AZD6234: a new option for adults with type 2 diabetes and excess weight

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This global, randomized, double-blind, parallel-group study compares AZD6234 with placebo in adults who have type 2 diabetes and body weight above 27 kg/m2. Participants will continue stable diabetes management and will be assigned to AZD6234 or placebo for 68 weeks to measure percent change in body weight from baseline. The trial also monitors safety and tolerability in a diverse, multicenter setting. Eligible participants include adults with type 2 diabetes for at least 90 days, a BMI of 27 or higher, and prior unsuccessful weight loss attempts. Enrollment is at sites in Alabama, with AstraZeneca as lead sponsor.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Males \& females (inclusive of all gender identities) age ≥18 years
* BMI ≥27 kg/m2
* Diagnosed with T2DM ≥90 days prior to Screening
* HbA1c value at Screening of ≥6.0% (42 mmol/mol) and ≤10% (86 mmol/mol) managed with diet and exercise alone or with a stable dose of any oral glycaemic-lowering agent (as per local labelling)
* Stable body weight (≤5% body weight change) for at least 3 months prior to Randomisation
* History of at least one self-reported unsuccessful attempt to lose body weight in lifetime

Exclusion Criteria:

* Obesity primarily caused by other endocrine disorders
* Type 1 diabetes mellitus (or any other diabetes mellitus that is not clearly Type 2 diabetes), OR have history of ketoacidosis or hyperosmolar coma/state within 3 months prior to Screening
* Significant hepatobiliary disease and/or any of the following results at Screening:

  * ALT ≥ 3.0 X ULN
  * AST ≥ 3.0 X ULN
  * TBL \> 1.5 X ULN (except for cases of known Gilbert's Syndrome)
* Has received treatment with a GLP-1 receptor agonist or GLP-1 containing medication for any indication within 3 months before Randomisation
* Use of insulin therapy for T2DM within 3 months prior to screening

Where it's running

• Research Site
  Fairhope, Alabama, United States Recruiting
• Research Site
  Phoenix, Arizona, United States Recruiting
• Research Site
  Gardena, California, United States Recruiting
• Research Site
  Lincoln, California, United States Recruiting
• Research Site
  Ocoee, Florida, United States Recruiting
• Research Site
  Woodstock, Georgia, United States Recruiting

+180 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.