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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD5004 | Experimental | Participants will receive AZD5004 orally. |
|
| Placebo | Placebo Comparator | Participants will receive Placebo orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD5004 | Drug | AZD5004 will be administered as an oral tablet once daily. |
| |
| 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. |
| 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) |
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Inclusion Criteria:
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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eccogene | Eccogene Clinical Trials | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China | ||
| The Fourth Affiliated Hospital of Harbin Medical University |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Placebo |
| Drug |
Placebo will be administered as an oral tablet once daily. |
|
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. |
| 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 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |