Status:
COMPLETED
Effects of AZD5004 in Adults Who Are Living With Obesity or Overweight With at Least 1 Weight-related Comorbidity
Lead Sponsor:
AstraZeneca
Conditions:
Obesity or Overweight
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 tab...
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 d...
Eligibility Criteria
Inclusion
- Adults ≥ 18 years of age.
- BMI of (a) ≥ 30 kg/m2, or (b) ≥ 27 kg/m2 and have a current diagnosis of at least 1 of the following weight-related comorbidities (treated or untreated):
- (i) Hypertension (ii) Dyslipidemia or hyperlipidemia (iii) CV disease (iv) Obstructive sleep apnea
- A stable body weight for 3 months prior to Screening (± 5% body weight change).
Exclusion
- Have obesity induced by other endocrine disorders, such as Cushing's syndrome or monogenic or syndromic obesity such as Prader-Willi syndrome.
- Has received prescription or non-prescription medication for weight loss within the last 3 months prior to Screening.
- Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier).
- History of type 1 diabetes mellitus or type 2 diabetes mellitus.
- Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper GI tract.
- History of acute or chronic pancreatitis.
Key Trial Info
Start Date :
October 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 21 2025
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT06579092
Start Date
October 8 2024
End Date
November 21 2025
Last Update
December 18 2025
Active Locations (62)
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1
Research Site
Chandler, Arizona, United States, 85225
2
Research Site
Huntington Park, California, United States, 90255
3
Research Site
La Mesa, California, United States, 91942
4
Research Site
Lincoln, California, United States, 95648