Recruiting

Phase 3

AZD6234A Study to Evaluate Effect of AZD6234 in Adult Participants With Type 2 Diabetes Mellitus and Obesity or Overweight

Sponsor:

AstraZeneca

Code:

NCT07784270

Conditions

Obesity or Overweight

Diabetes Mellitus, Type 2

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lenbelintide

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

Oct, 2026

Completion date

Aug 9, 2028

Anticipated

Primary completion date

Aug 9, 2028

Anticipated

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

Lenbelintide

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

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

Locations

Research Site

Recruiting

Fairhope, Alabama, United States, 36532

Research Site

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Phoenix, Arizona, United States, 85044

Research Site

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Gardena, California, United States, 90247

Research Site

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Lincoln, California, United States, 95648

Research Site

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Ocoee, Florida, United States, 34761

Research Site

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Woodstock, Georgia, United States, 30189

Research Site

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Lenexa, Kansas, United States, 66219

Research Site

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Franklin, Tennessee, United States, 37067

Research Site

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Houston, Texas, United States, 77099

Research Site

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Norfolk, Virginia, United States, 23504

Research Site

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Calgary, Alberta, Canada, T3R 1W9

Research Site

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Vancouver, British Columbia, Canada, V5Y 3W2

Research Site

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Moncton, New Brunswick, Canada, E1G 1A7

Research Site

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Truro, Nova Scotia, Canada, B2N 1L2

Research Site

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Hamilton, Ontario, Canada, L8L 5G8

Research Site

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Markham, Ontario, Canada, L3S 0A2

Research Site

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North York, Ontario, Canada, M6B 3H7

Research Site

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Sarnia, Ontario, Canada, N7T 4X3

Research Site

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Scarborough Village, Ontario, Canada, M1R 0B1

Research Site

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Stouffville, Ontario, Canada, L4A1H2

Research Site

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Toronto, Ontario, Canada, M4G3E8

Research Site

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Toronto, Ontario, Canada, M6G 1M2

Research Site

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Joliette, Quebec, Canada, J6E 6A9

Research Site

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Montreal, Quebec, Canada, H4J 1E3

Research Site

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Montreal, Quebec, Canada, H4N 2W2

Research Site

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Québec, Quebec, Canada, G2J 0C4

Research Site

Recruiting

Trois-Rivières, Quebec, Canada, G9A 4P3

More Information

Sponsor

AstraZeneca

Last update posted

Oct 28, 2026

Last verified

Oct, 2026

Keywords

Obesity
Overweight
AZD6234
Lenbelintide
Diabetes Mellitus, Type 2

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-08. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-10-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.