Trial · NCT03038022
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 | Mean Percent Change in LDL-C From Baseline To Week 12 | Baseline up to Week 12 | LDL-C was determined by ultracentrifugation or direct measure. Least-squares (LS) mean was provided for the comparison of MGL-3196 versus placebo and it used a linear model with percent change from baseline as the dependent variable and treatment as a factor. |
| Secondary | Mean Change From Baseline to Week 12 of Free Thyroxine (T4) | Baseline up to Week 12 | T4 was assessed at each study visit. |
| Secondary | Mean Change From Baseline to Week 12 of Free Triiodothyronine (T3) | Baseline up to Week 12 | Free T3 was assessed at each study visit. |
| Secondary | Mean Change From Baseline to Week 12 of Thyrotropin (TSH) | Baseline up to Week 12 | TSH was assessed at each study visit. |
| Secondary | Mean Change From Baseline to Week 12 of Thyroxine Binding Globulin (TBG) | Baseline up to Week 12 | TBG was assessed at all study visits except the Screening Visit. |
| Secondary | Mean Change From Baseline to Week 12 of Reverse Triiodothyronine (T3) | Baseline up to Week 12 | Reverse T3 was assessed at each study visit. |
| Secondary | Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 12 | Baseline up to Week 12 | Non-HDL-C were determined by ultracentrifugation. LS mean was provided for the comparison of MGL-3196 versus placebo and it used a linear model with percent change from baseline as the dependent variable and treatment as a factor |
| Secondary | Mean Percent Change In Triglycerides From Baseline To Week 12 | Baseline up to Week 12 | Triglycerides were determined by ultracentrifugation. LS mean was provided for the comparison of MGL-3196 versus placebo and it used a linear model with percent change from baseline as the dependent variable and treatment as a factor. |
| Secondary | Mean Percent Change In Lipoprotein(a) (Lp[a]) From Baseline To Week 12 | Baseline up to Week 12 | Lp(a) was determined by ultracentrifugation. LS mean was provided for the comparison of MGL-3196 versus placebo and it used a linear model with percent change from baseline as the dependent variable and treatment as a factor. |
| Secondary | Mean Percent Change in Apolipoprotein CIII From Baseline to Week 12 | Baseline up to Week 12 | Apolipoprotein CIII was determined by ultracentrifugation. LS mean was provided for the comparison of MGL-3196 versus placebo and it used a linear model with percent change from baseline as the dependent variable and treatment as a factor. |
| Secondary | Mean Percent Change In Apolipoprotein B (ApoB) From Baseline To Week 12 | Baseline up to Week 12 | ApoB was determined by ultracentrifugation. LS mean was provided for the comparison of MGL-3196 versus placebo and it used a linear model with percent change from baseline as the dependent variable and treatment as a factor. |
| Secondary | Mean Percent Change in Apolipoprotein B/Apolipoprotein A1 (ApoB/ApoA1) Ratio From Baseline to Week 12 | Baseline up to Week 12 | The ApoB/ApoA1 ratio was determined by ultracentrifugation. LS mean was provided for the comparison of MGL-3196 versus placebo and it used a linear model with percent change from baseline as the dependent variable and treatment as a factor. |
| Secondary | Mean Percent Change In Cholesterol/HDL-C Ratio From Baseline to Week 12 | Baseline up to Week 12 | The Cholesterol/HDL-C Ratio was determined by ultracentrifugation. LS mean was provided for the comparison of MGL-3196 versus placebo and it used a linear model with percent change from baseline as the dependent variable and treatment as a factor. |
| Secondary | Absolute Change in LDL-C From Baseline to Week 12 | Baseline up to Week 12 | LDL-C was determined by ultracentrifugation or direct measure . Least-squares (LS) mean was provided for the comparison of MGL-3196 versus placebo and it used a linear model with percent change from baseline as the dependent variable and treatment as a factor. |
| Secondary | Percent Change From Baseline in LDL-C at Week 2 and Week 4 in Patients in the 100 mg and the 60 mg Groups | Baseline to Week 2 and Week 4 | LDL-C was determined by ultracentrifugation or direct measure. Least-squares (LS) mean was provided for the comparison of MGL-3196 versus placebo and it used a linear model with percent change from baseline as the dependent variable and treatment as a factor. |
| Secondary | Percent Change in LDL-C From Baseline to Week 12 by Systemic Exposure Category | Baseline to Week 12 | The effect on percent change in LDL-C from baseline to Week 12 was determined by patient exposure category (higher/lower). Patients taking MGL-3196 were categorized into lower and higher exposure groups. Patients in the higher exposure group must either have had estimated Week 2 AUC ≥5,000 mg∙h/L, or if Week 2 AUC \<5,000 mg∙h/L but Week 4 pre-dose concentration \>1.5 ng/mL (if on 60 mg MGL-3196). All other patients were in the lower exposure group. |
| Secondary | Mean Change in Lipid Particle Concentration From Baseline To Week 12: Total LDL Particles | Baseline up to Week 12 | The effect of once-daily oral dosing of MGL-3196 versus placebo for 12 weeks in terms of change from baseline was assessed for LDL Particles. |
| Secondary | Mean Change in Lipid Particle Concentration From Baseline To Week 12: Small LDL Particles | Baseline up to Week 12 | The effect of once-daily oral dosing of MGL-3196 versus placebo for 12 weeks in terms of change from baseline was assessed for Small LDL Particles. |
| Secondary | Mean Change in Lipid Particle Concentration From Baseline To Week 12: Intermediate LDL Particles | Baseline up to Week 12 | The effect of once-daily oral dosing of MGL-3196 versus placebo for 12 weeks in terms of change from baseline was assessed for Intermediate LDL Particles. |
| Secondary | Mean Change in Lipid Particle Concentration From Baseline To Week 12: Large LDL Particles | Baseline up to Week 12 | The effect of once-daily oral dosing of MGL-3196 versus placebo for 12 weeks in terms of change from baseline was assessed for Large LDL Particles. |
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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