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Clinical Trial Details

Trial ID: L4100
Source ID: NCT06851858
Associated Drug: Azd6234
Title: Efficacy, Safety and Tolerability of AZD6234 in Participants Living With Overweight or Obesity With Type 2 Diabetes Who Are on a Stable Dose of GLP-1 Receptor Agonist
Acronym: ARAY
Status: RECRUITING
Study Results: NO
Results:
Conditions: Endocrinology|Diabetes, Type II|Obesity
Interventions: DRUG: AZD6234|DRUG: Placebo to match
Outcome Measures: Primary: Percent change in body weight from baseline at Study Week 26, To determine whether treatment with AZD6234 is superior to placebo for weight loss at Study Week 26, From baseline to week 26|Weight loss ≥ 5% from baseline at Study Week 26, To assess the effect of AZD6234 versus placebo on the proportion of participants with weight loss ≥ 5% from baseline at Study Week 26, From baseline to week 26 | Secondary: Weight loss ≥ 10% from baseline at Study Week 26, To assess the effect of AZD6234 versus placebo on the proportion of participants with weight loss ≥ 10% from baseline at Study Week 26, From baseline to week 26|Absolute change in body weight (kg) from baseline at Study Week 26, To determine whether AZD6234 is superior to placebo for absolute weight reduction (kg) at Study Week 26, From baseline to week 26|Change in HbA1c from baseline at Study Week 26., To assess the effect of AZD6234 versus placebo on glycaemic control at Study week 26, From baseline to week 26|AZD6234 plasma concentrations, To characterise the PK of AZD6234, From baseline to week 26|Change in serum glucose from baseline at Study Week 26., To assess the effect of AZD6234 versus placebo on glycaemic control at Study week 26, From baseline to week 26
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 64
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2025-03-12
Completion Date: 2026-01-27
Results First Posted:
Last Update Posted: 2025-04-11
Locations: Research Site, Birmingham, Alabama, 35205, United States|Research Site, Mobile, Alabama, 36608, United States|Research Site, Doral, Florida, 33166, United States|Research Site, Jacksonville, Florida, 32216, United States|Research Site, Miami, Florida, 33135, United States|Research Site, Winter Park, Florida, 32789, United States|Research Site, Canton, Georgia, 30114, United States|Research Site, Macon, Georgia, 31210, United States|Research Site, Chicago, Illinois, 60640, United States|Research Site, Oak Brook, Illinois, 60523, United States|Research Site, Newton, Kansas, 67114, United States|Research Site, Lexington, Kentucky, 40509, United States|Research Site, Kansas City, Missouri, 64114, United States|Research Site, Las Vegas, Nevada, 89119, United States|Research Site, Norman, Oklahoma, 73069, United States|Research Site, San Antonio, Texas, 78229, United States
URL: https://clinicaltrials.gov/show/NCT06851858