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

Last updated: April 9, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

2

Condition

Hypertriglyceridemia

Diabetes Mellitus, Type 2

Obesity

Treatment

AZD6234

Placebo to match

Clinical Study ID

NCT06851858
D8750C00005
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

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

Exclusion Criteria:

  1. Has received treatment with prescription or non-prescription medication for weightloss 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 weightloss device (eg, gastric balloon or duodenal barrier)

  6. Significant hepatobiliary disease (except for non-alcoholic steatohepatitis ornonalcoholic fatty liver disease without portal hypertension or cirrhosis)

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

Study Design

Total Participants: 64
Treatment Group(s): 2
Primary Treatment: AZD6234
Phase: 2
Study Start date:
March 12, 2025
Estimated Completion Date:
January 27, 2026

Study Description

This is a Phase II, randomised, parallel-group, double-blind, placebo-controlled, multi-centre study to assess the efficacy, safety, and tolerability of AZD6234 compared with placebo, given once weekly as a subcutaneous (SC) injection, in adults living with overweight or obesity and type 2 diabetes who are on a stable dose of GLP-1 RA. The study is being conducted across sites in the USA 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 total of 64 Participants, aged 18-75 with a BMI ≥ 27 kg/m², will be randomized to receive weekly subcutaneous injections of either AZD6234 or a placebo, alongside their current GLP-1 RA medication. The study involves a screening period and a treatment and follow-up period.

Connect with a study center

  • Research Site

    Birmingham, Alabama 35205
    United States

    Active - Recruiting

  • Research Site

    Mobile, Alabama 36608
    United States

    Active - Recruiting

  • Research Site

    Doral, Florida 33166
    United States

    Active - Recruiting

  • Research Site

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Research Site

    Miami, Florida 33135
    United States

    Active - Recruiting

  • Research Site

    Winter Park, Florida 32789
    United States

    Active - Recruiting

  • Research Site

    Canton, Georgia 30114
    United States

    Site Not Available

  • Research Site

    Macon, Georgia 31210
    United States

    Site Not Available

  • Research Site

    Chicago, Illinois 60640
    United States

    Active - Recruiting

  • Research Site

    Oak Brook, Illinois 60523
    United States

    Active - Recruiting

  • Research Site

    Newton, Kansas 67114
    United States

    Active - Recruiting

  • Research Site

    Lexington, Kentucky 40509
    United States

    Active - Recruiting

  • Research Site

    Kansas City, Missouri 64114
    United States

    Active - Recruiting

  • Research Site

    Las Vegas, Nevada 89119
    United States

    Active - Recruiting

  • Research Site

    Norman, Oklahoma 73069
    United States

    Active - Recruiting

  • Research Site

    San Antonio, Texas 78229
    United States

    Active - Recruiting

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