Trial Outcomes & Findings for Binge Eating Liraglutide Intervention (NCT NCT03279731)
NCT ID: NCT03279731
Last Updated: 2020-11-24
Results Overview
Change in objective binge episodes per week from randomization (week 0) to study end (week 17)
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
36 participants
Primary outcome timeframe
baseline and 17 weeks (or last observation carried forward)
Results posted on
2020-11-24
Participant Flow
Participants were recruited at university based medical school clinic setting. The first participant was randomized on September 29, 2017; the last participant completed participation on September 6, 2019. Note: 9 participants were censored from the trial due to an error in medication/placebo assignment by the Investigational Drug Service. As such, these 9 participants were not considered in any of the analyses presented, leaving 13 in the liraglutide and 14 in the placebo group.
Participants underwent a 2 week run in to assure that they continued to have binge episodes before being randomized to placebo or liraglutide 3.0 mg.
Participant milestones
| Measure |
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml
Pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg via subcutaneous injection. Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved. Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist.
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml: subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved.
|
Placebo
Pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg of placebo via subcutaneous injection. The placebo will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved.The inactive ingredients include: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection.
Placebo: subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). It is designed to be identical to the pen used for liraglutide (Saxenda). Placebo product inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
17
|
|
Overall Study
COMPLETED
|
13
|
14
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Binge Eating Liraglutide Intervention
Baseline characteristics by cohort
| Measure |
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml
n=13 Participants
Pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg via subcutaneous injection. Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved. Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist.
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml: subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved.
|
Placebo
n=14 Participants
Pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg of placebo via subcutaneous injection. The placebo will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved.The inactive ingredients include: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection.
Placebo: subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). It is designed to be identical to the pen used for liraglutide (Saxenda). Placebo product inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.4 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
42.1 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
44.2 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex/Gender, Customized
Male at birth
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female at birth
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
14 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
objective binge episodes per week
|
4.90 binge episodes/week
STANDARD_DEVIATION 0.69 • n=5 Participants
|
2.80 binge episodes/week
STANDARD_DEVIATION 0.67 • n=7 Participants
|
3.30 binge episodes/week
STANDARD_DEVIATION 2.13 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 17 weeks (or last observation carried forward)Change in objective binge episodes per week from randomization (week 0) to study end (week 17)
Outcome measures
| Measure |
Liraglutide
n=13 Participants
Participants randomized to liraglutide 3.0 mg/d
|
Placebo
n=14 Participants
Participants randomized to placebo
|
|---|---|---|
|
Binge Episodes
|
-3.97 objective binge episodes per week
Standard Deviation 0.56
|
-2.50 objective binge episodes per week
Standard Deviation .053
|
SECONDARY outcome
Timeframe: 13 to 17 weeksPopulation: Remission was calculated for completers who had data from weeks 13-17
the percentage of participants (completers) who have achieved remission from binge-eating (no binge episodes between weeks 13 - 17)
Outcome measures
| Measure |
Liraglutide
n=7 Participants
Participants randomized to liraglutide 3.0 mg/d
|
Placebo
n=8 Participants
Participants randomized to placebo
|
|---|---|---|
|
Remission From Binge-eating
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: week 17 (or last observation carried forward)week 17 rating on the interviewer-based Clinical Global Impression of Improvement (CGII) Scale for global assessment of BED symptoms The CGII includes the following rating scale: Compared to the patient's condition at baseline to the project \[prior to medication initiation\], this patient's condition is: 1 very much improved; 2 much improved; 3 improved; 4 no change; 5 worse; 6 much worse; 7 very much worse.
Outcome measures
| Measure |
Liraglutide
n=13 Participants
Participants randomized to liraglutide 3.0 mg/d
|
Placebo
n=14 Participants
Participants randomized to placebo
|
|---|---|---|
|
Assessment of Improvement of Binge Eating Symptoms
|
1.52 units on a scale
Standard Deviation .27
|
1.93 units on a scale
Standard Deviation .26
|
SECONDARY outcome
Timeframe: baseline and 17 weeks (or last observation carried forward)Population: Last Observation Carried Forward
changes in body weight
Outcome measures
| Measure |
Liraglutide
n=13 Participants
Participants randomized to liraglutide 3.0 mg/d
|
Placebo
n=14 Participants
Participants randomized to placebo
|
|---|---|---|
|
Change in Body Weight
|
-4.7 kg
Standard Deviation 0.83
|
-0.94 kg
Standard Deviation 0.73
|
Adverse Events
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml
n=19 participants at risk
Pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg via subcutaneous injection. Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved. Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist.
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml: subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved.
|
Placebo
n=17 participants at risk
Pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg of placebo via subcutaneous injection. The placebo will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved.The inactive ingredients include: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection.
Placebo: subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). It is designed to be identical to the pen used for liraglutide (Saxenda). Placebo product inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection
|
|---|---|---|
|
Gastrointestinal disorders
Hospitalization due to vomiting
|
5.3%
1/19 • Number of events 1 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
0.00%
0/17 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
|
Surgical and medical procedures
laparoscopic cholecystectomy
|
5.3%
1/19 • Number of events 1 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
0.00%
0/17 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
|
Gastrointestinal disorders
Ulcerative colitis flare
|
0.00%
0/19 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
5.9%
1/17 • Number of events 1 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
Other adverse events
| Measure |
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml
n=19 participants at risk
Pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg via subcutaneous injection. Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved. Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist.
Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml: subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved.
|
Placebo
n=17 participants at risk
Pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg of placebo via subcutaneous injection. The placebo will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved.The inactive ingredients include: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection.
Placebo: subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). It is designed to be identical to the pen used for liraglutide (Saxenda). Placebo product inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
26.3%
5/19 • Number of events 7 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
17.6%
3/17 • Number of events 3 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
|
Gastrointestinal disorders
diarrhea
|
26.3%
5/19 • Number of events 5 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
0.00%
0/17 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
|
General disorders
dry mouth
|
15.8%
3/19 • Number of events 3 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
0.00%
0/17 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
|
Infections and infestations
upper respiratory infection
|
10.5%
2/19 • Number of events 2 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
5.9%
1/17 • Number of events 1 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
|
Gastrointestinal disorders
indigestion
|
10.5%
2/19 • Number of events 2 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
11.8%
2/17 • Number of events 2 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
|
Cardiac disorders
tachycardua
|
15.8%
3/19 • Number of events 3 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
0.00%
0/17 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
|
Psychiatric disorders
suicidal ideation
|
5.3%
1/19 • Number of events 2 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
5.9%
1/17 • Number of events 1 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
|
General disorders
fatigue
|
0.00%
0/19 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
5.9%
1/17 • Number of events 1 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
|
Psychiatric disorders
depressive symptoms
|
0.00%
0/19 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
5.9%
1/17 • Number of events 1 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
|
Gastrointestinal disorders
gastroenteritis
|
10.5%
2/19 • Number of events 2 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
5.9%
1/17 • Number of events 1 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
|
Musculoskeletal and connective tissue disorders
joint pain
|
5.3%
1/19 • Number of events 1 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
11.8%
2/17 • Number of events 2 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
|
Renal and urinary disorders
UTI
|
0.00%
0/19 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
5.9%
1/17 • Number of events 1 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
|
Gastrointestinal disorders
constipation
|
5.3%
1/19 • Number of events 1 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
0.00%
0/17 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
|
Ear and labyrinth disorders
bilateral otitis media
|
5.3%
1/19 • Number of events 1 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
0.00%
0/17 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
|
Infections and infestations
strep throat
|
0.00%
0/19 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
5.9%
1/17 • Number of events 1 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
|
Infections and infestations
flu
|
5.3%
1/19 • Number of events 1 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
0.00%
0/17 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
|
Eye disorders
sty
|
0.00%
0/19 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
5.9%
1/17 • Number of events 1 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
|
Gastrointestinal disorders
cholitis flare
|
0.00%
0/19 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
5.9%
1/17 • Number of events 1 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
|
Psychiatric disorders
insomnia
|
0.00%
0/19 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
5.9%
1/17 • Number of events 1 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
|
General disorders
headache
|
5.3%
1/19 • Number of events 1 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
0.00%
0/17 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
|
Pregnancy, puerperium and perinatal conditions
vaginal bleeding
|
5.3%
1/19 • Number of events 1 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
0.00%
0/17 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
|
General disorders
allergic rhinitis
|
0.00%
0/19 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
5.9%
1/17 • Number of events 1 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
|
Infections and infestations
common cold
|
0.00%
0/19 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
5.9%
1/17 • Number of events 1 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
|
General disorders
toothache
|
0.00%
0/19 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
5.9%
1/17 • Number of events 1 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
|
General disorders
worsening edema
|
0.00%
0/19 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
5.9%
1/17 • Number of events 1 • from the beginning to the end of the 17 week trial
Adverse event data collection occurred at each study visit.
|
Additional Information
Kelly C. Allison, PhD
Perelman School of Medicine at the University of Pennsylvania
Phone: 2158982823
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place