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

Launched by ASTRAZENECA · Feb 24, 2025

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ClinConnect Summary

This clinical trial is studying a new medication called AZD6234 to see how well it works, how safe it is, and how well people tolerate it. The trial is specifically for adults aged 18 to 75 who are living with overweight or obesity and have been diagnosed with type 2 diabetes for at least six months. Participants must also be on a stable dose of a certain type of diabetes medication called a GLP-1 receptor agonist and have a body mass index (BMI) of 27 or higher.

If you join the trial, you will be randomly assigned to receive either the AZD6234 medication or a placebo (a harmless substance that looks like the drug but has no active ingredients) for a certain period of time. Throughout the study, you will be closely monitored to track your health and any side effects. This trial is important because it aims to find better treatment options for people with type 2 diabetes who are also managing their weight. However, there are specific criteria, such as no recent weight loss treatments or certain health conditions, that you need to meet to be eligible.

Gender

ALL

Eligibility criteria

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