Clinical trial

A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus

Recruiting now · Phase 3 · 5 countries · Registry ID NCT07784725

Recruiting nowPhase 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

Full registry criteria

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 * 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 their lifetime Exclusion Criteria: * Obesity primarily caused by other endocrine disorders * History of Type 1 or Type 2 Diabetes Mellitus, HbA1c ≥6.5% (48 mmol/mol), and/or treatment with glucose-lowering agent(s) within 3 months prior to Screening * 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) * Has received treatment with a GLP-1 receptor agonist or GLP-1 containing medication for any indication within 3 months before Randomisation.

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 treatment68 weeks

To evaluate the effect of AZD6234 as compared to placebo in percent body weight change

Study locations

212 locations were listed when this page was built. The first 40 are shown.

Research Site🇦🇷 Buenos Aires, 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🇦🇺 Kotara, Australia
Research Site🇦🇺 Malvern, Australia
Research Site🇦🇺 St Albans, Australia
Research Site🇦🇺 St Leonards, Australia
Research Site🇦🇺 Waitara, Australia
Research Site🇧🇷 Belo Horizonte, Brazil
Research Site🇧🇷 Brasília, Brazil
Research Site🇧🇷 Campinas, Brazil
Research Site🇧🇷 Campinas, Brazil
Research Site🇧🇷 Curitiba, Brazil
Research Site🇧🇷 Curitiba, Brazil
Research Site🇧🇷 Curitiba, Brazil
Research Site🇧🇷 Natal, Brazil
Research Site🇧🇷 Porto Alegre, Brazil
Research Site🇧🇷 Rio de Janeiro, Brazil
Research Site🇧🇷 São José dos Campos, Brazil
Research Site🇧🇷 São Paulo, Brazil
Research Site🌐 Montana, Bulgaria
Research Site🌐 Pleven, Bulgaria
Research Site🌐 Plovdiv, Bulgaria
Research Site🌐 Sofia, Bulgaria
Research Site🌐 Sofia, Bulgaria
Research Site🌐 Sofia, Bulgaria
Research Site🌐 Varna, Bulgaria
Research Site🌐 Yambol, Bulgaria
Research Site🇨🇦 Brampton, Ontario, Canada
Research Site🇨🇦 Calgary, Alberta, Canada
Research Site🇨🇦 Guelph, Ontario, Canada
Research Site🇨🇦 Hamilton, Ontario, Canada
Research Site🇨🇦 Mississauga, Ontario, Canada
Research Site🇨🇦 Moncton, New Brunswick, Canada
Research Site🇨🇦 Montreal, Quebec, Canada