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

Eccogene

Status and phase: Begins enrollment this month; Phase 1

Conditions: Obesity or Overweight; Type 2 Diabetes

Treatments: Drug: Placebo; Drug: AZD5004

Study type: Interventional

Funder types: Industry

Identifiers

NCT06988553

D7260C00005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 2 patient groups, including a placebo group

AZD5004

Experimental group

Description:

Participants will receive AZD5004 orally.

Treatment:

Drug: AZD5004

Placebo

Placebo Comparator group

Description:

Participants will receive Placebo orally.

Treatment:

Drug: Placebo