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

Completed · Phase 2 · Has a placebo group

Conditions studied: Obesity or Overweight

In brief

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

Key facts

Study ID

NCT06579092

Run by

AstraZeneca

People needed

310

Starts

2024-10-08

Expected to finish

2025-11-21

Last updated by the study team

2025-12-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Research Site — Huntington Park, California, United States
• Research Site — La Mesa, California, United States
• Research Site — Lincoln, California, United States
• Research Site — Walnut Creek, California, United States
• Research Site — Hialeah, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — Lombard, Illinois, United States
• Research Site — Valparaiso, Indiana, United States
• Research Site — West Des Moines, Iowa, United States
• Research Site — Roslindale, Massachusetts, United States
• Research Site — Farmington Hills, Michigan, United States
• Research Site — Chesterfield, Missouri, United States
• Research Site — Omaha, Nebraska, United States
• Research Site — Vestal, New York, United States
• Research Site — Durham, North Carolina, United States
• Research Site — Wilmington, North Carolina, United States
• Research Site — Fargo, North Dakota, United States
• Research Site — Beachwood, Ohio, United States
• Research Site — Cincinnati, Ohio, United States
• Research Site — North Charleston, South Carolina, United States
• Research Site — Spartanburg, South Carolina, United States
• Research Site — Knoxville, Tennessee, United States
• Research Site — Austin, Texas, United States
• Research Site — Dallas, Texas, United States
• Research Site — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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