Trial · NCT07588438
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 32
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Percent Change From Baseline in Body Weight at 52 Weeks. | Baseline and 52 weeks. | Percentage change in total body weight from baseline to week 52 for participants in Cohort A (Adults with obesity without diabetes). |
| Primary | Mean Change From Baseline in Glycated Hemoglobin (HbA1c) at 52 Weeks. | Baseline and 52 weeks. | Absolute change in HbA1c levels from baseline to week 52 for participants in Cohort B (Adults with type 2 diabetes). |
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs). | Through week 52. | Incidence, severity, and relationship of treatment-emergent adverse events (TEAEs), including gastrointestinal, pancreatic, cardiovascular, and other adverse events occurring during the 52-week treatment period. |
| Secondary | Mean Change From Baseline in Body Weight at 52 Weeks. | Baseline and 52 weeks. | Change in absolute body weight from baseline to week 52. |
| Secondary | Mean Change From Baseline in Body Mass Index (BMI) at 52 Weeks. | Baseline and 52 weeks. | Change in BMI calculated as weight in kilograms divided by height in meters squared (kg/m2). |
| Secondary | Percentage of Participants Achieving Body Weight Reduction Thresholds at 52 Weeks. | 52 weeks. | Percentage of participants achieving ≥5%, 10%, 15%, 20%, 25%, and 30% reduction from baseline body weight. |
| Secondary | Change From Baseline in Systolic Blood Pressure at 52 Weeks. | Baseline and 52 weeks. | Assessment of the absolute change in resting systolic blood pressure. |
| Secondary | Change From Baseline in Diastolic Blood Pressure at 52 Weeks. | Baseline and 52 weeks. | Assessment of the absolute change in resting diastolic blood pressure. |
| Secondary | Percentage Change From Baseline in Total Cholesterol at 52 Weeks. | Baseline and 52 weeks. | Assessment of percentage change in fasting total cholesterol concentrations from baseline to week 52. |
| Secondary | Percentage Change From Baseline in LDL Cholesterol (LDL-C) at 52 Weeks. | Baseline and 52 weeks. | Assessment of percentage change in fasting LDL cholesterol concentrations from baseline to week 52. |
| Secondary | Percentage Change From Baseline in HDL Cholesterol (HDL-C) at 52 Weeks. | Baseline and 52 weeks. | Assessment of percentage change in fasting HDL cholesterol concentrations from baseline to week 52. |
| Secondary | Percentage Change From Baseline in Triglycerides at 52 Weeks. | Baseline and 52 weeks. | Assessment of percentage change in fasting triglyceride concentrations from baseline to week 52. |
| Secondary | Change From Baseline in Total Fat Mass Measured by Bioelectrical Impedance Analysis (BIA) at 52 Weeks. | Baseline and 52 weeks. | Evaluation of changes in total fat mass measured by bioelectrical impedance analysis (BIA). |
| Secondary | Change From Baseline in Visceral Fat Mass Measured by Bioelectrical Impedance Analysis (BIA) at 52 Weeks. | Baseline and 52 weeks. | Evaluation of changes in visceral fat mass measured by bioelectrical impedance analysis (BIA). |
| Secondary | Change From Baseline in Lean Body Mass Measured by Bioelectrical Impedance Analysis (BIA) at 52 Weeks. | Baseline and 52 weeks. | Evaluation of changes in lean body mass measured by bioelectrical impedance analysis (BIA). |
| Secondary | Change From Baseline in Fasting Insulin at 52 Weeks. | Baseline and 52 weeks. | Assessment of the absolute change in fasting serum insulin concentrations from baseline to week 52. |
| Secondary | Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at 52 Weeks. | Baseline and 52 weeks. | Assessment of insulin resistance using the calculated Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to week 52. |
| Secondary | Percentage Change From Baseline in High-sensitivity C-reactive Protein (hs-CRP) at 52 Weeks. | Baseline and 52 weeks. | Assessment of systemic inflammation via hs-CRP percentage change. |
| Secondary | Percentage of Participants Achieving HbA1c Targets (Cohort 2) at 52 Weeks. | 52 weeks. | Percentage of participants with T2DM reaching HbA1c≤7.0%, 6.5%, and 5.7%. |
| Secondary | Percentage of Scheduled Tirzepatide Doses Successfully Administered Through 52 Weeks. | Through week 52. | Treatment adherence based on the proportion of scheduled tirzepatide doses successfully administered during the 52-week follow-up period. |
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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