Obesity or Overweight, Type 2 Diabetes
Conditions
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 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.
Interventions
DRUGAZD5004
AZD5004 will be administered as an oral tablet once daily.
DRUGPlacebo
Placebo will be administered as an oral tablet once daily.
Sponsors
Eccogene
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | From baseline to week 16. | To evaluate the safety and tolerability of AZD5004 compared with placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the concentration-time curve over a dosing interval (AUCtau) | Week 16. | To characterize the PK profile of AZD5004 following repeated administration. |
| Maximum Observed Plasma Concentration (Cmax) | Week 16. | To characterize the PK profile of AZD5004 following repeated administration. |
| AZD5004 concentrations in plasma | Week 16. | To characterize the PK profile of AZD5004 following repeated administration. |
| Time of Occurrence of Maximum Plasma Concentration (tmax) | Week 16. | To characterize the PK profile of AZD5004 following repeated administration. |
| Trough concentration (Ctrough) | Week 16. | To characterize the PK profile of AZD5004 following repeated administration. |
| Half-Life (t1/2) | Week 16. | To characterize the PK profile of AZD5004 following repeated administration. |
Countries
China
Outcome results
None listed