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

A Phase Ib, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AZD5004 in Chinese Participants With Overweight/Obesity With or Without Type 2 Diabetes Mellitus

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.

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.