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

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.

Eligibility

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 ≥ 6.0% (42 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

Conditions4

Locations18 sites

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