Trial · NCT07909889
Registered outcomes79
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 79
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Completion of the 26-week semaglutide treatment phase meeting all composite feasibility criteria | At completion of 26 weeks of semaglutide treatment: trial week 26 in Arm A and trial week 52 in Arm B. | Percentage of participants who complete the assigned 26-week treatment phase while meeting all three criteria: no permanent discontinuation of prescribed adjuvant endocrine therapy; no permanent discontinuation of semaglutide; and administration of at least 21 of 26 planned weekly semaglutide injections. Endocrine therapy continuation is assessed from prescription records and self-reported intake; semaglutide adherence is assessed from electronic dosing diaries with pen reconciliation. The proportion will be reported with a 95% confidence interval. |
| Secondary | Adverse events during semaglutide treatment and post-treatment follow-up | From the first semaglutide dose to end of follow-up: trial weeks 0-52 in Arm A and 26-78 in Arm B. | Number and percentage of participants with adverse events and total number of events, characterized by event type, maximum severity according to CTCAE version 6.0, relationship to semaglutide and event outcome. |
| Secondary | Serious adverse events | From randomization to end of follow-up: up to 52 weeks in Arm A and 78 weeks in Arm B. | Number and percentage of participants with at least one serious adverse event and total number of serious adverse events during trial participation. |
| Secondary | Suspected unexpected serious adverse reactions | From randomization to end of follow-up: up to 52 weeks in Arm A and 78 weeks in Arm B. | Number and percentage of participants with at least one suspected unexpected serious adverse reaction and total number of such reactions during trial participation. |
| Secondary | Adverse events of special interest | From randomization to end of follow-up: up to 52 weeks in Arm A and 78 weeks in Arm B. | Number and percentage of participants with protocol-defined adverse events of special interest and number of events, reported separately by event category. |
| Secondary | Patient-reported symptomatic adverse events | At protocol-specified assessments from treatment start to end of follow-up: trial weeks 0-52 in Arm A and 26-78 in Arm B. | Patient-reported symptomatic adverse events assessed using selected PRO-CTCAE items, with frequency, severity, interference or presence reported separately as applicable. Item scores range from 0 to 4, or 0 to 1 for presence/absence, with higher values indicating greater symptom burden. |
| Secondary | Semaglutide dose interruptions | During the 26-week semaglutide treatment phase: trial weeks 0-26 in Arm A and 26-52 in Arm B. | Number and percentage of participants with a temporary interruption of semaglutide, number of interruptions and recorded reasons. |
| Secondary | Semaglutide dose reductions | During the 26-week semaglutide treatment phase: trial weeks 0-26 in Arm A and 26-52 in Arm B. | Number and percentage of participants with a reduction in semaglutide dose, number of dose reductions and recorded reasons. |
| Secondary | Permanent discontinuation of semaglutide | During the 26-week semaglutide treatment phase: trial weeks 0-26 in Arm A and 26-52 in Arm B. | Number and percentage of participants who permanently discontinue semaglutide, with reasons for discontinuation. |
| Secondary | Time to permanent discontinuation of semaglutide | During the 26-week semaglutide treatment phase: trial weeks 0-26 in Arm A and 26-52 in Arm B. | Time in days from the first semaglutide dose to permanent discontinuation during the assigned treatment phase. |
| Secondary | Permanent discontinuation of adjuvant endocrine therapy | From randomization to end of follow-up: up to 52 weeks in Arm A and 78 weeks in Arm B. | Number and percentage of participants who permanently discontinue adjuvant endocrine therapy, with reasons for discontinuation. Temporary interruptions or modifications with maintained prescribing intent are not classified as permanent discontinuation. |
| Secondary | Completion of the semaglutide treatment phase | At trial week 26 in Arm A and trial week 52 in Arm B. | Percentage of participants who complete the assigned 26-week semaglutide treatment phase, summarized separately by arm. |
| Secondary | Participant-reported acceptability of semaglutide treatment | After treatment completion, within trial weeks 26-52 in Arm A and 52-78 in Arm B. | Qualitative themes from semi-structured interviews concerning acceptability, motivation, expectations, concerns, perceived stigma, support needs and barriers to participation. Approximately 10 participants across both arms are expected to be interviewed. |
| Secondary | Participants achieving at least 5% weight loss at trial week 26 | From randomization to trial week 26 in both arms. | Percentage of participants with at least 5% reduction in body weight from randomization baseline to trial week 26, compared between the immediate-start and delayed-start arms. Weight loss is calculated relative to body weight at randomization. |
| Secondary | Percentage change in body weight from randomization to trial week 12 | Randomization baseline and trial week 12 in both arms. | Mean percentage change in body weight from randomization baseline to trial week 12, representing early treatment in Arm A and the waiting period in Arm B. Negative values indicate weight loss. |
| Secondary | Change in fat mass after 26 weeks of treatment | From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B. | Fat mass measured by multi-frequency segmental bioelectrical impedance analysis, expressed as change from the value immediately before semaglutide initiation to the end of the 26-week treatment phase. Unit of change: kg. |
| Secondary | Change in fat mass percentage after 26 weeks of treatment | From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B. | Fat mass as a percentage of total body weight, measured by multi-frequency segmental bioelectrical impedance analysis, expressed as change from the value immediately before semaglutide initiation to the end of the 26-week treatment phase. Unit of change: percentage points. |
| Secondary | Change in fat-free mass after 26 weeks of treatment | From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B. | Fat-free mass measured by multi-frequency segmental bioelectrical impedance analysis, expressed as change from the value immediately before semaglutide initiation to the end of the 26-week treatment phase. Unit of change: kg. |
| Secondary | Change in fat-free mass percentage after 26 weeks of treatment | From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B. | Fat-free mass as a percentage of total body weight, measured by multi-frequency segmental bioelectrical impedance analysis, expressed as change from the value immediately before semaglutide initiation to the end of the 26-week treatment phase. Unit of change: percentage points. |
| Secondary | Change in skeletal muscle mass after 26 weeks of treatment | From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B. | Skeletal muscle mass measured by multi-frequency segmental bioelectrical impedance analysis, expressed as change from the value immediately before semaglutide initiation to the end of the 26-week treatment phase. Unit of change: kg. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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