Status:
COMPLETED
A Phase Ib Study of AZD5004 in Chinese Participants With Overweight/Obesity With or Without Type 2 Diabetes Mellitus
Lead Sponsor:
Eccogene
Conditions:
Obesity or Overweight
Type 2 Diabetes
Eligibility:
All Genders
18-74 years
Phase:
PHASE1
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.
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2025
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06988553
Start Date
June 17 2025
End Date
November 28 2025
Last Update
December 23 2025
Active Locations (6)
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1
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
2
The Fourth Affiliated Hospital of Harbin Medical University
Ha’erbin, China
3
The Second People's Hospital of Hefei
Hefei, China
4
Jinan Central Hospital
Jinan, China