Recruiting
Phase 3

AZD6234

Sponsor:

AstraZeneca

Code:

NCT07784270

Conditions

Obesity or Overweight

Diabetes Mellitus, Type 2

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AZD6234

Placebo

Study Details

Brief summary:

The study will evaluate how well AZD6234 works and how safe it is in adults with excess weight or obesity. Efficacy of AZD6234 will be compared to placebo in percent body weight change from baseline at 68 weeks of treatment

Conditions

Obesity or Overweight

Diabetes Mellitus, Type 2

Study ID

NCT07784270

Start date

Aug 20, 2026

Status verified date

Sep, 2026

Completion date

Aug 8, 2028

Anticipated

Primary completion date

Aug 8, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AZD6234 Dose 1

AZD6234 Dose 1

experimental: AZD6234 Dose 2

AZD6234 Dose 2

placebo comparator: Placebo

Matching placebo

Interventions

AZD6234

IMP injected subcutaneously, once a week. Unit dose strength as per CSP.

Placebo

Placebo matching IMP dose injected subcutaneously, once a week.

Primary outcome measure

  • Percent change in body weight from baseline at 68 weeks of treatment. [ Time Frame: 68 weeks ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Fairhope, Alabama, United States, 36532

Research Site

Recruiting

Lincoln, California, United States, 95648

Research Site

Recruiting

Lenexa, Kansas, United States, 66219

Research Site

Recruiting

Franklin, Tennessee, United States, 37067

Research Site

Recruiting

Norfolk, Virginia, United States, 23504

Research Site

Recruiting

Vancouver, British Columbia, Canada, V5Y 3W2

Research Site

Recruiting

Truro, Nova Scotia, Canada, B2N 1L2

Research Site

Recruiting

North York, Ontario, Canada, M6B 3H7

Research Site

Recruiting

Stouffville, Ontario, Canada, L4A1H2

Research Site

Recruiting

Toronto, Ontario, Canada, M4G3E8

Research Site

Recruiting

Toronto, Ontario, Canada, M6G 1M2

Research Site

Recruiting

Québec, Quebec, Canada, G2J 0C4

More Information

Sponsor

AstraZeneca

Last update posted

Sep 22, 2026

Last verified

Sep, 2026

Keywords

  • Obesity
  • Overweight
  • AZD6234
  • Diabetes Mellitus, Type 2

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-09-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.