NCT06988553

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Eccogene · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity or Overweight
• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	AZD5004	AZD5004 will be administered as an oral tablet once daily.
DRUG	Placebo	Placebo will be administered as an oral tablet once daily.

Timeline

• Start date: 2025-06-17
• Primary completion: 2025-11-28
• Completion: 2025-11-28
• First posted: 2025-05-25
• Last updated: 2025-12-23

Locations

6 sites across 1 country: China

Regulatory

• FDA-regulated drug study