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

Description

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.

Conditions

Endocrinology, Diabetes, Type II, Obesity

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Study Overview

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Study Details

Study overview

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.

A Phase II Randomised, Double-blind, Placebo-controlled Study to Evaluate the 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

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

Condition
Endocrinology
Intervention / Treatment

-

Contacts and Locations

Birmingham

Research Site, Birmingham, Alabama, United States, 35205

Mobile

Research Site, Mobile, Alabama, United States, 36608

Doral

Research Site, Doral, Florida, United States, 33166

Jacksonville

Research Site, Jacksonville, Florida, United States, 32216

Miami

Research Site, Miami, Florida, United States, 33135

Winter Park

Research Site, Winter Park, Florida, United States, 32789

Canton

Research Site, Canton, Georgia, United States, 30114

Macon

Research Site, Macon, Georgia, United States, 31210

Chicago

Research Site, Chicago, Illinois, United States, 60640

Oak Brook

Research Site, Oak Brook, Illinois, United States, 60523

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2026-01-27