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 (ARAY)

March 2, 2026 updated by: AstraZeneca

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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, safety, and tolerability of AZD6234 in adults with overweight or obesity and type 2 diabetes on stable GLP-1 RA therapy. A total of 64 Participants, aged 18-75 with a BMI ≥ 27 kg/m², will be randomized to receive weekly subcutaneous injections of either AZD6234 or a placebo, alongside their current GLP-1 RA medication. The study involves a screening period and a treatment and follow-up period.

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Research Site
      • Mobile, Alabama, United States, 36608
        • Research Site
    • Florida
      • Doral, Florida, United States, 33166
        • Research Site
      • Jacksonville, Florida, United States, 32216
        • Research Site
      • Miami, Florida, United States, 33136
        • Research Site
      • Miami, Florida, United States, 33135
        • Research Site
      • Winter Park, Florida, United States, 32789
        • Research Site
    • Georgia
      • Canton, Georgia, United States, 30114
        • Research Site
      • Fayetteville, Georgia, United States, 30214
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Research Site
      • Oak Brook, Illinois, United States, 60523
        • Research Site
    • Kansas
      • Newton, Kansas, United States, 67114
        • Research Site
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Research Site
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Research Site
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Research Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Research Site
    • Texas
      • San Antonio, Texas, United States, 78229
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Be 18 to 75 years old at the time of signing the informed consent.
  2. Diagnosed with type 2 diabetes ≥ 180 days before screening.
  3. HbA1c value at screening of ≥ 6.0% (42 mmol/mol) and ≤ 10% (86 mmol/mol).
  4. On a stable maintenance dose of an injectable GLP-1 RA.
  5. At Screening, have a BMI ≥ 27 kg/m2

Exclusion Criteria:

  1. 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).
  2. Self-reported weight change of > 5 % in the 3 months prior to screening.
  3. Diabetes mellitus that is not clearly type 2 diabetes.
  4. Use of insulin therapy for T2DM
  5. Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier)
  6. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AZD6234
Weekly SC injections of AZD6234
Drug: AZD6234
Weekly SC injections of AZD6234
Placebo Comparator: Placebo for AZD6234
Weekly SC injections of matching placebo
Drug: Placebo to match
Weekly SC injections of matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent change in body weight from baseline at Study Week 26
Time Frame: From baseline to 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
Time Frame: From baseline to 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight loss ≥ 10% from baseline at Study Week 26
Time Frame: From baseline to 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
Time Frame: From baseline to 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.
Time Frame: From baseline to 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
Time Frame: From baseline to week 26
To characterise the PK of AZD6234
From baseline to week 26
Change in serum glucose from baseline at Study Week 26.
Time Frame: From baseline to week 26
To assess the effect of AZD6234 versus placebo on glycaemic control at Study week 26
From baseline to week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2025

Primary Completion (Estimated)

May 27, 2026

Study Completion (Estimated)

May 27, 2026

Study Registration Dates

First Submitted

February 13, 2025

First Submitted That Met QC Criteria

February 24, 2025

First Posted (Actual)

February 28, 2025

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D8750C00005

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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