Effects of AZD5004 in Adults Who Are Living With Obesity or Overweight With at Least 1 Weight-related Comorbidity
NCT Number: NCT06579092
Acronym: VISTA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Obesity or Overweight
Interventions: DRUG: AZD5004|DRUG: Placebo
Sponsor: AstraZeneca
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 285
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2025-12-09
Locations: Research Site, Chandler, Arizona, 85225, United States|Research Site, Huntington Park, California, 90255, United States|Research Site, La Mesa, California, 91942, United States|Research Site, Lincoln, California, 95648, United States|Research Site, Walnut Creek, California, 94598, United States|Research Site, Hialeah, Florida, 33012, United States|Research Site, Palm Harbor, Florida, 34684, United States|Research Site, Tampa, Florida, 33607, United States|Research Site, Lombard, Illinois, 60148, United States|Research Site, Valparaiso, Indiana, 46383, United States|Research Site, West Des Moines, Iowa, 50265, United States|Research Site, Roslindale, Massachusetts, 02131, United States|Research Site, Farmington Hills, Michigan, 48334, United States|Research Site, Chesterfield, Missouri, 63005, United States|Research Site, Omaha, Nebraska, 68134, United States|Research Site, Vestal, New York, 13850, United States|Research Site, Durham, North Carolina, 27701, United States|Research Site, Wilmington, North Carolina, 28401, United States|Research Site, Fargo, North Dakota, 58104, United States|Research Site, Beachwood, Ohio, 44122, United States|Research Site, Cincinnati, Ohio, 45219, United States|Research Site, North Charleston, South Carolina, 29405, United States|Research Site, Spartanburg, South Carolina, 29303, United States|Research Site, Chattanooga, Tennessee, 37421, United States|Research Site, Knoxville, Tennessee, 37912, United States|Research Site, Austin, Texas, 78735, United States|Research Site, Beaumont, Texas, 77702, United States|Research Site, Dallas, Texas, 75230, United States|Research Site, Houston, Texas, 77040, United States|Research Site, Woodway, Texas, 76712, United States|Research Site, Ogden, Utah, 84405, United States|Research Site, Charlottesville, Virginia, 22911, United States|Research Site, Manassas, Virginia, 20110, United States|Research Site, Heidelberg West, 3081, Australia|Research Site, Merewether, 2291, Australia|Research Site, St Albans, 3021, Australia|Research Site, St Leonards, 2065, Australia|Research Site, Edmonton, Alberta, T6H 2L4, Canada|Research Site, Surrey, British Columbia, V3T 2V6, Canada|Research Site, Victoria, British Columbia, V8V 4A1, Canada|Research Site, Halifax, Nova Scotia, B3H 2Y9, Canada|Research Site, Guelph, Ontario, N1G 0B4, Canada|Research Site, Hamilton, Ontario, L8J 0B6, Canada|Research Site, Hamilton, Ontario, L8L 5G8, Canada|Research Site, Toronto, Ontario, M9V 4B4, Canada|Research Site, Toronto, Ontario, M9W 4L6, Canada|Research Site, Terrebonne, Quebec, J6X 4P7, Canada|Research Site, Bad Oeynhausen, 32545, Germany|Research Site, Berlin, 10787, Germany|Research Site, Essen, 45136, Germany|Research Site, Falkensee, 14612, Germany|Research Site, Hamburg, 22607, Germany|Research Site, Mannheim, 68167, Germany|Research Site, Münster, 48145, Germany|Research Site, Oldenburg, 23758, Germany|Research Site, Sankt Ingbert, 66386, Germany|Research Site, Kaohsiung, 807, Taiwan|Research Site, Taichung, 40447, Taiwan|Research Site, Tainan, 704, Taiwan|Research Site, Taipei, 10048, Taiwan|Research Site, Airdrie, ML6 0JS, United Kingdom|Research Site, Blackpool, FY3 7EN, United Kingdom|Research Site, Bristol, BS34 6BQ, United Kingdom|Research Site, Chesterfield, S40 4AA, United Kingdom|Research Site, Dundee, DD1 9SY, United Kingdom|Research Site, Leicester, LE5 4PW, United Kingdom|Research Site, Rotherham, S65 1DA, United Kingdom|Research Site, Witney, OX28 6JS, United Kingdom

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

Primary Outcome Measures: 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: 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