Trial Outcomes & Findings for Liraglutide in Obesity and Diabetes: Identification of CNS Targets Using fMRI (NCT NCT01562678)

Last Updated: 2017-05-31

Results Overview

Effect size (region of interest z-scores, derived from z-maps of the brain) shown below is the difference in parietal cortex activation to highly desirable (high fat or high calorie, e.g. cakes, pies, fries) versus less desirable (low fat or low calorie, e.g. vegetables, fruits) food cues for each treatment condition (liraglutide or placebo) at the end of the treatment period.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

28 participants

Primary outcome timeframe

18 days of Liraglutide or placebo treatment

Results posted on

2017-05-31

Participant Flow

Participant milestones

Participant milestones
Measure	Liraglutide First, Then Placebo 14 participants were randomized to receive Liraglutide and then were cross-overed to receive placebo	Placebo First, Then Liraglutide 14 participants were randomized to receive Placebo and then were cross-overed to receive Liraglutide
Overall Study STARTED	14	14
Overall Study COMPLETED	8	12
Overall Study NOT COMPLETED	6	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Liraglutide in Obesity and Diabetes: Identification of CNS Targets Using fMRI

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Liraglutide First, Then Placebo n=14 Participants 14 participants were randomized to receive Liraglutide and then were cross-overed to receive placebo	Placebo First, Then Liraglutide n=14 Participants 14 participants were randomized to receive Placebo and then were cross-overed to receive Liraglutide	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	52.5 years STANDARD_DEVIATION 10.5 • n=5 Participants	52.5 years STANDARD_DEVIATION 10.5 • n=7 Participants	52.5 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	14 participants n=7 Participants	28 participants n=5 Participants

PRIMARY outcome

Timeframe: 18 days of Liraglutide or placebo treatment

Population: Participants with incomplete MRI scans were excluded from the analysis.

Outcome measures

Outcome measures
Measure	Liraglutide n=18 Participants Liraglutide: In the experimental phase of this randomized, placebo-controlled, cross-over, double-blinded study to assess the effects of liraglutide, subjects started the treatment with a dose of 0.6 mg for the first week, then 1.2 mg for the second week and 1.8 mg for 3 days in the third week. This sequence may have occurred for their first phase or second phase (placebo was the other phase).	Placebo n=18 Participants Placebo: In the placebo phase of this randomized, placebo controlled, cross-over, double-blinded study to assess the effects of liraglutide, subjects will self-inject placebo once per day for 18 days. Participants had this first or second (liraglutide was the other phase).
Change Between Highly Desirable vs. Less Desirable Food Cues in the Effect Size of Cortical Activation During Food Visualization	-0.42 z-scores of activation in cortex Standard Error 0.27	0.53 z-scores of activation in cortex Standard Error 0.37

Adverse Events

Liraglutide

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Liraglutide n=28 participants at risk 14 participants were randomized to receive Liraglutide and then were cross-overed to receive placebo and 14 participants were randomized to receive Placebo and then were cross-overed to receive Liraglutide	Placebo n=28 participants at risk 14 participants were randomized to receive Placebo and then were cross-overed to receive Liraglutide and 14 participants were randomized to receive Liraglutide and then were cross-overed to receive placebo
Gastrointestinal disorders Nausea	25.0% 7/28 • Number of events 7 • Throughout the study (4 visits in each phase of liraglutide and placebo). There was a systematic assessment of adverse events at each visit (Days 0, 7, 14, and 17) by an MD who asked detailed medical questions and did a physical exam, plus through the use of visual analog scales administered 3 times per day where participants answered on a 10cm line questions such as "How nauseous do you feel right now?"	25.0% 7/28 • Number of events 7 • Throughout the study (4 visits in each phase of liraglutide and placebo). There was a systematic assessment of adverse events at each visit (Days 0, 7, 14, and 17) by an MD who asked detailed medical questions and did a physical exam, plus through the use of visual analog scales administered 3 times per day where participants answered on a 10cm line questions such as "How nauseous do you feel right now?"

Additional Information

Dr. Christos Mantzoros

Beth Israel Deaconess Medical Center

Phone: 617-667- 8630

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place