Nonalcoholic Fatty Liver DiseasePhase 1NCT04766476
A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-963272 in Participants With Nonalcoholic Fatty Liver Disease
A Phase 1 study testing BMS-963272 in people with Nonalcoholic Fatty Liver Disease, run by Bristol-Myers Squibb at 19 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-963272 compared to placebo in participants with nonalcoholic fatty liver disease (NAFLD) and high probability of advanced fibrosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease
- What is being tested?
- BMS-963272
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 19 sitesUnited States
- Study dates
- 24 Feb 2021to 12 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) ≥ 30 kg/m^2
- Magnetic resonance imaging-proton density fat fraction (MRI-PDFF) ≥ 10% as evaluated by central review
- FibroScan-based transient elastography ≥ 9.9 kPa
- Alanine aminotransferase (ALT): > 30 U/L
- If available, historical diagnosis of non-alcoholic steatohepatitis (NASH) according to NASH Clinical Research Network classification by liver biopsy within 6 months before screening will be recorded
- Must agree to follow specific methods of contraception, if applicable
Who cannot join
- Women who are breastfeeding
- Inability to tolerate the mixed meal or the testing conditions, oral medication, venipuncture and/or inadequate venous access
- History or current diagnosis of cirrhosis, hepatocellular carcinoma (HCC), or hepatic decompensation
- Recent history (within 2 years before screening) of drug or alcohol abuse or excessive alcohol intake, defined as 30 g/day (men) or 20 g/day (women)
- Use of lipase inhibitors such as orlistat within 4 weeks before screening or during screening
- Use of glucagon-like peptide-1 (GLP-1) receptor agonists within 12 weeks before screening or during screening
Show all 16Show fewer
- Uncontrolled hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg) during screening, unless discussed with the Medical Monitor
- Glycated hemoglobin (HbA1c) ≥ 9.5%
- NASH-modifying therapies including investigational therapies (e.g., obeticholic acid, ursodeoxycholic acid) within 90 days before screening or during screening
- Medications for obesity within 12 weeks before screening, or during screening
- If taking vitamin E at a dose ≥ 800 mg/day, the dose must be stable beginning at least 6 months before screening and should remain stable during screening
- If taking a thiazolidinedione, the dose must be stable beginning at least 12 weeks before screening and should remain stable during screening
- If taking a dipeptidyl peptidase (DPP)-4 inhibitor or other medications for diabetes, the dose must be stable beginning at least 12 weeks before screening and should remain stable during screening
- If taking insulin, the dose may be altered by up to 10% within 12 weeks before screening and during the screening period
- If taking a statin or other prescription or over-the-counter lipid-lowering drug, the dose must be stable beginning at least 6 weeks before screening and should remain stable during screening
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Pinnacle Clinical Research - Austin
Austin, Texas, 78757
Local Institution
Bastrop, Louisiana, 71220
Local Institution
Biloxi, Mississippi, 39532
Local Institution
Boca Raton, Florida, 33434
RecioMed Clinical Research Network
Boynton Beach, Florida, 33472
Local Institution
Chandler, Arizona, 85224
Local Institution
Chattanooga, Tennessee, 37421
Cullman Clinical Trials
Cullman, Alabama, 35055
Local Institution
Edinburg, Texas, 78539
Local Institution
Germantown, Tennessee, 38138
Local Institution
Kansas City, Missouri, 64131
Local Institution
McAllen, Texas, 78504
Local Institution
Miami, Florida, 33014
Advanced Pharma - Miami
Miami, Florida, 33147
Floridian Clinical Research
Miami Lakes, Florida, 33016
Local Institution
Port Orange, Florida, 32127
Local Institution
San Antonio, Texas, 78215
Local Institution
San Antonio, Texas, 78229
Arizona Liver Health - Tucson
Tucson, Arizona, 85712
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 1b Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BMS-963272 in Participants With Nonalcoholic Fatty Liver Disease
The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-963272 compared to placebo in participants with nonalcoholic fatty liver disease (NAFLD) and high probability of advanced fibrosis.
- Conditions
- Nonalcoholic Fatty Liver Disease
- Being tested
- BMS-963272, Placebo matching BMS-963272
- Keywords
- BMS-963272, Liver Fibrosis, Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH), Phase 1b
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-963272Drug
Specified dose on specified days
Placebo matching BMS-963272Other
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment (BMS-963272) Dosing Regimen 1 | Experimental | Not described Receives: Drug: BMS-963272 |
| Active Treatment (BMS-963272) Dosing Regimen 2 | Experimental | Not described Receives: Drug: BMS-963272 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo matching BMS-963272 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
Measured: Up to 166 days
Incidence of serious adverse events (SAEs)
Measured: Up to 166 days
Incidence of clinically significant changes in vital signs: Blood pressure
Measured: Up to 166 days
Incidence of clinically significant changes in vital signs: Heart rate
Measured: Up to 166 days
Incidence of clinically significant changes in physical examination findings
Measured: Up to 166 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
PR interval: The time from the onset of the P wave to the start of the QRS complex
Measured: Up to 166 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval
QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization
Measured: Up to 166 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
QT interval: Measured from the beginning of the QRS complex to the end of the T wave
Measured: Up to 166 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval
QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)
Measured: Up to 166 days
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry test
Measured: Up to 166 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Measured: Up to 166 days
Incidence of clinically significant changes in clinical laboratory results: Coagulation tests
Measured: Up to 166 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Measured: Up to 46 days
Incidence of clinically significant changes in clinical laboratory results: Liver function tests
Measured: Up to 166 days
Incidence of clinically significant changes in clinical laboratory results: Lipid panel tests
Measured: Up to 166 days
Secondary outcomes (4)
Pharmacokinetic (PK) sampling: Maximum observed plasma concentration (Cmax)
Measured: Day 1 and Day 84
Pharmacokinetic (PK) sampling: Time to maximum observed plasma concentration (Tmax)
Measured: Day 1 and Day 84
Pharmacokinetic (PK) sampling: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
Measured: Day 1 and Day 84
Trough observed plasma concentration (Ctrough)
Measured: Day 1, Day 15, Day 29, Day 57, and Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start24 Feb 2021
- Primary completion12 Aug 2021
- Study completion12 Aug 2021
Why it stopped: Business objectives have changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766476
- Sponsor's protocol ID
- MB006-025
- Status last verified
- Jun 2022
- First submitted
- 19 Feb 2021
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 1b Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BMS-963272 in Participants With Nonalcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT04766476
- Acronym / sponsor ID
- MB006-025
- Conditions
- Nonalcoholic Fatty Liver Disease
- Keywords
- BMS-963272, Liver Fibrosis, Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH), Phase 1b
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business objectives have changed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 12 Aug 2021 (actual)
- Study completion
- 12 Aug 2021 (actual)
- First posted
- 23 Feb 2021 (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 evaluate the safety, tolerability, and drug levels of BMS-963272 compared to placebo in participants with nonalcoholic fatty liver disease (NAFLD) and high probability of advanced fibrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Treatment (BMS-963272) Dosing Regimen 1 | Experimental | Drug: BMS-963272 |
| Active Treatment (BMS-963272) Dosing Regimen 2 | Experimental | Drug: BMS-963272 |
| Placebo | Placebo comparator | Other: Placebo matching BMS-963272 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Body mass index (BMI) ≥ 30 kg/m^2
- Magnetic resonance imaging-proton density fat fraction (MRI-PDFF) ≥ 10% as evaluated by central review
- FibroScan-based transient elastography ≥ 9.9 kPa
- Alanine aminotransferase (ALT): > 30 U/L
- If available, historical diagnosis of non-alcoholic steatohepatitis (NASH) according to NASH Clinical Research Network classification by liver biopsy within 6 months before screening will be recorded
Key exclusion criteria (16 listed)
- Women who are breastfeeding
- Inability to tolerate the mixed meal or the testing conditions, oral medication, venipuncture and/or inadequate venous access
- History or current diagnosis of cirrhosis, hepatocellular carcinoma (HCC), or hepatic decompensation
- Recent history (within 2 years before screening) of drug or alcohol abuse or excessive alcohol intake, defined as 30 g/day (men) or 20 g/day (women)
- Use of lipase inhibitors such as orlistat within 4 weeks before screening or during screening
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 |
|---|---|---|
| BMS-963272Specified dose on specified days | Drug | Active Treatment (BMS-963272) Dosing Regimen 1, Active Treatment (BMS-963272) Dosing Regimen 2 |
| Placebo matching BMS-963272Specified dose on specified days | Other | Placebo |
Primary outcome
Incidence of adverse events (AEs)
Time frame: Up to 166 days
Incidence of serious adverse events (SAEs)
Time frame: Up to 166 days
Incidence of clinically significant changes in vital signs: Blood pressure
Time frame: Up to 166 days
Incidence of clinically significant changes in vital signs: Heart rate
Time frame: Up to 166 days
Incidence of clinically significant changes in physical examination findings
Time frame: Up to 166 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
Time frame: Up to 166 days
PR interval: The time from the onset of the P wave to the start of the QRS complex
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval
Time frame: Up to 166 days
QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
Time frame: Up to 166 days
QT interval: Measured from the beginning of the QRS complex to the end of the T wave
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval
Time frame: Up to 166 days
QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry test
Time frame: Up to 166 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time frame: Up to 166 days
Incidence of clinically significant changes in clinical laboratory results: Coagulation tests
Time frame: Up to 166 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time frame: Up to 46 days
Incidence of clinically significant changes in clinical laboratory results: Liver function tests
Time frame: Up to 166 days
Incidence of clinically significant changes in clinical laboratory results: Lipid panel tests
Time frame: Up to 166 days
4 secondary outcomes
Pharmacokinetic (PK) sampling: Maximum observed plasma concentration (Cmax)
Time frame: Day 1 and Day 84
Pharmacokinetic (PK) sampling: Time to maximum observed plasma concentration (Tmax)
Time frame: Day 1 and Day 84
Pharmacokinetic (PK) sampling: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
Time frame: Day 1 and Day 84
Trough observed plasma concentration (Ctrough)
Time frame: Day 1, Day 15, Day 29, Day 57, and Day 84
Results and safety
The study was stopped early (reason given: Business objectives have changed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-963272 in people with Nonalcoholic Fatty Liver Disease, run by Bristol-Myers Squibb at 19 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 6 inclusion and 16 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: stopped early, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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 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 stopped early (reason given: Business objectives have changed). Results are not available in the source record.
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?
Incidence of adverse events (AEs) (time frame: Up to 166 days). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2022.