Health Trials

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

ConditionsObesity or OverweightDiabetes Mellitus, Type 2
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

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

ALT ≥ 3.0 X ULN

AST ≥ 3.0 X ULN

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

1,500 Participants
are divided into 3 treatment groups
Group A: AZD6234 Dose 1Experimental treatment 1 intervention
Group B: AZD6234 Dose 2Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent change in body weight from baseline at 68 weeks of treatment.

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

Time frame
68 weeks

Secondary outcomes

1

Absolute change in weight (kg) from baseline at 68 weeks of treatment

To evaluate the effect of AZD6234 compared to placebo on absolute change in weight

Time frame
68 weeks
2

Achievement of at least 5 % body weight loss from baseline at 68 weeks of treatment

To evaluate the effect of AZD6234 compared to placebo in body weight loss of at least 5%

Time frame
68 weeks
3

Achievement of at least 10 % body weight loss from baseline at 68 weeks of treatment

To evaluate the effect of AZD6234 compared to placebo in body weight loss of at least 10%

Time frame
68 weeks
4

Change in haemoglobin A1C from baseline at 68 weeks of treatment

To evaluate the effect of AZD6234 on haemoglobin A1C change

Time frame
68 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: