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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.

Placebo - Dose matched with each Experimental arm

A Phase IIb Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AZD6234 compared with placebo, given once a week as subcutaneous injection for 36 weeks, in male and female participants of at least 18 years of age who are living with obesity (body mass index [BMI] ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) and at least one weight-related comorbidity

A study in participants with obesity or overweight with at least one weight-related comorbidity

The study will comprise of:

A screening period of maximum 28 days

A treatment period of 36 weeks

A follow up period after last dose of study drug

This study will consist of 4 cohorts. Approximately 231 eligible participants will be randomized to AZD6234 or placebo

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Patient Level Data

Therapeutic Area

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

Placebo matching IMP dose injected subcutaneously, once a week.

Research Site

A Phase IIb Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AZD6234 in Participants Living with Obesity or Overweight with Comorbidity

To determine whether AZD6234 is superior to placebo for weight loss

To determine whether AZD6234 is superior to placebo in participants with weight loss ≥ 5% from baseline

To determine whether AZD6234 is superior to placebo in participants with weight loss ≥ 10% from baseline

To determine whether AZD6234 is superior to placebo for absolute weight loss

Arms	Assigned Interventions
Experimental: Arm 1 Dose 1	Drug: AZD6234 IMP injected subcutaneously, once a week. Unit dose strength as per CSP
Experimental: Arm 2 Dose 2	Drug: AZD6234 IMP injected subcutaneously, once a week. Unit dose strength as per CSP
Experimental: Arm 3 Dose 3	Drug: AZD6234 IMP injected subcutaneously, once a week. Unit dose strength as per CSP
Placebo Comparator: Arm 4 Placebo - Dose matched with each Experimental arm	Drug: Placebo comparator Placebo matching IMP dose injected subcutaneously, once a week.

A study in participants with obesity or overweight with at least one weight-related comorbidity - APRICUS

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