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

NCT06988553 | Completed Phase 1 FDA Drug

• 1 other identifier: D7260C00005
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Type 2 Diabetes; Obesity or Overweight

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• AZD5004 concentrations in plasma

  Week 16.

• Area under the concentration-time curve over a dosing interval (AUCtau)

  Week 16.

• Maximum Observed Plasma Concentration (Cmax)

  Week 16.

• Half-Life (t1/2)

  Week 16.

• Time of Occurrence of Maximum Plasma Concentration (tmax)

  Week 16.

Study Arms (2)

AZD5004

EXPERIMENTAL

Participants will receive AZD5004 orally.

Drug: AZD5004

Placebo

PLACEBO COMPARATOR

Participants will receive Placebo orally.

Drug: Placebo

Interventions

AZD5004 DRUG

AZD5004 will be administered as an oral tablet once daily.

AZD5004

Placebo DRUG

Placebo will be administered as an oral tablet once daily.

Placebo

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eccogene: lead

Study Sites (6)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

The Fourth Affiliated Hospital of Harbin Medical University

Ha’erbin, China

Location

The Second People's Hospital of Hefei

Hefei, China

Location

Jinan Central Hospital

Jinan, China

Location

Shanghai Pudong New District People's Hospital

Shanghai, China

Location

General Hospital of Tianjin Medical University

Tianjin, China

Location

MeSH Terms

Conditions

Obesity; Overweight; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Eccogene

  Eccogene Clinical Trials

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 25, 2025
• Study Start: June 17, 2025
• Primary Completion: November 28, 2025
• Study Completion: November 28, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)