A Phase Ib Study of AZD5004 in Chinese Participants With Overweight/Obesity With or Without Type 2 Diabetes Mellitus
NCT ID: NCT06988553
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
45 participants
INTERVENTIONAL
2025-06-17
2025-11-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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AZD5004
Participants will receive AZD5004 orally.
AZD5004
AZD5004 will be administered as an oral tablet once daily.
Placebo
Participants will receive Placebo orally.
Placebo
Placebo will be administered as an oral tablet once daily.
Interventions
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AZD5004
AZD5004 will be administered as an oral tablet once daily.
Placebo
Placebo will be administered as an oral tablet once daily.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Known clinically significant gastric emptying abnormality.
* Significant hepatic disease.
* Abnormal renal function.
* History of acute pancreatitis and chronic pancreatitis, gallstones.
* Uncontrolled thyroid disease.
18 Years
74 Years
ALL
No
Sponsors
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Eccogene
INDUSTRY
Responsible Party
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Principal Investigators
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Eccogene
Role: STUDY_DIRECTOR
Eccogene Clinical Trials
Locations
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West China Hospital, Sichuan University
Chengdu, Sichuan, China
The Fourth Affiliated Hospital of Harbin Medical University
Ha’erbin, , China
The Second People's Hospital of Hefei
Hefei, , China
Jinan Central Hospital
Jinan, , China
Shanghai Pudong New District People's Hospital
Shanghai, , China
General Hospital of Tianjin Medical University
Tianjin, , China
Countries
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Other Identifiers
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D7260C00005
Identifier Type: -
Identifier Source: org_study_id