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Clinical Trial NCT06851858 (ARAY) for Endocrinology, Diabetes, Type II, Obesity is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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AstraZenecaEfficacy, 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 (ARAY) Phase 2 69 Randomized Double-Blind Placebo-Controlled
Clinical Trial NCT06851858 (ARAY) is designed to study Treatment for Endocrinology, Diabetes, Type II, Obesity. It is a Phase 2 interventional study that is active, not recruiting, having started on March 12, 2025, with plans to enroll 69 participants. Led by AstraZeneca, it is expected to complete by May 27, 2026. The latest data from ClinicalTrials.gov was last updated on March 3, 2026.
Brief Summary
This Phase II study is a randomized, parallel group, double blinded, placebo-controlled, multicenter to evaluate the efficacy, safety, and tolerability of AZD6234 in adults with overweight or obesity and type 2 diabetes on stable GLP-1 RA therapy.
Detailed Description
This is a Phase II, randomised, parallel-group, double-blind, placebo-controlled, multi-centre study to assess the efficacy, safety, and tolerability of AZD6234 compared with placebo, given once weekly as a subcutaneous (SC) injection, in adults living with overweight or obesity and type 2 diabetes who are on a stable dose of GLP-1 RA. The study is being conducted across sites in the USA to evaluate the efficacy, saf...Show More
Official Title
A Phase II Randomised, Double-blind, Placebo-controlled Study to Evaluate the 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
Conditions
EndocrinologyDiabetes, Type IIObesityOther Study IDs
- ARAY
- D8750C00005
NCT ID Number
Start Date (Actual)
2025-03-12
Last Update Posted
2026-03-03
Completion Date (Estimated)
2026-05-27
Enrollment (Estimated)
69
Study Type
Interventional
PHASE
Phase 2
Status
Active, not recruiting
Keywords
Diabetes, Type II
Obesity
Obesity
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Sequential
Masking
Triple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalAZD6234 Weekly SC injections of AZD6234 | AZD6234 Weekly SC injections of AZD6234 |
Placebo ComparatorPlacebo for AZD6234 Weekly SC injections of matching placebo | Placebo to match Weekly SC injections of matching placebo |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- Be 18 to 75 years old at the time of signing the informed consent.
- Diagnosed with type 2 diabetes ≥ 180 days before screening.
- HbA1c value at screening of ≥ 6.0% (42 mmol/mol) and ≤ 10% (86 mmol/mol).
- On a stable maintenance dose of an injectable GLP-1 RA.
- At Screening, have a BMI ≥ 27 kg/m2
- Has received treatment with prescription or non-prescription medication for weight loss within the last 3 months prior to screening (other than a GLP-1 RA).
- Self-reported weight change of > 5 % in the 3 months prior to screening.
- Diabetes mellitus that is not clearly type 2 diabetes.
- Use of insulin therapy for T2DM
- Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier)
- Significant hepatobiliary disease (except for non-alcoholic steatohepatitis or nonalcoholic fatty liver disease without portal hypertension or cirrhosis)
8. Impaired renal function defined as eGFR ≤ 45 mL/minute/1.73m2 at screening
AstraZeneca772 active studies to exploreNo contact data.
18 Study Locations in 1 Countries
Alabama
Research Site, Birmingham, Alabama, 35205, United States
Research Site, Mobile, Alabama, 36608, United States
Florida
Research Site, Doral, Florida, 33166, United States
Research Site, Jacksonville, Florida, 32216, United States
Research Site, Miami, Florida, 33135, United States
Research Site, Miami, Florida, 33136, United States
Research Site, Winter Park, Florida, 32789, United States
Georgia
Research Site, Canton, Georgia, 30114, United States
Research Site, Fayetteville, Georgia, 30214, United States
Illinois
Research Site, Chicago, Illinois, 60640, United States
Research Site, Oak Brook, Illinois, 60523, United States
Kansas
Research Site, Newton, Kansas, 67114, United States
Kentucky
Research Site, Lexington, Kentucky, 40509, United States
Missouri
Research Site, Kansas City, Missouri, 64114, United States
Nevada
Research Site, Las Vegas, Nevada, 89119, United States
Oklahoma
Research Site, Norman, Oklahoma, 73069, United States
Tennessee
Research Site, Knoxville, Tennessee, 37909, United States
Texas
Research Site, San Antonio, Texas, 78229, United States