Nonalcoholic SteatohepatitisPhase 2CONTROLNCT02633956
Combination Obeticholic Acid (OCA) and Statins for Monitoring of Lipids (CONTROL)
A Phase 2 study testing Obeticholic Acid and Atorvastatin in people with Nonalcoholic Steatohepatitis, run by Intercept Pharmaceuticals at 22 sites in United States.
Trial summary
This Phase 2, double-blind, randomized, placebo-controlled, multicenter study, with an open-label long-term safety extension (LTSE), will evaluate the effect of Obeticholic Acid, and the subsequent addition of statin therapy, on lipoprotein metabolism in subjects with nonalcoholic steatohepatitis (NASH) with fibrosis… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Nonalcoholic Steatohepatitis
- What is being tested?
- Obeticholic Acid and Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 22 sitesUnited States
- Study dates
- 4 Dec 2015to 12 Mar 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Histologic evidence of NASH, as assessed by central reading of a liver biopsy obtained no more than 1 year prior to randomization, defined by the presence of all 3 key histological features of NASH with a score of at least 1 for each and a combined score of 4 or greater out of a possible 8 points according to NASH Clinical Research Network (CRN) criteria.
- Histologic evidence of fibrosis stage 1 to stage 4 (as defined by NASH CRN scoring of fibrosis) without any evidence of hepatic decompensation.
- If subject has type 2 diabetes, is on stable dose of anti-diabetic medication (except thiazolidinediones [TZDs]) for ≥3 months prior to Day 1.
- Is either not taking or is on stable doses of TZDs and/or Vitamin E for ≥6 months prior to Day 1.
- Contraception: Female subjects of childbearing potential must use ≥1 effective method of contraception during the study and until 30 days following the last dose of investigational product. Effective methods of contraception are considered to be the following: barrier method, ie, condom (male or female) with spermicide or diaphragm with spermicide, intrauterine device, vasectomy (partner), hormonal (eg, contraceptive pill, patch, intramuscular implant or injection), abstinence (defined as refraining from heterosexual intercourse).
- Must provide written informed consent and agree to comply with the study protocol, including adherence to protocol-described statin withdrawal and statin therapy.
Who cannot join
- Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to Screening Visit 1 (significant alcohol consumption is defined as more than 2 units/day in females and more than 4 units/day in males, on average)
- Prior intolerance to treatment with atorvastatin or other 3-hydroxy-3-methyl-glutaryl (HMG) Coenzyme A reductase inhibitors (including but not limited to rhabdomyolysis).
- LDL cholesterol ≥190 mg/dL and already on statin therapy at Screening Visit 1.
- LDL cholesterol >200 mg/dL at any Screening Visit in subjects who are not on statin therapy, or at Screening Visit 2 in statin washout subjects.
- Planned change in diet or exercise habits during participation in the double-blind period, or a significant weight change of >5% in the prior 6 months.
- Subjects who have undergone gastric bypass procedures (gastric lap band is acceptable) or ileal resection or plan to undergo either of these procedures.
Show all 57Show fewer
- History of biliary diversion
- Uncontrolled diabetes defined as HbA1c ≥9.5% within 60 days prior to randomization (Day 1).
- Administration of any of the following medications as specified below:
- Prohibited 30 days prior to Day 1:
- bile acid sequestrants (BAS) including cholestyramine and its derivatives, colesevelam, colestipol, or
- omega-3 fatty acid-containing dietary supplements
- Prohibited 3 months prior to Day 1:
- nicotinic acid and derivatives, ezetimibe
- any prescription or over-the-counter (OTC) medication or herbal remedy with putative NASH efficacy (except Vitamin E or TZDs)
- ursodeoxycholic acid
- fenofibrate or other fibrates
- any OTC or health food used to treat lipids including plant sterols and berberine
- Prohibited 6 months prior to Day 1:
- azathioprine, colchicine, cyclosporine, methotrexate, mycophenolate, mofetil, pentoxifylline; budesonide and other systemic corticosteroids, or
- potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid, isoniazide, or nitrofurantoin)
- Prohibited 12 months prior to Day 1:
- antibodies or immunotherapy directed against interleukins, or
- other cytokines or chemokines
- Evidence of other forms of chronic liver disease including but not limited to:
- Positive test result at Screening for hepatitis B surface antigen
- Active hepatitis C virus (HCV) infection (positive for HCV ribonucleic acid [RNA] at Screening) or history of positive HCV RNA test result
- Primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis or overlap syndrome
- Alcoholic liver disease
- Wilson's disease or hemochromatosis or iron overload
- Alpha-1-antitrypsin (A1AT) deficiency
- Prior known drug-induced liver injury within 5 years before Day 1
- Known or suspected hepatocellular carcinoma
- History of liver transplant, current placement on a liver transplant list, or current Model for End-Stage Liver Disease (MELD) score >12. Subjects who are placed on a transplant list despite relatively early disease stage (eg, per regional guidelines) may be eligible as long as they do not meet any of the other exclusion criteria
- Presence of hepatic decompensation, including:
- Gastroesophageal varices
- Ascites
- Hepatic encephalopathy
- Spontaneous bacterial peritonitis
- Hepatorenal or hepatopulmonary syndromes
- Total bilirubin ≥2x upper limit of normal (ULN) at any Screening Visit (subjects with Gilbert's syndrome may be enrolled despite a total bilirubin level >2x ULN if their conjugated bilirubin is <2x ULN)
- Creatine phosphokinase >5x ULN at Screening Visit 2
- Serum creatinine ≥1.5 mg/dL at any Screening Visit
- Serum alanine aminotransferase (ALT) >300 U/L at any Screening Visit
- Platelet count <75,000/mm3 at any Screening Visit
- Known positivity for human immunodeficiency virus (HIV) infection
- Subjects with recent history (within 1 year of randomization) of cardiovascular disease or with history or planned cardiovascular interventions to treat atherosclerotic cardiovascular disease
- Other concomitant disease, malignancy, or condition likely to significantly decrease life expectancy to <5 years, including known cancers (except carcinomas in situ or other stable, relatively benign conditions such as chronic lymphocytic leukemia) and moderate to severe congestive heart failure.
- Known substance abuse, including inhaled or injected drugs in the year before Screening.
- For female subjects: pregnancy, planned or potential for pregnancy and unwillingness to use effective birth control during the study, or breastfeeding
- Participation in a clinical research study with any investigational product being evaluated for the treatment of diabetes or NASH in the 6 months before Day 1.
- Receipt of any investigational product not being evaluated for the treatment of diabetes or NASH from Screening Visit 1 to Day 1, within 30 days prior to Day 1, or within 5 half-lives of the compound before Day 1 (whichever was longer)
- Previous exposure to Obeticholic Acid
- History of known or suspected clinically significant hypersensitivity to Obeticholic Acid or any of its components
- Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain
- Any other condition which, in the opinion of the Investigator, would impede compliance or hinder completion of the study
- Acute cholecystitis or acute biliary obstruction
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Texas Clinical Research Institute, LLC
Arlington, Texas, 76012
Mercy Medical Center, Institute for Digestive Health & Liver Disease
Baltimore, Maryland, 21202
Medical University of South Carolina
Charleston, South Carolina, 29425
ClinSearch
Chattanooga, Tennessee, 37421
Consultants for Clinical Research
Cincinnati, Ohio, 45249
Duke University Medical Center
Durham, North Carolina, 27710
Cumberland Research Associates, LLC
Fayetteville, North Carolina, 28304
The Queen's Medical Center - Liver Center
Honolulu, Hawaii, 96813
Liver Associates of Texas, P.A.
Houston, Texas, 77030
Nature Coast Clinical Research
Inverness, Florida, 34452
Kansas City Research Institute
Kansas City, Missouri, 64131
Scripps Clinic
La Jolla, California, 92037
University of Miamai, Schiff Center for Liver Diseases
Miami, Florida, 33136
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
University Gastroenterology Liver Center
Providence, Rhode Island, 02905
Inland Empire Liver Foundation
Rialto, California, 92377
McGuire DVAMC
Richmond, Virginia, 23249
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, 78215
St. Louis University
St Louis, Missouri, 63104
South Florida Center of Gastroenterology
Wellington, Florida, 33414
Florida Medical Clinic, P.A.
Zephyrhills, Florida, 33542
About this study
Official title: A Phase 2, Randomized, Double Blind, Placebo Controlled Clinical Study Investigating the Effects of Obeticholic Acid and Atorvastatin Treatment on Lipoprotein Metabolism in Subjects With Nonalcoholic Steatohepatitis
This Phase 2, double-blind, randomized, placebo-controlled, multicenter study, with an open-label long-term safety extension (LTSE), will evaluate the effect of Obeticholic Acid, and the subsequent addition of statin therapy, on lipoprotein metabolism in subjects with nonalcoholic steatohepatitis (NASH) with fibrosis stage 1 to 4, but no evidence of hepatic decompensation.
- Conditions
- Nonalcoholic Steatohepatitis
- Being tested
- Obeticholic Acid, Atorvastatin, Placebo
- Keywords
- Non-alcoholic Fatty Liver Disease, NAFLD, Fatty Liver Disease, NASH
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obeticholic AcidDrug
Also called OCA, 6alpha-ethylchenodeoxycholic acid (6-ECDCA), INT-747
Once a day (QD) by mouth (PO)
AtorvastatinDrug
Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).
Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.
Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated.
PlaceboDrug
Once a day (QD) by mouth (PO)
| Study group | Role | What they receive |
|---|---|---|
| 5 mg Obeticholic Acid | Experimental | 5 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg. Receives: Drug: Obeticholic Acid; Drug: Atorvastatin |
| 10 mg Obeticholic Acid | Experimental | 10 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg. Receives: Drug: Obeticholic Acid; Drug: Atorvastatin |
| 25 mg Obeticholic Acid | Experimental | 25 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg. Receives: Drug: Obeticholic Acid; Drug: Atorvastatin |
| Placebo | Placebo comparator | One tablet daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg. Receives: Drug: Atorvastatin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of Obeticholic Acid on Low-density Lipoprotein (LDL) Concentration (Least Squares Mean Change From Baseline at Week 16)
The effect of Obeticholic Acid on LDL metabolism in subjects with biopsy confirmed nonalcoholic steatohepatitis (NASH) and the ability of atorvastatin to modulate this effect as measured by change (least squares mean) from baseline at week 16 in LDL concentration
Measured: Baseline and Week 16
The Effect of Obeticholic Acid on LDL Particle Size (Least Squares Mean Change From Baseline at Week 16)
The effect of Obeticholic Acid on LDL metabolism in subjects with biopsy confirmed NASH and the ability of atorvastatin to modulate this effect as measured by change from baseline (least squares mean) at week 16 in LDL particle size. It is LDL particle diameter size (nm) that is reported.
Measured: Baseline and Week 16
The Effect of Obeticholic Acid on LDL Particle Concentration (Total) (Least Squares Mean Change From Baseline at Week 16)
The effect of Obeticholic Acid on LDL metabolism in subjects with biopsy confirmed nonalcoholic NASH and the ability of atorvastatin to modulate this effect as measured by change (least squares mean) from baseline at week 16 in LDL particle concentration (total)
Measured: Baseline and Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study start4 Dec 2015
- Primary completion21 Mar 2017
- Study completion12 Mar 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 Nonalcoholic SteatohepatitisStudies 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intercept Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Shapiro, MD, Study director, Intercept Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02633956
- Sponsor's protocol ID
- 747-209
- Acronym
- CONTROL
- Status last verified
- May 2018
- First submitted
- 18 Nov 2015
- Last updated
- 4 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Pockros PJ, Fuchs M, Freilich B, Schiff E, Kohli A, Lawitz EJ, Hellstern PA, Owens-Grillo J, Van Biene C, Shringarpure R, MacConell L, Shapiro D, Cohen DE. CONTROL: A randomized phase 2 study of obeticholic acid and atorvastatin on lipoproteins in nonalcoholic steatohepatitis patients. Liver Int. 2019 Nov;39(11):2082-2093. doi: 10.1111/liv.14209. Epub 2019 Sep 10.
PubMed 31402538
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double Blind, Placebo Controlled Clinical Study Investigating the Effects of Obeticholic Acid and Atorvastatin Treatment on Lipoprotein Metabolism in Subjects With Nonalcoholic Steatohepatitis
- ClinicalTrials.gov ID
- NCT02633956
- Acronym / sponsor ID
- CONTROL / 747-209
- Conditions
- Nonalcoholic Steatohepatitis
- Keywords
- Non-alcoholic Fatty Liver Disease, NAFLD, Fatty Liver Disease, NASH
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Intercept PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2015 (actual)
- Primary completion
- 21 Mar 2017 (actual)
- Study completion
- 12 Mar 2018 (actual)
- First posted
- 17 Dec 2015 (estimated)
- Results
- Posted 4 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 2, double-blind, randomized, placebo-controlled, multicenter study, with an open-label long-term safety extension (LTSE), will evaluate the effect of Obeticholic Acid, and the subsequent addition of statin therapy, on lipoprotein metabolism in subjects with nonalcoholic steatohepatitis (NASH) with fibrosis stage 1 to 4, but no evidence of hepatic decompensation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 5 mg Obeticholic Acid | Experimental | Drug: Obeticholic Acid, Drug: Atorvastatin5 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg. |
| 10 mg Obeticholic Acid | Experimental | Drug: Obeticholic Acid, Drug: Atorvastatin10 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg. |
| 25 mg Obeticholic Acid | Experimental | Drug: Obeticholic Acid, Drug: Atorvastatin25 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg. |
| Placebo | Placebo comparator | Drug: Atorvastatin, Drug: PlaceboOne tablet daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years
- Histologic evidence of NASH, as assessed by central reading of a liver biopsy obtained no more than 1 year prior to randomization, defined by the presence of all 3 key histological features of NASH with a score of at least 1 for each and a combined score of 4 or greater out of a possible 8 points according to NASH Clinical Research Network (CRN) criteria.
- Histologic evidence of fibrosis stage 1 to stage 4 (as defined by NASH CRN scoring of fibrosis) without any evidence of hepatic decompensation.
- If subject has type 2 diabetes, is on stable dose of anti-diabetic medication (except thiazolidinediones [TZDs]) for ≥3 months prior to Day 1.
- Is either not taking or is on stable doses of TZDs and/or Vitamin E for ≥6 months prior to Day 1.
Key exclusion criteria (57 listed)
- Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to Screening Visit 1 (significant alcohol consumption is defined as more than 2 units/day in females and more than 4 units/day in males, on average)
- Prior intolerance to treatment with atorvastatin or other 3-hydroxy-3-methyl-glutaryl (HMG) Coenzyme A reductase inhibitors (including but not limited to rhabdomyolysis).
- LDL cholesterol ≥190 mg/dL and already on statin therapy at Screening Visit 1.
- LDL cholesterol >200 mg/dL at any Screening Visit in subjects who are not on statin therapy, or at Screening Visit 2 in statin washout subjects.
- Planned change in diet or exercise habits during participation in the double-blind period, or a significant weight change of >5% in the prior 6 months.
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 |
|---|---|---|
| Obeticholic AcidAlso: OCA, 6alpha-ethylchenodeoxycholic acid (6-ECDCA), INT-747Once a day (QD) by mouth (PO) | Drug | 10 mg Obeticholic Acid, 25 mg Obeticholic Acid, 5 mg Obeticholic Acid |
| AtorvastatinInitiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO). Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated. Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated. | Drug | 10 mg Obeticholic Acid, 25 mg Obeticholic Acid, 5 mg Obeticholic Acid, Placebo |
| PlaceboOnce a day (QD) by mouth (PO) | Drug | Placebo |
Primary outcome
The Effect of Obeticholic Acid on Low-density Lipoprotein (LDL) Concentration (Least Squares Mean Change From Baseline at Week 16)
Time frame: Baseline and Week 16
The effect of Obeticholic Acid on LDL metabolism in subjects with biopsy confirmed nonalcoholic steatohepatitis (NASH) and the ability of atorvastatin to modulate this effect as measured by change (least squares mean) from baseline at week 16 in LDL concentration
The Effect of Obeticholic Acid on LDL Particle Size (Least Squares Mean Change From Baseline at Week 16)
Time frame: Baseline and Week 16
The effect of Obeticholic Acid on LDL metabolism in subjects with biopsy confirmed NASH and the ability of atorvastatin to modulate this effect as measured by change from baseline (least squares mean) at week 16 in LDL particle size. It is LDL particle diameter size (nm) that is reported.
The Effect of Obeticholic Acid on LDL Particle Concentration (Total) (Least Squares Mean Change From Baseline at Week 16)
Time frame: Baseline and Week 16
The effect of Obeticholic Acid on LDL metabolism in subjects with biopsy confirmed nonalcoholic NASH and the ability of atorvastatin to modulate this effect as measured by change (least squares mean) from baseline at week 16 in LDL particle concentration (total)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31402538Pockros PJ, Fuchs M, Freilich B, Schiff E, Kohli A, Lawitz EJ, Hellstern PA, Owens-Grillo J, Van Biene C, Shringarpure R, MacConell L, Shapiro D, Cohen DE. CONTROL: A randomized phase 2 study of obeticholic acid and atorvastatin on lipoproteins in nonalcoholic steatohepatitis patients. Liver Int. 2019 Nov;39(11):2082-2093. doi: 10.1111/liv.14209. Epub 2019 Sep 10.
Related trials for Nonalcoholic Steatohepatitis
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
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.
David Shapiro, MD study director
Intercept Pharmaceuticals
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Obeticholic Acid and Atorvastatin in people with Nonalcoholic Steatohepatitis, run by Intercept Pharmaceuticals at 22 sites 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 7 inclusion and 57 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 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites 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 4 Jun 2018). 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?
The Effect of Obeticholic Acid on Low-density Lipoprotein (LDL) Concentration (Least Squares Mean Change From Baseline at Week 16) (time frame: Baseline and Week 16). The study lists 3 primary outcomes in all. 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 NCT02633956, 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 2018.