A Study to Evaluate Effect of AZD6234 as an Adjunct to Incretin-based Therapies in Adult Participants With Obesity or Overweight With Weight-related Comorbidity With or Without Type 2 Diabetes Mellitus

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

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.

Eligibility criteria

Qualifiers

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

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

Disqualifiers

Obesity primarily caused by other endocrine disorders

Type 1 diabetes mellitus

ALT ≥ 3.0 × ULN

AST ≥ 3.0 × ULN

Trial design

Treatments tested in this trial

  • AZD6234
  • Placebo

Treatment groups

500 Participants
are divided into 2 treatment groups

Sponsors and collaborators