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

Last updated: October 28, 2025
Sponsor: AstraZeneca
Overall Status: Active - Not Recruiting

Phase

2

Condition

Obesity

Diabetes Prevention

Hypertriglyceridemia

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, 3081
    Australia

    Site Not Available

  • Research Site

    Heidelberg 2163654, 3081
    Australia

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  • Research Site

    Heidelberg West, 3081
    Australia

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  • Research Site

    Merewether, 2291
    Australia

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  • Research Site

    Merewether 8348074, 2291
    Australia

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  • Research Site

    St Albans, 3021
    Australia

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    St Albans 8015209, 3021
    Australia

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    St Leonards, 2065
    Australia

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    St Leonards 8029783, 2065
    Australia

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    Calgary, Alberta T2V 4J2
    Canada

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    Edmonton, Alberta T6H 2L4
    Canada

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    Calgary 5913490, Alberta 5883102 T2V 4J2
    Canada

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    Surrey, British Columbia V3T 2V6
    Canada

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    Victoria, British Columbia V8V 4A1
    Canada

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  • Research Site

    Surrey 6159905, British Columbia 5909050 V3T 2V6
    Canada

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    Victoria 6174041, British Columbia 5909050 V8V 4A1
    Canada

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    Halifax, Nova Scotia B3H 1V7
    Canada

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    Halifax 6324729, Nova Scotia 6091530 B3H 1V7
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    Guelph, Ontario N1G 0B4
    Canada

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    Hamilton, Ontario L8L 5G8
    Canada

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    Toronto, Ontario M9V 4B4
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    Guelph 5967629, Ontario 6093943 N1G 0B4
    Canada

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    Hamilton 5969782, Ontario 6093943 L8J 0B6
    Canada

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    Toronto 6167865, Ontario 6093943 M9V 4B4
    Canada

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    Terrebonne, Quebec J6X 4P7
    Canada

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    Terrebonne 6163012, Quebec 6115047 J6X 4P7
    Canada

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    Bad Oeynhausen, 32545
    Germany

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    Bad Oeynhausen 2953386, 32545
    Germany

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    Berlin, 10787
    Germany

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    Berlin 2950159, 10787
    Germany

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    Essen, 45136
    Germany

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    Falkensee, 14612
    Germany

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    Hamburg, 22607
    Germany

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    Hamburg 2911298, 22607
    Germany

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    Mannheim, 68167
    Germany

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    Mannheim 2873891, 68167
    Germany

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    Muenster, 48145
    Germany

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    Münster, 48145
    Germany

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    Münster 2867543, 48145
    Germany

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    Oldenburg, 23758
    Germany

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    Oldenburg 2857458, 23758
    Germany

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    Sankt Ingbert, 66386
    Germany

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    Sankt Ingbert 2841590, 66386
    Germany

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    Chuo-ku, 104-0031
    Japan

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    Shinjuku-ku, 160-0008
    Japan

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    Suita-shi, 565-0853
    Japan

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    Kaohsiung, 807
    Taiwan

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    Kaohsiung City 1673820, 807
    Taiwan

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    Taichung, 40447
    Taiwan

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    Taichung 1668399, 40447
    Taiwan

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    Tainan, 704
    Taiwan

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    Tainan City 1668355, 704
    Taiwan

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    Taipei, 10048
    Taiwan

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    Taipei 1668341, 10048
    Taiwan

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    Airdrie, ML6 0JS
    United Kingdom

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    Blackpool, FY3 7EN
    United Kingdom

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    Blackpool 2655459, FY3 7EN
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    Bristol, BS34 6BQ
    United Kingdom

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    Bristol 2654675, BS34 6BQ
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    Chesterfield, S40 4AA
    United Kingdom

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    Chesterfield 2653225, S40 4AA
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    Dundee, DD1 9SY
    United Kingdom

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    Leicester, LE5 4PW
    United Kingdom

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    Leicester 2644668, Le5 4PW
    United Kingdom

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    Rotherham, S65 1DA
    United Kingdom

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    Rotherham 2639093, S65 1DA
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    Witney, OX28 6JS
    United Kingdom

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    Witney 2633729, OX28 6JS
    United Kingdom

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    Chandler, Arizona 85225
    United States

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    Chandler 5289282, Arizona 5551752 85225
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    Huntington Park, California 90255
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    La Mesa, California 91942
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    Lincoln, California 95648
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    Riverside, California 92503
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    Walnut Creek, California 94598
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    Huntington Park 5358736, California 5332921 90255
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    La Mesa 5363990, California 5332921 91942
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    Lincoln 5366375, California 5332921 95648
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    Walnut Creek 5406990, California 5332921 94598
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    Hialeah, Florida 33012
    United States

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    Orlando, Florida 32806
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    Palm Harbor, Florida 34684
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    Tampa, Florida 33607
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    Hialeah 4158476, Florida 4155751 33012
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    Orlando 4167147, Florida 4155751 32806
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    Meridian, Idaho 83646
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    Champaign, Illinois 61822
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    Lombard, Illinois 60148
    United States

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    Lombard 4900373, Illinois 4896861 60148
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    Valparaiso, Indiana 46383
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    Valparaiso 4927537, Indiana 4921868 46383
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    West Des Moines, Iowa 50266
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    West Des Moines 4881346, Iowa 4862182 50266
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    Roslindale, Massachusetts 02131
    United States

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    Roslindale 4949068, Massachusetts 6254926 02131
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    Farmington Hills, Michigan 48334
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    Farmington Hills 4992523, Michigan 5001836 48334
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    Chesterfield, Missouri 63005
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    Chesterfield 4381072, Missouri 4398678 63005
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    Omaha, Nebraska 68134
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    Omaha 5074472, Nebraska 5073708 68134
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    Vestal, New York 13850
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    Vestal 5142296, New York 5128638 13850
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    Durham, North Carolina 27701
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    Wilmington, North Carolina 28401
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    Durham 4464368, North Carolina 4482348 27701
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    Wilmington 4499379, North Carolina 4482348 28401
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    Fargo, North Dakota 58104
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    Fargo 5059163, North Dakota 5690763 58104
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    Beachwood, Ohio 44122
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    Cincinnati, Ohio 45219
    United States

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    Beachwood 5146711, Ohio 5165418 44122
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  • Research Site

    Cincinnati 4508722, Ohio 5165418 45219
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    North Charleston, South Carolina 29405
    United States

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    Spartanburg, South Carolina 29303
    United States

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    North Charleston 4589387, South Carolina 4597040 29405
    United States

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    Spartanburg 4597200, South Carolina 4597040 29303
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    Chattanooga, Tennessee 37421
    United States

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    Knoxville, Tennessee 37912
    United States

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    Knoxville 4634946, Tennessee 4662168 37912
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    Austin, Texas 78735
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    Beaumont, Texas 77702
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    Dallas, Texas 75230
    United States

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    Houston, Texas 77040
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    Laredo, Texas 78041
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    Woodway, Texas 76712
    United States

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    Austin 4671654, Texas 4736286 78735
    United States

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    Dallas 4684888, Texas 4736286 75230
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    Houston 4699066, Texas 4736286 77040
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    Woodway 4743105, Texas 4736286 76712
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    Ogden, Utah 84405
    United States

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    Ogden 5779206, Utah 5549030 84405
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    Charlottesville, Virginia 22911
    United States

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    Manassas, Virginia 20110
    United States

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  • Research Site

    Charlottesville 4752031, Virginia 6254928 22911
    United States

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  • Research Site

    Manassas 4771401, Virginia 6254928 20110
    United States

    Site Not Available

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