Clinical trial
A Study to Evaluate Effect of AZD6234 in Adult Participants With Type 2 Diabetes Mellitus and Obesity or Overweight
Opening soon · Phase 3 · 4 countries · Registry ID NCT07784270
Opening soonPhase 3Interventional
What this study is about
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
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionObesity or Overweight, Diabetes Mellitus, Type 2
Full registry criteria
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
Treatments and study arms
AZD6234
Drug
IMP injected subcutaneously, once a week. Unit dose strength as per CSP.
Placebo
Drug
Placebo matching IMP dose injected subcutaneously, once a week.
Primary outcomes
Percent change in body weight from baseline at 68 weeks of treatment.68 weeks
To evaluate the effect of AZD6234 compared to placebo in percent body weight change
Study locations
218 locations were listed when this page was built. The first 40 are shown.
Research Site🇦🇷 CABA, Argentina
Research Site🇦🇷 CABA, Argentina
Research Site🇦🇷 Ciudad de Buenos Aires, Argentina
Research Site🇦🇷 Mendoza, Argentina
Research Site🇦🇷 Ramos Mejía, Argentina
Research Site🇦🇷 Rosario, Argentina
Research Site🇦🇷 San Nicolás, Argentina
Research Site🇦🇺 Botany, Australia
Research Site🇦🇺 Helensvale, Australia
Research Site🇦🇺 Kotara, Australia
Research Site🇦🇺 Malvern, Australia
Research Site🇦🇺 Maroubra, Australia
Research Site🇦🇺 Waitara, Australia
Research Site🇨🇦 Calgary, Alberta, Canada
Research Site🇨🇦 Hamilton, Ontario, Canada
Research Site🇨🇦 Joliette, Quebec, Canada
Research Site🇨🇦 Markham, Ontario, Canada
Research Site🇨🇦 Moncton, New Brunswick, Canada
Research Site🇨🇦 Montreal, Quebec, Canada
Research Site🇨🇦 Montreal, Quebec, Canada
Research Site🇨🇦 North York, Ontario, Canada
Research Site🇨🇦 Québec, Quebec, Canada
Research Site🇨🇦 Sarnia, Ontario, Canada
Research Site🇨🇦 Scarborough Village, Ontario, Canada
Research Site🇨🇦 Stoney Creek, Ontario, Canada
Research Site🇨🇦 Stouffville, Ontario, Canada
Research Site🇨🇦 Toronto, Ontario, Canada
Research Site🇨🇦 Toronto, Ontario, Canada
Research Site🇨🇦 Trois-Rivières, Quebec, Canada
Research Site🇨🇦 Truro, Nova Scotia, Canada
Research Site🇨🇦 Vancouver, British Columbia, Canada
Research Site🇨🇱 Concepción, Chile
Research Site🇨🇱 Concepción, Chile
Research Site🇨🇱 Concepción, Chile
Research Site🇨🇱 Iquique, Chile
Research Site🇨🇱 Providencia, Chile
Research Site🇨🇱 Santiago, Chile
Research Site🇨🇱 Santiago, Chile
Research Site🇨🇱 Santiago, Chile
Research Site🇨🇱 Santiago, Chile