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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

NCT06851858

Active Not RecruitingPhase 2

Sponsor: AstraZeneca

Conditions: Endocrinology, Diabetes, Type II, Obesity

Interventions: AZD6234, Placebo to match

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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 ≥ 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

Locations (18)

Birmingham, Alabama, United States
Mobile, Alabama, United States
Doral, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Winter Park, Florida, United States
Canton, Georgia, United States
Fayetteville, Georgia, United States
Chicago, Illinois, United States
Oak Brook, Illinois, United States
Newton, Kansas, United States
Lexington, Kentucky, United States
Kansas City, Missouri, United States
Las Vegas, Nevada, United States
Norman, Oklahoma, United States
Knoxville, Tennessee, United States
San Antonio, Texas, United States