AZD6234 for Type 2 Diabetes and Obesity

(ARAY Trial)

Recruiting at 15 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AZD6234 for adults with type 2 diabetes who are overweight or have obesity. The goal is to determine if this medication can effectively and safely manage blood sugar levels and weight while participants continue their usual diabetes treatment. Participants will receive either the new treatment or a placebo (a substance with no active medication) through weekly injections. Ideal candidates should have had type 2 diabetes for at least six months, be on a stable injectable diabetes medication, and have a body mass index (BMI) of 27 or higher. As a Phase 2 trial, this study measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important research.

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.

Is there any evidence suggesting that AZD6234 is likely to be safe for humans?

Research has shown that AZD6234, a treatment under study for type 2 diabetes and obesity, has undergone safety and tolerability testing in several studies. In one study, participants received repeated doses of AZD6234 to observe their bodily reactions. Another study tested single doses administered either subcutaneously or intravenously in healthy participants. These studies help researchers understand the treatment's mechanism in the body and identify any side effects.

These studies are ongoing, designed to monitor tolerance and detect any adverse effects. The current trial is in Phase 2, indicating some early safety evidence from previous research, but more information is needed to fully understand the treatment's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for type 2 diabetes and obesity?

AZD6234 is unique because it offers a novel approach to treating Type 2 Diabetes and Obesity with its weekly subcutaneous injections. Unlike standard treatments that often involve daily pills or insulin shots, AZD6234 simplifies the regimen with just once-a-week dosing. Researchers are particularly excited about its potential to improve patient compliance and its distinct mechanism that may provide more effective management of blood sugar levels and weight. This could open up new possibilities for those struggling with the demands of current treatment plans.

What evidence suggests that AZD6234 might be an effective treatment for type 2 diabetes and obesity?

Research has shown that AZD6234, which participants in this trial may receive, may help treat obesity and type 2 diabetes. In earlier studies, participants lost a significant amount of weight, with some losing over 10% of their body weight. This treatment affects how the body converts food into energy, helping control weight and blood sugar levels. Initial findings suggest AZD6234 is generally well-tolerated, with most people not experiencing serious side effects. These results are promising for those dealing with obesity and type 2 diabetes. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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)

At Screening, have a BMI ≥ 27 kg/m2

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06851858

Study Details | NCT06851858 | Efficacy, Safety and ... 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. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D8750C00004

A study in participants with obesity or overweight with at ... A Phase IIb Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AZD6234 in Participants Living with Obesity ...

3. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/579696

Efficacy, Safety and Tolerability of AZD6234 in Participants ... Secondary outcome measures · Weight loss ≥ 10% from baseline at Study Week 26 (From baseline to week 26) · Absolute change in body weight (kg) ...

4. astrazeneca.com astrazeneca.com/content/dam/az/Investor_Relations/events/Weight-Management-Virtual-Event-IR-presentation.pdf

Weight Management Virtual Event Presented at Obesity Week 2024. Phase I SAD demonstrated efficacy with promising tolerability. AZD6234 | LA amylin. Body weight change after ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06851858?term=AREA%5BConditionSearch%5D(Endocrinology)&rank=3

Efficacy, Safety and Tolerability of AZD6234 in Participants ... 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 ...

6. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D8750C00002

A study to assess the safety, tolerability, pharmacokinetics ... A study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD6234 after repeat dose administration in participants who are ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05511025

Study Details | NCT05511025 | Assess the Safety, ... The safety and tolerability of AZD6234 following subcutaneous and/or intravenous administration of single ascending doses in healthy participants, including ...