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)

AstraZeneca

Status and phase: Not yet enrolling; Phase 2

Conditions: Obesity; Diabetes, Type II; Endocrinology

Treatments: Drug: AZD6234; Drug: Placebo to match

Study type: Interventional

Funder types: Industry

Identifiers

NCT06851858

D8750C00005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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 ≥ 7.0% (53 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)

7. Impaired renal function defined as eGFR ≤ 45 mL/minute/1.73m2 at screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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64 participants in 2 patient groups, including a placebo group

AZD6234

Experimental group

Description:

Weekly SC injections of AZD6234

Treatment:

Drug: AZD6234

Placebo for AZD6234

Placebo Comparator group

Description:

Weekly SC injections of matching placebo

Treatment:

Drug: Placebo to match