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CompletedNCT02097277Updated Jul 31, 2019Results posted

A Study to Evaluate BMS-986036 in Obese Adults With Type-2 Diabetes

A Phase 2 interventional study of BMS-986036 and Placebo (Matching with BMS-986036) in Diabetes Mellitus Type 2, sponsored by Bristol-Myers Squibb. Completed at 16 sites in 2 countries. Per ClinicalTrials.gov, last updated 2019-07-31.

Sponsored by Bristol-Myers Squibb · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
219
Allocation
Randomized
Sex
All
01

Study summary

The purpose of this study is to assess the potential of BMS-986036 for treatment obese adults with type-2 diabetes.

02

Conditions studied

  • Diabetes Mellitus Type 2
03

In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's enrollment of 219 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,562 studies on the registry; 118 are open to participants now.

Of its 435 completed or terminated interventional studies of FDA-regulated products, 227 (52%) have results posted.

Browse Bristol-Myers Squibb studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion criteria

Inclusion Criteria:

  • Diagnosed with type-2 diabetes mellitus with HbA1c ≥6.5% to less than 10.0%
  • Body mass index 30.0 to 50.0

Exclusion criteria

Exclusion Criteria:

  • Any significant acute or chronic medical illness
  • Inability to self-administer subcutaneous injections
  • Inability to be venipunctured
  • Evidence of organ dysfunction beyond what is consistent with the target population
  • History of allergy to PEGylated compounds or Fibroblast growth factor 21 (FGF21) related compounds
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
219 participants (actual)

Study arms

  • Placebo comparator
    Treatment A: Placebo (Matching with BMS-986036 - Daily)

    Placebo (Matching with BMS-986036) 0 mg subcutaneous injection once daily for 12 weeks

    Biological: Placebo (Matching with BMS-986036)

  • Experimental
    Arm 2: Treatment B: BMS-986036 (1 mg Daily)

    BMS-986036 1 mg subcutaneous injection once daily for 12 weeks

    Biological: BMS-986036

  • Experimental
    Treatment C: BMS-986036 (5 mg Daily)

    BMS-986036 5 mg subcutaneous injection once daily for 12 weeks

    Biological: BMS-986036

  • Experimental
    Treatment D: BMS-986036 (20 mg Daily)

    BMS-986036 20 mg subcutaneous injection once daily for 12 weeks

    Biological: BMS-986036

  • Experimental
    Treatment E: BMS-986036 (20 mg Weekly)

    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

    Biological: BMS-986036 · Biological: Placebo (Matching with BMS-986036)

Interventions

  • BiologicalBMS-986036
  • BiologicalPlacebo (Matching with BMS-986036)
06

What researchers measure

Primary outcomes

  1. Percent Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 12

    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.

    Time frame: Baseline (Day 1) and Week 12

Secondary outcomes

  1. Change in Body Weight From Baseline to Week 12

    Change in Body Weight from Baseline to Week 12 as a part of Physical measurement was reported.

    Time frame: Baseline (Day 1) and Week 12

  2. Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Composite Index of Insulin Sensitivity (CISI) (Matsuda Index)

    Whole body insulin sensitivity as quantified by Matsuda Index at the end of the treatment period, calculated by the following equation: 10,000/square root of(FPG\*FI)\*(FPG+PG30\*2+PG60\*3+PG120\*2)/8\*(FPI+PI30\*2+PI60\*3+PI120\*2)/8). FPG=fasting plasma glucose level; FPI=fasting plasma insulin level; PG30,60,90, and 120=plasma glucose levels sampled at 30,60, and 120 minutes after oral glucose load; PI30,60,and 120=plasma insulin levels sampled at 30,60 and 120 minutes after the oral glucose load.

    Time frame: Baseline (Day 1) and Week 12

  3. Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

    Homeostasis model assessment of insulin resistance (HOMA-IR) was used as a validated measure of insulin resistance. HOMA-IR is calculated using the following formula's fasting glucose(mg/dL) x fasting insulin(mU/L) / 405.

    Time frame: Baseline (Day 1) and Week 12

  4. Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Quantitative Insulin Sensitivity Check Index (QUICKI)

    The Quantitative Insulin Sensitivity Check Index (QUICKI) score, measures insulin sensitivity which is the inverse of insulin resistance. QUICKI is derived using the inverse of the sum of the logarithms of the fasting insulin and fasting glucose: 1 / (log(fasting insulin mU/L) + log(fasting glucose mg/dL)).

    Time frame: Baseline (Day 1) and Week 12

  5. Change in Oral Glucose Tolerance Test (OGTT) Area Under the Curve From 0 to 2 Hours for Postprandial Glucose From Baseline to Week 12

    Blood samples were drawn after an overnight fast and standard OGTT from 0 to 120 minutes. Plasma Glucose levels over 2 hours were shown as Area Under the Curve, (AUC).

    Time frame: Baseline (Day 1) and Week 12

  6. Change in OGTT Insulin AUC (0-2 Hours) From Baseline to Week 12

    Blood samples were drawn after an overnight fast and standard OGTT from 0 to 120 minutes. Insulin levels over 2 hours were shown as Area Under the Curve, (AUC).

    Time frame: Bseline (Day 1) and Week 12

  7. Change in OGTT C-peptide AUC (0-2 Hours) From Baseline to Week 12

    Blood samples were drawn after an overnight fast and standard OGTT from 0 to 120 minutes. C-peptide levels over 2 hours were shown as Area Under the Curve, (AUC).

    Time frame: Baseline (Day 1) and Week 12

  8. Average Concentration (Cavg) of C-terminal Intact BMS-986036

    Cavg of C-terminal Intact BMS-986036 was reported.

    Time frame: Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126)

  9. Maximum Observed Concentration (Cmax) of C-terminal Intact BMS-986036

    Maximum observed concentration (Cmax) of C-terminal Intact BMS-986036 was reported.

    Time frame: Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126)

  10. Area Under the Concentration-time Curve From Time Zero to 24 Hours at Steady State (AUC [0-24 Hours, ss]) of C-terminal Intact BMS-986036

    AUC \[0-24 hours, ss\] of C-terminal Intact BMS-986036 was reported.

    Time frame: Pre-dose, 6, 24 hours postdose on Week 8

  11. Area Under the Concentration-time Curve From Time Zero to 168 Hours at Steady State (AUC [0-168 Hours, ss]) of C-terminal Intact BMS-986036

    AUC \[0-168 hours, ss\] of C-terminal Intact BMS-986036 was reported.

    Time frame: Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126)

  12. Average Concentration (Cavg) of Total BMS-986036

    Cavg of Total BMS-986036 was reported.

    Time frame: Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126)

  13. Maximum Observed Concentration (Cmax) of Total BMS-986036

    Maximum observed concentration (Cmax) of Total BMS-986036 was reported.

    Time frame: Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126)

  14. Area Under the Concentration-time Curve From Time Zero to 24 Hours at Steady State (AUC [0-24 Hours, ss]) Total BMS-986036

    AUC \[0-24 hours, ss\] of Total BMS-986036 was reported.

    Time frame: Pre-dose, 6, 24 hours postdose on Week 8

  15. Area Under the Concentration-time Curve From Time Zero to 168 Hours at Steady State (AUC [0-168 Hours, ss]) of Total BMS-986036

    AUC \[0-168 hours, ss\] of Total BMS- 986036 was reported.

    Time frame: Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126)

  16. Percentage of Participants With ANTI-BMS-986036 Antibody Response

    Percentage of Participants with ANTI-BMS-986036 Antibody Response (ADA positive and ADA Negative) was reported. Participants were monitored for antibodies to BMS-986036 with an anti-BMS-986036 antibody assay. Titers were reported for samples testing positive in an assay.

    Time frame: Baseline and Day 126

07

Results

Posted May 9, 2019

Participant flow

Participant flow — Overall Study
MilestoneTreatment A: PlaceboTreatment B: BMS-986036 (1 mg Daily)Treatment C: BMS-986036 (5 mg Daily)Treatment D: BMS-986036 (20 mg Daily)Treatment E: BMS-986036 (20 mg Weekly)
Started2424242424
Completed2221222023
Not completed23241
Withdrew: Subject no longer meets study criteria01010
Withdrew: Subject request to discontinue treatment00001
Withdrew: Lost to follow-up01100
Withdrew: Withdrawal by subject21010
Withdrew: Adverse event00120

Outcome measures

PrimaryPercent Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 12

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.

Time frame:
Baseline (Day 1) and Week 12
Reported as:
Mean · Percent Change
Percent Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 12
Percent ChangeTreatment A: PlaceboTreatment B: BMS-986036 (1 mg Daily)Treatment C: BMS-986036 (5 mg Daily)Treatment D: BMS-986036 (20 mg Daily)Treatment E: BMS-986036 (20 mg Weekly)
Percent Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 120.0005 ± 0.006220.0029 ± 0.008820.0007 ± 0.006920.0004 ± 0.00814-0.0004 ± 0.00418
SecondaryChange in Body Weight From Baseline to Week 12

Change in Body Weight from Baseline to Week 12 as a part of Physical measurement was reported.

Time frame:
Baseline (Day 1) and Week 12
Reported as:
Mean · Kilogram
Change in Body Weight From Baseline to Week 12
KilogramTreatment A: PlaceboTreatment B: BMS-986036 (1 mg Daily)Treatment C: BMS-986036 (5 mg Daily)Treatment D: BMS-986036 (20 mg Daily)Treatment E: BMS-986036 (20 mg Weekly)
Change in Body Weight From Baseline to Week 12-0.22 ± 2.615-0.26 ± 1.718-0.10 ± 2.883-1.09 ± 2.583-0.50 ± 2.297
SecondaryChange From Baseline to Week 12 in Insulin Sensitivity Quantified by Composite Index of Insulin Sensitivity (CISI) (Matsuda Index)

Whole body insulin sensitivity as quantified by Matsuda Index at the end of the treatment period, calculated by the following equation: 10,000/square root of(FPG\*FI)\*(FPG+PG30\*2+PG60\*3+PG120\*2)/8\*(FPI+PI30\*2+PI60\*3+PI120\*2)/8). FPG=fasting plasma glucose level; FPI=fasting plasma insulin level; PG30,60,90, and 120=plasma glucose levels sampled at 30,60, and 120 minutes after oral glucose load; PI30,60,and 120=plasma insulin levels sampled at 30,60 and 120 minutes after the oral glucose load.

Time frame:
Baseline (Day 1) and Week 12
Reported as:
Mean · Unit on a scale
Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Composite Index of Insulin Sensitivity (CISI) (Matsuda Index)
Unit on a scaleTreatment A: PlaceboTreatment B: BMS-986036 (1 mg Daily)Treatment C: BMS-986036 (5 mg Daily)Treatment D: BMS-986036 (20 mg Daily)Treatment E: BMS-986036 (20 mg Weekly)
Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Composite Index of Insulin Sensitivity (CISI) (Matsuda Index)-0.18 ± 0.967-0.19 ± 1.348-0.18 ± 2.1020.77 ± 2.4550.54 ± 1.772
SecondaryChange From Baseline to Week 12 in Insulin Sensitivity Quantified by Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

Homeostasis model assessment of insulin resistance (HOMA-IR) was used as a validated measure of insulin resistance. HOMA-IR is calculated using the following formula's fasting glucose(mg/dL) x fasting insulin(mU/L) / 405.

Time frame:
Baseline (Day 1) and Week 12
Reported as:
Mean · Unit on a Scale
Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Unit on a ScaleTreatment A: PlaceboTreatment B: BMS-986036 (1 mg Daily)Treatment C: BMS-986036 (5 mg Daily)Treatment D: BMS-986036 (20 mg Daily)Treatment E: BMS-986036 (20 mg Weekly)
Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)-0.19 ± 4.1360.00 ± 5.633-1.88 ± 8.940-1.73 ± 4.589-0.34 ± 3.707
SecondaryChange From Baseline to Week 12 in Insulin Sensitivity Quantified by Quantitative Insulin Sensitivity Check Index (QUICKI)

The Quantitative Insulin Sensitivity Check Index (QUICKI) score, measures insulin sensitivity which is the inverse of insulin resistance. QUICKI is derived using the inverse of the sum of the logarithms of the fasting insulin and fasting glucose: 1 / (log(fasting insulin mU/L) + log(fasting glucose mg/dL)).

Time frame:
Baseline (Day 1) and Week 12
Reported as:
Mean · Unit on a scale
Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Quantitative Insulin Sensitivity Check Index (QUICKI)
Unit on a scaleTreatment A: PlaceboTreatment B: BMS-986036 (1 mg Daily)Treatment C: BMS-986036 (5 mg Daily)Treatment D: BMS-986036 (20 mg Daily)Treatment E: BMS-986036 (20 mg Weekly)
Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Quantitative Insulin Sensitivity Check Index (QUICKI)0.00 ± 0.0110.00 ± 0.0100.00 ± 0.0150.00 ± 0.0160.00 ± 0.011
SecondaryChange in Oral Glucose Tolerance Test (OGTT) Area Under the Curve From 0 to 2 Hours for Postprandial Glucose From Baseline to Week 12

Blood samples were drawn after an overnight fast and standard OGTT from 0 to 120 minutes. Plasma Glucose levels over 2 hours were shown as Area Under the Curve, (AUC).

Time frame:
Baseline (Day 1) and Week 12
Reported as:
Mean · Millimole*hour per Liter (mmol*hr/L)
Change in Oral Glucose Tolerance Test (OGTT) Area Under the Curve From 0 to 2 Hours for Postprandial Glucose From Baseline to Week 12
Millimole*hour per Liter (mmol*hr/L)Treatment A: PlaceboTreatment B: BMS-986036 (1 mg Daily)Treatment C: BMS-986036 (5 mg Daily)Treatment D: BMS-986036 (20 mg Daily)Treatment E: BMS-986036 (20 mg Weekly)
Change in Oral Glucose Tolerance Test (OGTT) Area Under the Curve From 0 to 2 Hours for Postprandial Glucose From Baseline to Week 121.538 ± 4.29402.594 ± 5.8193-0.646 ± 7.0591-0.215 ± 4.7397-2.293 ± 4.9322
SecondaryChange in OGTT Insulin AUC (0-2 Hours) From Baseline to Week 12

Blood samples were drawn after an overnight fast and standard OGTT from 0 to 120 minutes. Insulin levels over 2 hours were shown as Area Under the Curve, (AUC).

Time frame:
Bseline (Day 1) and Week 12
Reported as:
Mean · mmol*hr/L
Change in OGTT Insulin AUC (0-2 Hours) From Baseline to Week 12
mmol*hr/LTreatment A: PlaceboTreatment B: BMS-986036 (1 mg Daily)Treatment C: BMS-986036 (5 mg Daily)Treatment D: BMS-986036 (20 mg Daily)Treatment E: BMS-986036 (20 mg Weekly)
Change in OGTT Insulin AUC (0-2 Hours) From Baseline to Week 12-64.648 ± 231.6043-72.155 ± 277.4819-83.850 ± 215.3974-58.313 ± 205.1879-150.679 ± 257.5965
SecondaryChange in OGTT C-peptide AUC (0-2 Hours) From Baseline to Week 12

Blood samples were drawn after an overnight fast and standard OGTT from 0 to 120 minutes. C-peptide levels over 2 hours were shown as Area Under the Curve, (AUC).

Time frame:
Baseline (Day 1) and Week 12
Reported as:
Mean · mmol*hr/L
Change in OGTT C-peptide AUC (0-2 Hours) From Baseline to Week 12
mmol*hr/LTreatment A: PlaceboTreatment B: BMS-986036 (1 mg Daily)Treatment C: BMS-986036 (5 mg Daily)Treatment D: BMS-986036 (20 mg Daily)Treatment E: BMS-986036 (20 mg Weekly)
Change in OGTT C-peptide AUC (0-2 Hours) From Baseline to Week 12-0.287 ± 1.24630.031 ± 1.3926-0.181 ± 0.8927-0.169 ± 1.0176-0.750 ± 1.2224
SecondaryAverage Concentration (Cavg) of C-terminal Intact BMS-986036

Cavg of C-terminal Intact BMS-986036 was reported.

Time frame:
Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126)
Reported as:
Geometric mean · Microgram per Liter (ug/L)
Average Concentration (Cavg) of C-terminal Intact BMS-986036
Microgram per Liter (ug/L)Treatment B: BMS-986036 (1 mg Daily)Treatment C: BMS-986036 (5 mg Daily)Treatment D: BMS-986036 (20 mg Daily)Treatment E: BMS-986036 (20 mg Weekly)
Average Concentration (Cavg) of C-terminal Intact BMS-98603650.6 ± 60.6204 ± 50.4762 ± 49.2197 ± 60.5
SecondaryMaximum Observed Concentration (Cmax) of C-terminal Intact BMS-986036

Maximum observed concentration (Cmax) of C-terminal Intact BMS-986036 was reported.

Time frame:
Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126)
Reported as:
Geometric mean · microgram/liter
Maximum Observed Concentration (Cmax) of C-terminal Intact BMS-986036
microgram/literTreatment B: BMS-986036 (1 mg Daily)Treatment C: BMS-986036 (5 mg Daily)Treatment D: BMS-986036 (20 mg Daily)Treatment E: BMS-986036 (20 mg Weekly)
Maximum Observed Concentration (Cmax) of C-terminal Intact BMS-98603653.3 ± 61.2213 ± 50.4807 ± 48.8459 ± 41.4
SecondaryArea Under the Concentration-time Curve From Time Zero to 24 Hours at Steady State (AUC [0-24 Hours, ss]) of C-terminal Intact BMS-986036

AUC \[0-24 hours, ss\] of C-terminal Intact BMS-986036 was reported.

Time frame:
Pre-dose, 6, 24 hours postdose on Week 8
Reported as:
Geometric mean · hour*microgram/liter
Area Under the Concentration-time Curve From Time Zero to 24 Hours at Steady State (AUC [0-24 Hours, ss]) of C-terminal Intact BMS-986036
hour*microgram/literTreatment B: BMS-986036 (1 mg Daily)Treatment C: BMS-986036 (5 mg Daily)Treatment D: BMS-986036 (20 mg Daily)Treatment E: BMS-986036 (20 mg Weekly)
Area Under the Concentration-time Curve From Time Zero to 24 Hours at Steady State (AUC [0-24 Hours, ss]) of C-terminal Intact BMS-9860361210 ± 60.64900 ± 50.418300 ± 49.2—
SecondaryArea Under the Concentration-time Curve From Time Zero to 168 Hours at Steady State (AUC [0-168 Hours, ss]) of C-terminal Intact BMS-986036

AUC \[0-168 hours, ss\] of C-terminal Intact BMS-986036 was reported.

Time frame:
Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126)
Reported as:
Geometric mean · hour*microgram/liter
Area Under the Concentration-time Curve From Time Zero to 168 Hours at Steady State (AUC [0-168 Hours, ss]) of C-terminal Intact BMS-986036
hour*microgram/literTreatment B: BMS-986036 (1 mg Daily)Treatment C: BMS-986036 (5 mg Daily)Treatment D: BMS-986036 (20 mg Daily)Treatment E: BMS-986036 (20 mg Weekly)
Area Under the Concentration-time Curve From Time Zero to 168 Hours at Steady State (AUC [0-168 Hours, ss]) of C-terminal Intact BMS-986036———31800 ± 57.6
SecondaryAverage Concentration (Cavg) of Total BMS-986036

Cavg of Total BMS-986036 was reported.

Time frame:
Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126)
Reported as:
Geometric mean · Microgram per Liter (ug/L)
Average Concentration (Cavg) of Total BMS-986036
Microgram per Liter (ug/L)Treatment B: BMS-986036 (1 mg Daily)Treatment C: BMS-986036 (5 mg Daily)Treatment D: BMS-986036 (20 mg Daily)Treatment E: BMS-986036 (20 mg Weekly)
Average Concentration (Cavg) of Total BMS-986036342 ± 42.31560 ± 44.66390 ± 43.21130 ± 38.9
SecondaryMaximum Observed Concentration (Cmax) of Total BMS-986036

Maximum observed concentration (Cmax) of Total BMS-986036 was reported.

Time frame:
Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126)
Reported as:
Geometric mean · microgram/liter
Maximum Observed Concentration (Cmax) of Total BMS-986036
microgram/literTreatment B: BMS-986036 (1 mg Daily)Treatment C: BMS-986036 (5 mg Daily)Treatment D: BMS-986036 (20 mg Daily)Treatment E: BMS-986036 (20 mg Weekly)
Maximum Observed Concentration (Cmax) of Total BMS-986036344 ± 42.51570 ± 44.56440 ± 43.11420 ± 36.1
SecondaryArea Under the Concentration-time Curve From Time Zero to 24 Hours at Steady State (AUC [0-24 Hours, ss]) Total BMS-986036

AUC \[0-24 hours, ss\] of Total BMS-986036 was reported.

Time frame:
Pre-dose, 6, 24 hours postdose on Week 8
Reported as:
Geometric mean · hour*microgram/liter
Area Under the Concentration-time Curve From Time Zero to 24 Hours at Steady State (AUC [0-24 Hours, ss]) Total BMS-986036
hour*microgram/literTreatment B: BMS-986036 (1 mg Daily)Treatment C: BMS-986036 (5 mg Daily)Treatment D: BMS-986036 (20 mg Daily)Treatment E: BMS-986036 (20 mg Weekly)
Area Under the Concentration-time Curve From Time Zero to 24 Hours at Steady State (AUC [0-24 Hours, ss]) Total BMS-9860368200 ± 42.337400 ± 44.6153000 ± 43.2—
SecondaryArea Under the Concentration-time Curve From Time Zero to 168 Hours at Steady State (AUC [0-168 Hours, ss]) of Total BMS-986036

AUC \[0-168 hours, ss\] of Total BMS- 986036 was reported.

Time frame:
Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126)
Reported as:
Geometric mean · hour*microgram/liter
Area Under the Concentration-time Curve From Time Zero to 168 Hours at Steady State (AUC [0-168 Hours, ss]) of Total BMS-986036
hour*microgram/literTreatment B: BMS-986036 (1 mg Daily)Treatment C: BMS-986036 (5 mg Daily)Treatment D: BMS-986036 (20 mg Daily)Treatment E: BMS-986036 (20 mg Weekly)
Area Under the Concentration-time Curve From Time Zero to 168 Hours at Steady State (AUC [0-168 Hours, ss]) of Total BMS-986036———172000 ± 39.1
SecondaryPercentage of Participants With ANTI-BMS-986036 Antibody Response

Percentage of Participants with ANTI-BMS-986036 Antibody Response (ADA positive and ADA Negative) was reported. Participants were monitored for antibodies to BMS-986036 with an anti-BMS-986036 antibody assay. Titers were reported for samples testing positive in an assay.

Time frame:
Baseline and Day 126
Reported as:
Number · Percentage of participants
Percentage of Participants With ANTI-BMS-986036 Antibody Response
Percentage of participantsTreatment B: BMS-986036 (1 mg Daily)Treatment C: BMS-986036 (5 mg Daily)Treatment D: BMS-986036 (20 mg Daily)Treatment E: BMS-986036 (20 mg Weekly)
ADA Positive37.579.283.358.3
ADA Negative62.516.712.537.5

Adverse events

Collected over Approximately 2 years. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment A: Placebo0/24 (0%)1/24 (4.2%)9/24 (37.5%)
Treatment B: BMS-986036 (1 mg Daily)0/24 (0%)0/24 (0%)12/24 (50%)
Treatment C: BMS-986036 (5 mg Daily)0/24 (0%)0/24 (0%)7/24 (29.2%)
Treatment D: BMS-986036 (20 mg Daily)0/24 (0%)1/24 (4.2%)10/24 (41.7%)
Treatment E: BMS-986036 (20 mg Weekly)0/24 (0%)0/24 (0%)10/24 (41.7%)
Most frequent serious events
Most frequent serious events
EventTreatment A: PlaceboTreatment B: BMS-986036 (1 mg Daily)Treatment C: BMS-986036 (5 mg Daily)Treatment D: BMS-986036 (20 mg Daily)Treatment E: BMS-986036 (20 mg Weekly)
Mitral Valve DiseaseCardiac disorders0/240/240/241/240/24
Tricuspid Valve DiseaseCardiac disorders0/240/240/241/240/24
Basal Cell CarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/240/240/240/240/24
Most frequent other events
Showing 10 of 14
Most frequent other events
EventTreatment A: PlaceboTreatment B: BMS-986036 (1 mg Daily)Treatment C: BMS-986036 (5 mg Daily)Treatment D: BMS-986036 (20 mg Daily)Treatment E: BMS-986036 (20 mg Weekly)
Injection Site BruisingGeneral disorders5/246/244/241/243/24
DiarrheaGastrointestinal disorders1/243/242/244/245/24
NasopharyngitisInfections and infestations1/243/241/241/242/24
NauseaGastrointestinal disorders0/242/240/241/243/24
DyspepsiaGastrointestinal disorders0/243/240/241/241/24
Increased AppetiteMetabolism and nutrition disorders2/241/243/241/241/24
Injection Site ErythemaGeneral disorders1/241/240/242/241/24
FatigueGeneral disorders0/241/241/240/242/24
HungerGeneral disorders0/240/242/242/240/24
Upper Respiratory Tract InfectionInfections and infestations0/240/242/240/241/24

Baseline characteristics

Age, Continuous
Age, Continuous(years)Treatment A: PlaceboTreatment B: BMS-986036 (1 mg Daily)Treatment C: BMS-986036 (5 mg Daily)Treatment D: BMS-986036 (20 mg Daily)Treatment E: BMS-986036 (20 mg Weekly)Total
Mean57.9 ± 7.5855.4 ± 9.4455.3 ± 9.9256.2 ± 8.1755.2 ± 12.6256.0 ± 9.60
Sex: Female, Male
Sex: Female, Male(Participants)Treatment A: PlaceboTreatment B: BMS-986036 (1 mg Daily)Treatment C: BMS-986036 (5 mg Daily)Treatment D: BMS-986036 (20 mg Daily)Treatment E: BMS-986036 (20 mg Weekly)Total
Female10111191253
Male141313151267
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Treatment A: PlaceboTreatment B: BMS-986036 (1 mg Daily)Treatment C: BMS-986036 (5 mg Daily)Treatment D: BMS-986036 (20 mg Daily)Treatment E: BMS-986036 (20 mg Weekly)Total
American Indian or Alaska Native000000
Asian0132410
Native Hawaiian or Other Pacific Islander000000
Black or African American2332515
White222018201595
More than one race000000
Unknown or Not Reported000000
08

Study locations

16 sites
  • Arkansas Clinical Research
    Little Rock, Arkansas 72205, United States
  • Anaheim Clinical Trials Llc
    Anaheim, California 92801, United States
  • National Research Institute
    Los Angeles, California 90057, United States
  • Encompass Clinical Research
    Spring Valley, California 91978-1522, United States
  • Encompass Clinical Research
    Spring Valley, California 91978, United States
  • All Medical Research, Llc
    Cooper City, Florida 33024, United States
  • Central Kentucky Research Associates, Inc.
    Lexington, Kentucky 40509, United States
  • Premier Research
    Trenton, New Jersey 08611, United States
  • Metrolina Internal Medicine
    Charlotte, North Carolina 28204, United States
  • Sterling Research Grp, Ltd.
    Cincinnati, Ohio 45219, United States
  • Manna Research Vancouver
    Vancouver, British Columbia V6J 1S3, Canada
  • Aggarwal And Associates
    Brampton, Ontario L6T 0G1, Canada
  • Rhodin Recherche Clinique
    Drummondville, Quebec J2B 7T1, Canada
  • Recherche Gcp Research
    Montreal, Quebec H1M 1B1, Canada
  • Alpha-Recherche Clinique
    Québec, Quebec G3K 2P8, Canada
  • Medexa Recherche
    Victoriaville, Quebec G6P 6P6, Canada
09

References and documents

Publications

  • Charles ED, Neuschwander-Tetri BA, Pablo Frias J, Kundu S, Luo Y, Tirucherai GS, Christian R. Pegbelfermin (BMS-986036), PEGylated FGF21, in Patients with Obesity and Type 2 Diabetes: Results from a Randomized Phase 2 Study. Obesity (Silver Spring). 2019 Jan;27(1):41-49. doi: 10.1002/oby.22344. Epub 2018 Dec 6. PubMed 30520566 ↗
10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2014 to primary completion in Sep 2015, 17 months.

Results were first posted in May 2019, 3 years 7 months after primary completion. A results delay was requested in Mar 2017.

Of 196 industry-sponsored phase 2 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 18. This study's 17 months is above that.

Counting every sponsor, half of 291 studies reached it within 14 months; a quarter within 10 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 19, 2014
First posted
Mar 27, 2014
StartActual
Apr 15, 2014
Primary completionActual
Sep 22, 2015
CompletionActual
May 17, 2016
Results delay requested
Mar 22, 2017
Results first posted
May 9, 2019
Last update
Jul 31, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 31, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02097277
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Mar 27, 2014
Start date
Apr 15, 2014
Primary completion
Sep 22, 2015
Completion
May 17, 2016
Results posted
May 9, 2019
Last update
Jul 31, 2019

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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