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

NCT ID: NCT06579092

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-08

Study Completion Date

2025-11-21

Brief Summary

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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

Detailed Description

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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.

Conditions

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Obesity or Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Arm 1

Active IMP

Group Type EXPERIMENTAL

AZD5004

Intervention Type DRUG

AZD5004 film-coated tablet once daily during 36 weeks

Arm 2

Active IMP

Group Type EXPERIMENTAL

AZD5004

Intervention Type DRUG

AZD5004 film-coated tablet once daily during 36 weeks

Arm 3

Active IMP

Group Type EXPERIMENTAL

AZD5004

Intervention Type DRUG

AZD5004 film-coated tablet once daily during 36 weeks

Arm 4

Active IMP

Group Type EXPERIMENTAL

AZD5004

Intervention Type DRUG

AZD5004 film-coated tablet once daily during 36 weeks

Arm 5

Active IMP

Group Type EXPERIMENTAL

AZD5004

Intervention Type DRUG

AZD5004 film-coated tablet once daily during 36 weeks

Arm 6

Matching placebo for each of the 5 active arms

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo matching AZD5004 film-coated tablet once daily during 36 weeks

Interventions

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AZD5004

AZD5004 film-coated tablet once daily during 36 weeks

Intervention Type DRUG

Placebo

Placebo matching AZD5004 film-coated tablet once daily during 36 weeks

Intervention Type DRUG

Other Intervention Names

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Active IMP

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prof Melanie Davies, MBChB MD

Role: PRINCIPAL_INVESTIGATOR

Diabetes Research Centre Leicester Diabetes Centre - Bloom University of Leicester

Locations

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Research Site

Chandler, Arizona, United States

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Huntington Park, California, United States

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La Mesa, California, United States

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Lincoln, California, United States

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Walnut Creek, California, United States

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Hialeah, Florida, United States

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Orlando, Florida, United States

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Lombard, Illinois, United States

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Valparaiso, Indiana, United States

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West Des Moines, Iowa, United States

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Roslindale, Massachusetts, United States

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Farmington Hills, Michigan, United States

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Chesterfield, Missouri, United States

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Omaha, Nebraska, United States

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Vestal, New York, United States

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Durham, North Carolina, United States

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Wilmington, North Carolina, United States

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Fargo, North Dakota, United States

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Beachwood, Ohio, United States

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Cincinnati, Ohio, United States

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North Charleston, South Carolina, United States

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Spartanburg, South Carolina, United States

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Knoxville, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Woodway, Texas, United States

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Ogden, Utah, United States

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Charlottesville, Virginia, United States

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Manassas, Virginia, United States

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Heidelberg, , Australia

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Merewether, , Australia

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St Albans, , Australia

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St Leonards, , Australia

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Calgary, Alberta, Canada

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Surrey, British Columbia, Canada

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Victoria, British Columbia, Canada

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Halifax, Nova Scotia, Canada

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Guelph, Ontario, Canada

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Hamilton, Ontario, Canada

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Hamilton, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Terrebonne, Quebec, Canada

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Bad Oeynhausen, , Germany

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Berlin, , Germany

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Hamburg, , Germany

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Mannheim, , Germany

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Münster, , Germany

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Oldenburg, , Germany

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Sankt Ingbert, , Germany

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Suita-shi, , Japan

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Kaohsiung City, , Taiwan

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Taichung, , Taiwan

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Tainan, , Taiwan

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Taipei, , Taiwan

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Blackpool, , United Kingdom

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Bristol, , United Kingdom

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Chesterfield, , United Kingdom

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Leicester, , United Kingdom

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Rotherham, , United Kingdom

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Witney, , United Kingdom

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Countries

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United States Australia Canada Germany Japan Taiwan United Kingdom

Other Identifiers

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2024-513691-18-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

D7260C00001

Identifier Type: -

Identifier Source: org_study_id