Trial Outcomes & Findings for Trial of Leptin Administration After Roux-en-Y Gastric Bypass (NCT NCT00710814)

Last Updated: 2015-11-16

Results Overview

For the Leptin Intervention, 16 week values were compared to baseline for those who received Leptin in the first period, and 32 week values were compared to 16 week values in those who received Leptin in the second period. For the Placebo Intervention, 16 week values were compared to baseline for those who received Placebo in the first period, and 32 week values were compared to 16 week values in those who received Placebo in the second period.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

31 participants

Primary outcome timeframe

0 weeks, 16 weeks and 32 weeks

Results posted on

2015-11-16

Participant Flow

Participant milestones

Participant milestones
Measure	Leptin-Placebo Leptin self-administered subcutaneously twice each day for 16 weeks, then Placebo for 16 weeks.	Placebo-Leptin Placebo self-administered subcutaneously twice each day for 16 weeks, then Leptin for 16 weeks.
Overall Study STARTED	15	16
Overall Study COMPLETED	14	13
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial of Leptin Administration After Roux-en-Y Gastric Bypass

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Leptin - Placebo n=15 Participants Leptin self-administered subcutaneously twice each day for 16 weeks, then Placebo for 16 weeks.	Placebo - Leptin n=16 Participants Placebo self-administered subcutaneously twice each day for 16 weeks, then Leptin for 16 weeks.	Total n=31 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	15 Participants n=5 Participants	16 Participants n=7 Participants	31 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	50.93 Years n=5 Participants	42.76 Years n=7 Participants	47 Years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	16 participants n=7 Participants	31 participants n=5 Participants

PRIMARY outcome

Timeframe: 0 weeks, 16 weeks and 32 weeks

Outcome measures

Outcome measures
Measure	Leptin Intervention n=27 Participants Participants in the Leptin-Placebo arm were randomized to first receive Leptin for the first 16 weeks, and participants in the Placebo-Leptin arm were randomized to receive Leptin for the second 16 weeks. Both Leptin and placebo were self-administered subcutaneously twice per day.	Placebo Intervention n=27 Participants Participants in the Placebo-Leptin arm were randomized to receive placebo for the first 16 weeks, and participants in the Leptin-Placebo arm were randomized to receive placebo for the second 16 weeks. Both Leptin and placebo were self-administered subcutaneously twice per day.
Weight Change (in kg.) After Each Intervention	-0.39 kg weight change Interval -1.08 to 0.3	0.02 kg weight change Interval -1.47 to 1.51

Adverse Events

Leptin Intervention

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Placebo Intervention

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Leptin Intervention n=27 participants at risk This group "Leptin Intervention" inlcudes the adverse events that were observed while the subjects in either crossover arms when they received Leptin only.	Placebo Intervention n=27 participants at risk This group "Placebo Intervention" inlcudes the adverse events that were observed while the subjects in either crossover arms when they received Placebo only.
Skin and subcutaneous tissue disorders Itchiness and bruising at injection site	33.3% 9/27 • Number of events 9 • 32 Weeks	0.00% 0/27 • 32 Weeks
Skin and subcutaneous tissue disorders Bruising at injection site	0.00% 0/27 • 32 Weeks	14.8% 4/27 • Number of events 4 • 32 Weeks

Additional Information

Judith Korner, M.D., PhD

Columbia University

Phone: 2123053725

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place