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

A Phase IIb Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AZD5004 in Participants Living With Obesity or Overweight With Comorbidity

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

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity or Overweight
• Intervention / Treatment: Drug: AZD5004; Drug: Placebo

Detailed 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 285 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.

• Study Type: Interventional
• Enrollment (Estimated): 285
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• Australia
  • Heidelberg West, Australia, 3081
    • Research Site
  • Merewether, Australia, 2291
    • Research Site
  • St Albans, Australia, 3021
    • Research Site
  • St Leonards, Australia, 2065
    • Research Site
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6H 2L4
      • Research Site
  • British Columbia
    • Surrey, British Columbia, Canada, V3T 2V6
      • Research Site
    • Victoria, British Columbia, Canada, V8V 4A1
      • Research Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Research Site
  • Ontario
    • Guelph, Ontario, Canada, N1G 0B4
      • Research Site
    • Hamilton, Ontario, Canada, L8L 5G8
      • Research Site
    • Hamilton, Ontario, Canada, L8J 0B6
      • Research Site
    • Toronto, Ontario, Canada, M9V 4B4
      • Research Site
    • Toronto, Ontario, Canada, M9W 4L6
      • Research Site
  • Quebec
    • Terrebonne, Quebec, Canada, J6X 4P7
      • Research Site
• Germany
  • Bad Oeynhausen, Germany, 32545
    • Research Site
  • Berlin, Germany, 10787
    • Research Site
  • Essen, Germany, 45136
    • Research Site
  • Falkensee, Germany, 14612
    • Research Site
  • Hamburg, Germany, 22607
    • Research Site
  • Mannheim, Germany, 68167
    • Research Site
  • Münster, Germany, 48145
    • Research Site
  • Oldenburg, Germany, 23758
    • Research Site
  • Sankt Ingbert, Germany, 66386
    • Research Site
• Taiwan
  • Kaohsiung, Taiwan, 807
    • Research Site
  • Taichung, Taiwan, 40447
    • Research Site
  • Tainan, Taiwan, 704
    • Research Site
  • Taipei, Taiwan, 10048
    • Research Site
• United Kingdom
  • Airdrie, United Kingdom, ML6 0JS
    • Research Site
  • Blackpool, United Kingdom, FY3 7EN
    • Research Site
  • Bristol, United Kingdom, BS34 6BQ
    • Research Site
  • Chesterfield, United Kingdom, S40 4AA
    • Research Site
  • Dundee, United Kingdom, DD1 9SY
    • Research Site
  • Leicester, United Kingdom, Le5 4PW
    • Research Site
  • Rotherham, United Kingdom, S65 1DA
    • Research Site
  • Witney, United Kingdom, OX28 6JS
    • Research Site
• United States
  • Arizona
    • Chandler, Arizona, United States, 85225
      • Research Site
  • California
    • Huntington Park, California, United States, 90255
      • Research Site
    • La Mesa, California, United States, 91942
      • Research Site
    • Lincoln, California, United States, 95648
      • Research Site
    • Walnut Creek, California, United States, 94598
      • Research Site
  • Florida
    • Hialeah, Florida, United States, 33012
      • Research Site
    • Palm Harbor, Florida, United States, 34684
      • Research Site
    • Tampa, Florida, United States, 33607
      • Research Site
  • Illinois
    • Lombard, Illinois, United States, 60148
      • Research Site
  • Indiana
    • Valparaiso, Indiana, United States, 46383
      • Research Site
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Research Site
  • Massachusetts
    • Roslindale, Massachusetts, United States, 02131
      • Research Site
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Research Site
  • Missouri
    • Chesterfield, Missouri, United States, 63005
      • Research Site
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • Research Site
  • New York
    • Vestal, New York, United States, 13850
      • Research Site
  • North Carolina
    • Durham, North Carolina, United States, 27701
      • Research Site
    • Wilmington, North Carolina, United States, 28401
      • Research Site
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Research Site
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Research Site
    • Cincinnati, Ohio, United States, 45219
      • Research Site
  • South Carolina
    • North Charleston, South Carolina, United States, 29405
      • Research Site
    • Spartanburg, South Carolina, United States, 29303
      • Research Site
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • Research Site
    • Knoxville, Tennessee, United States, 37912
      • Research Site
  • Texas
    • Austin, Texas, United States, 78735
      • Research Site
    • Beaumont, Texas, United States, 77702
      • Research Site
    • Dallas, Texas, United States, 75230
      • Research Site
    • Houston, Texas, United States, 77040
      • Research Site
    • Woodway, Texas, United States, 76712
      • Research Site
  • Utah
    • Ogden, Utah, United States, 84405
      • Research Site
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Research Site
    • Manassas, Virginia, United States, 20110
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Be at least 18 years old at the time of signing the informed consent.

• At Screening, have a BMI: (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)
• Capable of giving signed informed consent

• Female(s) of childbearing potential (FOCBP):

  • Must use adequate contraception from enrollment, through the study, after the last dose of IMP.
  • Oral contraceptives are not permitted.
• Female(s) not of childbearing potential

• Male participants:

  • Condom use is required for the duration of the trial after the last dose of IMP
  • Additional contraception must be used for the sexual partners of male trial participants throughout the clinical trial following the last dose of IMP

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 T2DM
• Hemoglobin A1c (HbA1c) ≥ 6.5% (48 mmol/mol) at Screening
• Treatment with diabetes medication in past 3 months prior to Screening
• Cardiac arrhythmia or electrocardiogram (ECG) morphology abnormalities, as considered by the investigator, that may interfere with interpretation of QT interval corrected for heart rate (QTc) interval changes, including ST wave morphology
• Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper GI tract
• History of psychosis or bipolar disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 2; 00mg dose or placebo	Drug: AZD5004; Active IMP daily during 36 weeks; Other Names: Active IMP; Drug: Placebo; Placebo daily during 36 weeks
Experimental: Arm 3; 00mg dose or placebo	Drug: AZD5004; Active IMP daily during 36 weeks; Other Names: Active IMP; Drug: Placebo; Placebo daily during 36 weeks
Experimental: Arm 4; 00mg dose or placebo	Drug: AZD5004; Active IMP daily during 36 weeks; Other Names: Active IMP; Drug: Placebo; Placebo daily during 36 weeks
Experimental: Arm 5; 00mg dose or placebo	Drug: AZD5004; Active IMP daily during 36 weeks; Other Names: Active IMP; Drug: Placebo; Placebo daily during 36 weeks
Experimental: Arm 1; 00mg dose or placebo	Drug: AZD5004; Active IMP daily during 36 weeks; Other Names: Active IMP; Drug: Placebo; Placebo daily during 36 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change in body weight from baseline	To determine whether AZD5004 is superior to placebo for weight loss	26 weeks
Proportion of participants with weight loss ≥ 5% from baseline weight	To determine whether AZD5004 is superior to placebo on the proportion of participants with weight loss ≥ 5% from baseline	26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change in body weight from baseline	To determine whether AZD5004 is superior to placebo for weight loss	36 weeks
Proportion of participants with weight loss ≥ 5%	To determine whether AZD5004 is superior to placebo on the proportion of participants with weight loss ≥ 5% from baseline	36 weeks
Absolute change from baseline in body weight	To determine whether AZD5004 is superior to placebo for absolute weight loss	Week 26 and Week 36
Proportion of participants with weight loss ≥ 10% as well as ≥ 15%	To assess the effect of AZD5004 versus placebo on the proportion of participants with weight loss ≥ 10% as well as ≥ 15%	Week 26 and Week 36

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Prof Melanie Davies, MBChB MD, Diabetes Research Centre Leicester Diabetes Centre - Bloom University of Leicester

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): August 5, 2025
• Study Completion (Estimated): December 9, 2025

Study Registration Dates

• First Submitted: August 12, 2024
• First Submitted That Met QC Criteria: August 12, 2024
• First Posted (Estimated): August 14, 2024

Study Record Updates

• Last Update Posted (Estimated): August 14, 2024
• Last Update Submitted That Met QC Criteria: August 12, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: D7260C00001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.

Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No