HypercholesterolemiaPhase 2NCT03193047

Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg When Added to PCSK9 Inhibitor Therapy

A Phase 2 study testing bempedoic acid 180mg and evolocumab in people with Hypercholesterolemia, run by Esperion Therapeutics, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine if bempedoic acid (ETC-1002) 180mg added to PCSK9 inhibitor (evolocumab) therapy is effective and safe in patients with elevated LDL cholesterol. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypercholesterolemia
What is being tested?: bempedoic acid 180mg and evolocumab
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 59 participants
Where: 1 siteUnited States
Study dates: 7 Apr 2017to 19 Feb 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

Age ≥18 years or legal age of majority depending on regional law
Fasting, calculated LDL-C at screening ≥160 mg/dL and following PCSK9i therapy ≥70 mg/dL
Men and nonpregnant, nonlactating women

Who cannot join

Heterozygous (HeFH) or Homozygous (HoFH) Familial Hypercholesterolemia
Total fasting TG ≥500 mg/dL
Renal dysfunction or a glomerulonephropathy; eGFR <30 mL/min/1.73 m2
Known cardiovascular disease (CVD), peripheral arterial disease (PAD), or cerebrovascular disease (CD)
History of type 1 or type 2 diabetes
Uncontrolled hypertension

Show all 14Show fewer

Uncontrolled hypothyroidism
Liver disease or dysfunction
Gastrointestinal conditions or procedures (including Lap-Band® or gastric bypass)
History of hematologic or coagulation disorders
History of malignancy (except non-metastatic basal or squamous cell carcinoma of the skin and cervical carcinoma in situ)
Unexplained creatine kinase (CK) >3 × ULN
Use of a cholesterylester transfer protein (CETP) inhibitor in the last 12 months prior to screening, such as: anacetrapib, dalcetrapib, or evacetrapib
Pregnant or breast feeding, or planning to become pregnant during treatment and/ or within 30 days after the end of treatment

Trial locations and contacts

1 site in 1 country.

United States1 site

L-MARC Research Center
Louisville, Kentucky, 40213

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg QD When Added to Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)-Inhibitor Therapy

The purpose of this study is to determine if bempedoic acid (ETC-1002) 180mg added to PCSK9 inhibitor (evolocumab) therapy is effective and safe in patients with elevated LDL cholesterol.

Conditions: Hypercholesterolemia
Being tested: bempedoic acid 180mg, placebo, evolocumab
Keywords: Cholesterol, PCSK9, Repatha, evolocumab, LDL-C
Medical subject headings: Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

bempedoic acid 180mgDrug
Also called ETC-1002
Daily bempedoic acid 180mg tablet in addition to monthly PCSK9i (evolocumab) background therapy
placeboOther
Daily matching placebo tablet in addition to monthly PCSK9i (evolocumab) background therapy
evolocumabDrug
Also called Repatha
Monthly PCSK9i (evolocumab) background therapy

Study groups in NCT03193047
Study group	Role	What they receive
bempedoic acid	Experimental	Bempedoic acid 180mg tablet taken orally, once daily plus evolocumab (Repatha) 420mg injection once monthly Receives: Drug: bempedoic acid 180mg; Drug: evolocumab
placebo	Placebo comparator	Matching placebo tablet taken orally, once daily plus evolocumab (Repatha) 420mg injection once monthly Receives: Other: placebo; Drug: evolocumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Month 2
Percent change from Baseline is calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value ) x 100. Baseline is defined as the average of the last two non-missing values within Month -1 (Screening Visit 4) and Day 1 (Treatment Visit 1) values (including unscheduled assessments). If only one value was available, then that single value was used at Baseline. Percent change from Baseline was analyzed using analysis of covariance (ANCOVA), with treatment group as a factor and Baseline as a covariate. Missing data were imputed using last observation carried forward (LOCF) (only post-Baseline values were carried forward).
Measured: Baseline; Month 2

Secondary outcomes (6)

Percent Change From Baseline in LDL-C at Month 1
Percent change from Baseline is calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value ) x 100. Baseline is defined as the average of the last two non-missing values within Month -1 (Screening Visit 4) and Day 1 (Treatment Visit 1) values (including unscheduled assessments). If only one value was available, then that single value was used at Baseline. Percent change from Baseline was analyzed using ANCOVA, with treatment group as a factor and Baseline as a covariate. Observed data were used for analysis.
Measured: Baseline; Month 1
Absolute Change From Baseline in LDL-C at Month 1 and Month 2
Change from Baseline is calculated as the post-Baseline value minus the Baseline value. Baseline is defined as the average of the Screening Visit 4 and the Day 1 value. If only 1 value is available, then that single value is used as Baseline. Change from Baseline was analyzed using ANCOVA, with treatment group as a factor and Baseline as a covariate. Observed data were used for analysis at Month 1. Missing Month 2 data were handled by LOCF.
Measured: Baseline; Month 1 and Month 2
Percent Change From Baseline in Lipid Profile Parameters at Month 1 and Month 2
Percent change from Baseline is calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value ) x 100. Baseline apolipoprotein B (apoB) is defined as the Day 1 value. Baseline total cholesterol (TC) and non-high-density lipoprotein cholesterol (non-HDL-C) are defined as the average of the Month -1 (Screening Visit 4) and the Day 1 (Treatment Visit 1) values. If a missing value presented at Month -1 or Day 1, then the last non-missing value prior to the first dose of double-blind study medication (including unscheduled assessments) within Month -1 and Day 1 was used to compute the Baseline measurements. Percent change from Baseline was analyzed using ANCOVA, with treatment group as a factor and Baseline as a covariate. Observed data were used for analysis at Month 1. Missing Month 2 data were handled by LOCF.
Measured: Baseline; Month 1 and Month 2
Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Month 1 and Month 2
Percent change from Baseline is calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value ) x 100. Baseline is defined as the Day 1 value. Percent change from Baseline was analyzed using a non-parametric approach. Missing Month 2 data were handled by LOCF. Observed data were used for analysis at Month 1.
Measured: Baseline; Month 1 and Month 2
Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE)
Treatment-emergent AEs (TEAEs) and SAEs (TESAEs) were reported and defined as any AE that began or worsened after the first dose of investigational medicinal product.
Measured: up to Month 2 (until 30 days after last dose)
Number of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) >3x the Upper Limit of Normal (ULN) at Month 1 and Month 2
The number of participants with ALT or AST >3x ULN was measured.
Measured: Month 1 and Month 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Apr 201719 Feb 2018

First posted20 Jun 2017
Study start7 Apr 2017
Primary completion29 Jan 2018
Study completion19 Feb 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 (4)Papers the sponsor has linked to this study.
Other trials for 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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 59 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03193047
Sponsor's protocol ID: 1002-039
Status last verified: Mar 2020
First submitted: 19 Jun 2017
Last updated: 3 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Pinkosky SL, Newton RS, Day EA, Ford RJ, Lhotak S, Austin RC, Birch CM, Smith BK, Filippov S, Groot PHE, Steinberg GR, Lalwani ND. Liver-specific ATP-citrate lyase inhibition by bempedoic acid decreases LDL-C and attenuates atherosclerosis. Nat Commun. 2016 Nov 28;7:13457. doi: 10.1038/ncomms13457.
PubMed 27892461
Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW, Eddleman KM, Jarrett NM, LaBresh K, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S1-45. doi: 10.1161/01.cir.0000437738.63853.7a. Epub 2013 Nov 12. No abstract available.
PubMed 24222016
Sharrett AR, Ballantyne CM, Coady SA, Heiss G, Sorlie PD, Catellier D, Patsch W; Atherosclerosis Risk in Communities Study Group. Coronary heart disease prediction from lipoprotein cholesterol levels, triglycerides, lipoprotein(a), apolipoproteins A-I and B, and HDL density subfractions: The Atherosclerosis Risk in Communities (ARIC) Study. Circulation. 2001 Sep 4;104(10):1108-13. doi: 10.1161/hc3501.095214.
PubMed 11535564
Thompson PD, Clarkson P, Karas RH. Statin-associated myopathy. JAMA. 2003 Apr 2;289(13):1681-90. doi: 10.1001/jama.289.13.1681.
PubMed 12672737

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

All Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg QD When Added to Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)-Inhibitor Therapy
ClinicalTrials.gov ID: NCT03193047
Acronym / sponsor ID: 1002-039
Conditions: Hypercholesterolemia
Keywords: Cholesterol, PCSK9, Repatha, evolocumab, LDL-C
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 59 participants (actual)
Lead sponsor: Esperion Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 7 Apr 2017 (actual)
Primary completion: 29 Jan 2018 (actual)
Study completion: 19 Feb 2018 (actual)
First posted: 20 Jun 2017 (actual)
Results: Posted 3 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine if bempedoic acid (ETC-1002) 180mg added to PCSK9 inhibitor (evolocumab) therapy is effective and safe in patients with elevated LDL cholesterol.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
bempedoic acid	Experimental	Drug: bempedoic acid 180mg, Drug: evolocumabBempedoic acid 180mg tablet taken orally, once daily plus evolocumab (Repatha) 420mg injection once monthly
placebo	Placebo comparator	Other: placebo, Drug: evolocumabMatching placebo tablet taken orally, once daily plus evolocumab (Repatha) 420mg injection once monthly

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age ≥18 years or legal age of majority depending on regional law
Fasting, calculated LDL-C at screening ≥160 mg/dL and following PCSK9i therapy ≥70 mg/dL
Men and nonpregnant, nonlactating women

Key exclusion criteria (14 listed)

Heterozygous (HeFH) or Homozygous (HoFH) Familial Hypercholesterolemia
Total fasting TG ≥500 mg/dL
Renal dysfunction or a glomerulonephropathy; eGFR <30 mL/min/1.73 m2
Known cardiovascular disease (CVD), peripheral arterial disease (PAD), or cerebrovascular disease (CD)
History of type 1 or type 2 diabetes

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
bempedoic acid 180mgAlso: ETC-1002Daily bempedoic acid 180mg tablet in addition to monthly PCSK9i (evolocumab) background therapy	Drug	bempedoic acid
placeboDaily matching placebo tablet in addition to monthly PCSK9i (evolocumab) background therapy	Other	placebo
evolocumabAlso: RepathaMonthly PCSK9i (evolocumab) background therapy	Drug	bempedoic acid, placebo

Primary outcome

Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Month 2
Time frame: Baseline; Month 2
Percent change from Baseline is calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value ) x 100. Baseline is defined as the average of the last two non-missing values within Month -1 (Screening Visit 4) and Day 1 (Treatment Visit 1) values (including unscheduled assessments). If only one value was available, then that single value was used at Baseline. Percent change from Baseline was analyzed using analysis of covariance (ANCOVA), with treatment group as a factor and Baseline as a covariate. Missing data were imputed using last observation carried forward (LOCF) (only post-Baseline values were carried forward).

6 secondary outcomes

Percent Change From Baseline in LDL-C at Month 1
Time frame: Baseline; Month 1
Absolute Change From Baseline in LDL-C at Month 1 and Month 2
Time frame: Baseline; Month 1 and Month 2
Percent Change From Baseline in Lipid Profile Parameters at Month 1 and Month 2
Time frame: Baseline; Month 1 and Month 2
Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Month 1 and Month 2
Time frame: Baseline; Month 1 and Month 2
Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE)
Time frame: up to Month 2 (until 30 days after last dose)
Number of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) >3x the Upper Limit of Normal (ULN) at Month 1 and Month 2
Time frame: Month 1 and Month 2

Results and safety

Results posted to the registry on 3 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Plus Evolocumab	31	29
Bempedoic Acid Plus Evolocumab	28	28

Primary outcome: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Month 2

Time frame: Baseline; Month 2. Least squares mean (Standard Error). Unit: percent change

Measure	Placebo Plus Evolocumab n = 26	Bempedoic Acid Plus Evolocumab n = 27
Value	2.783 (3.412)	-27.478 (4.310)

Placebo Plus Evolocumab vs Bempedoic Acid Plus Evolocumab: Least squares mean difference: -30.261 (95% CI -41.324 to -19.199), p <0.001, ANCOVA

Population analysed: Modified Intent-to-Treat (mITT) Population: all randomized participants with a Baseline lipid value and at least 1 post-Baseline lipid value who received investigational medicinal product (IMP) within 2 days before the lipid measurement and evolocumab 420 mg within 30 days plus or minus 3 days before the lipid measurement

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to Month 2 (until 30 days after last dose). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Plus Evolocumab	0 of 30 (0%)	7 of 30 (23.3%)	0 of 30
Bempedoic Acid Plus Evolocumab	1 of 28 (3.6%)	8 of 28 (28.6%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27892461Pinkosky SL, Newton RS, Day EA, Ford RJ, Lhotak S, Austin RC, Birch CM, Smith BK, Filippov S, Groot PHE, Steinberg GR, Lalwani ND. Liver-specific ATP-citrate lyase inhibition by bempedoic acid decreases LDL-C and attenuates atherosclerosis. Nat Commun. 2016 Nov 28;7:13457. doi: 10.1038/ncomms13457.
Background: PubMed 24222016Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW, Eddleman KM, Jarrett NM, LaBresh K, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S1-45. doi: 10.1161/01.cir.0000437738.63853.7a. Epub 2013 Nov 12. No abstract available.
Background: PubMed 11535564Sharrett AR, Ballantyne CM, Coady SA, Heiss G, Sorlie PD, Catellier D, Patsch W; Atherosclerosis Risk in Communities Study Group. Coronary heart disease prediction from lipoprotein cholesterol levels, triglycerides, lipoprotein(a), apolipoproteins A-I and B, and HDL density subfractions: The Atherosclerosis Risk in Communities (ARIC) Study. Circulation. 2001 Sep 4;104(10):1108-13. doi: 10.1161/hc3501.095214.
Background: PubMed 12672737Thompson PD, Clarkson P, Karas RH. Statin-associated myopathy. JAMA. 2003 Apr 2;289(13):1681-90. doi: 10.1001/jama.289.13.1681.
World Health Organization Fact Sheet No. 317Link provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Hypercholesterolemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

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.

Ron Haberman, MD study director

Esperion Therapeutics, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bempedoic acid 180mg and evolocumab in people with Hypercholesterolemia, run by Esperion Therapeutics, Inc. at 1 site in United States.

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 3 inclusion and 14 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 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 3 Apr 2020). 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?

Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Month 2 (time frame: Baseline; Month 2). 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 NCT03193047, which also lists 4 linked publications.

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 3 Apr 2020.