Trial Outcomes & Findings for Sitagliptin Versus Placebo in the Treatment of Non-alcoholic Fatty Liver Disease (NCT NCT01963845)

NCT ID: NCT01963845

Last Updated: 2016-10-20

Results Overview

Participants liver fat was measured at baseline and 24 weeks. This is the percentage change in liver fat assessed by MRI-PDFF and stratified by treatment group.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

Baseline and 24 weeks

Results posted on

2016-10-20

Participant Flow

Jan. 1, 2014 to May 1, 2015

Participant milestones

Participant milestones
Measure	Placebo Sitagliptin-matched placebo tablet	Active Drug Sitagliptin 100 mg
Overall Study STARTED	25	25
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sitagliptin Versus Placebo in the Treatment of Non-alcoholic Fatty Liver Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=25 Participants Sitagliptin-matched placebo tablet	Active Drug n=25 Participants Sitagliptin 100 mg	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=99 Participants	21 Participants n=107 Participants	43 Participants n=206 Participants
Age, Categorical >=65 years	3 Participants n=99 Participants	4 Participants n=107 Participants	7 Participants n=206 Participants
Sex: Female, Male Female	17 Participants n=99 Participants	12 Participants n=107 Participants	29 Participants n=206 Participants
Sex: Female, Male Male	8 Participants n=99 Participants	13 Participants n=107 Participants	21 Participants n=206 Participants
Region of Enrollment United States	25 participants n=99 Participants	25 participants n=107 Participants	50 participants n=206 Participants

PRIMARY outcome

Timeframe: Baseline and 24 weeks

Participants liver fat was measured at baseline and 24 weeks. This is the percentage change in liver fat assessed by MRI-PDFF and stratified by treatment group.

Outcome measures

Outcome measures
Measure	Placebo n=17 Participants Sitagliptin-matched placebo tablet	Active Drug n=24 Participants Sitagliptin 100 mg Sitagliptin
Percentage Change in Liver Fat Relative to Baseline Assessed by MRI-PDFF	13.9 percentage change in liver fat Standard Deviation 8.5	8.4 percentage change in liver fat Standard Deviation 11.6

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Population: All participants with AST measurements at baseline and 24 weeks

AST, measured in IU/L at baseline and 24 weeks

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants Sitagliptin-matched placebo tablet	Active Drug n=25 Participants Sitagliptin 100 mg Sitagliptin
AST, Aspartate Aminotransferase Baseline	28.5 IU/L Interval 19.0 to 37.0	28.0 IU/L Interval 24.0 to 39.0
AST, Aspartate Aminotransferase 24 weeks	23.5 IU/L Interval 19.0 to 30.0	27.0 IU/L Interval 22.0 to 42.0

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Population: All participants with ALT measurements at baseline and 24 weeks

ALT, measured in IU/L at baseline and 24 weeks

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants Sitagliptin-matched placebo tablet	Active Drug n=25 Participants Sitagliptin 100 mg Sitagliptin
ALT, Alanine Aminotransferase Baseline	40.0 IU/L Interval 22.0 to 51.0	43.0 IU/L Interval 28.0 to 54.0
ALT, Alanine Aminotransferase 24 weeks	28.5 IU/L Interval 20.0 to 50.0	34.0 IU/L Interval 27.0 to 56.0

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Population: All participants with LDL measurements at baseline and 24 weeks

LDL, measured in mg/dL at baseline and 24 weeks

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants Sitagliptin-matched placebo tablet	Active Drug n=25 Participants Sitagliptin 100 mg Sitagliptin
LDL, Low-density Lipoprotein Baseline	99.0 mg/dL Interval 72.0 to 134.0	100.0 mg/dL Interval 83.0 to 125.0
LDL, Low-density Lipoprotein 24 weeks	101.0 mg/dL Interval 76.0 to 131.0	98.0 mg/dL Interval 82.0 to 124.5

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Population: All participants with HOMA-IR calculated at baseline and 24 weeks

HOMA-IR, calculated as \[(glucose (mg/dL) X insulin (mg/dL)) / 405 \] at baseline and 24 weeks

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants Sitagliptin-matched placebo tablet	Active Drug n=25 Participants Sitagliptin 100 mg Sitagliptin
HOMA-IR, Homeostatic Model Assessment of Insulin Resistance Baseline	5.4 HOMA-IR score Interval 4.3 to 6.8	5.9 HOMA-IR score Interval 4.4 to 9.2
HOMA-IR, Homeostatic Model Assessment of Insulin Resistance 24 weeks	4.9 HOMA-IR score Interval 2.9 to 8.9	6.8 HOMA-IR score Interval 4.4 to 9.7

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Active Drug

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rohit Loomba, MD professor of Medicine

University of California, San Diego

Phone: 858-543-2230

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place