NASH (Nonalcoholic Steatohepatitis)Phase 1NCT04395950
Effects of ACC Inhibitor on Lipid and Lipoprotein Metabolism
A Phase 1 study testing PF-05221304 in people with NASH (Nonalcoholic Steatohepatitis) and NAFLD (Nonalcoholic Fatty Liver Disease), run by Columbia University.
Trial summary
The purpose of this study is to assess the effects of an investigational drug, PF-05221304 (PF'1304) on the way the liver handles fat. The planned study will identify why the fat in the blood increases at the same time this drug reduces fat in the liver. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- NASH (Nonalcoholic Steatohepatitis), NAFLD (Nonalcoholic Fatty Liver Disease)
- What is being tested?
- PF-05221304
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to 19 Aug 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) of ≥ 25 kg/m2 but < 40 kg/m2 and at least 2 of 5 traits of metabolic syndrome (fasting blood glucose >100 mg/dl or diagnosis of diabetes mellitus; BP >130/85; fasting TG >150 mg/dl; HDL cholesterol <40 mg/dl for men and <50 mg/dl for women; waist circumference >101 cm for men and >89 cm for women).
- NASH will be defined as a FibroScan® of CAP >280 db/m and >7 kPa, OR demonstrated by liver biopsy, plus:
- ALT > ULN but < 5 X ULN.
- FIB4 score <3.5 (see below)
- BP of ≤ 160/100 mmHg.
- Alkaline phosphatase ≤ ULN.
Show all 13Show fewer
- Total bilirubin ≤ ULN (unless the subject has Gilbert's syndrome, a benign genetic problem where bilirubin is not conjugated normally and indirect bilirubin (unconjugated bilirubin increases) in which case direct bilirubin must be ≤ ULN with total bilirubin > ULN).
- Platelet count ≥ LLN (155,000/mm3).
- Albumin ≥ LLN (3.0 g/L).
- INR ≤ 1.3.
- Fasting serum triglycerides ≤ 350 mg/dL either non-pharmacologically managed or pharmacologically managed with stable doses of up to 3 oral agents for at least 6 months. They may be receiving statins if the dose has been stable for at least 3 months.
- Subjects may have diabetes but must have an HbA1C ≤ 8.0% with glycemic control either non-pharmacologically managed or pharmacologically managed with stable doses of up to 3 oral agents for at least 6 months. Subjects taking a stable dose of long-acting insulin or an injectable GLP-1 inhibitor may be enrolled at the discretion of the investigators.
- No changes in drugs affecting blood lipid or glucose or insulin levels will be permitted during the study without approval by the investigators.
Who cannot join
- Individuals with a history of plasma TG >1000 mg/dl and/or pancreatitis.
- Females of childbearing potential.
- Chronic kidney disease defined by estimated glomerular filtration rate < 30 ml/min/1.73 m² by the modification of diet in renal disease equation.
- Documented chronic hepatitis B or C. Subjects with hepatitis C are eligible provided there is proof of sustained virology response (SVR) for ≥ 3 years.
- History of active malignancy within 5 years (subjects with non-melanoma skin cancer may be included).
- Any other disease, condition, or laboratory value that, in the opinion of the principal investigator or clinical study team would place the subject at an unacceptable risk or interfere with the evaluation of the investigative product.
Show all 15Show fewer
- History of organ transplantation (other than corneal).
- History of hepatobiliary malignancy even if subject "cured".
- Pancreas divisum or a congenital abnormality of the pancreas
- History of pancreatic surgery.
- Subjects taking anti -coagulants or anti-platelet agents other than 81 mg ASA daily.
- Treatment with immunomodulators.
- Drugs associated with acute pancreatitis as asparaginase, azathioprine, didanosine, mecaptourinol, mesalamine, opiates, pentamidine, pentavalent anti-monials, valproic acid, and rifampin.
- OATP inhibitors such as gemfibrozil and cyclosporinea. Drugs substrates for CYP3A4/5 with a narrow therapeutic index - these include: alfentanil, astemizole, cisapride, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus, and terfenadine will be reason for exclusion.
- a = the major clearance mechanism of PF-05221304 is active uptake into liver (mainly via hepatic transporters OATP1B1/1B3) followed by hepatic carbonyl reductase 1, 11b-hydroxysteroid dehydrogenase, and CYP 3A4/5-mediated metabolism. It is anticipated that potent OATP inhibitors may increase plasma concentrations of PF-05221304. As such, subjects treated with clinically relevant OATP inhibitors will be excluded from this study.
About this study
Official title: A Phase 1B, Single-Blinded, Linear Two Period, Placebo-controlled Study to Evaluate the Effects of 10 mg/Day of PF-05221304, Liver Targeted Acetyl-CoA Carboxylase Inhibitor (ACCi) on Very Low Density Lipoprotein ApoB100 and TG Secretion
The purpose of this study is to assess the effects of an investigational drug, PF-05221304 (PF'1304) on the way the liver handles fat. The planned study will identify why the fat in the blood increases at the same time this drug reduces fat in the liver. The study will have two treatment periods of 6 weeks each, separated by a 3 week rest period with no treatment. The subjects will receive the active drug in one of the 6 week treatment periods and a placebo in the other 6 week period. The investigators will know when the subjects are receiving active treatment or placebo, but the subject will not know.
Read the detailed description
Nonalcoholic Fatty Liver Disease (NAFLD) is a condition in which fat builds up in the liver. As its name suggests, it is not associated to heavy alcohol use. Non-Alcoholic Steatohepatitis (NASH) is a condition of liver inflammation and damage that is caused by the buildup of fat in the liver. It is usually associated with prediabetes, diabetes (high blood sugar in the blood), a high concentration of fat (triglycerides) in the blood, and obesity (increase in fat all over the body). The signs and symptoms of NASH are often not seen until the liver is damaged beyond repair, making NASH very difficult to diagnose (be picked up by your doctor) in its early stages where treatments might be able to reverse the damage.
There are no treatments currently approved for people with NASH but several new medications are under study in people with NAFLD or NASH. This study uses a treatment being developed for treating NASH. The investigators will conduct a study to assess the effects of PF-05221304 (PF'1304) on the way the liver handles fat. In early studies, this new drug has shown promise for lowering the level of fat in the liver. However, it also, unexpectedly, increases the level of fat in the blood, which could increase the risk of heart disease and inflammation of the pancreas.
The planned study will identify why the fat in the blood increases. Subjects will undergo a screening period where we will obtain medical history and physical exam. Additionally, we will obtain the results of liver imaging or liver biopsy previously performed by the subject's doctor that confirm the presence of an abnormal amount of liver fat and liver stiffness. The enrolled subjects will receive placebo (an inactive pill) during the first 6 weeks, followed by a 3 week washout period and then 6 weeks of active treatment. Blood samples will be collected during outpatient visits to check for study safety and measurements of fat in the blood and particles that carry that fat. There will also be 2 long outpatient studies that last approximately 15 hours each, where we will test why there is increase in fat blood levels during treatment with PF'1304. All visits will occur at the CUIMC Irving Institute for Clinical and Translational Research. Subject risk will be minimized through strict eligibility criteria to avoid enrollment of unstable or high-risk subjects and by close monitoring of adverse events (AE's), laboratory parameters, and vital signs during the study. In addition, blood fat levels will be measured on an ongoing basis.
- Being tested
- PF-05221304, Placebo
- Keywords
- NASH, NAFLD, non-alcoholic steatohepatitis, liver disease
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-05221304Drug
Also called PF1304
PF-05221304 10 mg daily (two 5mg tablets daily in the morning for 6 weeks)
PlaceboDrug
Also called Placebo tablets
Placebo two tablets daily in the morning for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| PF-0522130 | Active comparator | PF-05221304 10 mg daily (two 5mg tablets daily in the morning). Receives: Drug: PF-05221304 |
| Placebo | Placebo comparator | Placebo (two tablets daily in the morning). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Secretion (also called production-PR) of VLDL TG (mg/kg/day)
This is also called the production rate of very low density lipoprotein (VLDL) triglycerides (TG).
Measured: Up to 20 weeks
Fractional Clearance Rate (FCR) of VLDL TG (pool/day)
This is obtained from the modeling of enrichment data obtained by mass spectrometry.
Measured: Up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study startDec 2020 (estimated)
- Primary completion19 Aug 2021
- Study completion19 Aug 2021
Why it stopped: Poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for NASH (Nonalcoholic Steatohepatitis)Studies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Henry Ginsberg, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04395950
- Sponsor's protocol ID
- AAAS9106
- Status last verified
- Aug 2021
- First submitted
- 15 May 2020
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choi SH, Ginsberg HN. Increased very low density lipoprotein (VLDL) secretion, hepatic steatosis, and insulin resistance. Trends Endocrinol Metab. 2011 Sep;22(9):353-63. doi: 10.1016/j.tem.2011.04.007. Epub 2011 May 26.
PubMed 21616678Donnelly KL, Smith CI, Schwarzenberg SJ, Jessurun J, Boldt MD, Parks EJ. Sources of fatty acids stored in liver and secreted via lipoproteins in patients with nonalcoholic fatty liver disease. J Clin Invest. 2005 May;115(5):1343-51. doi: 10.1172/JCI23621.
PubMed 15864352Diraison F, Moulin P, Beylot M. Contribution of hepatic de novo lipogenesis and reesterification of plasma non esterified fatty acids to plasma triglyceride synthesis during non-alcoholic fatty liver disease. Diabetes Metab. 2003 Nov;29(5):478-85. doi: 10.1016/s1262-3636(07)70061-7.
PubMed 14631324Kim CW, Addy C, Kusunoki J, Anderson NN, Deja S, Fu X, Burgess SC, Li C, Ruddy M, Chakravarthy M, Previs S, Milstein S, Fitzgerald K, Kelley DE, Horton JD. Acetyl CoA Carboxylase Inhibition Reduces Hepatic Steatosis but Elevates Plasma Triglycerides in Mice and Humans: A Bedside to Bench Investigation. Cell Metab. 2017 Aug 1;26(2):394-406.e6. doi: 10.1016/j.cmet.2017.07.009.
PubMed 28768177Goedeke L, Bates J, Vatner DF, Perry RJ, Wang T, Ramirez R, Li L, Ellis MW, Zhang D, Wong KE, Beysen C, Cline GW, Ray AS, Shulman GI. Acetyl-CoA Carboxylase Inhibition Reverses NAFLD and Hepatic Insulin Resistance but Promotes Hypertriglyceridemia in Rodents. Hepatology. 2018 Dec;68(6):2197-2211. doi: 10.1002/hep.30097.
PubMed 29790582Reyes-Soffer G, Moon B, Hernandez-Ono A, Dionizovik-Dimanovski M, Jimenez J, Obunike J, Thomas T, Ngai C, Fontanez N, Donovan DS, Karmally W, Holleran S, Ramakrishnan R, Mittleman RS, Ginsberg HN. Complex effects of inhibiting hepatic apolipoprotein B100 synthesis in humans. Sci Transl Med. 2016 Jan 27;8(323):323ra12. doi: 10.1126/scitranslmed.aad2195.
PubMed 26819195Ramakrishnan R, Ramakrishnan JD. Using mass measurements in tracer studies--a systematic approach to efficient modeling. Metabolism. 2008 Aug;57(8):1078-87. doi: 10.1016/j.metabol.2008.03.011.
PubMed 18640385Hellerstein MK, Neese RA. Mass isotopomer distribution analysis at eight years: theoretical, analytic, and experimental considerations. Am J Physiol. 1999 Jun;276(6):E1146-70. doi: 10.1152/ajpendo.1999.276.6.E1146.
PubMed 10362629Caulfield MP, Li S, Lee G, Blanche PJ, Salameh WA, Benner WH, Reitz RE, Krauss RM. Direct determination of lipoprotein particle sizes and concentrations by ion mobility analysis. Clin Chem. 2008 Aug;54(8):1307-16. doi: 10.1373/clinchem.2007.100586. Epub 2008 May 29.
PubMed 18515257
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1B, Single-Blinded, Linear Two Period, Placebo-controlled Study to Evaluate the Effects of 10 mg/Day of PF-05221304, Liver Targeted Acetyl-CoA Carboxylase Inhibitor (ACCi) on Very Low Density Lipoprotein ApoB100 and TG Secretion
- ClinicalTrials.gov ID
- NCT04395950
- Acronym / sponsor ID
- AAAS9106
- Keywords
- NASH, NAFLD, non-alcoholic steatohepatitis, liver disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Poor enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Dec 2020 (estimated)
- Primary completion
- 19 Aug 2021 (actual)
- Study completion
- 19 Aug 2021 (actual)
- First posted
- 20 May 2020 (actual)
- Results
- Not posted in the source record
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 assess the effects of an investigational drug, PF-05221304 (PF'1304) on the way the liver handles fat. The planned study will identify why the fat in the blood increases at the same time this drug reduces fat in the liver. The study will have two treatment periods of 6 weeks each, separated by a 3 week rest period with no treatment. The subjects will receive the active drug in one of the 6 week treatment periods and a placebo in the other 6 week period. The investigators will know when the subjects are receiving active treatment or placebo, but the subject will not know.
Detailed description
Nonalcoholic Fatty Liver Disease (NAFLD) is a condition in which fat builds up in the liver. As its name suggests, it is not associated to heavy alcohol use. Non-Alcoholic Steatohepatitis (NASH) is a condition of liver inflammation and damage that is caused by the buildup of fat in the liver. It is usually associated with prediabetes, diabetes (high blood sugar in the blood), a high concentration of fat (triglycerides) in the blood, and obesity (increase in fat all over the body). The signs and symptoms of NASH are often not seen until the liver is damaged beyond repair, making NASH very difficult to diagnose (be picked up by your doctor) in its early stages where treatments might be able to reverse the damage.
There are no treatments currently approved for people with NASH but several new medications are under study in people with NAFLD or NASH. This study uses a treatment being developed for treating NASH. The investigators will conduct a study to assess the effects of PF-05221304 (PF'1304) on the way the liver handles fat. In early studies, this new drug has shown promise for lowering the level of fat in the liver. However, it also, unexpectedly, increases the level of fat in the blood, which could increase the risk of heart disease and inflammation of the pancreas.
The planned study will identify why the fat in the blood increases. Subjects will undergo a screening period where we will obtain medical history and physical exam. Additionally, we will obtain the results of liver imaging or liver biopsy previously performed by the subject's doctor that confirm the presence of an abnormal amount of liver fat and liver stiffness. The enrolled subjects will receive placebo (an inactive pill) during the first 6 weeks, followed by a 3 week washout period and then 6 weeks of active treatment. Blood samples will be collected during outpatient visits to check for study safety and measurements of fat in the blood and particles that carry that fat. There will also be 2 long outpatient studies that last approximately 15 hours each, where we will test why there is increase in fat blood levels during treatment with PF'1304. All visits will occur at the CUIMC Irving Institute for Clinical and Translational Research. Subject risk will be minimized through strict eligibility criteria to avoid enrollment of unstable or high-risk subjects and by close monitoring of adverse events (AE's), laboratory parameters, and vital signs during the study. In addition, blood fat levels will be measured on an ongoing basis.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PF-0522130 | Active comparator | Drug: PF-05221304PF-05221304 10 mg daily (two 5mg tablets daily in the morning). |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (two tablets daily in the morning). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Body mass index (BMI) of ≥ 25 kg/m2 but < 40 kg/m2 and at least 2 of 5 traits of metabolic syndrome (fasting blood glucose >100 mg/dl or diagnosis of diabetes mellitus; BP >130/85; fasting TG >150 mg/dl; HDL cholesterol <40 mg/dl for men and <50 mg/dl for women; waist circumference >101 cm for men and >89 cm for women).
- NASH will be defined as a FibroScan® of CAP >280 db/m and >7 kPa, OR demonstrated by liver biopsy, plus:
- ALT > ULN but < 5 X ULN.
- FIB4 score <3.5 (see below)
- BP of ≤ 160/100 mmHg.
Key exclusion criteria (15 listed)
- Individuals with a history of plasma TG >1000 mg/dl and/or pancreatitis.
- Females of childbearing potential.
- Chronic kidney disease defined by estimated glomerular filtration rate < 30 ml/min/1.73 m² by the modification of diet in renal disease equation.
- Documented chronic hepatitis B or C. Subjects with hepatitis C are eligible provided there is proof of sustained virology response (SVR) for ≥ 3 years.
- History of active malignancy within 5 years (subjects with non-melanoma skin cancer may be included).
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 |
|---|---|---|
| PF-05221304Also: PF1304PF-05221304 10 mg daily (two 5mg tablets daily in the morning for 6 weeks) | Drug | PF-0522130 |
| PlaceboAlso: Placebo tabletsPlacebo two tablets daily in the morning for 6 weeks | Drug | Placebo |
Primary outcome
Rate of Secretion (also called production-PR) of VLDL TG (mg/kg/day)
Time frame: Up to 20 weeks
This is also called the production rate of very low density lipoprotein (VLDL) triglycerides (TG).
Fractional Clearance Rate (FCR) of VLDL TG (pool/day)
Time frame: Up to 20 weeks
This is obtained from the modeling of enrichment data obtained by mass spectrometry.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Background: PubMed 21616678Choi SH, Ginsberg HN. Increased very low density lipoprotein (VLDL) secretion, hepatic steatosis, and insulin resistance. Trends Endocrinol Metab. 2011 Sep;22(9):353-63. doi: 10.1016/j.tem.2011.04.007. Epub 2011 May 26.
- Background: PubMed 15864352Donnelly KL, Smith CI, Schwarzenberg SJ, Jessurun J, Boldt MD, Parks EJ. Sources of fatty acids stored in liver and secreted via lipoproteins in patients with nonalcoholic fatty liver disease. J Clin Invest. 2005 May;115(5):1343-51. doi: 10.1172/JCI23621.
- Background: PubMed 14631324Diraison F, Moulin P, Beylot M. Contribution of hepatic de novo lipogenesis and reesterification of plasma non esterified fatty acids to plasma triglyceride synthesis during non-alcoholic fatty liver disease. Diabetes Metab. 2003 Nov;29(5):478-85. doi: 10.1016/s1262-3636(07)70061-7.
- Background: PubMed 28768177Kim CW, Addy C, Kusunoki J, Anderson NN, Deja S, Fu X, Burgess SC, Li C, Ruddy M, Chakravarthy M, Previs S, Milstein S, Fitzgerald K, Kelley DE, Horton JD. Acetyl CoA Carboxylase Inhibition Reduces Hepatic Steatosis but Elevates Plasma Triglycerides in Mice and Humans: A Bedside to Bench Investigation. Cell Metab. 2017 Aug 1;26(2):394-406.e6. doi: 10.1016/j.cmet.2017.07.009.
- Background: PubMed 29790582Goedeke L, Bates J, Vatner DF, Perry RJ, Wang T, Ramirez R, Li L, Ellis MW, Zhang D, Wong KE, Beysen C, Cline GW, Ray AS, Shulman GI. Acetyl-CoA Carboxylase Inhibition Reverses NAFLD and Hepatic Insulin Resistance but Promotes Hypertriglyceridemia in Rodents. Hepatology. 2018 Dec;68(6):2197-2211. doi: 10.1002/hep.30097.
- Background: PubMed 26819195Reyes-Soffer G, Moon B, Hernandez-Ono A, Dionizovik-Dimanovski M, Jimenez J, Obunike J, Thomas T, Ngai C, Fontanez N, Donovan DS, Karmally W, Holleran S, Ramakrishnan R, Mittleman RS, Ginsberg HN. Complex effects of inhibiting hepatic apolipoprotein B100 synthesis in humans. Sci Transl Med. 2016 Jan 27;8(323):323ra12. doi: 10.1126/scitranslmed.aad2195.
- Background: PubMed 18640385Ramakrishnan R, Ramakrishnan JD. Using mass measurements in tracer studies--a systematic approach to efficient modeling. Metabolism. 2008 Aug;57(8):1078-87. doi: 10.1016/j.metabol.2008.03.011.
- Background: PubMed 10362629Hellerstein MK, Neese RA. Mass isotopomer distribution analysis at eight years: theoretical, analytic, and experimental considerations. Am J Physiol. 1999 Jun;276(6):E1146-70. doi: 10.1152/ajpendo.1999.276.6.E1146.
- Background: PubMed 18515257Caulfield MP, Li S, Lee G, Blanche PJ, Salameh WA, Benner WH, Reitz RE, Krauss RM. Direct determination of lipoprotein particle sizes and concentrations by ion mobility analysis. Clin Chem. 2008 Aug;54(8):1307-16. doi: 10.1373/clinchem.2007.100586. Epub 2008 May 29.
- 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.
Henry Ginsberg, MD principal investigator
Columbia University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-05221304 in people with NASH (Nonalcoholic Steatohepatitis) and NAFLD (Nonalcoholic Fatty Liver Disease), run by Columbia University.
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 13 inclusion and 15 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: withdrawn, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Rate of Secretion (also called production-PR) of VLDL TG (mg/kg/day) (time frame: Up to 20 weeks). The study lists 2 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 NCT04395950, which also lists 9 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 25 Aug 2021.