RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-03-12
Study Completion:2026-01-27
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06851858

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Be 18 to 75 years old at the time of signing the informed consent.
  2. 2. Diagnosed with type 2 diabetes ≥ 180 days before screening.
  3. 3. HbA1c value at screening of ≥ 7.0% (53 mmol/mol) and ≤ 10% (86 mmol/mol).
  4. 4. On a stable maintenance dose of an injectable GLP-1 RA.
  5. 5. At Screening, have a BMI ≥ 27 kg/m2
  1. 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. 2. Self-reported weight change of \> 5 % in the 3 months prior to screening.
  3. 3. Diabetes mellitus that is not clearly type 2 diabetes.
  4. 4. Use of insulin therapy for T2DM
  5. 5. Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier)
  6. 6. Significant hepatobiliary disease (except for non-alcoholic steatohepatitis or nonalcoholic fatty liver disease without portal hypertension or cirrhosis)
  7. 8. Impaired renal function defined as eGFR ≤ 45 mL/minute/1.73m2 at screening

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Study Locations (Sites)

Research Site
Birmingham, Alabama, 35205
United States
Research Site
Mobile, Alabama, 36608
United States
Research Site
Doral, Florida, 33166
United States
Research Site
Jacksonville, Florida, 32216
United States
Research Site
Miami, Florida, 33135
United States
Research Site
Winter Park, Florida, 32789
United States
Research Site
Canton, Georgia, 30114
United States
Research Site
Macon, Georgia, 31210
United States
Research Site
Chicago, Illinois, 60640
United States
Research Site
Oak Brook, Illinois, 60523
United States
Research Site
Newton, Kansas, 67114
United States
Research Site
Lexington, Kentucky, 40509
United States
Research Site
Kansas City, Missouri, 64114
United States
Research Site
Las Vegas, Nevada, 89119
United States
Research Site
Norman, Oklahoma, 73069
United States
Research Site
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-12
Study Completion Date2026-01-27

Study Record Updates

Study Start Date2025-03-12
Study Completion Date2026-01-27

Terms related to this study

Keywords Provided by Researchers

  • Diabetes, Type II
  • Obesity

Additional Relevant MeSH Terms

  • Endocrinology
  • Diabetes, Type II
  • Obesity