Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BMS-986036 · 10 trials · 12 indications
The percentage of participants who achieved a ≥1-stage improvement in fibrosis without worsening of NASH or NASH improvement with no worsening of fibrosis at week 24 in liver biopsy. Improvement in fibrosis is defined by the NASH Clinical Research Network (CRN) Fibrosis Score. Improvement in NASH is defined by a ≥2-stage decrease in the nonalcoholic fatty liver disease activity score (NAS). Worsening of NASH is defined as an increase of the nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS) by ≥1 point. Worsening of fibrosis is defined as an increase of fibrosis by ≥1 point as determined by the NASH CRN Fibrosis Score. NASH CRN Fibrosis is staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis).
An improvement in fibrosis is defined as a decrease of fibrosis by ≥1-stage in the NASH Clinical Research Network (CRN) Fibrosis Score at week 48 in liver biopsy. Worsening of NASH is defined as an increase of the nonalcoholic fatty liver disease activity score (NAS) by ≥ 1-stage. Worsening of NASH is defined as an increase of the nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS) by ≥1 point. Worsening of fibrosis is defined as an increase of fibrosis by ≥1 point as determined by the NASH CRN Fibrosis Score.
The mean change in percent hepatic fat fraction (%) by MRI from baseline to Week 16 was assessed for each arm. A longitudinal repeated measures analysis was used to analyze the change in hepatic fat fraction (%) at Week 16 from baseline in the treated population who have both a baseline and at least one post-baseline measurement.
The number of participants with on-study AEs was reported for each arm.
The number of participants with on-study SAEs was reported for each arm.
The number of participants with on-study injection site reactions was reported for each arm.
The number of participants with on-study AEs leading to discontinuation was reported for each arm.
The number of deaths was reported for each arm.
The number of participants whose worst toxicity grade increased from baseline to grade 3 or 4 (Toxicity Scale: DAIDS Version 1.0) is reported for each arm.
The number of participants with out-of-range vital signs noted during interim or final vital sign assessments was reported for each arm.
The number of participants with out-of-range ECG intervals observed during interim or final electrocardiogram assessments was reported for each arm.
The number of participants with abnormalities observed during interim or final physical examination assessments is reported for each arm.
The mean percent change in bone mineral density from baseline to day 112 reported for each arm.
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Percent Change in Glycosylated Hemoglobin A1c (HbA1c) from Baseline to Week 12 was reported.
Safety
Safety
| Arm | Type | Description |
|---|---|---|
| BMS-986036 Dose Level 1 | EXPERIMENTAL | Administered by subcutaneous injection. |
| BMS-986036 Dose Level 2 | EXPERIMENTAL | Administered by subcutaneous injection. |
| BMS-986036 Dose Level 3 | EXPERIMENTAL | Administered by subcutaneous injection. |
| Placebo | PLACEBO_COMPARATOR | Administered by subcutaneous injection. |
| Treatment Group A: BMS-986036 | EXPERIMENTAL | Administered as specified on specified days |
| Treatment Group B: BMS-986036 | EXPERIMENTAL | Administered as specified on specified days |
| Treatment Group C: Placebo | PLACEBO_COMPARATOR | Administered as specified on specified days |
| Treatment Group D: | EXPERIMENTAL | Administered as specified on specified days |
| Treatment Group E: | PLACEBO_COMPARATOR | Administered as specified on specified days |
| Treatment A: Placebo (Matching with BMS-986036 - Daily) | PLACEBO_COMPARATOR | Placebo (Matching with BMS-986036) 0 mg subcutaneous injection once daily for 12 weeks |
| Arm 2: Treatment B: BMS-986036 (1 mg Daily) | EXPERIMENTAL | BMS-986036 1 mg subcutaneous injection once daily for 12 weeks |
| Treatment C: BMS-986036 (5 mg Daily) | EXPERIMENTAL | BMS-986036 5 mg subcutaneous injection once daily for 12 weeks |
| Treatment D: BMS-986036 (20 mg Daily) | EXPERIMENTAL | BMS-986036 20 mg subcutaneous injection once daily for 12 weeks |
| Treatment E: BMS-986036 (20 mg Weekly) | EXPERIMENTAL | BMS-986036 20 mg subcutaneous injection once weekly (on Day 1 of each week) for 12 weeks Followed by Placebo (Matching with BMS-986036) 0 mg subcutaneous injection on Days 2-7 of each week for 12 weeks |
| Group A: Moderate Hepatic Impairment | EXPERIMENTAL | - |
| Group B: Severe Hepatic Impairment | EXPERIMENTAL | - |
| Group C: Normal Hepatic Function | EXPERIMENTAL | - |
| Part A: 1 x BMS-986036 via auto-injector or pre-filled syringe | EXPERIMENTAL | - |
| Part B: 2 x BMS-986036 via auto-injector or pre-filled syringe | EXPERIMENTAL | - |
| Mild Renal Impairment | EXPERIMENTAL | The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening. |
| Moderate Renal Impairment | EXPERIMENTAL | The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening. |
| Severe Renal Impairment | EXPERIMENTAL | The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening. |
| Normal | OTHER | The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening. |
| Cohort 1 | EXPERIMENTAL | BMI 18.0 to ≤ 25.0 |
| Cohort 2 | EXPERIMENTAL | BMI \>25.0 to ≤ 30.0 |
| Cohort 3 | EXPERIMENTAL | BMI \>30.0 ≤ 40.0 |
| Module A | EXPERIMENTAL | BMS-986036 Arm |
| Module B | PLACEBO_COMPARATOR | Placebo Arm |
| Name | Type | Description |
|---|---|---|
| BMS-986036 | DRUG | Specified dose on specified days. |
| Placebo | OTHER | Specified dose on specified days. |
| Placebo (Matching with BMS-986036) | BIOLOGICAL | - |
Inclusion Criteria: * Liver biopsy performed within 6 months (26 weeks) prior to the screening period. If historical biopsy is not available, a liver biopsy will be performed during the screening period. Biopsy must be consistent with NASH, with: a) a score of at least 1 for each NAS component (ste...
BMS-986036 is an investigational monoclonal antibody being studied for metabolic conditions including non-alcoholic steatohepatitis (NASH), liver fibrosis, hepatic cirrhosis, and moderate liver impairment. It has been evaluated in healthy participants and in adults with NASH and stage 3 liver fibrosis or cirrhosis.
BMS-986036 is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company has sponsored clinical trials of the drug in the United States, Japan, Czechia, and Hungary.
BMS-986036 is in Phase 2 clinical development. It has completed Phase 1 and Phase 2 trials, including a Phase 2 study in adults with NASH and stage 3 liver fibrosis and another in adults with NASH and liver cirrhosis. It remains investigational and is not FDA approved.
BMS-986036 has completed four clinical trials: NCT03445208 in healthy participants, NCT03486899 in NASH with stage 3 liver fibrosis, NCT03486912 in NASH with cirrhosis, and NCT03674476 in participants with varying kidney function. All trials are completed with no active studies ongoing.
No, BMS-986036 is not the same as pegbelfermin. BMS-986036 is a monoclonal antibody, whereas pegbelfermin is a different molecule. The two are distinct investigational drugs with different mechanisms and are not interchangeable.