Trial · NCT03038022

Study of MGL-3196 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH)

NCT03038022, Phase 2, Completed, Madrigal Pharmaceuticals, Inc.; results first posted 2025-12-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of MGL-3196 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH). Trials, record NCT03038022. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03038022

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of MGL-3196 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH)
NCT number: NCT03038022
Status: Completed
Phases: Phase 2
Enrollment: 116 participants, actual
Lead sponsor: Madrigal Pharmaceuticals, Inc.
Conditions: Heterozygous Familial Hypercholesterolemia
Interventions: MGL-3196 (resmetirom), Placebo
First posted: 2017-01-31
Last updated: 2026-06-04
Other registries' IDs: eudract:2016-002315-17
Results first posted: 2025-12-23

Source ClinicalTrials.gov

Registered outcomes25

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

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.

1 to 10 of 25Source ClinicalTrials.gov

See all 25 registered outcomes

Outcomes25

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Percent Change in LDL-C From Baseline To Week 12	Baseline up to Week 12	Modified Intent-to-Treat (mITT) population: all participants who were randomized in the study, received at least 2 weeks of study drug, and had a valid lipid measurement at Week 2 or later.	percent change	LEAST_SQUARES_MEAN
SECONDARY	Mean Change From Baseline to Week 12 of Free Thyroxine (T4)	Baseline up to Week 12	Safety population: all participants who were randomized in the study and received at least 1 dose of study drug.	ng/dL	LEAST_SQUARES_MEAN
SECONDARY	Mean Change From Baseline to Week 12 of Free Triiodothyronine (T3)	Baseline up to Week 12	Safety population: all participants who were randomized in the study and received at least 1 dose of study drug.	ng/L	LEAST_SQUARES_MEAN
SECONDARY	Mean Change From Baseline to Week 12 of Thyrotropin (TSH)	Baseline up to Week 12	Safety population: all participants who were randomized in the study and received at least 1 dose of study drug.	mIU/L	LEAST_SQUARES_MEAN
SECONDARY	Mean Change From Baseline to Week 12 of Thyroxine Binding Globulin (TBG)	Baseline up to Week 12	Safety population: all participants who were randomized in the study and received at least 1 dose of study drug.	mg/L	LEAST_SQUARES_MEAN
SECONDARY	Mean Change From Baseline to Week 12 of Reverse Triiodothyronine (T3)	Baseline up to Week 12	Safety population: all participants who were randomized in the study and received at least 1 dose of study drug.	ng/dL	LEAST_SQUARES_MEAN
SECONDARY	Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 12	Baseline up to Week 12		percent change	LEAST_SQUARES_MEAN
SECONDARY	Mean Percent Change In Triglycerides From Baseline To Week 12	Baseline up to Week 12	mITT population: all participants who were randomized in the study, received at least 2 weeks of study drug, and had a valid lipid measurement at Week 2 or later.	percent change	LEAST_SQUARES_MEAN
SECONDARY	Mean Percent Change In Lipoprotein(a) (Lp[a]) From Baseline To Week 12	Baseline up to Week 12	mITT population: all participants who were randomized in the study, received at least 2 weeks of study drug, and had a valid lipid measurement at Week 2 or later.	percent change	LEAST_SQUARES_MEAN
SECONDARY	Mean Percent Change in Apolipoprotein CIII From Baseline to Week 12	Baseline up to Week 12		percent change	LEAST_SQUARES_MEAN

1 to 10 of 25Source ClinicalTrials.gov

See all 25 outcomes

Results by group53

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Mean Percent Change in LDL-C From Baseline To Week 12	MGL-3196	-10.6	Standard Error 2.59	percent change
Mean Percent Change in LDL-C From Baseline To Week 12	Placebo	8.2	Standard Error 3.71	percent change
Mean Change From Baseline to Week 12 of Free Thyroxine (T4)	MGL-3196	-0.268	Standard Error 0.0130	ng/dL
Mean Change From Baseline to Week 12 of Free Thyroxine (T4)	Placebo	0.009	Standard Error 0.0185	ng/dL
Mean Change From Baseline to Week 12 of Free Triiodothyronine (T3)	MGL-3196	-0.04	Standard Error 0.038	ng/L
Mean Change From Baseline to Week 12 of Free Triiodothyronine (T3)	Placebo	0.10	Standard Error 0.054	ng/L
Mean Change From Baseline to Week 12 of Thyrotropin (TSH)	MGL-3196	-0.027	Standard Error 0.0690	mIU/L
Mean Change From Baseline to Week 12 of Thyrotropin (TSH)	Placebo	0.114	Standard Error 0.0987	mIU/L
Mean Change From Baseline to Week 12 of Thyroxine Binding Globulin (TBG)	MGL-3196	-2.31	Standard Error 0.256	mg/L
Mean Change From Baseline to Week 12 of Thyroxine Binding Globulin (TBG)	Placebo	-0.44	Standard Error 0.367	mg/L

1 to 10 of 53Source ClinicalTrials.gov

See all 53 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	MGL-3196	78
Overall Study	STARTED	Placebo	38
Overall Study	Received at Least 1 Dose of Study Drug	MGL-3196	78
Overall Study	Received at Least 1 Dose of Study Drug	Placebo	38
Overall Study	COMPLETED	MGL-3196	72
Overall Study	COMPLETED	Placebo	36
Overall Study	NOT COMPLETED	MGL-3196	6
Overall Study	NOT COMPLETED	Placebo	2

Source ClinicalTrials.gov

Adverse events40

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Diarrhea	Gastrointestinal disorders	MGL-3196	15	78
other	Diarrhea	Gastrointestinal disorders	Placebo	4	38
other	Nausea	Gastrointestinal disorders	MGL-3196	16	78
other	Nausea	Gastrointestinal disorders	Placebo	2	38
other	Abdominal Pain	Gastrointestinal disorders	MGL-3196	5	78
other	Abdominal Pain	Gastrointestinal disorders	Placebo	2	38
other	Flatulence	Gastrointestinal disorders	MGL-3196	5	78
other	Flatulence	Gastrointestinal disorders	Placebo	0	38
other	Vomiting	Gastrointestinal disorders	MGL-3196	4	78
other	Vomiting	Gastrointestinal disorders	Placebo	1	38

1 to 10 of 40Source ClinicalTrials.gov

See all 40 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	MGL-3196	0	78
Total, all-cause mortality	Placebo	0	38
Total, other adverse events	MGL-3196	65	78
Total, other adverse events	Placebo	28	38
Total, serious adverse events	MGL-3196	0	78
Total, serious adverse events	Placebo	1	38

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35331419	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
MGL-3196 vs Placebo: deaths from any cause	Trial comparisons
MGL-3196 vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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 trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03038022

GET https://conductscience.org/api/trials/v1/NCT03038022/registered?page=2

API reference For AI assistants