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

NCT06579092 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2025-12-18

No results posted yet for this study

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

Conditions

  • Obesity or Overweight

Interventions

DRUG

AZD5004

AZD5004 film-coated tablet once daily during 36 weeks

DRUG

Placebo

Placebo matching AZD5004 film-coated tablet once daily during 36 weeks

Sponsors & Collaborators

Principal Investigators

  • Prof Melanie Davies, MBChB MD · Diabetes Research Centre Leicester Diabetes Centre - Bloom University of Leicester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-08
Primary Completion
2025-11-21
Completion
2025-11-21
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Germany
  • Japan
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06579092 on ClinicalTrials.gov