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

Last updated: April 30, 2025
Sponsor: AstraZeneca
Overall Status: Active - Not Recruiting

Phase

2

Condition

Obesity

Hypertriglyceridemia

Diabetes Prevention

Treatment

Placebo

AZD5004

Clinical Study ID

NCT06579092
D7260C00001
2024-513691-18-00
  • Ages > 18
  • All Genders

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

Eligibility Criteria

Inclusion

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 1of 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

Exclusion Criteria:

  • Have obesity induced by other endocrine disorders, such as Cushing's syndrome ormonogenic or syndromic obesity such as Prader-Willi syndrome.

  • Has received prescription or non-prescription medication for weight loss within thelast 3 months prior to Screening.

  • Previous or planned (within study period) bariatric surgery or fitting of a weightloss 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, orsurgery affecting the upper GI tract.

  • History of acute or chronic pancreatitis.

Study Design

Total Participants: 310
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
October 08, 2024
Estimated Completion Date:
December 09, 2025

Study 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.

Connect with a study center

  • Research Site

    Heidelberg West, 3081
    Australia

    Site Not Available

  • Research Site

    Merewether, 2291
    Australia

    Site Not Available

  • Research Site

    St Albans, 3021
    Australia

    Site Not Available

  • Research Site

    St Leonards, 2065
    Australia

    Site Not Available

  • Research Site

    Calgary, Alberta T2V 4J2
    Canada

    Site Not Available

  • Research Site

    Edmonton, Alberta T6H 2L4
    Canada

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  • Research Site

    Surrey, British Columbia V3T 2V6
    Canada

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  • Research Site

    Victoria, British Columbia V8V 4A1
    Canada

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  • Research Site

    Halifax, Nova Scotia B3H 1V7
    Canada

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  • Research Site

    Guelph, Ontario N1G 0B4
    Canada

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  • Research Site

    Hamilton, Ontario L8L 5G8
    Canada

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  • Research Site

    Toronto, Ontario M9W 4L6
    Canada

    Site Not Available

  • Research Site

    Terrebonne, Quebec J6X 4P7
    Canada

    Site Not Available

  • Research Site

    Bad Oeynhausen, 32545
    Germany

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  • Research Site

    Berlin, 10787
    Germany

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  • Research Site

    Essen, 45136
    Germany

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  • Research Site

    Falkensee, 14612
    Germany

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  • Research Site

    Hamburg, 22607
    Germany

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  • Research Site

    Mannheim, 68167
    Germany

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  • Research Site

    Muenster, 48145
    Germany

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  • Research Site

    Münster, 48145
    Germany

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  • Research Site

    Oldenburg, 23758
    Germany

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  • Research Site

    Sankt Ingbert, 66386
    Germany

    Site Not Available

  • Research Site

    Chuo-ku, 104-0031
    Japan

    Site Not Available

  • Research Site

    Shinjuku-ku, 160-0008
    Japan

    Site Not Available

  • Research Site

    Suita-shi, 565-0853
    Japan

    Site Not Available

  • Research Site

    Kaohsiung, 807
    Taiwan

    Site Not Available

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    Taichung, 40447
    Taiwan

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    Tainan, 704
    Taiwan

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  • Research Site

    Taipei, 10048
    Taiwan

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  • Research Site

    Airdrie, ML6 0JS
    United Kingdom

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  • Research Site

    Blackpool, FY3 7EN
    United Kingdom

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    Bristol, BS34 6BQ
    United Kingdom

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    Chesterfield, S40 4AA
    United Kingdom

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  • Research Site

    Dundee, DD1 9SY
    United Kingdom

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    Leicester, Le5 4PW
    United Kingdom

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    Rotherham, S65 1DA
    United Kingdom

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    Witney, OX28 6JS
    United Kingdom

    Site Not Available

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    Chandler, Arizona 85225
    United States

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    Huntington Park, California 90255
    United States

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    La Mesa, California 91942
    United States

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    Lincoln, California 95648
    United States

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    Riverside, California 92503
    United States

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    Walnut Creek, California 94598
    United States

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    Hialeah, Florida 33012
    United States

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    Orlando, Florida 32806
    United States

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    Palm Harbor, Florida 34684
    United States

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  • Research Site

    Tampa, Florida 33607
    United States

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    Meridian, Idaho 83646
    United States

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    Champaign, Illinois 61822
    United States

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  • Research Site

    Lombard, Illinois 60148
    United States

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  • Research Site

    Valparaiso, Indiana 46383
    United States

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  • Research Site

    West Des Moines, Iowa 50266
    United States

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    Roslindale, Massachusetts 02131
    United States

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    Farmington Hills, Michigan 48334
    United States

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  • Research Site

    Chesterfield, Missouri 63005
    United States

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  • Research Site

    Omaha, Nebraska 68134
    United States

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    Vestal, New York 13850
    United States

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    Durham, North Carolina 27701
    United States

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  • Research Site

    Wilmington, North Carolina 28401
    United States

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  • Research Site

    Fargo, North Dakota 58104
    United States

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  • Research Site

    Beachwood, Ohio 44122
    United States

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  • Research Site

    Cincinnati, Ohio 45219
    United States

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  • Research Site

    North Charleston, South Carolina 29405
    United States

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  • Research Site

    Spartanburg, South Carolina 29303
    United States

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  • Research Site

    Chattanooga, Tennessee 37421
    United States

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  • Research Site

    Knoxville, Tennessee 37912
    United States

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  • Research Site

    Austin, Texas 78735
    United States

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  • Research Site

    Beaumont, Texas 77702
    United States

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  • Research Site

    Dallas, Texas 75230
    United States

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  • Research Site

    Houston, Texas 77040
    United States

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  • Research Site

    Laredo, Texas 78041
    United States

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  • Research Site

    Woodway, Texas 76712
    United States

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  • Research Site

    Ogden, Utah 84405
    United States

    Site Not Available

  • Research Site

    Charlottesville, Virginia 22911
    United States

    Site Not Available

  • Research Site

    Manassas, Virginia 20110
    United States

    Site Not Available

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