NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

CompletedPhase 2

Sponsor: AstraZeneca

Conditions: Obesity or Overweight

Interventions: AZD5004, Placebo

Countries: United States, Australia, Canada, Germany, Japan, Taiwan, United Kingdom

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Locations (62)

Chandler, Arizona, United States
Huntington Park, California, United States
La Mesa, California, United States
Lincoln, California, United States
Walnut Creek, California, United States
Hialeah, Florida, United States
Orlando, Florida, United States
Lombard, Illinois, United States
Valparaiso, Indiana, United States
West Des Moines, Iowa, United States
Roslindale, Massachusetts, United States
Farmington Hills, Michigan, United States
Chesterfield, Missouri, United States
Omaha, Nebraska, United States
Vestal, New York, United States
Durham, North Carolina, United States
Wilmington, North Carolina, United States
Fargo, North Dakota, United States
Beachwood, Ohio, United States
Cincinnati, Ohio, United States
North Charleston, South Carolina, United States
Spartanburg, South Carolina, United States
Knoxville, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Woodway, Texas, United States
Ogden, Utah, United States
Charlottesville, Virginia, United States
Manassas, Virginia, United States
+ 32 more on CT.gov