Trial Outcomes & Findings for Leptin in the Maintenance of Reduced Body Weight (NCT NCT01155180)

Results Overview

Body weight was recorded to the nearest 0.1 kg at baseline and at 6 months after randomization. Then the percentage change was calculated.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

baseline and 6 months after randomization

Results posted on

2017-04-07

Participant Flow

Subjects who have successfully completed 1of the 4 hospital-based participating weight loss programs (Boston Medical Center, Tufts Medical Center, Massachusetts General Hospital, Beth Israel Deaconess Medical Center (BIDMC)-Joslin Center) \& have achieved a \>8% (average 10%, range 8-14%) weight loss will be invited to participate in the study.

Participant milestones

Participant milestones
Measure	Leptin We will start the leptin at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women Leptin: Hormone - daily self injections for 6 months	Placebo We will start the placebo at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women Placebo: Placebo
Overall Study STARTED	18	6
Overall Study COMPLETED	18	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Leptin in the Maintenance of Reduced Body Weight

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Leptin n=18 Participants We will start the leptin at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women Leptin: Hormone - daily self injections for 6 months	Placebo n=6 Participants We will start the placebo at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women Placebo: Placebo-daily self injections for 6 months	Total n=24 Participants Total of all reporting groups
Age, Customized years	32 years n=99 Participants	45.5 years n=107 Participants	45 years n=206 Participants
Sex: Female, Male Female	9 Participants n=99 Participants	6 Participants n=107 Participants	15 Participants n=206 Participants
Sex: Female, Male Male	9 Participants n=99 Participants	0 Participants n=107 Participants	9 Participants n=206 Participants
Region of Enrollment United States	18 participants n=99 Participants	6 participants n=107 Participants	24 participants n=206 Participants

PRIMARY outcome

Timeframe: baseline and 6 months after randomization

Body weight was recorded to the nearest 0.1 kg at baseline and at 6 months after randomization. Then the percentage change was calculated.

Outcome measures

Outcome measures
Measure	Leptin n=18 Participants We will start the leptin at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women Leptin: Hormone - daily self injections for 6 months	Placebo n=6 Participants We will start the placebo at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women Placebo: Placebo
Percent Change From Baseline in Body Weight at 6 Months	10.2 percentage change Standard Error 1.7	12.7 percentage change Standard Error 1.2

Adverse Events

Leptin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Dr. Christos Manztoros

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