Recruiting
Phase 3

AZD6234

Sponsor:

AstraZeneca

Code:

NCT07776509

Conditions

Obesity or Overweight

Weight-Related Comorbidity

With/Without 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

Weight-Related Comorbidity

With/Without Diabetes Mellitus, Type 2

Study ID

NCT07776509

Start date

Aug 24, 2026

Status verified date

Sep, 2026

Completion date

Aug 9, 2028

Anticipated

Primary completion date

Aug 9, 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 ≥ 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

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AZD6234

AZD6234

placebo comparator: Placebo

Matching placebo

Interventions

AZD6234

IMP injected subcutaneously, once a week.

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

Lincoln, California, United States, 95648

Research Site

Recruiting

Woodstock, Georgia, United States, 30189

Research Site

Recruiting

Fargo, North Dakota, United States, 58104

Research Site

Recruiting

Surrey, British Columbia, Canada, V3T 4G8

Research Site

Recruiting

Vancouver, British Columbia, Canada, V5Y 3W2

Research Site

Recruiting

Guelph, Ontario, Canada, N1H 1B1

Research Site

Recruiting

Stouffville, Ontario, Canada, L4A1H2

Research Site

Recruiting

Montreal, Quebec, Canada, H4J 1E3

More Information

Sponsor

AstraZeneca

Last update posted

Sep 10, 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 2026-09-11. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-09-10.