AZD6234 added to current diabetes therapy to help with weight loss in adults who are overweight or have obesity

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 is a Phase 3, global, randomized, parallel-group, double-blind trial evaluating the safety and efficacy of AZD6234 as an add-on to ongoing incretin-based therapies in adults with obesity or overweight and at least one weight-related comorbidity, with or without type 2 diabetes. Participants will be randomly assigned to receive AZD6234 or a matching placebo while continuing their background incretin-based treatment. The primary endpoint is percent body weight change from baseline at 68 weeks. The study will be conducted across multiple centers with stable background therapy and predefined inclusion criteria to ensure enrolled individuals have significant weight-related health risks. Lead sponsor is AstraZeneca.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Males \& females (inclusive of all gender identities) age ≥18 years
* BMI ≥ 30 kg/m2 OR BMI ≥ 27 kg/m2 with at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, heart failure, chronic kidney disease, metabolic dysfunction associated steatotic liver disease, osteoarthritis of the knee, or stress urinary incontinence
* For participants with T2DM only:

  * Diagnosed with T2DM ≥ 90 days prior to Screening
  * HbA1c value at Screening of ≥6.0% (42 mmol/mol) and ≤9.0% (75 mmol/mol) managed with diet and exercise alone or with a stable dose of any oral glycaemic-lowering agent and/or incretin-based medication
* Receiving a stable dose of incretin- based medications at a dose level that is sufficient for chronic weight management for at least 3 months prior to Screening and Randomisation.
* Stable body weight (≤ 3% 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 their lifetime

Exclusion Criteria:

* Obesity primarily caused by other endocrine disorders
* Type 1 diabetes mellitus
* Significant hepatobiliary disease and/or any of the following results at Screening:

  * ALT ≥ 3.0 × ULN
  * AST ≥ 3.0 × ULN
  * TBL \> 1.5 × ULN (except for cases of known Gilbert's Syndrome)
* Use of insulin therapy for T2DM within 3 months prior to screening

Where it's running

• Research Site
  Lincoln, California, United States Recruiting
• Research Site
  Stockbridge, Georgia, United States Recruiting
• Research Site
  Woodstock, Georgia, United States Recruiting
• Research Site
  Champaign, Illinois, United States Recruiting
• Research Site
  Chicago, Illinois, United States Recruiting
• Research Site
  Kansas City, Missouri, United States Recruiting

+46 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Petrelintide for weight management in adults with overweight or obesity

  This study tests whether petrelintide helps people with overweight or obesity lose weight when combined with a reduced-calorie diet and more exercise, compared with a placebo.

  Recruiting at 8 sites Phase 3 Hoffmann-La Roche · Anniston, Alabama and 7 other locations · NCT07843498

• Petrelintide for weight management in adults with overweight/obesity and type 2 diabetes

  This study tests whether petrelintide, added to a reduced-calorie diet and more physical activity, helps people with overweight or obesity and type 2 diabetes lose weight more effectively than a placebo.

  Recruiting at 2 sites Phase 3 Hoffmann-La Roche · Los Angeles, California and 1 other locations · NCT07843485

• Petrelintide for weight loss in people with overweight/obesity and heart disease

  This study tests whether petrelintide helps people with overweight or obesity and cardiovascular disease lose weight when added to a reduced-calorie diet and more physical activity, compared with a placebo.

  Recruiting at 3 sites Phase 3 Hoffmann-La Roche · Anniston, Alabama and 2 other locations · NCT07843472

• AZD6234: a new weekly shot to help adults lose weight

  This Phase 3 trial tests whether AZD6234 helps adults with obesity or overweight and weight-related health issues lose weight compared to placebo.

  Recruiting at 76 sites Phase 3 AstraZeneca · Dothan, Alabama and 219 other locations · NCT07784725

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

  A phase 3 trial tests whether AZD6234 helps adults with type 2 diabetes and overweight or obesity more than placebo over about 68 weeks.

  Recruiting at 58 sites Phase 3 AstraZeneca · Fairhope, Alabama and 229 other locations · NCT07784270

• Switching GLP-1 RA to Maridebart Cafraglutide in Adults with Obesity or Overweight

  This study tests whether switching from a GLP-1 receptor agonist to maridebart cafraglutide is safe and tolerable for adults who are overweight or obese.

  Recruiting at 56 sites Phase 3 Amgen · Pelham, Alabama and 56 other locations · NCT07575399

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.