.
• History of acute pancreatitis and chronic pancreatitis, gallstones.
• Uncontrolled thyroid disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AZD5004; Participants will receive AZD5004 orally.	Drug: AZD5004; AZD5004 will be administered as an oral tablet once daily.
Placebo Comparator: Placebo; Participants will receive Placebo orally.	Drug: Placebo; Placebo will be administered as an oral tablet once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events (AEs), serious adverse events (SAEs), adverse event leading to the discontinuation of study intervention (DAEs), death, and Adverse events of special interest (AESIs)	To evaluate the safety and tolerability of AZD5004 compared with placebo.	From baseline to week 16.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AZD5004 concentrations in plasma	To characterize the PK profile of AZD5004 following repeated administration.	Week 16.
Area under the concentration-time curve over a dosing interval (AUCtau)	To characterize the PK profile of AZD5004 following repeated administration.	Week 16.
Maximum Observed Plasma Concentration (Cmax)	To characterize the PK profile of AZD5004 following repeated administration.	Week 16.
Half-Life (t1/2)	To characterize the PK profile of AZD5004 following repeated administration.	Week 16.
Time of Occurrence of Maximum Plasma Concentration (tmax)	To characterize the PK profile of AZD5004 following repeated administration.	Week 16.
Trough concentration (Ctrough)	To characterize the PK profile of AZD5004 following repeated administration.	Week 16.

Collaborators and Investigators

• Sponsor: Eccogene
• Investigators: Study Director: Eccogene, Eccogene Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2025
• Primary Completion (Actual): November 28, 2025
• Study Completion (Actual): November 28, 2025

Study Registration Dates

• First Submitted: May 16, 2025
• First Submitted That Met QC Criteria: May 16, 2025
• First Posted (Actual): May 25, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Diabetes Mellitus, Type 2; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: D7260C00005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes