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

Eccogene45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Obesity or Overweight Type 2 Diabetes

Interventions

AZD5004DRUG

AZD5004 will be administered as an oral tablet once daily.

PlaceboDRUG

Placebo will be administered as an oral tablet once daily.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 74 Years

Medical Language ↔ Plain English

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.

Locations (6)

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

Outcomes

Primary Outcomes

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.

Time frame: From baseline to week 16.