Trial · NCT04216589
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change (Absolute) in IHTG (%) | Measured at pre-entry and Week 24 | The absolute change in intra-hepatic triglyceride content (%), as quantfied by MRI-PDFF, from the pre-entry visit to the Week 24 visit. |
| Secondary | Change (Percent) in IHTG (%) | Measured at pre-entry and Week 24 | The percentage change in intra-hepatic triglyceride content (%), as quantfied by MRI-PDFF, from the pre-entry visit to the Week 24 visit. The percentage change is defined as IHTC % at week 24 minus IHTC % at pre-entry, then divided by IHTC % at pre-entry, then multiplied by 100. |
| Secondary | Level of IHTG (%) | Measured at Week 24 | Intra-hepatic triglyceride content (%) at Week 24 (\<5% vs. \>=5%). All participants were \>=5% at pre-entry. |
| Secondary | Occurrence of Premature Discontinuation of Study Treatment | Measured through Week 24 | Premature study treatment discontinuation prior to the Week 24 visit. |
| Secondary | Occurrence of Grade ≥3 Adverse Event That is Related to Study Treatment | Measured through Week 24 | Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. |
| Secondary | Change (Absolute) in Body Mass Index (BMI) | Measured at Week 0 and Week 24 | The absolute change in body mass index from the study entry (Week 0) visit to the Week 24 visit. |
| Secondary | Change (Absolute) in Body Mass Index (BMI) | Measured from Week 0 to Week 12 | The absolute change in body mass index from the study entry (Week 0) visit to the Week 12 visit. |
| Secondary | Change (Absolute) in Body Weight | Measured at Week 0 and Week 24 | The absolute change in body weight from the study entry (Week 0) visit to the Week 24 visit. |
| Secondary | Change (Absolute) in Body Weight | Measured at Week 0 and Week 12 | The absolute change in body weight from the study entry (Week 0) visit to the Week 12 visit. |
| Secondary | Change (Absolute) in Minimum Waist Circumference (WC) | Measured at Week 0 and Week 24 | The absolute change in minimum WC from the study entry (Week 0) visit to the Week 24 visit. |
| Secondary | Change (Absolute) in Minimum Waist Circumference (WC) | Measured at Week 0 and Week 12 | The absolute change in minimum WC from the study entry (Week 0) visit to the Week 12 visit. |
| Secondary | Change (Absolute) in Insulin Resistance (HOMA-IR) | Measured at Week 0 and Week 24 | The absolute change in HOMA-IR from the study entry (Week 0) visit to the Week 24 visit. HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) is a method used to estimate how well your body responds to insulin. HOMA-IR is caluclated with the following formula: (fasting glucose in mmol/L x fasting insulin in mIU/mL)/22.5 A higher HOMA-IR score indicates a greater likelihood of insulin resistance. |
| Secondary | Change (Absolute) in Insulin Resistance (HOMA-IR) | Measured at Week 0 and Week 12 | The absolute change in HOMA-IR from the study entry (Week 0) visit to the Week 12 visit. HOMA-IR (Homeostatic Model Assessment of Insulin Resistanc) is a method used to estimate how well your body responds to insulin. HOMA-IR is caluclated with the following formula: (fasting glucose in mmol/L x fasting insulin in mIU/mL)/22.5 A higher HOMA-IR score indicates a greater likelihood of insulin resistance. |
| Secondary | Change (Absolute) in Hemoglobin A1C (HbA1c) | Measured at Week 0 and Week 24 | The absolute change in HbA1c from the study entry (Week 0) visit to the Week 24 visit. |
| Secondary | Change (Absolute) in Fasting Glucose | Measured at Week 0 and Week 24 | The absolute change in fasting glucose from the study entry (Week 0) visit to the Week 24 visit. |
| Secondary | Change (Absolute) in Fasting Glucose | Measured at Week 0 and Week 12 | The absolute change in fasting glucose from the study entry (Week 0) visit to the Week 12 visit. |
| Secondary | Change (Absolute) in Fasting Total Cholesterol | Measured at Week 0 and Week 24 | The absolute change in fasting total cholesterol from the study entry (Week 0) visit to the Week 24 visit. |
| Secondary | Change (Absolute) in Fasting Total Cholesterol | Measured at Week 0 and Week 12 | The absolute change in fasting total cholesterol from the study entry (Week 0) visit to the Week 12 visit. |
| Secondary | Change (Absolute) in Fasting LDL Cholesterol | Measured at Week 0 and Week 24 | The absolute change in fasting LDL cholesterol from the study entry (Week 0) visit to the Week 24 visit. |
| Secondary | Change (Absolute) in Fasting LDL Cholesterol | Measured at Week 0 and Week 12 | The absolute change in fasting LDL cholesterol from the study entry (Week 0) visit to the Week 12 visit. |
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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