Trial · NCT07574723
Registered outcomes35
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 35
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to discontinuation of the treatment regimen | Randomization to Week 76 | Time from randomization to permanent discontinuation of the assigned tirzepatide titration regimen due to adverse events. Analyzed as restricted mean time on treatment (RMST), estimated as the area under the Kaplan-Meier curve up to 76 weeks and reported in weeks. Participants remaining on treatment at Week 76 are censored at that time. Higher values indicate longer time on treatment (better outcome). |
| Secondary | Exposure-adjusted rate of vomiting episodes assessed using the Modified Index of Nausea, Vomiting, and Retching (M-INVR) | Baseline to Week 76 | Vomiting is assessed weekly using the validated M-INVR. The vomiting component is scored from 0 (no vomiting) to 4 (severe or frequent vomiting), with higher scores indicating worse outcomes. Vomiting burden will be summarized as weekly vomiting severity scores and as an exposure-adjusted rate (episodes per patient-week), calculated as the total number of vomiting episodes divided by each participant's total follow-up time |
| Secondary | Incidence, frequency, and duration of vomiting assessed using the MASCC Antiemesis Tool - Modified Index of Nausea and Vomiting (M-INVR) | Baseline to Week 76 | Vomiting is assessed weekly using the MASCC Antiemesis Tool - Modified Index of Nausea and Vomiting (M-INVR), a validated patient-reported outcome measure. The vomiting subscale score is calculated as the sum of relevant vomiting items, with scores ranging from 0 to 16, where higher scores indicate greater incidence, frequency, and duration of vomiting (worse outcome). |
| Secondary | Change in body weight | Baseline to Week 76 | Absolute and percentage change in body weight from baseline. |
| Secondary | Proportion of participants remaining on active study medication | Week 76 | Number of participants continuing to receive active study medication at the end of the trial. |
| Secondary | Change in glycated hemoglobin (HbA1c) | Baseline to Week 76 | Change in HbA1c from baseline. |
| Secondary | Change in lean body mass assessed by dual-energy X-ray absorptiometry (DEXA) | Baseline to Week 76 | Change in total lean body mass measured by dual-energy X-ray absorptiometry (DEXA). |
| Secondary | Change in visceral adiposity assessed by dual-energy X-ray absorptiometry (DEXA) | Baseline to Week 76 | Change in visceral adipose tissue measured by dual-energy X-ray absorptiometry (DEXA). |
| Secondary | Change in fat body mass assessed by dual-energy X-ray absorptiometry (DEXA) | Baseline to Week 76 | Change in total fat body mass measured by dual-energy X-ray absorptiometry (DEXA). |
| Secondary | Change in Alanine Aminotransferase (ALT) | Baseline to Week 76 | Change from baseline in serum alanine aminotransferase (ALT) levels in U/L, measured using standard laboratory methods. |
| Secondary | Change in Aspartate Aminotransferase (AST) | Baseline to Week 76 | Change from baseline in serum aspartate aminotransferase (AST) levels in U/L, measured using standard laboratory methods. |
| Secondary | Change in Gamma-Glutamyl Transferase (GGT) | Baseline to Week 76 | Change from baseline in serum gamma-glutamyl transferase (GGT) levels in U/L, measured using standard laboratory methods. |
| Secondary | Change in Alkaline Phosphatase (ALP) | Baseline to Week 76 | Change from baseline in serum alkaline phosphatase (ALP) levels in U/L, measured using standard laboratory methods. |
| Secondary | Change in Fibrosis-4 (FIB-4) index | Baseline to Week 76 | Change from baseline in the Fibrosis-4 (FIB-4) index, a composite score calculated as: FIB-4 = (Age × AST) / (Platelet count × √ALT), where age is measured in years, AST and ALT in U/L, and platelet count in 10⁹/L. The FIB-4 index is reported as a unitless value, with higher values indicating greater liver fibrosis. Values typically range from approximately 0 to 10. |
| Secondary | Change in Total Cholesterol | Baseline to Week 76 | Change from baseline in fasting total cholesterol levels measured using standard laboratory methods. |
| Secondary | Change in Low-Density Lipoprotein Cholesterol (LDL-C) | Baseline to Week 76 | Change from baseline in fasting low-density lipoprotein cholesterol (LDL-C) levels measured using standard laboratory methods. |
| Secondary | Change in High-Density Lipoprotein Cholesterol (HDL-C) | Baseline to Week 76 | Change from baseline in fasting high-density lipoprotein cholesterol (HDL-C) levels measured using standard laboratory methods. |
| Secondary | Change in Triglycerides | Baseline to Week 76 | Change from baseline in fasting triglyceride levels measured using standard laboratory methods. |
| Secondary | Change in estimated glomerular filtration rate (eGFR) | Baseline to Week 76 | Change from baseline in estimated glomerular filtration rate (eGFR) calculated using a standard equation. |
| Secondary | Change in serum creatinine | Baseline to Week 76 | Change from baseline in serum creatinine measured using standard laboratory methods. |
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
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GET https://conductscience.org/api/trials/v1/NCT07574723/registered