Heterozygous Familial HypercholesterolemiaPhase 2NCT03038022
Study of MGL-3196 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH)
A Phase 2 study testing MGL-3196 (resmetirom) in people with Heterozygous Familial Hypercholesterolemia, run by Madrigal Pharmaceuticals, Inc. at 13 sites in 3 countries.
Trial summary
The primary objective of this study is to determine the effect of once-daily oral MGL-3196 on the percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in participants with Heterozygous Familial Hypercholesterolemia (HeFH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heterozygous Familial Hypercholesterolemia
- What is being tested?
- MGL-3196 (resmetirom)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 13 sitesin 3 countries
- Study dates
- 23 Feb 2017to 15 Jan 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be willing to participate in the study and provide written informed consent;
- Male and female adults ≥18 years of age;
- Female participants of child bearing potential with negative serum pregnancy (beta human chorionic gonadotropin) test who are not breastfeeding, do not plan to become pregnant during the study, and agree to use effective birth control per locally agreed requirements; male participants who have sexual intercourse with a female partner of child bearing potential from the first dose of study drug until 1 month after study completion must either be surgically sterile (confirmed by documented azoospermia >90 days after the procedure) or agree to use a condom with spermicide. All male participants must agree not to donate sperm from the first dose of study drug until 1 month after study completion;
- Must have a diagnosis of HeFH by genetic testing or by having met the diagnostic criteria for definite familial hypercholesterolemia outlined by the Simon Broome Register Group or World Health Organization/Dutch Lipid Network (score >8);
- Must have had a fasting LDL-C (low density lipoprotein cholesterol) ≥2.6 mmol/L (100 mg/dL); and
- Must be on a stable or maximally tolerated dose (≥4 weeks prior to screening) of an approved statin (rosuvastatin ≤40 mg daily, atorvastatin ≤80 mg daily), with or without ezetimibe. Patients intolerant to statins were allowed.
Who cannot join
- Homozygous familial hypercholesterolemia
- LDL or plasma apheresis within 2 months prior to randomization;
- New York Heart Association class III or IV heart failure, or known left ventricular ejection fraction <30%;
- Uncontrolled cardiac arrhythmia, including confirmed QT interval corrected using Fridericia's formula >450 msec for males and >470 msec for females at the screening electrocardiogram assessment;
- Myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft, or stroke within 3 months prior to randomization;
- Type 1 diabetes, or newly diagnosed or uncontrolled type 2 diabetes (hemoglobin A1c >8%);
Show all 25Show fewer
- History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening; Note: Significant alcohol consumption is defined as average of >20 g/day in female participants and >30 g/day in male participants;
- Hyperthyroidism;
- Thyroid replacement therapy;
- Hypothyroidism;
- Evidence of chronic liver disease;
- Hepatitis B, as defined by the presence of hepatitis B surface antigen;
- Hepatitis C, as defined by the presence of hepatitis C virus (HCV) antibody (anti-HCV) and HCV ribonucleic acid (RNA). Participants with positive anti-HCV who test negative for HCV RNA at screening will be allowed to participate in the study;
- Serum alanine aminotransferase >1.5 x upper limit of normal (ULN) (one repeat allowed);
- Estimated glomerular filtration rate <60 mL/min;
- Creatine kinase >3 x ULN (one repeat allowed);
- History of biliary diversion;
- Positive for human immunodeficiency virus infection;
- History of malignant hypertension;
- Systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg at screening or randomization and confirmed at an unscheduled visit;
- Triglycerides >5.7 mmol/L (500 mg/dL) at screening and confirmed by repeat assessment;
- Active, serious medical disease with likely life expectancy <2 years;
- Active substance abuse, including inhaled or injection drugs within the year prior to screening;
- Participation in an investigational new drug trial within the 30 days prior to randomization; or
- Any other condition which, in the opinion of the Investigator, would impede compliance, hinder completion of the study, or compromise the well-being of the participants.
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
Netherlands6 sites
Madrigal Research Site
Amsterdam
Madrigal Research Site
Apeldoorn
Madrigal Research Site
Goes
Madrigal Research Site
Hoorn
Madrigal Research Site
Nijmegen
Madrigal Research Site
Zwijndrecht
Denmark5 sites
Madrigal Research Site
Aalborg
Madrigal Research Site
Copenhagen
Madrigal Research Site
Esbjerg
Madrigal Research Site
Herlev
Madrigal Research Site
Viborg
About this study
Official title: A Phase 2, Multi-Center, Double-Blind, Randomized, Placebo Controlled Study of MGL-3196 in Patients With Heterozygous Familial Hypercholesterolemia
The primary objective of this study is to determine the effect of once-daily oral MGL-3196 on the percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in participants with Heterozygous Familial Hypercholesterolemia (HeFH).
- Being tested
- MGL-3196 (resmetirom), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGL-3196 (resmetirom)Drug
Oral
PlaceboDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| MGL-3196 | Experimental | Study Drug Receives: Drug: MGL-3196 (resmetirom) |
| Placebo | Placebo comparator | Matching Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Change in LDL-C From Baseline 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.
Measured: Baseline up to Week 12
Secondary outcomes (24)
Mean Change From Baseline to Week 12 of Free Thyroxine (T4)
T4 was assessed at each study visit.
Measured: Baseline up to Week 12
Mean Change From Baseline to Week 12 of Free Triiodothyronine (T3)
Free T3 was assessed at each study visit.
Measured: Baseline up to Week 12
Mean Change From Baseline to Week 12 of Thyrotropin (TSH)
TSH was assessed at each study visit.
Measured: Baseline up to Week 12
Mean Change From Baseline to Week 12 of Thyroxine Binding Globulin (TBG)
TBG was assessed at all study visits except the Screening Visit.
Measured: Baseline up to Week 12
Mean Change From Baseline to Week 12 of Reverse Triiodothyronine (T3)
Reverse T3 was assessed at each study visit.
Measured: Baseline up to Week 12
Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline 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
Measured: Baseline up to Week 12
Mean Percent Change In Triglycerides From Baseline 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.
Measured: Baseline up to Week 12
Mean Percent Change In Lipoprotein(a) (Lp[a]) From Baseline 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.
Measured: Baseline up to Week 12
Mean Percent Change in Apolipoprotein CIII From Baseline 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.
Measured: Baseline up to Week 12
Mean Percent Change In Apolipoprotein B (ApoB) From Baseline 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.
Measured: Baseline up to Week 12
Mean Percent Change in Apolipoprotein B/Apolipoprotein A1 (ApoB/ApoA1) Ratio From Baseline 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.
Measured: Baseline up to Week 12
Mean Percent Change In Cholesterol/HDL-C Ratio From Baseline 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.
Measured: Baseline up to Week 12
Absolute Change in LDL-C From Baseline 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.
Measured: Baseline up to Week 12
Percent Change From Baseline in LDL-C at Week 2 and Week 4 in Patients in the 100 mg and the 60 mg Groups
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.
Measured: Baseline to Week 2 and Week 4
Percent Change in LDL-C From Baseline to Week 12 by Systemic Exposure Category
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.
Measured: Baseline to Week 12
Mean Change in Lipid Particle Concentration From Baseline To Week 12: Total LDL Particles
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.
Measured: Baseline up to Week 12
Mean Change in Lipid Particle Concentration From Baseline To Week 12: Small LDL Particles
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.
Measured: Baseline up to Week 12
Mean Change in Lipid Particle Concentration From Baseline To Week 12: Intermediate LDL Particles
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.
Measured: Baseline up to Week 12
Mean Change in Lipid Particle Concentration From Baseline To Week 12: Large LDL Particles
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.
Measured: Baseline up to Week 12
Mean Change in Lipid Particle Concentration From Baseline To Week 12:Total Very Low-Density Lipoprotein (VLDL) and Chylomicron Particles
The effect of once-daily oral dosing of MGL-3196 versus placebo for 12 weeks in terms of change from baseline was assessed for VLDL and Chylomicron Particles.
Measured: Baseline up to Week 12
Mean Change in Lipid Particle Concentration From Baseline To Week 12: Total HDL Particles
The effect of once-daily oral dosing of MGL-3196 versus placebo for 12 weeks in terms of change from baseline was assessed for Total HDL Particles.
Measured: Baseline up to Week 12
Mean Change in Lipid Particle Concentration From Baseline To Week 12: LDL Particle Size
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 Particle size.
Measured: Baseline up to Week 12
Mean Change in Lipid Particle Concentration From Baseline To Week 12: VLDL Particle Size
The effect of once-daily oral dosing of MGL-3196 versus placebo for 12 weeks in terms of change from baseline was assessed for VLDL Particle Size.
Measured: Baseline up to Week 12
Mean Change in Lipid Particle Concentration From Baseline To Week 12: HDL Particle Size
The effect of once-daily oral dosing of MGL-3196 versus placebo for 12 weeks in terms of change from baseline was assessed for HDL Particle Size.
Measured: Baseline up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start23 Feb 2017
- Primary completion15 Jan 2018
- Study completion15 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heterozygous Familial HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Madrigal Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rebecca Taub, MD, Study director, Madrigal Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03038022
- Sponsor's protocol ID
- MGL-3196-06
- Other IDs
- 2016-002315-17, 2016
- Status last verified
- Sep 2025
- First submitted
- 30 Jan 2017
- Last updated
- 4 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hovingh GK, Klausen IC, Heggen E, McCarty K, Zhou R, Isaac BF, Taub R, Langslet G, Kastelein JJP. Resmetirom (MGL-3196) in Patients With Heterozygous Familial Hypercholesterolemia. J Am Coll Cardiol. 2022 Mar 29;79(12):1220-1222. doi: 10.1016/j.jacc.2022.01.023. No abstract available.
PubMed 35331419
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-Center, Double-Blind, Randomized, Placebo Controlled Study of MGL-3196 in Patients With Heterozygous Familial Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT03038022
- Acronym / sponsor ID
- MGL-3196-06
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Madrigal Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Feb 2017 (actual)
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Posted 23 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to determine the effect of once-daily oral MGL-3196 on the percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in participants with Heterozygous Familial Hypercholesterolemia (HeFH).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MGL-3196 | Experimental | Drug: MGL-3196 (resmetirom)Study Drug |
| Placebo | Placebo comparator | Drug: PlaceboMatching Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must be willing to participate in the study and provide written informed consent;
- Male and female adults ≥18 years of age;
- Female participants of child bearing potential with negative serum pregnancy (beta human chorionic gonadotropin) test who are not breastfeeding, do not plan to become pregnant during the study, and agree to use effective birth control per locally agreed requirements; male participants who have sexual intercourse with a female partner of child bearing potential from the first dose of study drug until 1 month after study completion must either be surgically sterile (confirmed by documented azoospermia >90 days after the procedure) or agree to use a condom with spermicide. All male participants must agree not to donate sperm from the first dose of study drug until 1 month after study completion;
- Must have a diagnosis of HeFH by genetic testing or by having met the diagnostic criteria for definite familial hypercholesterolemia outlined by the Simon Broome Register Group or World Health Organization/Dutch Lipid Network (score >8);
- Must have had a fasting LDL-C (low density lipoprotein cholesterol) ≥2.6 mmol/L (100 mg/dL); and
Key exclusion criteria (25 listed)
- Homozygous familial hypercholesterolemia
- LDL or plasma apheresis within 2 months prior to randomization;
- New York Heart Association class III or IV heart failure, or known left ventricular ejection fraction <30%;
- Uncontrolled cardiac arrhythmia, including confirmed QT interval corrected using Fridericia's formula >450 msec for males and >470 msec for females at the screening electrocardiogram assessment;
- Myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft, or stroke within 3 months prior to randomization;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MGL-3196 (resmetirom)Oral | Drug | MGL-3196 |
| PlaceboOral | Drug | Placebo |
Primary outcome
Mean Percent Change in LDL-C From Baseline To Week 12
Time frame: 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.
24 secondary outcomes
Mean Change From Baseline to Week 12 of Free Thyroxine (T4)
Time frame: Baseline up to Week 12
Mean Change From Baseline to Week 12 of Free Triiodothyronine (T3)
Time frame: Baseline up to Week 12
Mean Change From Baseline to Week 12 of Thyrotropin (TSH)
Time frame: Baseline up to Week 12
Mean Change From Baseline to Week 12 of Thyroxine Binding Globulin (TBG)
Time frame: Baseline up to Week 12
Mean Change From Baseline to Week 12 of Reverse Triiodothyronine (T3)
Time frame: Baseline up to Week 12
Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 12
Time frame: Baseline up to Week 12
Mean Percent Change In Triglycerides From Baseline To Week 12
Time frame: Baseline up to Week 12
Mean Percent Change In Lipoprotein(a) (Lp[a]) From Baseline To Week 12
Time frame: Baseline up to Week 12
Mean Percent Change in Apolipoprotein CIII From Baseline to Week 12
Time frame: Baseline up to Week 12
Mean Percent Change In Apolipoprotein B (ApoB) From Baseline To Week 12
Time frame: Baseline up to Week 12
Mean Percent Change in Apolipoprotein B/Apolipoprotein A1 (ApoB/ApoA1) Ratio From Baseline to Week 12
Time frame: Baseline up to Week 12
Mean Percent Change In Cholesterol/HDL-C Ratio From Baseline to Week 12
Time frame: Baseline up to Week 12
Absolute Change in LDL-C From Baseline to Week 12
Time frame: Baseline up to Week 12
Percent Change From Baseline in LDL-C at Week 2 and Week 4 in Patients in the 100 mg and the 60 mg Groups
Time frame: Baseline to Week 2 and Week 4
Percent Change in LDL-C From Baseline to Week 12 by Systemic Exposure Category
Time frame: Baseline to Week 12
Mean Change in Lipid Particle Concentration From Baseline To Week 12: Total LDL Particles
Time frame: Baseline up to Week 12
Mean Change in Lipid Particle Concentration From Baseline To Week 12: Small LDL Particles
Time frame: Baseline up to Week 12
Mean Change in Lipid Particle Concentration From Baseline To Week 12: Intermediate LDL Particles
Time frame: Baseline up to Week 12
Mean Change in Lipid Particle Concentration From Baseline To Week 12: Large LDL Particles
Time frame: Baseline up to Week 12
Mean Change in Lipid Particle Concentration From Baseline To Week 12:Total Very Low-Density Lipoprotein (VLDL) and Chylomicron Particles
Time frame: Baseline up to Week 12
Mean Change in Lipid Particle Concentration From Baseline To Week 12: Total HDL Particles
Time frame: Baseline up to Week 12
Mean Change in Lipid Particle Concentration From Baseline To Week 12: LDL Particle Size
Time frame: Baseline up to Week 12
Mean Change in Lipid Particle Concentration From Baseline To Week 12: VLDL Particle Size
Time frame: Baseline up to Week 12
Mean Change in Lipid Particle Concentration From Baseline To Week 12: HDL Particle Size
Time frame: Baseline up to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35331419Hovingh GK, Klausen IC, Heggen E, McCarty K, Zhou R, Isaac BF, Taub R, Langslet G, Kastelein JJP. Resmetirom (MGL-3196) in Patients With Heterozygous Familial Hypercholesterolemia. J Am Coll Cardiol. 2022 Mar 29;79(12):1220-1222. doi: 10.1016/j.jacc.2022.01.023. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Taub, MD study director
Madrigal Pharmaceuticals, Inc.
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MGL-3196 (resmetirom) in people with Heterozygous Familial Hypercholesterolemia, run by Madrigal Pharmaceuticals, Inc. at 13 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Netherlands, Denmark, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Percent Change in LDL-C From Baseline To Week 12 (time frame: Baseline up to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03038022, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.