Trial Outcomes & Findings for Liraglutide (Saxenda(R)) in Adolescents With Obesity After Sleeve Gastrectomy (NCT NCT04883346)

Last Updated: 2024-11-20

Results Overview

The change in BMI (kg/m2) measured from the baseline visit to the week 16 visit was used to inform a power calculation for a subsequent randomized controlled trial, assuming no change in BMI for the placebo group and the change in BMI that was found in this study at 16 weeks for the liraglutide group. There is no statistical analysis associated with this result.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

16 weeks

Results posted on

2024-11-20

Participant Flow

A total of 43 participants were screened in person. A total of 34 participants were found eligible and prescribed liraglutide

Participant milestones

Participant milestones
Measure	Liraglutide Treated with Liraglutide Liraglutide: Liraglutide by subcutaneous injection administered daily. Dose was initiated at 0.6mg per day and increased to a maximum of 3.0 mg per day as tolerated.
Overall Study STARTED	34
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Liraglutide (Saxenda(R)) in Adolescents With Obesity After Sleeve Gastrectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Liraglutide n=34 Participants Treated with Liraglutide Liraglutide: Liraglutide by subcutaneous injection administered daily. Dose was initiated at 0.6mg per day and increased to a maximum of 3.0 mg per day as tolerated.
Age, Continuous	17.97 years STANDARD_DEVIATION 2.0 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	22 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants
Suboptimal response to sleeve gastrectomy (<20% BMI rediction at BMI nadir	8 Participants n=5 Participants
BMI	41.2 kg/m2 STANDARD_DEVIATION 7.7 • n=5 Participants
Body Mass Index Z-score	2.70 Z-score STANDARD_DEVIATION 0.95 • n=5 Participants
Weight	114.9 kg STANDARD_DEVIATION 21.0 • n=5 Participants
Years after vertical sleeve gastrectomy was performed	2.12 years STANDARD_DEVIATION 1.13 • n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: Intent to treat sample

Outcome measures

Outcome measures
Measure	Liraglutide n=34 Participants Treated with Liraglutide Liraglutide: Liraglutide by subcutaneous injection administered daily. Dose will be initiated at 0.6mg per day and increased to a maximum of 3.0 mg per day as tolerated.
Cohen's d (the Standardized Mean Difference)	2.145 cohen's d Interval 1.72 to 2.55

SECONDARY outcome

Timeframe: 16 weeks

Population: Intent to treat analysis using last observation carried forward. Note one participant did not have data at baseline.

Change in fat mass (in kg) from baseline to the week 16 visit using the full intention to treat sample with last observation carried forward if data were missing

Outcome measures

Outcome measures
Measure	Liraglutide n=33 Participants Treated with Liraglutide Liraglutide: Liraglutide by subcutaneous injection administered daily. Dose will be initiated at 0.6mg per day and increased to a maximum of 3.0 mg per day as tolerated.
Change in Fat Mass	-3.2 kg Standard Deviation 3.4

SECONDARY outcome

Timeframe: 16 weeks

Population: Intent to treat analysis using last observation carried forward

The change in BMI (kg/m2) from baseline to the week 16 visit using the full intention to treat sample with last observation carried forward if data were missing

Outcome measures

Outcome measures
Measure	Liraglutide n=34 Participants Treated with Liraglutide Liraglutide: Liraglutide by subcutaneous injection administered daily. Dose will be initiated at 0.6mg per day and increased to a maximum of 3.0 mg per day as tolerated.
Change in BMI	-1.7 kg/m2 Standard Deviation 1.5

SECONDARY outcome

Timeframe: 16 weeks

Population: Intention to treat sample with last observation carried forward

The change in Body Mass Index Z-score (standard deviation score for age and sex based on US Centers for Disease Control Standards from baseline to the week 16 visit using the full intention to treat sample with last observation carried forward if data were missing. Please see description for Body Mass Index Z-score in baseline information section for more details on calculation of Body Mass Index Z-score.

Outcome measures

Outcome measures
Measure	Liraglutide n=34 Participants Treated with Liraglutide Liraglutide: Liraglutide by subcutaneous injection administered daily. Dose will be initiated at 0.6mg per day and increased to a maximum of 3.0 mg per day as tolerated.
Change in Body Mass Index Z-score	-0.2 Z-score Standard Deviation 0.1

SECONDARY outcome

Timeframe: 16 weeks

Population: Intent to treat sample with last observation carried forward

The change in body weight (kg) from baseline to the week 16 visit using the full intention to treat sample with last observation carried forward if data were missing

Outcome measures

Outcome measures
Measure	Liraglutide n=34 Participants Treated with Liraglutide Liraglutide: Liraglutide by subcutaneous injection administered daily. Dose will be initiated at 0.6mg per day and increased to a maximum of 3.0 mg per day as tolerated.
Change in Body Weight	-4.4 kg Standard Deviation 4.4

Adverse Events

Liraglutide

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Liraglutide n=34 participants at risk Treated with Liraglutide Liraglutide: Liraglutide by subcutaneous injection administered daily. Dose was initiated at 0.6mg per day and increased to a maximum of 3.0 mg per day as tolerated.
Gastrointestinal disorders Dyspepsia	23.5% 8/34 • Number of events 16 • 16 weeks Adverse events were collected using a detailed checklist for commonly observed adverse events with liraglutide treatment, supplemented by reports from clinician interviews.
Gastrointestinal disorders Constipation	11.8% 4/34 • Number of events 4 • 16 weeks Adverse events were collected using a detailed checklist for commonly observed adverse events with liraglutide treatment, supplemented by reports from clinician interviews.
General disorders Fatigue	11.8% 4/34 • Number of events 8 • 16 weeks Adverse events were collected using a detailed checklist for commonly observed adverse events with liraglutide treatment, supplemented by reports from clinician interviews.
General disorders Dizziness	8.8% 3/34 • Number of events 6 • 16 weeks Adverse events were collected using a detailed checklist for commonly observed adverse events with liraglutide treatment, supplemented by reports from clinician interviews.

Additional Information

Jack A. Yanovski, MD, PhD

Section on Growth and Obesity, NICHD, NIH

Phone: 301-496-0858

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place