EU Clinical Trial Information System (CTIS)

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

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 Study to evaluate effect of AZD6234 in adult participants with Type 2 Diabetes Mellitus and obesity or overweight

This is a Phase III, global, randomized, parallel-group, double-blind, multicentre study to assess the efficacy and safety of AZD6234 compared with placebo in adults with Type 2 Diabetes Mellitus (T2DM) and obesity or overweight. Eligible participants will be randomized to either receive AZD6234 or matching placebo respectively.

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IMP injected subcutaneously, once a week. Unit dose strength as per CSP.

Placebo matching IMP dose injected subcutaneously, once a week.

Research Site

International, multi-centre, randomised, double-blind, placebo-controlled, parallel-group

A Phase III Randomized, Double-Blind, Placebo-Controlled Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 in Participants with Type 2 Diabetes Mellitus and Obesity or Overweight (SELENE 2)

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

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

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

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

To evaluate the effect of AZD6234 on haemoglobin A1C change

To evaluate the effect of AZD6234 compared to placebo on waist circumference change

To evaluate the effect of AZD6234 compared to placebo on triglycerides percent change

To evaluate the effect of AZD6234 compared to placebo on systolic blood pressure change

Body Composition Sub-study: To evaluate the effect of AZD6234 compared to placebo on body composition change in the DXA subset of participants

Arms	Assigned Interventions
Experimental: AZD6234 Dose 1 AZD6234 Dose 1	Drug: AZD6234 IMP injected subcutaneously, once a week. Unit dose strength as per CSP.
Experimental: AZD6234 Dose 2 AZD6234 Dose 2	Drug: AZD6234 IMP injected subcutaneously, once a week. Unit dose strength as per CSP.
Placebo Comparator: Placebo Matching placebo	Drug: Placebo Placebo matching IMP dose injected subcutaneously, once a week.

A Study to evaluate effect of AZD6234 in adult participants with Type 2 Diabetes Mellitus and obesity or overweight - SELENE 2

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