AZD6234 for Type 2 Diabetes and Obesity

(ARAY Trial)

Recruiting at 14 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AstraZeneca

Must be taking: GLP-1 RA

Must not be taking: Insulin, Weight loss drugs

Disqualifiers: Bariatric surgery, Hepatobiliary disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

64 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be on a stable dose of a GLP-1 RA (a type of diabetes medication) to participate.

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults with type 2 diabetes who are overweight or obese and currently taking a stable dose of GLP-1 receptor agonist medication. Specific eligibility criteria details were not provided.

Inclusion Criteria

I was diagnosed with type 2 diabetes more than 6 months ago.

HbA1c value at screening of ≥ 7.0% (53 mmol/mol) and ≤ 10% (86 mmol/mol)

I am on a steady dose of GLP-1 RA injections.

Exclusion Criteria

I use insulin to manage my type 2 diabetes.

My kidney function is low, with an eGFR of 45 or less.

Self-reported weight change of > 5% in the 3 months prior to screening

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly subcutaneous injections of AZD6234 or placebo for weight loss

26 weeks

Weekly visits for injections

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• AZD6234

Trial Overview The study tests the effectiveness, safety, and tolerability of AZD6234 compared to a placebo in participants. It's a Phase II trial where participants are randomly assigned to either the drug or placebo group without knowing which they receive.

Participant Groups

Group I: AZD6234 Experimental Treatment 1 Intervention

Weekly SC injections of AZD6234

Group II: Placebo for AZD6234 Placebo Group 1 Intervention

Weekly SC injections of matching placebo

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology