Trial · NCT06989437
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent change from baseline in body weight for ponsegromab compared to placebo | Baseline, Week 12 | |
| Primary | Change from baseline in Functional Assessment of Anorexia/Cachexia Therapy 5-item Anorexia Symptom Scale scores | Baseline, Week 12 | Scale consists of five items, each rated 0-4. Total score ranges from 0 (minimum) to 20 (maximum). Higher scores are associated with a better outcome. |
| Secondary | Change from baseline in non-sedentary physical activity time | Baseline, Week 12 | measured by wearable Digital Health Technology watch |
| Secondary | Overall survival | Randomization through completion of Phase 3 of the study, an average of 1 year | Outcome defined as the time from randomization to occurrence of all-cause death |
| Secondary | Change from baseline in body weight (kg) | Baseline, Week 12 and up to Week 52 | |
| Secondary | Change from baseline at Week 12 in physical activity as measured by total vector magnitude | Baseline, Week 12 | measured by wearable Digital Health Technology watch |
| Secondary | Effect on progression free survival | Randomization through completion of Phase 3 of the study, an average of 1 year | determined by Blinded Independent Central Review |
| Secondary | Effect on objective response rate | Baseline, Week 52 | determined by Blinded Independent Central Review |
| Secondary | Effect on disease control rate | Baseline, Week 52 | determined by Blinded Independent Central Review |
| Secondary | Effect on duration of response | Baseline, Week 52 | determined by Blinded Independent Central Review |
| Secondary | Change from baseline in skeletal muscle area and radiodensity at third lumbar vertebra (L3) | Baseline, Week 12 | measured by CT (or MRI) scan |
| Secondary | Change from baseline in intermuscular adipose area and radiodensity at L3 | Baseline, Week 12 | measured by CT (or MRI) scan |
| Secondary | Change from baseline in subcutaneous adipose area and radiodensity at L3 | Baseline, Week 12 | measured by CT (or MRI) scan |
| Secondary | Change from baseline in visceral adipose area and radiodensity at L3 | Baseline, Week 12 | measured by CT (or MRI) scan |
| Secondary | Number of participants with incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to permanent discontinuation from study intervention or from study. | Baseline, Week 12 and up to Week 52 | |
| Secondary | Number of participants with laboratory test abnormalities. | Baseline, Week 12 and up to Week 52 | |
| Secondary | Number of participants with vital signs abnormalities. | Baseline, Week 12 and up to Week 52 | |
| Secondary | Change in physical function, assessed on participant completed Patient-Reported Outcomes Measurement Information System Physical Function (version 8c) questionnaire. | Baseline, Week 12 and up to Week 52 | The overall score range for the T-score is 0-100. Higher scores indicate better outcome. |
| Secondary | Change in fatigue, as assessed on participant completed Patient-Reported Outcomes Measurement Information System - Fatigue (version 7a) questionnaire. | Baseline, Week 12 and up to Week 52 | The overall score range for the T-score is 29.4-83.2. Lower scores indicate better outcome. |
| Secondary | Occurrence and severity of symptomatic AEs including diarrhea, nausea, vomiting, decreased appetite, fatigue and mouth sores by maximum grade as assessed by the NCI PRO CTCAE. | Baseline, Week 52 |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT06989437/registered