EndocrinologyPhase 2ARAYNCT06851858
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 2 study testing AZD6234 in people with Endocrinology and Diabetes, Type II, run by AstraZeneca at 18 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Endocrinology, Diabetes, Type II, Obesity
- What is being tested?
- AZD6234
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 18 sitesUnited States
- Study dates
- 12 Mar 2025to 26 May 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Research Site
Birmingham, Alabama, 35205
Research Site
Canton, Georgia, 30114
Research Site
Chicago, Illinois, 60640
Research Site
Doral, Florida, 33166
Research Site
Fayetteville, Georgia, 30214
Research Site
Jacksonville, Florida, 32216
Research Site
Kansas City, Missouri, 64114
Research Site
Knoxville, Tennessee, 37909
Research Site
Las Vegas, Nevada, 89119
Research Site
Lexington, Kentucky, 40509
Research Site
Miami, Florida, 33135
Research Site
Miami, Florida, 33136
Research Site
Mobile, Alabama, 36608
Research Site
Newton, Kansas, 67114
Research Site
Norman, Oklahoma, 73069
Research Site
Oak Brook, Illinois, 60523
Research Site
San Antonio, Texas, 78229
Research Site
Winter Park, Florida, 32789
About this study
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
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.
Read the 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.
- Conditions
- Endocrinology, Diabetes, Type II, Obesity
- Being tested
- AZD6234, Placebo to match
- Keywords
- Diabetes, Type II, Obesity
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD6234Drug
Weekly SC injections of AZD6234
Placebo to matchDrug
Weekly SC injections of matching placebo
| Study group | Role | What they receive |
|---|---|---|
| AZD6234 | Experimental | Weekly SC injections of AZD6234 Receives: Drug: AZD6234 |
| Placebo for AZD6234 | Placebo comparator | Weekly SC injections of matching placebo Receives: Drug: Placebo to match |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: From baseline to week 26
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: From baseline to week 26
AZD6234 plasma concentrations
To characterise the PK of AZD6234
Measured: 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
Measured: From baseline to week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start12 Mar 2025
- Primary completion26 May 2026
- Study completion26 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndocrinologyStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The study spans approx. 37 weeks per participant, including a screening period, a treatment period and a follow-up period. Around 64 eligible participants will be randomized to receive either AZD6234 or a matching placebo, in addition to their stable GLP-1 RA regimen. Treatments consist of weekly subcutaneous injections, with AZD6234 dosing adjustments allowed based on individual tolerance.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851858
- Sponsor's protocol ID
- D8750C00005
- Acronym
- ARAY
- Status last verified
- Sep 2026
- First submitted
- 13 Feb 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.