ARAY

Active not recruitingPhase 2

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

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

Lead sponsor

AstraZeneca

Asset

AZD6234

Subcutaneous · Amylin analog

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥27•HbA1c ≥6%

Primary endpoints

•Body weight, % change•≥5% weight-loss responders

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06851858

Org study IDD8750C00005

Timeline

Milestones

Study first posted2025-02-28actual

Study start2025-03-12actual

Last update posted2026-03-03actual

Primary completion2026-05-27estimated

Study completion2026-05-27estimated

Assets

Investigational agents

AZD6234

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersAccepted

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

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

4 endpoints

Primary/protocol endpoint

Percent change in body weight from baseline at Study Week 26

Time frame:From baseline to week 26

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Weight loss ≥ 5% from baseline at Study Week 26

Time frame:From baseline to week 26

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Weight loss ≥ 10% from baseline at Study Week 26

Time frame:From baseline to week 26

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Absolute change in body weight (kg) from baseline at Study Week 26

Time frame:From baseline to week 26

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Change in HbA1c from baseline at Study Week 26.

Time frame:From baseline to week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in serum glucose from baseline at Study Week 26.

Time frame:From baseline to week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

AZD6234 plasma concentrations

Time frame:From baseline to week 26

Plasma concentration (steady state)

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.