NCT06579092

Effects of AZD5004 in Adults Who Are Living With Obesity or Overweight With at Least 1 Weight-related Comorbidity

A Phase IIb Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AZD5004 in Participants Living With Obesity or Overweight With Comorbidity

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 310 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase IIb, global, randomized, parallel-group, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of AZD5004 compared with placebo, given once daily as an oral tablet(s) for 36 weeks, in male and female participants at least 18 years of age who are living with obesity (body mass index \[BMI\] ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) who have at least 1 weight-related comorbidity

Detailed description

This is a Phase IIb, global, randomized, parallel-group, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of 5 doses of AZD5004 compared with placebo, given once daily as an oral tablet or tablets for a duration of 36 weeks, in adults aged 18 years and above, who are living with obesity (BMI ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) and have at least 1 weight-related comorbidity (Hypertension, Dyslipidemia or hyperlipidemia, CV disease and/or Obstructive sleep apnea). Approximately 304 participants will be randomized in the study. The dual primary endpoints are percent change in body weight from baseline at 26 weeks and the proportion of participants with weight loss ≥ 5% of baseline weight at 26 weeks.

Conditions

• Obesity or Overweight

Interventions

Type	Name	Description
DRUG	AZD5004	AZD5004 film-coated tablet once daily during 36 weeks
DRUG	Placebo	Placebo matching AZD5004 film-coated tablet once daily during 36 weeks

Timeline

• Start date: 2024-10-08
• Primary completion: 2025-11-21
• Completion: 2025-11-21
• First posted: 2024-08-30
• Last updated: 2025-12-18

Locations

62 sites across 7 countries: United States, Australia, Canada, Germany, Japan, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study