A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly

First key secondary endpoint. If one of the IGF-1 values at Week 22 or Week 24 was missing, the other value was used to define a responder/non-responder in the analysis. The variable of interest was considered missing only if no IGF-1 value could be obtained from either the Week 22 or the Week 24 sample. A composite strategy was assumed for intercurrent events, and a participant was considered as a non-responder if they discontinued IMP and/or was switched to rescue medication. For this endpoint, a patient who had their dose reduced was not directly classified as a non-responder. No participant had their dose reduced during the trial. ULN was derived from the participant's sex and age at screening. In order to account for all participants in the ITT analysis set, multiple imputation was applied. The mean proportion of responders was calculated as an average of responders across the imputed datasets. The resulting proportion was multiplied by 100 to present "Percentage of participants"

Second key secondary endpoint. If one of the IGF-1 values at Week 22 or Week 24 was missing, the other value was used to define a responder/non-responder in the analysis. The variable of interest was considered missing only if no IGF-1 value could be obtained from either the Week 22 or the Week 24 sample or no GH value at Week 24. A composite strategy was assumed for intercurrent events, and a patient was considered as a non-responder if they discontinued IMP or had the dose reduced prior to Week 22 (regardless of IGF-1 values), and/or was switched to rescue medication. ULN was based on the patient's sex and age at screening. In order to account for all participants in the ITT analysis set, multiple imputation was applied. The mean proportion of responders was calculated as an average of responders across the imputed datasets. The resulting proportion was multiplied by 100 to present "Percentage of participants".

For the responder analysis of mean GH \<2.5 µg/L at Week 24, a composite strategy was assumed for intercurrent events. A participant was considered as a non-responder if they discontinued IMP, or had the dose reduced prior to Week 24 (regardless of mean GH values), and/or was switched to rescue medication. In order to account for all participants in the ITT analysis set, multiple imputation was applied. The mean proportion of participants was calculated as an average of responders across the imputed datasets. The resulting proportion was multiplied by 100 to present "Percentage of participants".

For the responder analysis of mean GH \<1.0 µg/L at Week 24, a composite strategy was assumed for intercurrent events. A participant was considered as a non-responder if they discontinued IMP, or had the dose reduced prior to Week 24 (regardless of mean GH values), and/or was switched to rescue medication. In order to account for all participants in the ITT analysis set, multiple imputation was applied. The mean proportion of participants was calculated as an average of responders across the imputed datasets. The resulting proportion was multiplied by 100 to present "Percentage of participants".

A treatment emergent adverse event was defined as an adverse event that occurred during or after the first administration of the IMP to the end of trial visit or the next dose of any acromegaly treatment, whichever came first.

During participants'/partners' first three attempts during the trial period of 24 weeks whenever these visits took place. Percentages were based on those who opted for self-/partner-administration.

Plasma samples were taken pre-dose on dosing days.